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Enforcement Report - Week of August 8, 2012

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Biologics Devices Drugs Food / Cosmetics Veterinary

Class I Drugs Event

Event ID	61108
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	02-Dec-11
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Eagle Pharmaceuticals Inc.
City	Woodcliff Lake
State	NJ
Country	US
Distribution Pattern	New Jersey

Associated Products

Product Description	Argatroban Injection 50 mg per 50ml (1 mg per ml) For Intravenous Infusion Only, a) Single Use Vial (NDC 42367-203-07), b) 10 Single Use Vials(NDC 42367-203-84), Rx Only, Manufactured by: Cipla LTD, India, Manufactured for: Eagle Pharmaceuticals, Inc. Woodcliff Lake, NJ 07677 USA, Marketed by: The Medicines Company, Parsippany, NJ 07054 USA
Code Info	Lot #V10189, Lot #V10191, Lot #V10194, Exp 01/13; Lot #V10223; Exp 02/13
Classification	Class I
Reason for Recall	A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a single vial from Lot V10194. Additional small visible particles consisting of fibers were identified.
Product Quantity	19,660 vials
Recall Number	D-1429-2012

Class I Devices Event

Event ID	61247
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	14-Feb-12
Initial Firm Notification of Consignee or Public	Visit

Recalling Firm	Smiths Medical ASD, Inc.
City	Saint Paul
State	MN
Country	US
Distribution Pattern	Worldwide Distribution -- USA, including the state of CA, and country of Canada.

Associated Products

Product Description	Smiths Medical, Medfusion® Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.
Code Info	2000245 2000246 2000247 2000248 2000249 2000250 2000251 2000252 2000253 2000254 2000255 2000256 2000257 2000258 2000259 2000260 2000261 2000262 2000263 2000264 2000265 2000266 2000267 2000268 2000269 2000270 2000271 2000272 2000273 2000274 2000275 2000276 2000277 2000278 2000279 2000280 2000281 2000282 2000283 2000284 2000285 2000286 2000287 2000288 2000289 2000290 2000291 2000292 2000293 2000294 2000295 2000296 2000297 2000298 2000299 2000300 2000301 2000302 2000303 2000304 2000305 2000307 2000308 2000309 2000310 2000311 2000312 2000313 2000314 2000315 2000316 2000317 2000318 2000319 2000320 2000321 2000322 2000323 2000324 2000325 2000326 2000327 2000328 2000329 2000330 2000331 2000332 2000333 2000334 2000336 2000337 2000338 2000339 2000340 2000341 2000342 2000343 2000344 2000345 2000346 2000347 2000348 2000349 2000350 2000351 2000352 2000353 2000354 2000355 2000356 2000357 2000358 2000359 2000360 2000361 2000362 2000363 2000364 2000365 2000366 2000367 2000368 2000369 2000370 2000371 2000372 2000373 2000374 2000375 2000376 2000377 2000378 2000379 2000380 2000381 2000382 2000383 2000384 2000385 2000386 2000387 2000388 2000389 2000390 2000391 2000392 2000393 2000394 2000395 2000396 2000397 2000398 2000399 2000400 2000401 2000402 2000403 2000404 2000405 2000406 2000408 2000409 2000412 2000413 2000414 2000415 2000416 2000417 2000418 2000419 2000422 2000423 2000425 2000426 2000428 2000430 2000431 2000433 2000434 2000436 2000437 2000438 2000439 2000440 2000441 2000442 2000443 2000445 2000446 2000447 2000448 2000449 2000450 2000451 2000452 2000453 2000454 2000455 2000456 2000457 2000458 2000459 2000460 2000461 2000462 2000463 2000464 2000465 2000466 2000467 2000468 2000469 2000470 2000471 2000472 2000473 2000474 2000475 2000476 2000477 2000478 2000479 2000480 2000481 2000482 2000483 2000484 2000485 2000486 2000487 2000488 2000489 2000490 2000491 2000492 2000493 2000494 2000495 2000496 2000497 2000498 2000499 2000500 2000501 2000502 2000503 2000504 2000505 2000506 2000507 2000508 2000509 2000510 2000511 2000512 2000513 2000514 2000515 2000516 2000517 2000518 2000519 2000520 2000521 2000522 2000523 2000524 2000525 2000526 2000527 2000528 2000529 2000530 2000531 2000532 2000533 2000534 2000535 2000536 2000537 2000538 2000539 2000540 2000541 2000542 2000543 2000544 2000545 2000546 2000547 2000548 2000549 2000550 2000551 2000552 2000553 2000554 2000555 2000556 2000557 2000558 2000559 2000560 2000561 2000562 2000563 2000564 2000565 2000566 2000567 2000568 2000569 2000570 2000571 2000572 2000573 2000574 2000575 2000576 2000577 2000578 2000579 2000580 2000581 2000582 2000583 2000584 2002080 2002081 2002082 2002083 2002084 2002085 2002086 2002087 2002089 2002090 2002091 2002092 2002093 2002094 2002095 2002096 2002097 2002098 2002099 2002100 2002101 2002102 2002103 2002104 2002105 2002106 2002107 2002108 2002109 2002110 2002111 2002112 2002113 2002114 2002115 2002116 2002117 2002118 2002119 2002120 2002121 2002122 2002123 2002124 2002125 2002128 2002129 2002130 2002131 2002132 2002133 2002134 2002135 2002136 2002137 2002138 2002139 2002140 2002141 2002142 2002143 2002144 2002145 2002146 2002147 2002148 2002149 2002150 2002151 2002152 2002153 2002154 2002155 2002156 2002157 2002158 2002159 2002160 2002161 2002162 2002163 2002164 2002165 2002166 2002167 2002168 2002169 2002170 2002171 2002173 2002174 2002175 2002176 2002177 2002178 2002179 2002180 2002181 2002182 2002183 2002184 2002185 2002186 2002187 2002188 2002189 2002190 2002204 2002205 2002206 2002207 2002208 2002209 2002210 2002211 2002212 2002213 2002214 2002215 2002217 2002218 2002219 2002220 2002221 2002222 2002223 2002224 2002225 2002226 2002227 2002228 2002229 2002230 2002231 2002232 2002233 2002234 2002235 2002236 2002237 2002238 2002239 2002240 2002242 2002244 2002245 2002246 2002247 2002248 2002249 2002250 2002251 2002252 2002254 2002256 2002257 2002258 2002259 2002260 2002261 2002262 2002263 2002264 2002265 2002267 2002268 2002269 2002270 2002271 2002273 2002274 2002275 2002276 2002277 2002278 2002279 2002280 2002281 2002282 2002284 2002285 2002286 2002287 2002288 2002289 2002290 2002291 2002292 2002293 2002294 2002295 2002296 2002297 2002298 2002299 2002300 2002301 2002302 2002303 2002304 2002306 2002308 2002309 2002310 2002311 2002312 2002313 2002314 2002315 2002316 2002317 2002318 2002319 2002320 2002321 2002322 2002323 2002325 2002326 2002327 2002328 2002329 2002330 2002331 2002332 2002333 2002334 2002335 2002336 2002337 2002338 2002340 2002341 2002342 2002343 2002345 2002346 2002348 2002349 2002350 2002351 2002352 2002353 2002354 2002357 2002358 2002359 2002360 2002371 2002372 2002373 2002374 2002375 2002376 2002377 2002563 2002564 2002565 2002566 2002567 2002568 2002569 2002570 2002571 2002572 2002573 2002574 2002575 2002576 2002577 2002578 2004514 2004528 2004531 2004536 2004537 2004538 2004541 2004542, and 2004550.
Classification	Class I
Reason for Recall	Smiths Medical has identified a software anomaly in the Medfusion 4000 Syringe Infusion Pump that causes a device history log corruption and triggers a Watchdog Fail-Safe alarm. When the device exhibits this failure mode, visual and audible alarms will sound and the device ceases operation.
Product Quantity	607 pumps (257 USA, 350 Canada)
Recall Number	Z-2107-2012

Class I Veterinary Event

Event ID	61507
Status	Ongoing
Product Type	Veterinary
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	29-Mar-12
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	Hartz Mountain Corp.
City	Secaucus
State	NJ
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Wardley Advanced Nutrition Perfect Protein Tropical Fish Flake Food Net Wt. 1 OZ. (28 g) UPC 0-43324-00591-7 Made in the USA by The Hartz Mountain Corporation Secaucus, New Jersey 07094
Code Info	Lot PP34911, PP34912, PP35011, and PP35012
Classification	Class I
Reason for Recall	Fish food may be contaminated with Salmonella
Product Quantity	7,056 containers
Recall Number	V-191-2012

Class I Veterinary Event

Event ID	61748
Status	Ongoing
Product Type	Veterinary
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	30-Apr-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Central Garden & Pet Company
City
State	AZ
Country	US
Distribution Pattern	Nationwide including Puerto Rico. OUS to include: Abu Dhabi, Argentina, Australia, Brazil, Brunei, Canada, China, Costa Rica, Czechoslovakia, Dominican Republic, Dutch Antilles, Finland, Germany, Great Britain, Greece, Guam, Honduras, Hong Kong, Ireland, Israel, Japan, Korea, Kuwait, Mexico, New Zealand, Pakistan, Panama, Russia, Singapore, South Africa, Sweden, Thailand, and Trinidad.

Associated Products

Product Description	Kaytee Forti-Diet Pro Health Mouse, Rat & Hamster, with DHA Omega-3 supports Heart, Brain & Visual Functions. Nutritionally Enhanced Daily Diet for a long, happier, healthier life. Packaged into the following sizes and UPC codes. - 3lb (1.36 kg), UPC 71859-99994, - 5lb. (2.27kg) UPC 71859-00001; - 25 lb. (11.34 kg) UPC 71859-99995; and - 25 lb bags for use within Petco stores UPC 71859-00000. Manufactured by: Kaytee Products, Inc., Chilton, WI 53014 USA.
Code Info	Best Before Codes: 30 Mar 2013 (25 lb - Petco stores only), 31 Mar 2013 (25 lb), 31 Mar 2013 K63 (6/3 lb), and 03 Apr 2013 K61 (6/5 lb)
Classification	Class I
Reason for Recall	Kaytee Pet Products is recalling a single manufacturing batch of Kaytee Forti-Diet Pro Health Mouse, Rat and Hamster due to possible contamination with Salmonella
Product Quantity	27,213
Recall Number	V-193-2012

Class I Veterinary Event

Event ID	61806
Status	Ongoing
Product Type	Veterinary
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	04-May-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Wellpet Llc
City	Tewksbury
State	MA
Country	US
Distribution Pattern	Nationwide Canada

Associated Products

Product Description	Wellness Complete Health Super5Mix Large Breed Puppy, packaged in: 15 lb. and 30 lb. bags and 5 oz. sample bags Product Code: 89591 UPC: 4 00 76344 89591 4 Super5Mix Large Breed Puppy 12/5oz;. Product Code: 89114 UPC: 0 76344 89114 7 Super5Mix Large Breed Puppy 15 lb.; Product Code: 89115 UPC: 0 76344 89115 4 Super5Mix Large Breed Puppy 30 lb.
Code Info	Best by dates of JAN 9 2013 through JAN 11 2013.
Classification	Class I
Reason for Recall	Product maybe potentially contaminated with salmonella (manufactured by Diamond Pet Foods)
Product Quantity	10,308 units
Recall Number	V-192-2012

Class I Food/Cosmetics Event

Event ID	62608
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	18-Jul-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	The Wright Group dba Wright Enrichment, Inc.
City	Crowley
State	LA
Country	US
Distribution Pattern	IN

Associated Products

Product Description	WE-24541 Vit/Min Premix Toddler (1-4 yr old) w/o DHA*ARA, NET WEIGHT 22.68 KG
Code Info	LOT NUMBER: 61104094
Classification	Class I
Reason for Recall	The product contains Galactooliosaccharide which was recalled due to possible salmonella contamination.
Product Quantity	136.077 KGS
Recall Number	f-1812-2012

Class I Food/Cosmetics Event

Event ID	62666
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	24-Jul-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	CHETAK SAN FRANCISCO LLC.
City	Union City
State	CA
Country	US
Distribution Pattern	Northern CA only

Associated Products

Product Description	Crispy Just Baked Punjabi Cookies sold in 800 gr clamshell packages. Manufactured by : TWI Foods, Inc., Mississauga, ON, Canada.
Code Info	UPC 6 27265 00152 0
Classification	Class I
Reason for Recall	FDA was notified of a recall by CFIA for Punjabi Cookies manufactured by TWI Foods, Canada that may not declare milk as an ingredient.
Product Quantity	xx
Recall Number	F-1816-2012

Class II Devices Event

Event ID	33854
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Jun-12
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	Advanced Sterilization Products
City	Irvine
State	CA
Country	US
Distribution Pattern	Worldwide Distribution - USA (nationwide)

Associated Products

Product Description	STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part of STERRAD System Validation kits and STERRAD test packs. The STERRAD CYCLESURE 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
Code Info	Lot# 002127, 003127, 005127, 006127, 007127, 008127, 009127, 010127, 011128, 012127, 013127, 014127, 015127, 016127, 018127, 019127, 020127, 021127, 023127, 024127, 025127, 026127, 027127, 028127, 030127, 031127, 032127, 033127, 034127, 035127, 036127, 037127, 038121, 038127 039127, 040127, 041121, 042127, 043127, 044127, 045121, 045127, 046127, 047127, 048127, 049127, 052127, 053121, 053127, 054127, 055121, 056127, 057127, 058127, 059127, 060127, 061127, 062121, 062127, 063127, 064127, 065127, 067127, 068127, 069121, 069127, 070127, 071127, 072127, 073127, 074127, 076121, 077127, 078127, 078128, 079127, 081127, 082127, 084127, 085127, 086121, 086127, 087127, 089127, 090127, 092127, 093121, 094127, 095127, 100121, 100127, 101127, 102127, 104127, 107121, 107127, 107128, 109127, 109128, 110127, 111127, 114121, 114127, 118127, 121121, 121127, 123127, 124127, 125127, 128121, 128127, 129127, 130127, 131127, 132127, 135121, 135127, 136127, 137127, 138127, 139127, 142121, 142127, 143127, 144127, 145127, 146127, 150121, 150127, 151127, 152127, 152128,156127, 157127, 158127, 159127, 160127, 163127, 164127,165127, 339117, 340117, 341117, 342117, 343117, 344117, 345117, 346117, 347117, 348117, 349117, 350117, 351117, 352117, 353117, 354117, 355117, 357117, 360117, 362117, 363117, 364117.
Classification	Class II
Reason for Recall	Advanced Sterilization Products (ASP) is recalling certain lots of the STERRAD CYCLESURE 24 Biological Indicator (BI) product because it does not have adequate data to support the entire duration of the product's labeled shelf-life.
Product Quantity	38,693 units
Recall Number	Z-2100-2012

Class II Biologics Event

Event ID	42130
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Apr-06
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Northern California Community Blood Bank
City	Eureka
State	CA
Country	US
Distribution Pattern	CA, NJ, OH, TN

Associated Products

Product Description	Red Blood Cells
Code Info	4509212, 4509442, 4509478, 4509605, 4509696, 4509805, 4510024, 4510090, 4510106, 4510132, 4510164, 4510177, 4510447, 4510488, 4510588, 4510940, 4511365, 4511467, 4511575, 4511757, 4511817, 4512262, 4512463, 4512867, 4512909, 4513438, 4513646, 4513777, 4514154, 4514814, 4515587, 4515632, 4518110, 4520848, 5508255, 5508770, 5508851, 5509004, 5509487, 5509648, 5509928, 5510214, 5510239, 5510915, 5511767, 5511838, 5512680, 4517732, 4526960, 4534465, 4536300, 5519447, 4505205, 4505609, 4506269, 4506432, 4507505, 4507712, 4508580, 5502890, 5503010, 5503070, 5503368, 5503796, 5503926, 5505119, 5505217, 5505534, 5505623, 5505877, 5505996, 5506299, 5506349, 5506350, 5506581, 5506839, 5506852, 5507042, 5507782, 5507898, 5508055, 5508223, 5508677, 5508737
Classification	Class II
Reason for Recall	Blood products, collected from donors whose confirmatory syphilis testing was invalid, were distributed.
Product Quantity	84
Recall Number	B-1776-12

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	5523111, 5523111, 4509534, 4512975, 4515077, 4515182, 4515903, 4516052, 4516095, 4516161, 4516568, 4516729, 4519211, 4519255, 4519381, 4519587, 4519812, 4520674, 5512187, 5512343, 5512542, 5513003, 5513120, 5513141, 5515307, 5515497, 5515980, 5516634, 5516643, 5516647, 5517146, 5517324, 4503210, 4517361, 4517486, 4521445, 4524499, 4524530, 4524695, 4525274, 4525392, 4525894, 4526651, 4526750, 4527024, 4527032, 4527375, 4527402, 4527735, 4527793, 4528165, 4528210, 4528318, 4528427, 4528621, 4528674, 4528756, 4528771, 4529623, 4529759, 4530146, 4530170, 4530176, 4530660, 4531509, 4531960, 4532232, 4532297, 4533447, 4533528, 4533547, 4534603, 4535112, 4536584, 4536744, 4538230, 4538258, 4538687, 4539147, 4540392, 4540707, 4540746, 4541404, 4543435, 5514406, 5517736, 5518206, 5518212, 5518981, 5519879, 5519882, 5520083, 5520339, 5520755, 5521289, 5522042, 5522874, 5523087, 5523191, 5523319, 5523379, 5523846, 5524053, 5524079, 5524100, 5524837, 5525075, 5525714, 5526462, 5526510, 5527024, 5527507, 5527588, 5527751, 5528692, 5528942, 5529724, 5531070, 6501366, 6501857, 6502434, 6503078, 6503108, 6503146, 6503147, 6503167, 6503444, 6504576
Classification	Class II
Reason for Recall	Blood products, collected from donors whose confirmatory syphilis testing was invalid, were distributed.
Product Quantity	128
Recall Number	B-1777-12

Product Description	Cryoprecipitated AHF
Code Info	4503210, 4507505, 4512262, 4512867, 4514814, 4515182, 4515587, 4518110, 4519381, 4521445, 4524695, 4526651, 4527024, 4527375, 4527402, 4527793, 4528427, 4528621, 4528674, 4528756, 4528771, 4529623, 4529759, 4530146, 4530660, 4531509, 4533447, 4533528, 4533547, 4534603, 4535112, 4536300, 4536584, 4536744, 4538230, 4538258, 4538687, 4539147, 4540392, 4540707, 4540746, 4541404, 4541841, 5515497, 5516643, 5516647, 5517146, 5517324, 5519447, 5520083, 5523075, 5523087, 5523111, 5523319, 5523379, 5524079, 5526510, 5528942, 5529724, 5531070, 6501366, 6501857, 6503167, 6504576, 4507936, 4512975, 5512343
Classification	Class II
Reason for Recall	Blood products, collected from donors whose confirmatory syphilis testing was invalid, were distributed.
Product Quantity	67
Recall Number	B-1778-12

Product Description	Plasma
Code Info	4505652, 4507702
Classification	Class II
Reason for Recall	Blood products, collected from donors whose confirmatory syphilis testing was invalid, were distributed.
Product Quantity	2
Recall Number	B-1779-12

Product Description	Whole Blood
Code Info	4505924, 4527043, 4527164, 4515076
Classification	Class II
Reason for Recall	Blood products, collected from donors whose confirmatory syphilis testing was invalid, were distributed.
Product Quantity	4
Recall Number	B-1780-12

Product Description	Fresh Frozen Plasma
Code Info	4507646, 4508628, 4510588, 4511817, 4513438, 4516568, 4520674, 4524499, 4524530, 4527032, 4528165, 4528210, 4528318, 4530176, 4531960, 4532232, 4532297, 5518981, 5519879, 5522874, 5523846, 5524100, 5525075, 5525714, 5527024, 5527507, 6502434, 6503146, 6503147, 4510294, 4531492, 4520127, 4530283, 4538221, 4530571
Classification	Class II
Reason for Recall	Blood products, collected from donors whose confirmatory syphilis testing was invalid, were distributed.
Product Quantity	35
Recall Number	B-1781-12

Product Description	Red Blood Cells Leukocytes Reduced Irradiated
Code Info	5509654, 4541841, 5523075
Classification	Class II
Reason for Recall	Blood products, collected from donors whose confirmatory syphilis testing was invalid, were distributed.
Product Quantity	3
Recall Number	B-1782-12

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	4530571
Classification	Class II
Reason for Recall	Blood products, collected from donors whose confirmatory syphilis testing was invalid, were distributed.
Product Quantity	1
Recall Number	B-1783-12

Product Description	Platelets
Code Info	4505205, 4505609, 4506269, 4506432, 4508580, 4509534, 4509696, 4510090, 4510106, 4510132, 4510447, 4510940, 4511365, 4511575, 4511757, 4511817, 4512463, 4513646, 4514154, 4515077, 4515903, 4516052, 4516161, 4516729, 4517361, 4517486, 4519211, 4519812, 4520674, 4524530, 4525274, 4525392, 4527735, 4528210, 4528318, 4543435, 5503010, 5503070,5503368, 5505217, 5505534, 5505623, 5505996, 5508223, 5509487, 5510915, 5512680, 5514406, 5516634, 5518026, 5518212, 5520339, 5522042, 5522874, 4507712
Classification	Class II
Reason for Recall	Blood products, collected from donors whose confirmatory syphilis testing was invalid, were distributed.
Product Quantity	55
Recall Number	B-1784-12

Class II Biologics Event

Event ID	42143
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	14-Jun-06
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	American National Red Cross (The)
City	Pomona
State	CA
Country	US
Distribution Pattern	CA

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	06GQ23679
Classification	Class II
Reason for Recall	Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Product Quantity	1
Recall Number	B-1694-12

Class II Biologics Event

Event ID	45051
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-Jul-07
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	ZLB Bioplasma, Inc.
City	Columbus
State	OH
Country	US
Distribution Pattern	Illinois

Associated Products

Product Description	Source Plasma
Code Info	4090207495, 4090205675, 4090204264, 4090235520, 4090233769, 4090232778, 4090230841, 4090229972, 4090228164, 4090226516, 4090225586, 4090216820, 4090215970, 4090214383, 4090213727, 4090210202, 4090209066
Classification	Class II
Reason for Recall	Blood products, collected from a donor who did not have a physical examination, were distributed.
Product Quantity	17 units
Recall Number	B-1741-12

Class II Biologics Event

Event ID	48920
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	23-Jun-08
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	San Antonio Eye Bank
City	San Antonio
State	TX
Country	US
Distribution Pattern	CA, Saudi Arabia

Associated Products

Product Description	Cornea
Code Info	SA200801181, SA200801182
Classification	Class II
Reason for Recall	Corneas, recovered from a donor who had not been properly evaluated for hemodilution, were distributed.
Product Quantity	2
Recall Number	B-1636-12

Class II Food/Cosmetics Event

Event ID	51441
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	05-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Cafe Moto
City	San Diego
State	CA
Country	US
Distribution Pattern	All direct consignees located within the state of CA.

Associated Products

Product Description	Flavored coffee. Cafe Moto Almond Truffle Flavored Coffee, 16 oz.
Code Info	Lot numbers CM120621 through CM121241.
Classification	Class II
Reason for Recall	The recall was initiated because the Almond Truffle flavoring used in the manufacturing of the recalled product contains a small percentage of whey, a milk derivative.
Product Quantity	Unknown
Recall Number	F-1841-2012

Class II Biologics Event

Event ID	53172
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Aug-09
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Heartland Lions Eye Bank
City	Kansas City
State	MO
Country	US
Distribution Pattern	Corneas were distributed to Jordan Eye Bank, Jordan University Hospital, Queen Rania Street, Amman, Jordan

Associated Products

Product Description	Cornea for human transplant
Code Info	2009076029 and 2009076030
Classification	Class II
Reason for Recall	Human Cornea, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	2
Recall Number	B-2149-12

Class II Biologics Event

Event ID	57771
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Dec-10
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Delta Blood Bank
City	Stockton
State	CA
Country	US
Distribution Pattern	CA.

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W128710103915
Classification	Class II
Reason for Recall	Blood product, which was collected from a donor who traveled to malarial endemic areas, was distributed.
Product Quantity	1
Recall Number	B-1775-12

Class II Biologics Event

Event ID	59504
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	26-Jul-11
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Memorial Blood Centers
City	Saint Paul
State	MN
Country	US
Distribution Pattern	MN

Associated Products

Product Description	Red Blood Cells
Code Info	W051511030223; W051511005040; W051511004139; W051511004138;
Classification	Class II
Reason for Recall	Blood products, for which testing for hepatitis B surface antigen was invalid, were distributed.
Product Quantity	4
Recall Number	B-1700-12

Class II Biologics Event

Event ID	60492
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	10-Oct-11
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Memorial Blood Centers
City	Saint Paul
State	MN
Country	US
Distribution Pattern	NC, NJ, MN, WI, OH, CA, MI.

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced Irradiated
Code Info	W051511076332; W051511074167; W051511075950;
Classification	Class II
Reason for Recall	Blood products, collected from donors whose arm preparation was inadequate, were distributed.
Product Quantity	3
Recall Number	B-1696-12

Product Description	Red Blood Cells
Code Info	W051511074195; W051511074261; W051511074258; W051511056112; W051511074282; W051511074204; W051511073797; W051511073804; W051511074012; W051511074015; W051511075942; W051511074095; W051511074092; W051511074097; W051511072056;W051511074260; W051511056105; W051511056113; W051511074135; W051511074008; W051511074009; W051511075962; W051511072123; W051511074061; W051511074105; W051511074189; W051511075952; W051511074265; W051511074369; W051511072007; W051511072021; W051511074399; W051511074395; W051511072067; W051511056107; W051511056115; W051511073818; W051511072019; W051511056116;
Classification	Class II
Reason for Recall	Blood products, collected from donors whose arm preparation was inadequate, were distributed.
Product Quantity	39
Recall Number	B-1697-12

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W051511076343; W051511074068; W051511074381; W051511072051; W051511074376; W051511074081; W051511074213; W051511074276; W051511073834; W051511072128; W051511076395; W051511072059; W051511073815; W051511072046; W051511074363; W051511056114; W051511074268; W051511076338; W051511074216; W051511074161; W051511074207; W051511075940; W051511075960; W051511072113; W051511072117; W051511072132;
Classification	Class II
Reason for Recall	Blood products, collected from donors whose arm preparation was inadequate, were distributed.
Product Quantity	26
Recall Number	B-1698-12

Product Description	Fresh Frozen Plasma
Code Info	W051511076332; W051511076343; W051511074068; W051511074167; W051511074195; W051511074261; W051511074258; W051511074381; W051511072051; W051511074200; W051511074143; W051511072067; W051511074061; W051511072113; W051511072117
Classification	Class II
Reason for Recall	Blood products, collected from donors whose arm preparation was inadequate, were distributed.
Product Quantity	15
Recall Number	B-1699-12

Class II Devices Event

Event ID	60853
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	22-Dec-11
Initial Firm Notification of Consignee or Public	Other

Recalling Firm	Church & Dwight Inc
City	Princeton
State	NJ
Country	US
Distribution Pattern	Worldwide Distribution.

Associated Products

Product Description	Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro-Clean, various models. Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal.
Code Info	Spinbrush Pro Clean Soft (6687800078) Spinbrush Pro Clean Medium (6687800079) Spinbrush Pro Clean Replacement Head Soft 2 ct (6687800080) Spinbrush Pro Clean Replacement Head Medium 2 ct (6687800081) Spinbrush Pro Clean 3 ct BJs (6687800145) Spinbrush Pro Clean 2 ct (6687800425) Spinbrush Pro Clean Extra Soft 2 ct (6687800433) Spinbrush Pro Clean Combo Pack (6687800461) Spinbrush Pro Clean Value Pack (6687800466) Spinbrush Pro Clean Soft Value Pack (6687800709) Total Spinbrush Pro Clean Spinbrush Pro Recharge Spinbrush Pro Clean Recharge (6687800160) Total Spinbrush
Classification	Class II
Reason for Recall	Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended 3-month brush head life.
Product Quantity	22.783 million units
Recall Number	Z-0857-2012

Product Description	Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro Clean Re-Charge Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal.
Code Info	Spinbrush Pro Clean Recharge (6687800160)
Classification	Class II
Reason for Recall	Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended 3-month brush head life.
Product Quantity	0.731 million units
Recall Number	Z-0858-2012

Product Description	Arm and Hammer Spinbrush Dual Action Powered Toothbrush Spinbrush Pro Whitening Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal.
Code Info	Spinbrush Pro Whitening Soft (6687800191) Spinbrush Pro Whitening Replacement Head Soft 2 ct (6687800192) Spinbrush Pro Whitening Medium (6687800193) Spinbrush Pro Whitening Replacement Head Medium 2 ct (6687800194)
Classification	Class II
Reason for Recall	Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended 3-month brush head life.
Product Quantity	15.589 million units
Recall Number	Z-0859-2012

Product Description	Arm and Hammer Spinbrush Pro Clean Sonic Powered Toothbrush Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal.
Code Info	Arm and Hammer Spinbrush Pro Clean Sonic Powered Toothbrush (668780016201)
Classification	Class II
Reason for Recall	Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended 3-month brush head life.
Product Quantity	1.744 million units
Recall Number	Z-2093-2012

Product Description	Arm and Hammer Spinbrush Pro Clean Sonic Color Wear Powered Toothbrush Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal
Code Info	Arm and Hammer Spinbrush Pro Clean Sonic Color Wear Powered Toothbrush (668780016202)
Classification	Class II
Reason for Recall	Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended 3-month brush head life.
Product Quantity	0.113 million units
Recall Number	Z-2094-2012

Product Description	Arm and Hammer Spinbrush Pro White Sonic Crest Powered Toothbrush Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal
Code Info	Arm and Hammer Spinbrush Pro White Sonic Crest Powered Toothbrush (668780016400)
Classification	Class II
Reason for Recall	Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended 3-month brush head life.
Product Quantity	0.032 million units
Recall Number	Z-2095-2012

Product Description	Arm and Hammer Spinbrush Pro White Sonic Toothbrush Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal
Code Info	Arm and Hammer Spinbrush Pro White Sonic Toothbrush (668780016401)
Classification	Class II
Reason for Recall	Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended 3-month brush head life.
Product Quantity	0.054 million units
Recall Number	Z-2096-2012

Product Description	Arm and Hammer Spinbrush Pro Clean Sonic Tray BJS Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal.
Code Info	Arm and Hammer Spinbrush Pro Clean Sonic Tray BJS (6687800614408)
Classification	Class II
Reason for Recall	Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended 3-month brush head life.
Product Quantity	0.024 million units
Recall Number	Z-2097-2012

Product Description	Arm and Hammer Spinbrush Pro Clean Sonic Recharge Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal.
Code Info	Arm and Hammer Spinbrush Pro Clean Sonic Recharge (668780094001)
Classification	Class II
Reason for Recall	Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended 3-month brush head life.
Product Quantity	0.347 million units
Recall Number	Z-2098-2012

Product Description	Arm and Hammer Spinbrush ProClean Sonic Recharge Color Wear Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal.
Code Info	Arm and Hammer Spinbrush Pro Clean Sonic Recharge (668780094002)
Classification	Class II
Reason for Recall	Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended 3-month brush head life.
Product Quantity	0.0003 million units
Recall Number	Z-2099-2012

Class II Biologics Event

Event ID	61075
Status	Ongoing
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Oct-11
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Seattle Sperm Bank LLC
City	Seattle
State	WA
Country	US
Distribution Pattern	Approximately two thirds of product went to Denmark, Australia, Canada, and Mexico. The remaining one third distributed domestically nationwide.

Associated Products

Product Description	Human semen for intracervical insemination and/or intrauterine insemination. Vials are labeled with the donor number, date of donation, and "Seattle Sperm Bank". Vials that are for intrauterine insemination (IUI-ready) have a green color band indicating it is ready for intra uterine insemination after thawing. Vials that do not have a green band indicate that the semen is an intra cervical insemination sample (ICI).
Code Info	Vials are labeled with the donor number. Affected donor numbers are: 8503, 8505, 8508, 8509, 8521, 8523, 8528, 8534, 8535, 8543, 8547, 8552, 8558, 8566, 8578, 8579, 8582, 8598, 8609, 8612, 8615, 8625, 8636, 8643, 8652, and 8664
Classification	Class II
Reason for Recall	Human semen, collected from donors that did not have repeat physical exam within 6 months prior to donation, was distributed.
Product Quantity	26 Donors
Recall Number	B-2152-12

Class II Biologics Event

Event ID	61324
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Jan-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	International Sight Restoration, Inc.
City	Tampa
State	FL
Country	US
Distribution Pattern	Cario, Egypt

Associated Products

Product Description	Cornea
Code Info	20110475OS, 20110475OD
Classification	Class II
Reason for Recall	Human corneas, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	2
Recall Number	B-2150-12

Class II Devices Event

Event ID	61655
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-Feb-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Integra LifeSciences Corp.
City	Plainsboro
State	NJ
Country	US
Distribution Pattern	Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NM, NJ, NY, NV, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA & WI and internationally to Belgium; Danemark; France; Germany; Israël; Italy; Lebanon; Luxemburg; Netherlands; Norway; Portugal; Saudi Arabia; Spain; Switzerland; Turkey & United Kingdom.

Associated Products

Product Description	Integra® Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536 The Advansys plates are intended for bone fixation such as: Arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus, Lisfranc arthrodesis, Mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint.
Code Info	Model #181041S, Batch #s EKU8, EN2D, EN2B, EMOK & EN2B; Model #181051S, Batch #s EJQY, FOSU, ECEB & E179; Model #181041, Batch #s EB1E, EBKY, ECE9, EHA7, E647, E8NP, E8P7, E8ML, E8N5, E8PV, E8N5 & E5GV; Model #181042, Batch #s E648, EB1F, E8MM, E8NQ, E8PW, E5GW, E8N6, E8P8, E5GY, E8PW & EBKZ; Model #181052, Batch #s E5GY, E64A, E8PY, E5GW, E8PA, E8NS, E8N8, E8MP & EB1H; Model #181051, Batch #s E649, E5GX, E8MN, E8N7, E8P9, E8NR, E8PX, ECEB, EJ79, EB1G, EBLO & ECEB; Model #181052S, Batch #s E8PY, EB1H, EB14 & E8MP; Model #181042S, Batch #s E8MM, EB1F & EBKZ.
Classification	Class II
Reason for Recall	Incorrect technique applied may cause potential rupture of the tibialis anterior tendon during surgery.
Product Quantity	2,437 units
Recall Number	Z-2123-2012

Class II Devices Event

Event ID	61764
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	30-Apr-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Zimmer Inc.
City	Warsaw
State	IN
Country	US
Distribution Pattern	Worldwide Distribution - USA (nationwide) and the countries of Singapore, China, Hong Kong,Canada, Australia, Japan, Europe, Germany, India, and Finland.

Associated Products

Product Description	Nextgen Complete Knee Solution Femoral and Provisional Impactor/ Extractor, REF 00-5901-026-00, Non-Sterile Zimmer, Warsaw Indiana The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
Code Info	Part 00-5901-026-00 Lot 11002148, 11002149, 11002791, 11002792, 11002831, 11003439, 11003449, 61800676, 61814993, 61909414, 61924920, 61980656, 61985378, 61988272, 61990656, 62003795, 62011220, 77000065, 77000573, 77000574, 77000575, 77000583, 77000654, 77000786, 77000787, 77000788, 77000789, 77000790, 77000795, 77000797, 77000798, 77000799, 77000804, 77000848, 77000849, 77000872, 77000873, 77001039, 77001048, 77001096, 77001097, 77001118, and 77001119
Classification	Class II
Reason for Recall	Postmarket reports indicate that the spring clip may fracture or fall off of the instrument during use, posing the risk that a device fragment may be left in the surgical site. The risk of disassembly or fracture appears to be happening during use of this instrument where the instrument is typically impacted with a mallet to aid in insertion. The applied forces are contributing to the instrument fractures. The fracture of the spring clip is an unintended use oft he product. Zimmer initiated a recall of this instrument in March 2011, at which time an updated design to the spring clip for the jaw assembly was implemented due to fractures of the spring clip. Zimmer has received 62 complaints (as of April 25, 2012) for the spring clip fracturing on the updated design.
Product Quantity	1662 units
Recall Number	Z-2091-2012

Product Description	Nextgen Complete Knee Solution Replacement Jaw for Use with Femoral and Provisional Impactor/Extractor, REF 00-5901-026-40, Non-Sterile Zimmer, Warsaw Indiana The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
Code Info	Part 00-5901-026-40 Lot 62011774, 61870067, and 61813699 Initially the 00-5901-026-40 replacement jaws will remain available for order until all of the alternative instruments are in place, however they will also be required to be returned. The final lot numbers and manufacture dates will be provided in a subsequent status update.
Classification	Class II
Reason for Recall	Postmarket reports indicate that the spring clip may fracture or fall off of the instrument during use, posing the risk that a device fragment may be left in the surgical site. The risk of disassembly or fracture appears to be happening during use of this instrument where the instrument is typically impacted with a mallet to aid in insertion. The applied forces are contributing to the instrument fractures. The fracture of the spring clip is an unintended use oft he product. Zimmer initiated a recall of this instrument in March 2011, at which time an updated design to the spring clip for the jaw assembly was implemented due to fractures of the spring clip. Zimmer has received 62 complaints (as of April 25, 2012) for the spring clip fracturing on the updated design.
Product Quantity	65 units
Recall Number	Z-2092-2012

Class II Biologics Event

Event ID	61782
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-Mar-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Arc Blood Services, New England Region
City	Dedham
State	MA
Country	US
Distribution Pattern	Connecticut; California

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	033FQ44139;
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was previously deferred, were distributed.
Product Quantity	1
Recall Number	B-1525-12

Product Description	Recovered Plasma
Code Info	033FQ44139;
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was previously deferred, were distributed.
Product Quantity	1
Recall Number	B-1526-12

Product Description	Platelets Pooled Leukocytes Reduced
Code Info	POOL#50506;
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was previously deferred, were distributed.
Product Quantity	1
Recall Number	B-1527-12

Class II Biologics Event

Event ID	61784
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Mar-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Central California Blood Center
City	Fresno
State	CA
Country	US
Distribution Pattern	Ohio; Maryland; California; New York

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced Washed
Code Info	W115911274341;
Classification	Class II
Reason for Recall	Blood products, collected from a donor who traveled to a malaria endemic area, were distributed.
Product Quantity	1
Recall Number	B-1530-12

Product Description	Red Blood Cells Leukocytes Reduced Irradiated
Code Info	W115912081153; W115911048352;
Classification	Class II
Reason for Recall	Blood products, collected from a donor who traveled to a malaria endemic area, were distributed.
Product Quantity	2
Recall Number	B-1531-12

Product Description	Platelets Pheresis Leukocytes Reduced Irradiated
Code Info	W115911014575;
Classification	Class II
Reason for Recall	Blood products, collected from a donor who traveled to a malaria endemic area, were distributed.
Product Quantity	1
Recall Number	B-1532-12

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W115912050151; W115911055120; W115911087792; W115911086284; W115911028245; W115911026948; W115911028133; W115911026079; W115911242742; W115911276347; W115911056484; W115911055417; W115911283967; W115911087172; W115911265921; W115911265619; W115911086370; W115911265213; W115911265258; W115911026455; W115911025188; W115911046827; W115911273078; W115911046723; W115911242945; W115911242946; W115911276348; W115911055415; W115911084863; W115911087547; W115912250344; W115911276278; W115912040618; W115911087738; W115912080071; W115911201854; W115911027557;
Classification	Class II
Reason for Recall	Blood products, collected from a donor who traveled to a malaria endemic area, were distributed.
Product Quantity	37
Recall Number	B-1533-12

Class II Biologics Event

Event ID	61800
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	27-Apr-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	LifeServe Blood Center
City	Des Moines
State	IA
Country	US
Distribution Pattern	Iowa

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	W044112107244 Part 1; W044112107244 Part 2;
Classification	Class II
Reason for Recall	Blood products, which did not meet acceptable product specifications, were distributed.
Product Quantity	2
Recall Number	B-1537-12

Product Description	Platelets Pheresis Leukocytes Reduced Irradiated
Code Info	W044112109670; W044112107244 Part 3;
Classification	Class II
Reason for Recall	Blood products, which did not meet acceptable product specifications, were distributed.
Product Quantity	2
Recall Number	B-1538-12

Class II Biologics Event

Event ID	61810
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Feb-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Gulf Coast Regional Blood Center
City	Houston
State	TX
Country	US
Distribution Pattern	Texas

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W044611295391;
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was previously deferred, were distributed.
Product Quantity	1
Recall Number	B-1539-12

Product Description	Plasma Frozen After 24 Hours
Code Info	W044611295391;
Classification	Class II
Reason for Recall	Blood products, collected from a donor who was previously deferred, were distributed.
Product Quantity	1
Recall Number	B-1540-12

Class II Biologics Event

Event ID	62021
Status	Ongoing
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	11-Nov-11
Initial Firm Notification of Consignee or Public	Other

Recalling Firm	SCC Soft Computer
City	Clearwater
State	FL
Country	US
Distribution Pattern	New York and Michigan

Associated Products

Product Description	SoftBank II versions 23.1 and 25.1 applications are decision support software devices. SoftBank II versions 23.1 documents the receipt of inventory from an outside source, multi-side inventory control, records the confirmatory testing on the units and allows for records keeping on component preparation for transfusion.
Code Info	Soft Bank II versions 23.1 and 25.1
Classification	Class II
Reason for Recall	Software, with a glitch or defect, was distributed.
Product Quantity	2 products
Recall Number	B-1162-12

Class II Devices Event

Event ID	62371
Status	Completed
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	01-Jan-11
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Abbott Point Of Care Inc.
City	Princeton
State	NJ
Country	US
Distribution Pattern	USA ( nationwide )

Associated Products

Product Description	I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 cartridge is intended to be used for quantitatively measure sodium, potassium, ionized calcium, oxygen, carbon dioxide, partial pressure in arterial, venous, or capillary whole blood.
Code Info	List number 03P76-25 Lot number S10246A
Classification	Class II
Reason for Recall	i-Stat EG7 cartridges may generate falsely depressed PCO2 results for samples above 26 mm hg when stored at room temperature for four weeks or longer.
Product Quantity	52,750 cartridges
Recall Number	Z-2133-2012

Class II Food/Cosmetics Event

Event ID	62398
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Jun-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	J F C International Inc
City	Los Angeles
State	CA
Country	US
Distribution Pattern	Nationwide in the US

Associated Products

Product Description	Oyster IQF L size Frozen Wild, 10/4lbs.
Code Info	JFC#03751
Classification	Class II
Reason for Recall	JFC International Inc. is recalling Oyster IQF L size Frozen wild, PAFCO Oyster Meat Tiny IQF, Oyster M Frozen Farm, Breaded Oyster Frozen, Tablemark Kaki (oyster) Fry, and Pacific Surf Breaded Oyster Fry. The products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.
Product Quantity	23,711 units total
Recall Number	F-1835-2012

Product Description	PAFCO Oyster Meat Tiny IQF, 40/8 oz.
Code Info	JFC#21757
Classification	Class II
Reason for Recall	JFC International Inc. is recalling Oyster IQF L size Frozen wild, PAFCO Oyster Meat Tiny IQF, Oyster M Frozen Farm, Breaded Oyster Frozen, Tablemark Kaki (oyster) Fry, and Pacific Surf Breaded Oyster Fry. The products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.
Product Quantity	23,711 units total
Recall Number	F-1836-2012

Product Description	Oyster M Frozen Farm, 10/4 lbs.
Code Info	JFC#47341
Classification	Class II
Reason for Recall	JFC International Inc. is recalling Oyster IQF L size Frozen wild, PAFCO Oyster Meat Tiny IQF, Oyster M Frozen Farm, Breaded Oyster Frozen, Tablemark Kaki (oyster) Fry, and Pacific Surf Breaded Oyster Fry. The products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.
Product Quantity	23,711 units total
Recall Number	F-1837-2012

Product Description	Breaded Oyster Frozen, 10/2 lbs.
Code Info	JFC#63669
Classification	Class II
Reason for Recall	JFC International Inc. is recalling Oyster IQF L size Frozen wild, PAFCO Oyster Meat Tiny IQF, Oyster M Frozen Farm, Breaded Oyster Frozen, Tablemark Kaki (oyster) Fry, and Pacific Surf Breaded Oyster Fry. The products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.
Product Quantity	23,711 units total
Recall Number	F-1838-2012

Product Description	Tablemark Kaki (Oyster) Fry, 2/12/6.34 oz.
Code Info	JFC#17208
Classification	Class II
Reason for Recall	JFC International Inc. is recalling Oyster IQF L size Frozen wild, PAFCO Oyster Meat Tiny IQF, Oyster M Frozen Farm, Breaded Oyster Frozen, Tablemark Kaki (oyster) Fry, and Pacific Surf Breaded Oyster Fry. The products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.
Product Quantity	23,711 units total
Recall Number	F-1839-2012

Product Description	Pacific Surf Breaded Oyster Fry, 12/2 lbs.
Code Info	JFC#03479
Classification	Class II
Reason for Recall	JFC International Inc. is recalling Oyster IQF L size Frozen wild, PAFCO Oyster Meat Tiny IQF, Oyster M Frozen Farm, Breaded Oyster Frozen, Tablemark Kaki (oyster) Fry, and Pacific Surf Breaded Oyster Fry. The products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health.
Product Quantity	23,711 units total
Recall Number	F-1840-2012

Class II Drugs Event

Event ID	62421
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	30-Sep-11
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	VistaPharm, Inc.
City	Largo
State	FL
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, 50 unit dose cups, VISTAPHARM, Largo, FL NDC 66689-036-50
Code Info	Lot #'s 210900, 214000, 220100, 224800, 228700, 232800
Classification	Class II
Reason for Recall	Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume.
Product Quantity	27,221 unit dose cups
Recall Number	D-1440-2012

Class II Biologics Event

Event ID	62425
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	25-May-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	LifeSouth Community Blood Centers Inc - Birmingham Region
City	Birmingham
State	AL
Country	US
Distribution Pattern	Alabama

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	W1151121841133;
Classification	Class II
Reason for Recall	Blood product, which did not meet acceptable product specifications, was distributed.
Product Quantity	1
Recall Number	B-2068-12

Class II Biologics Event

Event ID	62426
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	04-May-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	LifeSouth Community Blood Centers Inc - Birmingham Region
City	Birmingham
State	AL
Country	US
Distribution Pattern	Alabama

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	W115112166816A;
Classification	Class II
Reason for Recall	Blood product, which did not meet acceptable product specifications, was distributed.
Product Quantity	1
Recall Number	B-2069-12

Class II Biologics Event

Event ID	62427
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	24-May-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	LifeSouth Community Blood Centers, Inc.
City	Gainesville
State	FL
Country	US
Distribution Pattern	Florida

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	W115112156534P;
Classification	Class II
Reason for Recall	Blood product, which did not meet acceptable product specifications, was distributed.
Product Quantity	1
Recall Number	B-2070-12

Class II Biologics Event

Event ID	62428
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	14-May-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	LifeShare Blood Centers
City	Beaumont
State	TX
Country	US
Distribution Pattern	Texas

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W036512047744;
Classification	Class II
Reason for Recall	Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Product Quantity	1
Recall Number	B-2071-12

Class II Biologics Event

Event ID	62430
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	16-Mar-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Blood Systems Inc/dba United Blood Services
City	Meridian
State	MS
Country	US
Distribution Pattern	Mississippi; Alabama

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W041612006849W; W041612006809B; W041611056969L; W041611057366M;
Classification	Class II
Reason for Recall	Blood products, collected using equipment that had not been validated, were distributed.
Product Quantity	4
Recall Number	B-2073-12

Class II Devices Event

Event ID	62449
Status	Terminated
Product Type	Devices
Voluntary/Mandated	FDA Mandated
Recall Initiation Date	27-Mar-07
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	GE OEC Medical Systems, Inc
City	Salt Lake City
State	UT
Country	US
Distribution Pattern	Worldwide Distribution - US (nationwide) and the countries of: Canada, France, Japan, and China.

Associated Products

Product Description	OEC 9800 Plus Digital; MDL number A349855. Product Usage: Is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.
Code Info	62-0212 , 69-0054 , 82-0023-RC , 82-0034 , 82-0072 , 82-0274 , 82-0587, 8S-0668 , 82-1710 , 82-1803 , 82-2147 , 82-2620 , 82-2754 , 82-2815 , 82-3014 , 82-3234 , 82-7010-MH , 86-0254 , 86-0354 , 86-1078 , 89-0505 , 89-0509 , 89-0595 , 89-0605 , 89-0987 , 89-1048 , 89-1776 , 89-1837 , 89-2132 , 89-2303 , 89-2335 , 89-2348 , 89-2350 , 89-2610 , 89-2645 , 8S-0066 , 8S-0079 , 8S-0341 , 8S-0562 , 8S-0615-C , 8S-0847 , 8S-0849-C , 8S-1312 , 8S-1971 , 8S-2015-N , 8S-2116 , 8S-2117 , 8S-2199 , 8S-2204 , 8S-2320 , 8S-2411 , P4-0097-R , P4-0101-R , P4-0325-R , P4-0346-L , P4-0477-L , P6-0432-R , W2-0012 , W2-0580-R , W2-0591-R , 82-0030
Classification	Class II
Reason for Recall	Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC had discovered an issue with the hard disk drives that were installed on OEC device models: UroView 2800; 9800 Plus Digital; MiniView 6800; and FlexiView 8800 Mobile C-Arm. The devices were manufactured between October 15, 2004 and December 8, 2004. This issue could potentially result in the system failing to store images when the hard disk drive capacity exceeds 170 images instead of the expected 400. Systems may also fail to boot or lose patient data as this image capacity is approached.
Product Quantity	Part of a total of 82 units distributed.
Recall Number	Z-2125-2012

Product Description	OEC MiniView 6800 Mobile; MDL number A349855. Product Usage: The mini 6800 digital mobile c arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical, orthopedic, and extremity imaging. The device is not intended for whole body pediatric imaging.
Code Info	62-0212 , 69-0054 , 82-0023-RC , 82-0034 , 82-0072 , 82-0274 , 82-0587, 8S-0668 , 82-1710 , 82-1803 , 82-2147 , 82-2620 , 82-2754 , 82-2815 , 82-3014 , 82-3234 , 82-7010-MH , 86-0254 , 86-0354 , 86-1078 , 89-0505 , 89-0509 , 89-0595 , 89-0605 , 89-0987 , 89-1048 , 89-1776 , 89-1837 , 89-2132 , 89-2303 , 89-2335 , 89-2348 , 89-2350 , 89-2610 , 89-2645 , 8S-0066 , 8S-0079 , 8S-0341 , 8S-0562 , 8S-0615-C , 8S-0847 , 8S-0849-C , 8S-1312 , 8S-1971 , 8S-2015-N , 8S-2116 , 8S-2117 , 8S-2199 , 8S-2204 , 8S-2320 , 8S-2411 , P4-0097-R , P4-0101-R , P4-0325-R , P4-0346-L , P4-0477-L , P6-0432-R , W2-0012 , W2-0580-R , W2-0591-R , 82-0030
Classification	Class II
Reason for Recall	Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC had discovered an issue with the hard disk drives that were installed on OEC device models: UroView 2800; 9800 Plus Digital; MiniView 6800; and FlexiView 8800 Mobile C-Arm. The devices were manufactured between October 15, 2004 and December 8, 2004. This issue could potentially result in the system failing to store images when the hard disk drive capacity exceeds 170 images instead of the expected 400. Systems may also fail to boot or lose patient data as this image capacity is approached.
Product Quantity	Part of a total of 82 units distributed.
Recall Number	Z-2126-2012

Product Description	UroView 2800; MDL number A349855. Product Usage: Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical application may include but are not limited to urologic and endoscopic procedures. The system may be ued for other imaging applications at the physician's discretion.
Code Info	62-0212 , 69-0054 , 82-0023-RC , 82-0034 , 82-0072 , 82-0274 , 82-0587, 8S-0668 , 82-1710 , 82-1803 , 82-2147 , 82-2620 , 82-2754 , 82-2815 , 82-3014 , 82-3234 , 82-7010-MH , 86-0254 , 86-0354 , 86-1078 , 89-0505 , 89-0509 , 89-0595 , 89-0605 , 89-0987 , 89-1048 , 89-1776 , 89-1837 , 89-2132 , 89-2303 , 89-2335 , 89-2348 , 89-2350 , 89-2610 , 89-2645 , 8S-0066 , 8S-0079 , 8S-0341 , 8S-0562 , 8S-0615-C , 8S-0847 , 8S-0849-C , 8S-1312 , 8S-1971 , 8S-2015-N , 8S-2116 , 8S-2117 , 8S-2199 , 8S-2204 , 8S-2320 , 8S-2411 , P4-0097-R , P4-0101-R , P4-0325-R , P4-0346-L , P4-0477-L , P6-0432-R , W2-0012 , W2-0580-R , W2-0591-R , 82-0030
Classification	Class II
Reason for Recall	Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC had discovered an issue with the hard disk drives that were installed on OEC device models: UroView 2800; 9800 Plus Digital; MiniView 6800; and FlexiView 8800 Mobile C-Arm. The devices were manufactured between October 15, 2004 and December 8, 2004. This issue could potentially result in the system failing to store images when the hard disk drive capacity exceeds 170 images instead of the expected 400. Systems may also fail to boot or lose patient data as this image capacity is approached.
Product Quantity	Part of a total of 82 units.
Recall Number	Z-2127-2012

Class II Devices Event

Event ID	62493
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	26-Jun-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Sunrise Medical (US) LLC
City	Fresno
State	CA
Country	US
Distribution Pattern	Worldwide Distribution - US (nationwide) and the countries of Argentina, Brazil, Columbia, Costa Rica, Mexico, Panama, Uruguay and Venezuela.

Associated Products

Product Description	Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quickie Q7 (EIR4), GT (EIR3), GTi (EIT4) and Zippie Zone (EIRZ1). Product Usage: To empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions.
Code Info	Receiver Product number 109207.
Classification	Class II
Reason for Recall	Reports of injury when the Padded Swing Away Armrest is used for full body weight. Owner's manual states that armrest is only designed for resting of forearm.
Product Quantity	14, 035
Recall Number	Z-2113-2012

Class II Food/Cosmetics Event

Event ID	62497
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	03-Jul-12
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	Andante Dairy
City	Petaluma
State	CA
Country	US
Distribution Pattern	CA, OH and NY to retail stores and restaurants.

Associated Products

Product Description	Multiple lots of cheese produced by Andante Dairy, Petaluma, CA; Sold in 5 oz to 8 oz sizes with no code date or variety information on packaged. Varieties include: Largo, a triple-creme cow's milk, and Picolo, a triple-creme cow's milk. Also made with cow's milk: Pianoforte, Nocturne. Goat's milk cheese varieties: Acapella, Impromptu, Pastoral, Fresh Goat and Crottin, Minuet, a triple-creme goat's milk variety. Mixed Milk cheese varieties: Rondo, Metronome, Melange. Other varieties include Cavatina, Contralto, Vivace, Partita, Tri, Mini Alto, Figaro,Cadence
Code Info	No code information
Classification	Class II
Reason for Recall	Lack of proper pasteurization could have allowed dangerous pathogens to survive in multiple lots of cheese.
Product Quantity	3870 packages
Recall Number	F-1809-2012

Class II Devices Event

Event ID	62504
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Jul-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Stryker Instruments Div. of Stryker Corporation
City	Portage
State	MI
Country	US
Distribution Pattern	Worldwide Distribution - US Nationwide and the countries of England, France, Netherlands, and Switzerland.

Associated Products

Product Description	RF Cannula, 100 mm,Curved 5 MM, 20 G, REF 0406-630-115 RX only, Disposable ( 10/pk) Product Usage: The Stryker RF Cannulae, in combination with the Stryker RF Generator/Multi- Gen and electrodes, are intended for coagulation of soft tissue in orthopedic, arthroscopic, spinal, and neurosurgical applications.
Code Info	REF 0406-630-115, lot 1000035056
Classification	Class II
Reason for Recall	Stryker has received 6 complaints that the 5mm needle was placed in 10 mm package and 10 mm needle was placed in the 5 mm package. If the clinician does not recognize that the active tip on the cannula is 10 mm instead of 5mm and the cannula is used in a cervical procedure there is a potential for a thermal skin lesion due to a larger lesion creation. If the 10 mm active tip cannula, as opposed to the 5mm active tip, is placed perpendicular to the target on a very thin patient, there is a potential for the patient to be exposed to skin burn.
Product Quantity	210
Recall Number	Z-2134-2012

Product Description	RF Cannula, 100 mm,Curved 10 MM, 20 G, REF 0406-630-125 RX only, Disposable ( 10/pk) Product Usage: The Stryker RF Cannulae, in combination with the Stryker RF Generator/Multi- Gen and electrodes, are intended for coagulation of soft tissue in orthopedic, arthroscopic, spinal, and neurosurgical applications.
Code Info	REF 0406-630-125, lot 1000037535
Classification	Class II
Reason for Recall	Stryker has received 6 complaints that the 5mm needle was placed in 10 mm package and 10 mm needle was placed in the 5 mm package. If the clinician does not recognize that the active tip on the cannula is 10 mm instead of 5mm and the cannula is used in a cervical procedure there is a potential for a thermal skin lesion due to a larger lesion creation. If the 10 mm active tip cannula, as opposed to the 5mm active tip, is placed perpendicular to the target on a very thin patient, there is a potential for the patient to be exposed to skin burn.
Product Quantity	226
Recall Number	Z-2135-2012

Class II Devices Event

Event ID	62512
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	27-Jun-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Perkinelmer
City	Waltham
State	MA
Country	US
Distribution Pattern	Worldwide Distribution - US (nationwide) and the countries of Australia, Belgium, Brazil, Egypt, France, Germany, Netherlands, Norway, Saudi Arabia,Switzerland,

Associated Products

Product Description	Perkin Elmer Genetic Screening Processor (GSP) Product Code: 2021-0010 Product Usage: The GSP instrument is a fully automated, high throughput batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The reagent kits running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders. Currently assays for the determination of T4, TSH, 17OHP, IRT and GALT are cleared and available for use with the GSP instrument.
Code Info	Serial Numbers: 20210001 through 20210078
Classification	Class II
Reason for Recall	Contamination from GSP Shaker unit results in decreased signal activity of assay measurements for Genetic Screening for Neonatal IRT, TSH and IRT
Product Quantity	78 units
Recall Number	Z-2121-2012

Class II Devices Event

Event ID	62526
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Beekley Corporation
City	Bristol
State	CT
Country	US
Distribution Pattern	US Nationwide Distribution

Associated Products

Product Description	Beekley S-Spots Floral Skin Markers -Order Number: 750 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern
Code Info	Lot Numbers: A020, A021, A022, A023, A024, AO25, A026
Classification	Class II
Reason for Recall	Digital Skin Mammography Marker separating from the backing of the spot material
Product Quantity	36,518 units
Recall Number	Z-2109-2012

Product Description	Beekley A-Spots Floral Skin Markers -Order Number: 751 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern
Code Info	Lot Numbers: A015, A016, AO17, A018
Classification	Class II
Reason for Recall	Digital Skin Mammography Marker separating from the backing of the spot material
Product Quantity	32,640 units
Recall Number	Z-2110-2012

Product Description	Beekley O-Spots Floral Skin Markers -Order Number: 752 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern
Code Info	Lot Numbers: A036, A037, A038, A039, A040, A041, A042, A044, A045, A046
Classification	Class II
Reason for Recall	Digital Skin Mammography Marker separating from the backing of the spot material
Product Quantity	267,332 units
Recall Number	Z-2111-2012

Product Description	Beekley Altus Floral Skin Markers -Order Number: 754 Product Usage: designed for Digital Mammography-Disposable skin markers for marking areas of concern or pain
Code Info	Lot Numbers: A004
Classification	Class II
Reason for Recall	Digital Skin Mammography Marker separating from the backing of the spot material
Product Quantity	6420 units
Recall Number	Z-2112-2012

Class II Devices Event

Event ID	62528
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Baxter Healthcare Renal Div
City	Waukegan
State	IL
Country	US
Distribution Pattern	Nationwide Distribution includingArizona, California, Ohio, Pennsylvania and Virginia.

Associated Products

Product Description	Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic Container, PL-146 used with Automated Peritoneal Dialysis System/Automated PD Set with Cassette; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. The HomeChoice dialysis system is a personal cycler automated peritoneal dialysis system for pediatric and adult renal patients with fill volumes ranging from 60 mL to 3000 mL. DIANEAL Low Calcium peritoneal dialysis solutions are indicated for use in chronic renal failure patients being maintained on peritoneal dialysis. - and- The Personal Cycler Peritoneal Dialysis System [cycler and ancillary sets] is used for automatic control of dialysate solution exchanges in treatment of renal failure patients undergoing peritoneal dialysis. The Personal Cycler System automatically cycles a prescribed volume of dialysis solution into and out of the peritoneal cavity during the dialysis treatment.
Code Info	all lots and serial numbers
Classification	Class II
Reason for Recall	Baxter discovered that a Baxter technical service representative was providing incorrect instructions for inspection of solution bags for a blocked frangible prior to connection to the Automated PD Set with Cassette.
Product Quantity	N/A
Recall Number	Z-2132-2012

Class II Devices Event

Event ID	62538
Status	Completed
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Apr-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	ICU Medical, Inc.
City	San Clemente
State	CA
Country	US
Distribution Pattern	Nationwide distribution

Associated Products

Product Description	High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV.
Code Info	Part Number 423530401 510(k) K052865 Lot#s: 2432974, 2441508, 2448504, 2455568
Classification	Class II
Reason for Recall	The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded.
Product Quantity	4625
Recall Number	Z-2128-2012

Product Description	Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Product Usage: For waste managment.
Code Info	Part Number 460730418 510(k) K052865 Lot number 2444750
Classification	Class II
Reason for Recall	The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded.
Product Quantity
Recall Number	Z-2129-2012

Product Description	94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rotating Luer, Non-DEHP Tubing
Code Info	Part Number B30059 510(k) K964435 Lot number 2418897, 2423996, 2425137, 2430044, 2431861, 2436569, 2443559, 2447238, 2448099, 2452377, 2457453, 2459025, 2464569, 2467687.
Classification	Class II
Reason for Recall	The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded.
Product Quantity
Recall Number	Z-2130-2012

Product Description	Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit
Code Info	Part Number AG8137 510(k) K052865 Lot number 2466161
Classification	Class II
Reason for Recall	The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded.
Product Quantity
Recall Number	Z-2131-2012

Class II Devices Event

Event ID	62553
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Intuitive Surgical, Inc.
City	Sunnyvale
State	CA
Country	US
Distribution Pattern	Worldwide Distribution - US Nationwide and the countries of: Australia, Spain, India, Italy and Saudi Arabia.

Associated Products

Product Description	INSTRUMENT ARM DRAPE IS2000, 20 PACK: Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
Code Info	Part number: 420015-03; Lot numbers: D120745A, D120765, D120795, D120845, D120895A, D120935, D120955.
Classification	Class II
Reason for Recall	Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.
Product Quantity	89670 total instrument Drapes
Recall Number	Z-2101-2012

Product Description	KIT,DISPOSABLE ACCESSORY,3ARM,IS2000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
Code Info	Part number: 420256-01 Lot numbers: D120745, D120755, D120835, D120865.
Classification	Class II
Reason for Recall	Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.
Product Quantity	89670 total instrument Drapes
Recall Number	Z-2102-2012

Product Description	KIT,DISPOSABLE ACCESSORY,4ARM,IS2000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
Code Info	Part number: 420258-01 Lot numbers: D120755 ,D120755A , D120825.
Classification	Class II
Reason for Recall	Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.
Product Quantity	89670 total instrument Drapes
Recall Number	Z-2103-2012

Product Description	KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
Code Info	Part number: 420290-03 Lot numbers: D120735,,D120745,D120815, D120815A, D120885, D120895, D120905 D120945, D120955, D120955A, D120965, D121025, D121035, D121045, D121075, D121075A, D121095, D121155, D121165, D121165A, D121215.
Classification	Class II
Reason for Recall	Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.
Product Quantity	89670 total instrument Drapes
Recall Number	Z-2104-2012

Product Description	KIT,DISPOSABLE ACCESSORY,4ARM,IS3000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
Code Info	Part number: 420291-03 Lot numbers: D120795 ,D120795A , D120805, D120815, D120875, D120885, D120885A, D120935, D120935A,D120945 D121015 D121025 D121025A D121105 D121105A D121355A
Classification	Class II
Reason for Recall	Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.
Product Quantity	89670 total instrument Drapes
Recall Number	Z-2105-2012

Product Description	ACCESSORY BASE STARTER KIT,IS3000; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
Code Info	Part number: 380595-02 Lot numbers: 298601, 298602, 298608, 298613, 298625, 298627, 298629.
Classification	Class II
Reason for Recall	Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.
Product Quantity	89670 total instrument Drapes
Recall Number	Z-2106-2012

Class II Food/Cosmetics Event

Event ID	62560
Status	Completed
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	27-Jun-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Winn Dixie Stores, Inc.
City	Jacksonville
State	FL
Country	US
Distribution Pattern	Florida, Georgia, Alabama, Mississippi, Louisiana

Associated Products

Product Description	Winn-Dixie Cheeseburger Macaroni Skillet Dinner WD Code 202410, Size 5.8 oz
Code Info	WD Code 202410, Lot# 051413CA85, Sell by date 05/14/2013
Classification	Class II
Reason for Recall	Potentially contains small metal fragments
Product Quantity	222 cases
Recall Number	F-1810-2012

Class II Devices Event

Event ID	62566
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	15-Jun-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Exactech, Inc.
City	Gainesville
State	FL
Country	US
Distribution Pattern	Worldwide Distribution - USA including FL, MO, MA, AL, KY, IN, NC, LA,PA, VA, OH, NY, ME, MI, TX, KS, TN, OK, NJ, WA, CO, GA, CA, MN, IA, OR, and IL and Internationaly to Austria, Luxenbourg, Sweden, Germany, Spain, France, Greece, Italy, Nederland, United Kingdom, Canada, India, Australia, Switzerland, and Sao Palo.

Associated Products

Product Description	Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty
Code Info	Sizes: 1.5 mm: Catalog Number 300-10-15 Serial Range 1653131-2381151 4.5 mm: Catalog Number 300-10-45 Serial Range 1622046-2381151
Classification	Class II
Reason for Recall	Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that the device labeling identifies the affected parts as having a ten year shelf life; however, the packaging configuration that was used it qualified to a five year shelf life.
Product Quantity	54,877 units for all products in Recall Event
Recall Number	Z-2115-2012

Product Description	Equinoxe Fixed Angle Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty.
Code Info	Size: 0mm Catalog Number: 300-25-00 Serial Range: 1999574-2381151
Classification	Class II
Reason for Recall	Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that the device labeling identifies the affected parts as having a ten year shelf life; however, the packaging configuration that was used it qualified to a five year shelf life.
Product Quantity	54,877 units for all products in Recall Event
Recall Number	Z-2116-2012

Product Description	Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
Code Info	Sizes: 4.5x18mm Catalog # 320-20-18 Serial Range 1610445-2381151 4.5x22mm Catalog # 320-20-22 Serial Range 1610391-2381151 4.5x26mm Catalog # 320-20-26 Serial Range 1611237-2381151 4.5x30mm Catalog # 320-20-30 Serial Range 1617556-2381151 4.5x34mm Catalog # 320-20-34 Serial Range 1611290-2381151 4.5x38mm Catalog # 320-20-38 Serial Range 1610260-2381151 4.5x42mm Catalog # 320-20-42 Serial Range 1630006-2381151 4.5x46mm Catalog # 320-20-46 Serial Range 1644317-2381151
Classification	Class II
Reason for Recall	Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that the device labeling identifies the affected parts as having a ten year shelf life; however, the packaging configuration that was used it qualified to a five year shelf life.
Product Quantity	54,877 units for all products in Recall Event
Recall Number	Z-2117-2012

Product Description	Equinoxe Reverse Shoulder Fracture Adapter Tray Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
Code Info	Catalog Number 324-11-00 Serial Range 1653706-2381151
Classification	Class II
Reason for Recall	Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that the device labeling identifies the affected parts as having a ten year shelf life; however, the packaging configuration that was used it qualified to a five year shelf life.
Product Quantity	54,877 units for all products in Recall Event
Recall Number	Z-2118-2012

Product Description	Equinoxe Reverse Glenosphere Locking Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
Code Info	Catalog Number 324-15-05 Serial Range 1620549-2381151
Classification	Class II
Reason for Recall	Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that the device labeling identifies the affected parts as having a ten year shelf life; however, the packaging configuration that was used it qualified to a five year shelf life.
Product Quantity	54,877 units for all products in Recall Event
Recall Number	Z-2119-2012

Product Description	Octane-C Cervical, 6º Lordotic Intended for anterior cervical spine intervertebral body fusion procedures at one level (C3-C7).
Code Info	Sizes: 5 mm Catalog # 05-010-02-0605 All serial numbers 6 mm Catalog # 05-010-02-0606 All serial numbers 7 mm Catalog # 05-010-02-0607 All serial numbers 8 mm Catalog # 05-010-02-0608 All serial numbers 9 mm Catalog # 05-010-02-0609 All serial numbers 10mm Catalog # 05-010-02-0610 All serial numbers 11mm Catalog # 05-010-02-0611 All serial numbers 12mm Catalog # 05-010-02-0612 All serial numbers
Classification	Class II
Reason for Recall	Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that the device labeling identifies the affected parts as having a ten year shelf life; however, the packaging configuration that was used it qualified to a five year shelf life.
Product Quantity	54,877 units for all products in Recall Event
Recall Number	Z-2120-2012

Class II Drugs Event

Event ID	62574
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	30-Apr-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Apotex Inc.
City	Toronto
State
Country	CA
Distribution Pattern	Nationwide and Puerto Rico

Associated Products

Product Description	Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, 10mL bottle, For Topical Application in the Eye, Sterile Ophthalmic Solution, Rx Only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9
Code Info	Lot #s: JN1060, JN1061, JN1062, Exp 06/12
Classification	Class II
Reason for Recall	Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates.
Product Quantity	119,794 Bottles
Recall Number	D-1439-2012

Class II Devices Event

Event ID	62590
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Apr-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Maquet Medical Systems, Usa
City	Wayne
State	NJ
Country	US
Distribution Pattern	Worldwide Distribution - USA (nationwide) and the countries of United Arab Emirates, Austria, Australia, Belgium, Brazil, Canada, Switzerland, China, Germany, Denmark, Spain, France, Hong Kong, Ireland, Israel, India, Italy, Japan, South Korea, Netherlands, Poland, Russia, Saudi Arabia, Sweden, Singapore, and Thailand.

Associated Products

Product Description	Maquet Getinge Group Operating Table System Magnus Carbon-Fibre Table Top Version 1180.16 The carbon-fibre MAGNUS table top (1180-16XX) serves to support and position patients for surgical procedures (e.g. cardiovascular surgery) and interventional examination immediately before, during and after the surgical phase. The table top is radiotranslucent and enables intraoperative use of X-ray equipment.
Code Info	Model # 1180.16F2 Serial #s 1,3,7, & 8; Model # 1180.16F3 Serial # 1; Model #1180.16F5 Serial #4; Model # T285.7000 Serial #s 1,2,3,4, & 7.
Classification	Class II
Reason for Recall	As a result of a small number of customer complaints, MAQUET conducted an investigation and identified a potential problem with specific MAGNUS Carbon-Fibre Table Tops manufactured between February 23, 2010 and February 28, 2012 and distributed between November 11, 2010 and April 6, 2012. There is a potential issue with the motor brakes for the longitudinal shift drive, and the tilt drive.
Product Quantity	164 Units located in 27 Countries
Recall Number	Z-2108-2012

Class II Drugs Event

Event ID	62591
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-Apr-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Dr. Reddy's Laboratories, Inc.
City	Bridgewater
State	NJ
Country	US
Distribution Pattern	Nationwide and Puerto Rico

Associated Products

Product Description	Dr. Reddy's Amlodipine Besylate and Benazepril Hydrochloride 5 mg*/20 mg, 500 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325 INDIA, NDC 55111-340-05
Code Info	C201293 Exp Date 08/2013
Classification	Class II
Reason for Recall	Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and Ciprofloxacin Tablets.
Product Quantity	1656 bottles
Recall Number	D-1434-2012

Product Description	Dr. Reddy's Ciprofloxacin Tablets, USP 500 mg*, 500 Tablets, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325 INDIA, NDC 55111-127-05
Code Info	C201293 Exp Date 08/2013
Classification	Class II
Reason for Recall	Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and Ciprofloxacin Tablets
Product Quantity	1656 bottles
Recall Number	D-1435-2012

Class II Drugs Event

Event ID	62605
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	14-Mar-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Zydus Pharmaceuticals USA Inc
City	Pennington
State	NJ
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Metformin Hydrochloride Tablets, USP, 1000 mg, Rx only, 1000 count tablets per Bottle, Manufactured by: Cadila Healthcare LTD. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-030-10.
Code Info	Lot #: ML9605 Exp. 10/2013
Classification	Class II
Reason for Recall	Presence of Foreign Substance(s): A product complaint was received from a pharmacist who discovered that several tablets displayed brown specks. The same complainant also reported that metal shaving like material was observed on the surface of one tablet.
Product Quantity	1176 Bottles
Recall Number	D-1428-2012

Class II Devices Event

Event ID	62626
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Aesculap Implant Systems LLC
City	Center Valley
State	PA
Country	US
Distribution Pattern	US Nationwide Distribution - including the states of CO, OH, OK and TX.

Associated Products

Product Description	Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree Trial Implant (SJ780T-US) Product Usage: The Aesculap Implant Systems SIBD Trial Implant instruments assist the surgeon in selecting the correct size implant for the patient
Code Info	4 degree - SJ768T-US and 9 degree SJ780T-US
Classification	Class II
Reason for Recall	The 4 degree and 9 degree trial instruments (SJ768T-US/SJ780T-US) are correctly dimensioned, but the part number etched on the instrument may be incorrect. The 4 degree trial instrument (SJ768T-US) may be marked with the incorrect part number of the 9 degree trail instrument (SJ780T-US) and the 9 degree trial instrument (SJ780T-US) may be marked with the incorrect part number of the 4 degree trial instrument (SJ768T-US). The incorrect etching was not identified at final inspection.
Product Quantity	5
Recall Number	Z-2114-2012

Class II Drugs Event

Event ID	62627
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Apr-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	West-ward Pharmaceutical Corp.
City	Eatontown
State	NJ
Country	US
Distribution Pattern	All lots were distributed throughout the US.

Associated Products

Product Description	Fosphenytoin Sodium Injection, USP, 100 mg PE per 2 mL (50 mg PE per mL), 2 mL Single Dose Vial, packaged in 25-count x 2 mL Single Dose Vials per carton, Rx only, Mfd. By: Hikma Farmaceutica (Portugal), S.A.; Dist. By: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA under the labels a) NOVAPLUS (NDC 0143-9704-25), b) West-Ward (NDC 0143-9788-25).
Code Info	Lot #s: a) 113153.1, 113154.1, 113155.1, Exp 05/13; 113248.1, Exp 07/13; b) 103196.1, 103197.1, 103197.2, 103198.1, Exp 07/12; 103317.1, 103318.1, 103319.1, 103345.1, 103345.2, Exp 11/12; 103346.1, 103347.1, 103348.1, 103349.1, 103350.1, Exp 12/12; 113030.1, 113031.1, 113032.1, 113033.1, 113034.1, 113035.1, 113036.1, Exp 01/13; 113245.1, 113246.1, 113247.1, Exp 07/13
Classification	Class II
Reason for Recall	Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.
Product Quantity	a) 308,275 vials; b) 2,008,850 vials
Recall Number	D-1437-2012

Product Description	Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL (50 mg PE per mL), 10 mL Single Dose Vial, packaged in 10-count x 10 mL Single Dose Vials per carton, Rx only, Mfd. By: Hikma Farmaceutica (Portugal), S.A.; Dist. By: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA under the labels a) NOVAPLUS (NDC 0143-9703-10), b) West-Ward (NDC 0143-9782-10).
Code Info	Lot #s: a) 112161.1, 112162.1, 112163.1, Exp 05/13; b) 102165.2, 102167.1, Exp 05/12; 102190.1, 102191.1, 102191.2, 102192.1, 102213.1, Exp 07/12; 102240.1, 102241.1, 10227.1, 102272.1, 102272.2, 102273.1, 102274.1, 102275.1, Exp 09/12; 102319.1, 102320.1, 102321.1, 102322.1, 102323.1, 102324.1, 102325.1, Exp 11/12; 102342.1, 102343.1, 102344.1, 102345.1, Exp 12/12; 112019.1, 112020.1, 112021.1, 112022.1, 112023.1, Exp 01/13; 112156.1, 112157.1, 112158.1, 112159.1, 112160.1, Exp 05/13; 112164.1, Exp 06/13; 112203.1, 112204.1, 112205.1, 112206.1, Exp 07/13; 112262.1, 112263.1, Exp 09/13; 112301.1, 112302.1, 112303.1, 112304.1, Exp 10/13; 112323.1, 112324.1, 112325.1, Exp 11/13
Classification	Class II
Reason for Recall	Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.
Product Quantity	a) 74,960 vials; b) 911,070 vials
Recall Number	D-1438-2012

Class II Drugs Event

Event ID	62643
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	24-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Cadence Pharmaceuticals
City	San Diego
State	CA
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	OFIRMEV (acetaminophen) injection, 1000 mg/100 mL (10 mg/mL), 24-count Single Use 100 mL Vials per carton, Rx only, Manufactured for: Cadence Pharmaceuticals, Inc., San Diego, CA 92130, NDC 43825-102-01, UPC 3 43825 10201 7.
Code Info	Lot #: V006015, V006023, V006031, V006056, V006064, V006080, V006106, V006114, V006130, V006148, V006155, Exp 07/12; V006171, V006189, V006197, V006205, V006213, V006221, V006254, V006262, V006270, V006296, V006304, V006312, V006320, V006338, V006346, V006353, V006361, V006379, V006387, V006395, Exp 08/12; V006403, V006429, V006437, V006445, V006460, V006494, V006510, V006528, V006536, V006544, Exp 09/12.
Classification	Class II
Reason for Recall	Presence of Particulate Matter: The firm initiated the recall due to visible presence of particulate matter.
Product Quantity	1,098,912 vials
Recall Number	D-1432-2012

Class II Drugs Event

Event ID	62651
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	08-May-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Bayer HealthCare Pharmaceuticals Inc.
City	Wayne
State	NJ
Country	US
Distribution Pattern	Kansas and California.

Associated Products

Product Description	Estradiol Hemihydrate M20 EP/USP Powder, packaged in a) 1.5 kg and b) 2.5 kg fiber drums, Rx only, Art. No. 165811, Bayer Pharma AG, D-13342 Berlin.
Code Info	Lot Number: 81202450, Exp 06/15/16
Classification	Class II
Reason for Recall	Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due to cross contamination with another product.
Product Quantity	112.295 kg
Recall Number	D-1433-2012

Class III Biologics Event

Event ID	38935
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	24-Apr-07
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	New York Blood Center, Inc.
City	Long Island City
State	NY
Country	US
Distribution Pattern	NY

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	Unit # 7162431
Classification	Class III
Reason for Recall	Blood products, for which donor's whole blood unit was screened for hemoglobin utilizing the hemocue was not quality controlled, was distributed.
Product Quantity	1 unit
Recall Number	B-1186-12

Class III Biologics Event

Event ID	42178
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	24-Mar-06
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Central Kentucky Blood Center, Inc.
City	Lexington
State	KY
Country	US
Distribution Pattern	KY

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	2268768, 2266307A, 2256611, 2271023, 2256594, 2261965, 2264412, 2266496, 2247581
Classification	Class III
Reason for Recall	Blood products, which may have reached an unacceptable temperature during shipment, were distributed.
Product Quantity	9 units
Recall Number	B-1737-12

Class III Biologics Event

Event ID	43470
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Oct-06
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	American National Red Cross (The)
City	Pomona
State	CA
Country	US
Distribution Pattern	CA

Associated Products

Product Description	Red Blood Cells
Code Info	006FP55966; 006FP55967; 006FP55969; 006FP55970
Classification	Class III
Reason for Recall	Blood products, labeled with the incorrect expiration date, were distributed.
Product Quantity	4
Recall Number	B-1695-12

Class III Food/Cosmetics Event

Event ID	54145
Status	Terminated
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	27-Jun-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Nestle USA
City	Glendale
State	CA
Country	US
Distribution Pattern	Distributed to distributor and retail in US State of TX.

Associated Products

Product Description	Nestle Nesquik Chocolate Flavor, chocolate beverage powder, New Wt 48.7 OZ. Product labeling reads in part:"*Nestle Nesquick Chocolate FLAVOR* NET WT*48.7OZDISTRIBUTED BYNESTLE USA, INC., GLENDALE, CA 91203 USA*".
Code Info	Recalled product under following Batch number: 210458802G, 210558802G, 210758803G, 210658801g, 210658801G. Code Date Breakdown: 2-Year code (2012) 104-Julian code 5880-plant code 2-shift G-line designation
Classification	Class III
Reason for Recall	Firm initiated recall due to potential contamination with metal fragments.
Product Quantity	405 cases at 6 per case
Recall Number	F-1811-2012

Class III Biologics Event

Event ID	60075
Status	Ongoing
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	25-Aug-11
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Bacterin International Inc. Biologics Division
City	Belgrade
State	MT
Country	US
Distribution Pattern	Distributed nationwide

Associated Products

Product Description	Tendon products are derived from donated cadaver human tissue. They were prepared from tissue procured from a cadaver donor using aseptic surgical techniques. Each donor receives a Bacterin ID number, each graft from that donor receives a numeric graft ID. Individual grafts from the same donor will have the same base donor ID, but differing numeric graft ID's. Bacterin's product code and graft ID are placed on the finished product label.
Code Info	Graft ID#s B100123001; B100123002; B100123007; B100123008; B100123009; B100123010; B100124001; B100124002; B100124003; B100124005; B100124006; B100124007; B100124008; B100124011; B100124012; B100124013; B100125003; B100125004; B100126001; B100126002; B100126006; B100126014; B100127002; B100127003; B100127004; B100141001; B100141006; B100141007; B100141008; B100141009; B100141012; B100141013; B100141014; B100141015; B100141016; B100141017; B100142001; B100142002; B100142003; B100142005; B100142006; B100142011; B100142012; B100142013; B100145007; B100145008; B100152001; B100152002; B100152007; B100153001; B100153005; B100153006; B100155001; B100155004; B100155005; B100159002; B100159003; B100159004; B100159007; B100187001; B100187002; B100187007; B100187008; B100187009; B100187010; B100187012; B100187013; B100187014; B100188006; B100188009; B110002001; B110002002; B110002003; B110002004; B110002007; B110002008; B110002009; B110002010; B110002011; B110002012; B110034001; B110034002; B110043001; B110043009; B110048001; B110048002; B110048005; B110048006; B110048009; B110048010; B110048011; B110048012; B110049005; B110049006; B110049007; B110049011; B110065001; B110065004; and B110091004
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	100 units
Recall Number	B-2146-12

Product Description	Bone products are derived from donated cadaver human tissue. They were prepared from tissue procured from a cadaver donor using aseptic surgical techniques. Each donor receives a Bacterin ID number, each graft from that donor receives a numeric graft ID. Individual grafts from the same donor will have the same base donor ID, but differing numeric graft ID's. Bacterin's product code and graft ID are placed on the finished product label.
Code Info	B100123201; B100123202; B100123203; B100123204; B100123205; B100123206; B100123207; B100123208; B100123209; B100123210; B100123215; B100123217; B100123218; B100123219; B100123220; B100123221; B100123222; B100123223; B100123224; B100123225; B100123226; B100123227; B100123228; B100123229; B100123230; B100123231; B100123232; B100123233; B100123234; B100123235; B100123236; B100123237; B100123238; B100123239; B100123240; B100123241; B100123242; B100123243; B100123244; B100123245; B100123246; B100123271; B100123281; B100123294; B100123295; B100123296; B100123297; B100123298; B100123801; B100123802; B100123803; B100123804; B100123805; B100123806; B100123808; B100123809; B100123812; B100123813; B100123814; B100123815; B100123816; B100123817; B100123818; B100123819; B100123820; B100123821; B100123822; B100123824; B100123825; B100123826; B100123827; B100123828; B100123829; B100123830; B100123831; B100123832; B100123833; B100123834; B100123835; B100123837; B100123839; B100123840; B100123841; B100123843; B100123844; B100123845; B100123846; B100124202; B100124203; B100124204; B100124207; B100124209; B100124211; B100124212; B100124213; B100124214; B100124215; B100124216; B100124217; B100124218; B100124219; B100124220; B100124223; B100124224; B100124225; B100124226; B100124234; B100124235; B100124236; B100124237; B100124238; B100124801; B100124802; B100124803; B100124804; B100124805; B100124807; B100124808; B100124810; B100124811; B100124812; B100124813; B100124814; B100124815; B100124816; B100124817; B100124818; B100124823; B100124824; B100124825; B100124826; B100124827; B100124828; B100124831; B100124832; B100124833; B100124834; B100124835; B100124836; B100124837; B100124838; B100124839; B100124840; B100124841; B100124842; B100124843; B100124844; B100124845; B100124846; B100124848; B100124849; B100124850; B100124851; B100124852; B100124853; B100124854; B100124855; B100124856; B100124857; B100124858; B100125201; B100125202; B100125203; B100125204; B100125205; B100125206; B100125207; B100125208; B100125209; B100125210; B100125211; B100125212; B100125213; B100125214; B100125215; B100125216; B100125217; B100125218; B100125219; B100125220; B100125221; B100125222; B100125223; B100125224; B100125226; B100125227; B100125228; B100125229; B100125230; B100125231; B100125232; B100125233; B100125234; B100125235; B100125236; B100125237; B100125239; B100125240; B100125241; B100125242; B100125243; B100125244; B100125245; B100125246; B100125247; B100125248; B100125249; B100125250; B100125251; B100125252; B100125253; B100125254; B100125255; B100125256; B100125257; B100125258; B100125259; B100125260; B100125261; B100125262; B100125263; B100125264; B100125265; B100125266; B100125267; B100125268; B100125269; B100125270; B100125271; B100125272; B100125273; B100125274; B100125275; B100125276; B100125277; B100125278; B100125283; B100125284; B100125702; B100125703; B100125704; B100125705; B100125706; B100125708; B100125709; B100125710; B100125712; B100125713; B100125714; B100125715; B100125720; B100125721; B100125723; B100125724; B100125725; B100125726; B100125727; B100125728; B100125729; B100125730; B100125730; B100125731; B100125732; B100125733; B100125734; B100125735; B100125736; B100125737; B100125738; B100125739; B100125740; B100125741; B100125742; B100125743; B100125744; B100125745; B100125746; B100125748; B100125749; B100125750; B100125751; B100125752; B100125753; B100125754; B100125755; B100125756; B100125761; B100125762; B100125763; B100125764; B100125765; B100125766; B100125767; B100125768; B100125769; B100125770; B100125771; B100125773; B100125774; B100125775; B100125776; B100125778; B100125779; B100125781; B100126201; B100126202; B100126203; B100126204; B100126205; B100126206; B100126207; B100126208; B100126209; B100126210; B100126211; B100126212; B100126213; B100126214; B100126215; B100126216; B100126217; B100126218; B100126219; B100126220; B100126221; B100126222; B100126223; B100126224; B100126227; B100126228; B100126229; B100126230; B100126231; B100126232; B100126233; B100126234; B100126235; B100126236; B100126237; B100126241; B100126242; B100126248; B100126249; B100126250; B100126252; B100126253; B100126254; B100126255; B100126256; B100126257; B100126264; B100126265; B100126266; B100126267; B100126269; B100127202; B100127203; B100127204; B100127205; B100127206; B100127207; B100127208; B100127210; B100127211; B100127212; B100127213; B100127214; B100127215; B100127216; B100127217; B100127218; B100127219; B100127220; B100127221; B100127222; B100127223; B100127224; B100127225; B100127226; B100127227; B100127228; B100127229; B100127230; B100127231; B100127232; B100127233; B100127234; B100127235; B100127236; B100127237; B100127238; B100127239; B100127240; B100127241; B100127243; B100127244; B100127245; B100127246; B100127247; B100127248; B100127249; B100127250; B100127251; B100127252; B100127253; B100127254; B100127255; B100127256; B100127257; B100127258; B100127259; B100127260; B100127261; B100127262; B100127263; B100127264; B100127265; B100127266; B100127267; B100127268; B100127269; B100127270; B100127271; B100127272; B100127273; B100127274; B100127275; B100127276; B100127277; B100127278; B100127279; B100127291; B100127292; B100127293; B100127294; B100141210; B100141211; B100141212; B100141214; B100141215; B100141216; B100141217; B100141218; B100141219; B100141220; B100141221; B100141222; B100141223; B100141230; B100141231; B100141234; B100141235; B100141236; B100141237; B100141238; B100141239; B100141240; B100141241; B100141242; B100141243; B100141244; B100141245; B100141246; B100141247; B100141248; B100141249; B100141250; B100141251; B100141253; B100141254; B100141255; B100141256; B100141257; B100141258; B100141260; B100141261; B100141262; B100141263; B100141264; B100141265; B100141266; B100141267; B100141268; B100141269; B100141270; B100141271; B100141272; B100141273; B100141274; B100141275; B100141276; B100141277; B100141278; B100141279; B100141280; B100141281; B100141282; B100141283; B100141284; B100141285; B100141286; B100141287; B100141288; B100141289; B100141290; B100141291; B100141292; B100141293; B100141294; B100141295; B100141296; B100141297; B100141298; B100141299; B100141300; B100141806; B100141808; B100141809; B100141810; B100141811; B100141814; B100141816; B100141817; B100141820; B100141821; B100141822; B100141823; B100141824; B100141826; B100141827; B100141828; B100141846; B100141847; B100141848; B100141849; B100141850; B100141851; B100141852; B100141853; B100141854; B100141855; B100141856; B100141858; B100141859; B100141860; B100141861; B100141862; B100141863; B100141864; B100141865; B100141866; B100141867; B100141868; B100141869; B100141870; B100141871; B100141872; B100141873; B100141874; B100141875; B100141876; B100142101; B100142201; B100142202; B100142203; B100142204; B100142205; B100142206; B100142209; B100142211; B100142212; B100142213; B100142214; B100142215; B100142216; B100142217; B100142218; B100142219; B100142220; B100142221; B100142222; B100142223; B100142224; B100142225; B100142227; B100142228; B100142229; B100142230; B100142231; B100142232; B100142233; B100142234; B100142235; B100142236; B100142237; B100142238; B100142239; B100142240; B100142241; B100142242; B100142243; B100142244; B100142246; B100142247; B100142248; B100142249; B100142250; B100142251; B100142252; B100142253; B100142254; B100142255; B100142256; B100142257; B100142258; B100142259; B100142260; B100142261; B100142262; B100142263; B100142264; B100142265; B100142266; B100142267; B100142268; B100142269; B100142270; B100142271; B100142272; B100142273; B100145215; B100145216; B100145217; B100145218; B100145221; B100145222; B100145223; B100145224; B100145225; B100145226; B100145227; B100145228; B100145230; B100145231; B100145232; B100145233; B100145234; B100145235; B100145236; B100145237; B100145238; B100145239; B100145240; B100145241; B100145242; B100145243; B100145244; B100145245; B100145246; B100145247; B100145248; B100145249; B100145250; B100145251; B100145252; B100145253; B100145254; B100145255; B100145256; B100145257; B100145258; B100145259; B100145260; B100145261; B100145263; B100145264; B100145265; B100145266; B100145267; B100145268; B100145269; B100145270; B100145273; B100145274; B100145275; B100145276; B100145277; B100145278; B100145279; B100145280; B100145281; B100145282; B100145283; B100145284; B100145285; B100145286; B100145287; B100145288; B100145289; B100145290; B100145291; B100145292; B100145293; B100145294; B100145295; B100145296; B100145297; B100145298; B100145299; B100145300; B100145501; B100145502; B100145503; B100145504; B100145505; B100145506; B100145507; B100145508; B100145509; B100145510; B100145801; B100145802; B100145803; B100145805; B100145805; B100145806; B100145807; B100145808; B100145809; B100145810; B100145811; B100145812; B100145813; B100145814; B100145815; B100145817; B100145818; B100145819; B100145820; B100145821; B100145822; B100145823; B100145824; B100145825; B100145826; B100145827; B100145828; B100145829; B100145830; B100145831; B100145832; B100145833; B100145834; B100145835; B100145836; B100145837; B100145838; B100145839; B100145840; B100145841; B100145842; B100145844; B100145845; B100145846; B100145847; B100145848; B100145849; B100145850; B100145851; B100145852; B100145853; B100145854; B100145855; B100145856; B100145857; B100145858; B100145859; B100145861; B100145862; B100145863; B100145865; B100145866; B100145867; B100145868; B100145869; B100145870; B100152101; B100152102; B100152201; B100152202; B100152203; B100152204; B100152206; B100152207; B100152208; B100152209; B100152210; B100152211; B100152212; B100152213; B100152214; B100152215; B100152216; B100152217; B100152219; B100152220; B100152221; B100152222; B100152223; B100152224; B100152225; B100152226; B100152227; B100152229; B100152230; B100152231; B100152232; B100152233; B100152234; B100152236; B100152240; B100152240; B100152242; B100152243; B100152244; B100152245; B100152246; B100152247; B100152248; B100152249; B100152251; B100152273; B100152274; B100152275; B100152276; B100152277; B100152278; B100152279; B100152281; B100152282; B100152283; B100152284; B100152285; B100152286; B100152291; B100152294; B100152300; B100152303; B100152304; B100153101; B100153102; B100153201; B100153202; B100153203; B100153204; B100153205; B100153206; B100153207; B100153208; B100153209; B100153210; B100153211; B100153212; B100153213; B100153214; B100153215; B100153216; B100153217; B100153218; B100153219; B100153220; B100153221; B100153222; B100153223; B100153224; B100153225; B100153226; B100153227; B100153228; B100153229; B100153230; B100153231; B100153232; B100153233; B100153234; B100153235; B100153237; B100153238; B100153239; B100153240; B100153241; B100153243; B100153244; B100153260; B100153270; B100153276; B100153277; B100153279; B100153280; B100153283; B100153284; B100153285; B100153286; B100153287; B100153288; B100153289; B100153290; B100153291; B100153292; B100153293; B100153294; B100153295; B100153296; B100153297; B100153298; B100153299; B100153300; B100153301; B100155101; B100155102; B100155104; B100155201; B100155202; B100155203; B100155204; B100155205; B100155207; B100155208; B100155209; B100155210; B100155211; B100155212; B100155213; B100155214; B100155215; B100155216; B100155217; B100155219; B100155220; B100155221; B100155222; B100155223; B100155224; B100155225; B100155226; B100155227; B100155228; B100155229; B100155230; B100155231; B100155232; B100155233; B100155234; B100155235; B100155236; B100155237; B100155238; B100155239; B100155240; B100155241; B100155242; B100155243; B100155244; B100155245; B100155246; B100155247; B100155248; B100155249; B100155250; B100155251; B100155252; B100155253; B100155254; B100155255; B100155256; B100155257; B100155258; B100155259; B100155260; B100155261; B100155262; B100155263; B100155274; B100155275; B100155276; B100155277; B100155278; B100155279; B100155878; B100155880; B100155881; B100155882; B100155883; B100155884; B100155885; B100155886; B100155889; B100155892; B100155895; B100155897; B100155898; B100159101; B100159103; B100159105; B100159105; B100159201; B100159202; B100159203; B100159204; B100159205; B100159206; B100159207; B100159208; B100159209; B100159210; B100159211; B100159212; B100159213; B100159216; B100159217; B100159218; B100159219; B100159220; B100159221; B100159222; B100159239; B100159240; B100159241; B100159242; B100159243; B100159244; B100159245; B100159246; B100159247; B100159248; B100159250; B100159251; B100159252; B100159253; B100159254; B100159255; B100159256; B100159257; B100159258; B100159259; B100159260; B100159261; B100159262; B100159263; B100159264; B100159265; B100159266; B100159269; B100159270; B100159273; B100159274; B100159275; B100159276; B100159277; B100159278; B100159279; B100159280; B100159281; B100159282; B100159283; B100159284; B100159285; B100187101; B100187102; B100187201; B100187202; B100187203; B100187205; B100187206; B100187207; B100187207; B100187208; B100187209; B100187210; B100187211; B100187212; B100187213; B100187214; B100187215; B100187216; B100187218; B100187227; B100187228; B100187229; B100187230; B100187231; B100187232; B100187233; B100187234; B100187235; B100187236; B100187237; B100187238; B100187239; B100187240; B100187241; B100187243; B100187244; B100187245; B100187246; B100187249; B100187250; B100187251; B100187252; B100187253; B100187254; B100187255; B100187256; B100187257; B100187258; B100187259; B100187260; B100187261; B100187262; B100187263; B100187264; B100187265; B100187266; B100187267; B100187268; B100187269; B100187270; B100187271; B100188201; B100188202; B100188203; B100188204; B100188205; B100188206; B100188207; B100188208; B100188209; B100188210; B100188211; B100188212; B100188215; B100188216; B100188217; B100188218; B100188220; B100188221; B100188222; B100188223; B100188224; B100188225; B100188228; B100188229; B100188230; B100188231; B100188232; B100188233; B100188234; B100188235; B100188236; B100188237; B100188238; B100188239; B100188246; B100189201; B100189202; B100189203; B100189204; B100189205; B100189206; B100189208; B100189209; B100189210; B100189211; B100189212; B100189213; B100189214; B100189215; B100189216; B100189217; B100189218; B100189219; B100189220; B100189221; B100189222; B100189223; B100189224; B100189225; B100189226; B100189227; B100189228; B100189229; B100189230; B100189231; B100189232; B100189233; B100189235; B100189236; B100189237; B100189238; B100189238; B100189239; B100189241; B100189242; B100189243; B100189244; B100189245; B100189246; B100189247; B100189251; B100189252; B100189253; B100189254; B100189255; B100189256; B100189257; B100189258; B100189259; B100189260; B100189261; B100189262; B100189263; B100189264; B100189265; B100189266; B100189267; B100189268; B100189269; B100189270; B100189271; B100189272; B100189273; B100189274; B100189275; B100189276; B100189277; B100189278; B100189279; B100189280; B100189281; B100189282; B100189284; B110002101; B110002205; B110002206; B110002207; B110002208; B110002209; B110002210; B110002211; B110002212; B110002213; B110002214; B110002215; B110002216; B110002217; B110002218; B110002219; B110002220; B110002221; B110002222; B110002223; B110002224; B110002225; B110002226; B110002227; B110002228; B110002229; B110002230; B110002231; B110002232; B110002233; B110002234; B110002235; B110002236; B110002237; B110002238; B110002239; B110002240; B110002245; B110002246; B110002247; B110002248; B110002249; B110002250; B110002252; B110002255; B110002256; B110002257; B110002258; B110002259; B110002260; B110002261; B110002262; B110002263; B110002274; B110002275; B110002276; B110002278; B110002279; B110002280; B110002286; B110002287; B110002292; B110002293; B110002294; B110002295; B110002296; B110002297; B110002298; B110002299; B110002300; B110024202; B110024203; B110024204; B110024205; B110024206; B110024207; B110024208; B110024209; B110024210; B110024211; B110024212; B110024213; B110024214; B110024215; B110024216; B110024217; B110024218; B110024219; B110024220; B110024221; B110024269; B110024270; B110024271; B110024272; B110024273; B110024274; B110024275; B110024276; B110024277; B110024278; B110024279; B110024280; B110024281; B110024282; B110024283; B110024284; B110024285; B110024286; B110024287; B110024288; B110024289; B110024290; B110024291; B110024292; B110024294; B110024295; B110024296; B110024297; B110024298; B110024299; B110024300; B110024301; B110024302; B110024303; B110024304; B110024305; B110024306; B110024307; B110024307; B110024309; B110024310; B110024311; B110024312; B110024313; B110024314; B110024315; B110024316; B110024317; B110024318; B110024319; B110024320; B110024321; B110024322; B110024323; B110024324; B110024325; B110024326; B110024327; B110024328; B110024329; B110024330; B110024331; B110024332; B110024333; B110024334; B110024335; B110024336; B110024337; B110024338; B110024339; B110024340; B110024341; B110024342; B110024343; B110024344; B110024345; B110024346; B110024347; B110024348; B110024349; B110024350; B110024351; B110024352; B110024353; B110024354; B110024361; B110024363; B110025201; B110025202; B110025204; B110025213; B110025214; B110025215; B110025220; B110025221; B110025222; B110025223; B110025224; B110025225; B110025226; B110025227; B110025228; B110025261; B110025262; B110025264; B110025265; B110025266; B110025267; B110025268; B110025270; B110025273; B110025274; B110025275; B110025276; B110025277; B110025278; B110025279; B110025280; B110025281; B110025282; B110034101; B110034102; B110034201; B110034205; B110034206; B110034207; B110034208; B110034209; B110034210; B110034211; B110034212; B110034213; B110034214; B110034215; B110034216; B110034217; B110034218; B110034222; B110034223; B110034224; B110034225; B110034226; B110034227; B110034228; B110034229; B110034230; B110034231; B110034232; B110034233; B110034234; B110034235; B110034236; B110034237; B110034239; B110034240; B110034241; B110034242; B110034243; B110034244; B110034245; B110034247; B110034248; B110034250; B110034251; B110034252; B110034253; B110034254; B110034257; B110034258; B110034259; B110034260; B110034261; B110034262; B110034263; B110034264; B110034272; B110034273; B110034274; B110034275; B110034309; B110034315; B110034316; B110034319; B110034320; B110034321; B110034322; B110034323; B110034324; B110034327; B110034328; B110034329; B110034501; B110034502; B110034503; B110034504; B110034505; B110034506; B110034507; B110034508; B110034509; B110034510; B110034511; B110034512; B110034513; B110034514; B110034515; B110034516; B110034517; B110034518; B110037201; B110037202; B110037203; B110037204; B110037205; B110037206; B110037207; B110037210; B110037213; B110037214; B110037215; B110037216; B110037217; B110037218; B110037220; B110037220; B110037221; B110037222; B110037223; B110037224; B110037225; B110037226; B110037227; B110037228; B110037229; B110037230; B110037231; B110037232; B110037233; B110037234; B110037235; B110037244; B110037245; B110037247; B110037248; B110037249; B110037250; B110037251; B110037252; B110037253; B110037254; B110037255; B110037256; B110037257; B110037258; B110037264; B110037267; B110037268; B110037269; B110037270; B110037271; B110037272; B110037273; B110043201; B110043202; B110043203; B110043205; B110043206; B110043207; B110043208; B110043209; B110043210; B110043211; B110043212; B110043213; B110043214; B110043215; B110043216; B110043217; B110043218; B110043219; B110043220; B110043221; B110043222; B110043223; B110043224; B110043225; B110043226; B110043227; B110043228; B110043229; B110043230; B110043231; B110043232; B110043233; B110043234; B110043235; B110043236; B110043237; B110043239; B110043240; B110043241; B110043242; B110046221; B110046222; B110046223; B110046224; B110046225; B110046226; B110046228; B110046229; B110046236; B110046245; B110046246; B110046247; B110046248; B110046249; B110046250; B110046263; B110046264; B110046265; B110046266; B110046267; B110046268; B110046269; B110048101; B110048102; B110048202; B110048203; B110048204; B110048205; B110048206; B110048207; B110048208; B110048209; B110048210; B110048211; B110048212; B110048213; B110048214; B110048215; B110048216; B110048217; B110048218; B110048219; B110048220; B110048221; B110048222; B110048223; B110048224; B110048225; B110048226; B110048227; B110048228; B110048229; B110048230; B110048231; B110048232; B110048233; B110048234; B110048235; B110048236; B110048237; B110048238; B110048239; B110048240; B110048241; B110048242; B110048243; B110048244; B110048245; B110048246; B110048247; B110048248; B110048249; B110048250; B110048251; B110048252; B110048253; B110048254; B110048255; B110048256; B110048257; B110048258; B110048259; B110048260; B110048261; B110048262; B110048263; B110048264; B110048276; B110048277; B110048278; B110048279; B110048280; B110049202; B110049203; B110049204; B110049205; B110049206; B110049207; B110049208; B110049209; B110049210; B110049213; B110049214; B110049215; B110049216; B110049217; B110049218; B110049219; B110049220; B110049221; B110049222; B110049223; B110049224; B110049225; B110049226; B110049227; B110049228; B110049229; B110049230; B110049231; B110049232; B110049233; B110049234; B110049235; B110049236; B110049237; B110049238; B110049239; B110049240; B110049241; B110049242; B110049243; B110049244; B110049245; B110049246; B110049247; B110049248; B110049249; B110049250; B110049251; B110049252; B110049253; B110049254; B110049255; B110049256; B110049257; B110049258; B110049259; B110049260; B110049261; B110049262; B110049263; B110049264; B110049265; B110049266; B110049267; B110049268; B110049269; B110049270; B110049271; B110049272; B110049273; B110049274; B110049275; B110049276; B110049277; B110049278; B110049281; B110049282; B110049283; B110049284; B110049285; B110057201; B110057202; B110057203; B110057204; B110057205; B110057206; B110057207; B110057208; B110057209; B110057210; B110057211; B110057212; B110057214; B110057216; B110057218; B110057219; B110057221; B110057222; B110057223; B110057229; B110057240; B110057241; B110057243; B110057244; B110057245; B110057246; B110065214; B110065215; B110065216; B110065217; B110065218; B110065219; B110065220; B110065221; B110065222; B110065223; B110065224; B110065225; B110065226; B110065227; B110065228; B110065229; B110065232; B110065233; B110065234; B110065235; B110065236; B110065237; B110065238; B110068201; B110068204; B110068205; B110068206; B110068207; B110068208; B110068209; B110068210; B110068211; B110068212; B110068213; B110068214; B110068215; B110068220; B110068221; B110068222; B110068223; B110068233; B110082221; B110082222; B110082223; B110082224; B110082226; B110082227; B110082228; B110082231; B110082232; B110082233; B110082234; B110082256; B110082258; B110082259; B110082260; B110082263; B110082264; B110082265; B110082701; B110082702; B110082703; B110082705; B110082706; B110082707; B110082708; B110082709; B110082710; B110082711; B110082712; B110082713; B110082714; B110082715; B110082716; B110082717; B110082718; B110082719; B110082720; B110082721; B110082722; B110082725; B110082726; B110082727; B110082728; B110082729; B110082730; B110082731; B110082732; B110082733; B110082734; B110082735; B110082736; B110082737; B110082738; B110082739; B110082740; B110082741; B110082742; B110082743; B110082744; B110082745; B110082746; B110082747; B110082748; B110082749; B110082750; B110082751; B110082752; B110082753; B110082754; B110082755; B110082756; B110082757; B110082758; B110082759; B110082760; B110082761; B110082762; B110082763; B110082765; B110082766; B110082767; B110082768; B110082769; B110082770; B110082771; B110082772; B110082773; B110082774; B110082775; B110082776; B110082777; B110082778; B110082779; B110082780; B110082781; B110082782; B110082783; B110082784; B110082785; B110082786; B110082787; B110082788; B110082790; B110082791; B110082792; B110082793; B110082794; B110082795; B110082796; B110082797; B110082798; B110082799; B110082801; B110082802; B110082803; B110082804; B110082805; B110082806; B110082807; B110082808; B110082809; B110082810; B110082811; B110082813; B110082814; B110082815; B110082816; B110082817; B110082818; B110082819; B110082820; B110082821; B110082822; B110082824; B110082825; B110082826; B110082827; B110082828; B110082829; B110082830; B110082831; B110082832; B110082833; B110082834; B110082835; B110082836; B110082838; B110082839; B110082840; B110082841; B110082842; B110082843; B110082844; B110082845; B110082846; B110082847; B110082848; B110082850; B110082851; B110082852; B110082853; B110082854; B110082855; B110082856; B110082857; B110082858; B110082860; B110082861; B110082862; B110082863; B110082864; B110091201; B110091202; B110091203; B110091204; B110091205; B110091206; B110091207; B110091208; B110091209; B110091210; B110091211; B110091212; B110091214; B110091215; B110091216; B110091217; B110091218; B110091221; and B110091222
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	2063 units
Recall Number	B-2147-12

Product Description	Fascia product is derived from donated cadaver human tissue. It was prepared from tissue procured from a cadaver donor using aseptic surgical techniques. Each donor receives a Bacterin ID number, each graft from that donor receives a numeric graft ID. Individual grafts from the same donor will have the same base donor ID, but differing numeric graft ID's. Bacterin's product code and graft ID are placed on the finished product label.
Code Info	B100124252
Classification	Class III
Reason for Recall	Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed.
Product Quantity	1 unit
Recall Number	B-2148-12

Class III Biologics Event

Event ID	60941
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Jan-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Metro Blood Services
City	Yonkers
State	NY
Country	US
Distribution Pattern	New Jersey

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	8440344; 8440289, 8440288, 8440281, 8432734, 8433109, 8433451, 8427671, 8438591, 8439520, 8436503, 8436512, 8436506, 8436605, 8436606, 8441668, 8433614, 8433616, 8438156, 8438147, 8438146, 8447972, 1001530, 1001841, 1002531, 8445631, 8447551, 8447474, 8447473, 8447409, 8447489, 8447490, 8447408, 8447492, 8447493, 8443193, 8441733, 8441739, 8441742, 8441687, 8441689, 8441738, 8443186, 8443192, 8443196, 8443006, 8443005, 8444010, 8443934, 8444007, 8443804, W09101131135000, W09101131130900, W09101130659700, W09101130598000, W09101130287900 , W09101129552300, W09101129577700, W09101131203400, W09101129593200, W09101129583100, W09101130232000, W09101130683100, W09101129895900, W09101130595600, W09101129878300, W09101128740300, W09101130594900, W05171164398100, W09101131675500, W09101131578100, W03681130545500, W05171164933000, W05171164936700, W05171164930500, W05171164929600, W05171164718300, W03951145404300, W33361110232000, W33361111000100, W33361110139500, W04441131117000, W12161119376500, W05331150655100, W05331160910800, W03951145293600, W33361110429800, W33361110859000, W33361109602200, W03951145294200, W04441150670800, W04441150670400, W04441170583800, W33361110456700, W33361108461700, W33361109603000, W05331160951600, 8438848, 8432450, 8420822, 8420824, 8429327, 8442021, 8442020, 8423761, 8423759, 8423763, 8423760, 8423762, 8431103, 8431096, 8431147, 8431218, 8431221, 8431222, 8431220, 8431148, 8431149, 8431150, 8431153, 8431235, 8431224, 8431234, 8431057, 8431059, 8431060, 8431064, 8421618, 8421620, 8421616, 8421627, 8421623, 8421624, 8421533, 8424309, 8424244, 8421284, 8421285, 8421287, 8421286, 8421281, 8421181, 8421194, 8421187, 8421191, 8421179, 8421177, 8432986, 8432987, 8433037, 8433044, 8436103, 8435014, 8435015, 8435036, 8435037, 8435090, 8435099, 8435111, 8435115, 8435116, 8435118, 8435121, 8435122, 8437717, 8440015, 8440014, 8440307, 8440301, 8440453, 8433900, 8433889, 8433892, 8433895, 8427545, 8427462, 8427442, 8427645, 8427653, 8427512, 8427659, 8425050, 8425052, 8425057, 8425113, 8425262, 8425265, 8425267, 8425268, 8435924, 8435883, 8435890, 8435994, 8435998, 8435716, 8435722, 8435724, 8435727, 8445271, 8445279, 8441364, 8441360, 8441363, 8441300, 8441295, 8441294, 8441348, 8441296, 8441302, 8441303, 8442535, 8442520, W09101127389500, W09101127481000, W09101124990900, W09101125892800, W09101128043500, W09101126938100, W09101126938800, W09101125807400, W09101127417300, W09101128162600, W09101127819400, W09101128163400, W09101129088800, W09101129300600, W09101128720100, W09101128732200, W09101127330200, W09101129000900, W09101129293900, W09101129294000, W09101128720000, W09101129323100, W09101131080900, W09101130235500, W09101131066400, W09101129502800, W09101131815000, W09101131277400, W09101130852000, W09101131833000, W06711107805300, W09101130526300, W09101131277800, W09101130826900, W09101131825800, W09101130827200, W09101127181100, W09101131826000, W09101131277100, W09101131278200, W09101132112000, W09101130220100, W09101130853700, W09101131335800, W09101130813100, W09101130225700, W09101131065900, W03681127693900, W11651131411000, W11651131412100, W11651131412300, W11651131411100, W11651131411700, W03681120059100, W03681129744700, W03681129744400, W03681120059400, W03681123915400, W03681129312500, W08791180564900, W08791180564300, W08791180563000, W03681126586500, W03681126156400, W03681126421300, W03681121095700, W03681126520700, W03681120434400, W03681126521000, W03681126586300, W03681121777500, W03681126421600, W03681120459400, W03681120355100, W03681128209200, W05171163809500, W05171163591600, W05171163520500, W05171163591300, W03681126451000, W03681130348800, W03681130621000, W33361104422300, W33361109098800, W33361108715200, W03951144758000, W33361108092400, W03951144628800, W33361107957900, W33351101762100, W33341101685800, W33361108643700, W33361108090200, W03951144755900, W33361109342600, W33361108427700, W33361108617400, W33341101272200, W33341101482100, W33341101294100, W33341101294600, W03951143392100, W33361106066700, W33351101707200, W33361108171300, W33351101681100, W33361108245500, W33361108245300, W33361108076200, W33361108238700, W33361108246200, W33361108242700, W33361109055400, W04441130916000, W04441170477200, W04441130924400, W33341101670900, W04441130924300, W33341101671200, W03951144784300, W33361106068800, W04441130925400, W33351101754600, W33351101753300, W33361107891200, W33341101609100, W33341101541100, W12161117622500, W12161117448700, W12161117813100, W12161117783400, W12161117813000, W12161117448500, W03951144773300, W33341101802000, W03951144876400, W33341101801500, W33341101804200 W33351101783100, W03951144392000, W33341101582300, W33341101805900, W33361104348800, W12161119166700, W12161119436600, W12161119610500, W33361109896800, W33361109013700, W33341101929800, W33361108879900, W33361109637200, W33361109211000, W33361109636300, W33361109896100, W33361108453600, W33361110583200, W33341101782100, W03951144924600, W33361110585900, W33361108573200, W33361108972200, W05171164107900, 8447984, 8447836, W09101131661400, W09101131636100
Classification	Class III
Reason for Recall	Unlicensed blood products were distributed in interstate commerce.
Product Quantity	379
Recall Number	B-1541-12

Product Description	Fresh Frozen Plasma
Code Info	7906862, 7906870, 7906873, 7906877, W12361100144900, W12361100145000, W12361100145300, W12361100147100, W12361100147300, W12361100147400, W03681111542700, W03681107539000, W03681110925000, W03681118531800, W03681112027400, W03681108575700, W03681117991400, W03681111325400, W03681118504400, W03681110945200, W03681121552600, W03681122143200, W05171164413600, W05171164413900, W05171164581000, W05171111394800, W05171164580800, W05171164318100, W05171111357900, W05171111377300, W05171164575800, W05171164603400, W05171164512800, W05171164601700, W05171164601100, W05171164600600, W05171140880400, W12361100160500, W12361100160900, W05171163937600, W05171163799700, W05171163884700, W05171163249100, W05171163274400, W05171130266100, W05171164667600, W05171164952500, W05171164514100, W05171164048100, W05171164741400, W05171120359700, W05171140939700, W05171164289200, W05171140826300, W05171164039300, W05171164135100, W05171120310100, W05171111283200, W05171111297500, W05171140825600, W05171165053000, W05171111505900, W05171164813700, W05171164813000, W05171164484800, W03681120656800, W05171164579700, W05171111384500, W05171164348100, W05171164441500, W05171140892200, W05171140891800, W05171164611200, W05171164392100, W05171164513600, W05171164348600, W05171164144600, W05171164267300, W05171164267200, W05171120337100, W05171150373300, W05171140894200, W05171164579300, W05171164578900, W05171111369000, W05171164606100, W05171164604300, W05171163811900, W05171130265200, W05171163787200, W05171163785000, W05171120290200, W05171111205000, W05171164887400, W05171164891200, W05171164199000, W05171164718000, W05171165140900, W05171165200100, W05171165178200, W05171165175600, W03681120704900, 8417138, 8417139, W05171164506300, W05171164505300, W05171164460600, W05171164862200, W05171165050100, W05171164192900, W05171164347300, W05171120330400, W05171164413700, W05171140892800, W05171111179700, W05171164737600, W05171164762200, W05171111555200, W05171111572300, W05171164833900, W05171164324600, W05171165100900, W05171164448700, W05171165100300, W05171111523900, W05171111520200, W05171164149900, W05171130347700
Classification	Class III
Reason for Recall	Unlicensed blood products were distributed in interstate commerce.
Product Quantity	128
Recall Number	B-1542-12

Product Description	Cryoprecipitated AHF, Pooled
Code Info	1002682, 1002686, 1002685, 1002683, 1002684, 1002779, 1002681
Classification	Class III
Reason for Recall	Unlicensed blood products were distributed in interstate commerce.
Product Quantity	7
Recall Number	B-1543-12

Product Description	Platelet Pheresis Leukocytes Reduced Irradiated
Code Info	8446741, 1001150, 8446743, 1002276, 1002251, 1000624, 1000686, 8435643, 8433585, 8444533, 8427355, 8436046, 8433649, 8436045, W12781120286000, E05211100678200
Classification	Class III
Reason for Recall	Unlicensed blood products were distributed in interstate commerce.
Product Quantity	16
Recall Number	B-1544-12

Product Description	Red Blood Cells
Code Info	8433046, 8433045, W12161118809800, 8430533, 8430390, 8433300, 8433297, 8433293, 8433287, 8430389, W12161119002500, 8437455, w12161118809500, W12161118802500, W12161119033100, W12161119032600, W12161119079000, 8437456, 8437453, 8433203
Classification	Class III
Reason for Recall	Unlicensed blood products were distributed in interstate commerce.
Product Quantity	20
Recall Number	B-1545-12

Product Description	Platelet Pheresis Leukocytes Reduced
Code Info	W14091211078600, W33361108852000, W14091121651300, 8438920, 8434095, W09101128748600, W14091121642200, W14091121651200, W33361110978000, 8438441, W09101133902400, W14091211599300, W03581200781800, W03581201730100, W14091210304200, W14091210303800, W14091210304800, W09101130646900, W14091121697300, W03581201183600, 8438912, 8438913, 8438922, W14091210309200, W14091210310600, 1002980, W05171111702400, 8440672, W14091211155400, 8440671, W14091211155400, W14091121632000, W03951144709800, W09101127756000, W03581121729100, W09101130004100, W33361108521800, W03581118618100, W03581119806600, W05211100662800, W09101129852600, W09101132237500, W09101128899100, W14091211576600, W03581118702500, W03581117037100, W03581119692900, 8434094, W03581200452900, 8431833, W03581120054400, W09101127744000, 8441151, W03681130391200, W14091211087300
Classification	Class III
Reason for Recall	Unlicensed blood products were distributed in interstate commerce.
Product Quantity	55
Recall Number	B-1546-12

Product Description	FP24
Code Info	W33341101954700, W33341101800000, W33361110410700, W33361110162500, W33361111100500, W33341101913400, W33361110265700, W03951145189400, W33361110888800, W33361109223100, W33361111172900, W03951145063500, W03951145186900, W09101130724500, W09101128795900, W03951145185900, W33361110023300, W33361111152200, W03951144823600, W09101131130400, W09101130087800, W09101126841300, W09101129502800, W33341101955600 , W09101130683600, 8426192
Classification	Class III
Reason for Recall	Unlicensed blood products were distributed in interstate commerce.
Product Quantity	26
Recall Number	B-1547-12

Product Description	Red Blood Cells Apheresis Leukocytes Reduced
Code Info	8430878, 8430799, 8431565, 8425625, 8425623, 8423797, 8430709, 8436539, 8436264, 8436272, 8436302, 8436231, 8436305, 8436268, 8436544, 8433964, 8434015, 8434016, 8434025, 8434029, 8434030, 8434031, 8434032, 8434285, 8434286, 8434348, 8438626, 8439095, 8439089, 8439093, 8435740, 8435828, 8435824, 8434461, 8434466, 8434468, 8434472, 8439096, 8439097, 8439101, 8439108, 8439105, 8439103, 8439104, 8440948, 8440950, 8440949, 8441037, 8440956, 8440954, 8441042, 8441038, 8441039, 8441044, 8441045, 8441046, 8442214, 8442203, 8442263, 8444433, 8447363, 8443574, 8430671, 8430684, 8430678, 8430683, 8431544, 8431562, 8430666, 8430670, 8428182, 8428184, 8428503, 8428488, 8428487, 8428139, 8428138, 8426096, 8430708, 8430428, 8430713, 8430711, 8430716, 8436256, 8436257, 8436777, 8436737, 8436772, 8433914, 8433962, 8434022, 8434024, 8434026, 8434027, 8434028, 8434033, 8434390, 8434391, 8434392, 8434396, 8434402, 8434428, 8434429, 8438517, 8438524, 8438519, 8438521, 8438530, 8438522, 8438523, 8438512, 8435308, 8435548, 8435551, 8435375, 8435382, 8435289, 8435739, 8435819, 8435823, 8434307, 8434308, 8434311, 8434312, 8434397, 8434400, 8434403, 8434405, 8434414, 8434418, 8440460, 8440462, 8440465, 8442262, 8442265, 8442955, 8442966, 8444436, 8447436, 8447438, 8447439 , W33361108147900 (bag 1 &2); W03681120133000, W03681120133000, W04441130925100, 8438847, W05171111291100 (bag1 &2) ;W05171165030600 (bag1 &2); 8434270; 8438305, ;8438248, 8438249, 8440962, ;8440968, 8440963, 8440964, 8440976, 8436886, 8436394, 8436522, 8436523, 8436390, 8436532, 8436535, 8448584, 8448395, 1001785, 1001805, 1002677, 8445977, 8445974, 8446139, 8446130, 8446131, 8440938, 8440930, 8435918, 8438214, 8438215, 8438217, 8438206, 8438212, 8438216, 8438220, 8438219, 8438732, 8440886, 8438017, 8436885, 8436898, 8439994, 8439999, 8448581, 8449474, 8445975, 8446123, W04441250025000, W04441111183500, W03681126258500, W03681235662800, W33361111227100, 1002678, 1002680, 1002676, 1002679, 8446129, 8448679, 8448681
Classification	Class III
Reason for Recall	Unlicensed blood products were distributed in interstate commerce.
Product Quantity	211
Recall Number	B-1548-12

Product Description	Fresh Frozen Plasma Apheresis
Code Info	W03681121290100; W03681119762600; W03681127687000; W03681123988500; W03681121840900; W05171130338500; W05171150390400; W03681127433100; W03681110651300; W05171111485500; W03681110652300; W03681127323100; W05171111498100; W03681127331200; W03681131889800; W03681123908700; W03681121776800; W03681120590300; W03681122054000; W05171130308300; W05171111574100 (bag 1 and bag 2)
Classification	Class III
Reason for Recall	Unlicensed blood products were distributed in interstate commerce.
Product Quantity	22
Recall Number	B-1549-12

Class III Biologics Event

Event ID	61150
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	31-Aug-09
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Haemonetics Corporation
City	Braintree
State	MA
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Haemonetics MCS+9000 Pump Encoder Automated Blood Cell Separator Model LN 9000
Code Info	Serial Numbers: 00A124-1 00F002-1 00F003 00F046-1 00F047-1 01M260 01M264 01 M265-1 01M279-2 01M282-2 02B151-2 02B155-2 02B156-2 02B157-2 02B160-3 02C033-3 02C036-3 02C037-3 02M202-1 02M203-1 03E020 03E021 03E075 03E076 03F089 04J033 04K025 04K026 04M080 04M081 04M082 05C014 05D056 05F064-1 05G101 05G103 05K067-1 06A297 06B355 06B357-1 06C075-1 06C076-1 06C361-1 06C362-1 06C363-1 06G004 06G005 06G006 06G008 06L117 06L118 06L119 07E194 07E195 07E269 07E270 07E271 07E274-1 07H336 07H340 07J101 07J102 07J103 07J179 07J180 07J190 07J192 07J297 08A325 08A326 08A327 08A328 08A345 08A348 08J142 08J143 08J144 08J408 08J409 08J410 08J411 08J412 08J498 08K030 08K031 08K033 08K034 09B093 09B294 09B295 09B296 09B297 09B298 09B299 09B300 09B301 09B302 09C056 09C057 09C058 09C059 09C060 09C167 09C168 09C169 94A124-MC+9 94A 127 -MC+9 94A 129-MC+9 94A130-1 94A135U-1 94A 138-MC+9 94A 139-MC+9 94A 146U-MC+ 94A147-MC+9 94A 149U-MC+ 94A151 U-MC+ 94A 152U-MC+ 94A 154-MC+9 94F275-MC+9 94F276-MC+9 94F290-MC+9 94F291-MC+9 95M039-MC+9 95M040-MC+9 95M041-MC+9 95M042-MC+9 95M043-MC+9 95M044-MC+9 95M081-MC+9 95M082-MC+9 95M083-MC+9 95M085-MC+9 95M086-MC+9 95M170U-MC-t 95M173U 95M174-MC+9 95M175-MC+9 95M177-MC+9 95M182U-1 95M191-MC+9 95M192-MC+9 95M194-MC+9 95M196U 95M198-MC+9 95M200-MC+9 96A044U-MC+ 96A045-MC+9 96A220-MC+9 96A221-MC+9 96A222-MC+9 96A223U-MC+ 96A225U-MC+ 96A226-MC+9 96B042-MC+9 96B043 96B044 96B046-MC+9 96B047-MC+9 96C078-MC+9 96C079-MC+9 96C195 96C370-MC+9 96C372-MC+9 96C373-MC+9 96C374U-MC+ 96C375-MC+9 96C376-MC+9 96C378-MC+9 96C380-MC+9 96C381-MC+9 96C478-MC+9 96C479-MC+9 96C484-MC+9 96C485 96D003-MC+9 96D004-MC+9 960008U 960099-MC+9 960101-MC+9 960102-MC+9 96D103-MC+9 96D104-MC+9 96D105-MC+9 96E041-MC+9 96E042-MC+9 96E042U 96E043-MC+9 96E044-MC+9 96E044U 96E045-MC+9 96E046-MC+9 96E047-MC+9 96E048-MC+9 96E049-MC+9 96E050-MC+9 96E051-MC+9 96E052-MC+9 96E053-MC+9 96E054-MC+9 96E207-MC+9 96E208-MC+9 96E209-MC+9 96E210-MC+9 96E323-MC+9 96E324U-MC+ 96F056-MC+9 96F059 96F068 96F092-MC+9 96F093-MC+9 96F095U-MC+ 96F097 96F097 -MC+9 96F097U 96F098-MC+9 96F105-MC+9 96F270-MC+9 96F271-MC+9 96F272-MC+9 96F273-MC+P 96F276-MC+9 96F278-MC+9 96F279-MC+9 96F280-MC+9 96F281-MC+9 96F283-MC+9 96F414-MC+9 96F415-MC+9 96F416-MC+9 96F418-MC+9 96F420-MC+9 96F422-MC+9 96F424-MC+9 96F425-MC+9 96F579-MC+9 96F580-MC+9 96F583-MC+9 96F584-MC+9 96F585-MC+9 96F586-MC+9 96F587 -MC+9 96F588-MC+9 96G103-MC+9 96G104-MC+9 96G106-MC+9 96G107-MC+9 96G108-MC+9 96K073-MC+9 96K074-MC+9 96K076-MC+9 96K077 -MC+9 96K078-MC+9 96K170-MC+9 96K171-MC+ 96K175C-1 96K176C-1 96K182U-MC+ 96K184-MC+9 96K185-MC+9 96K186U 96K188U 96L252-MC+9 96L339-MC+9 96L340-MC+9 96L341-MC+9 96L343-MC+9 96L426-MC+9 96L430U 96L432-MC+9 96L433 96M041-MC+9 96M042-MC+9 96M046-MC+9 96M047-MC+9 96M048-MC+9 96M049-MC+9 96M421-MC+9 96M425-MC+9 96M427 -MC+9 96M428-MC+9 96M429-MC+9 96M436-MC+9 96M437 -MC+9 96M438-MC+9 97B037 -MC+9 97B038-MC+9 97B040-MC+9 97B041-MC+9 97B042-MC+9 97B043-MC+9 97B204-MC+9 97B206-MC+9 97B320-MC+9 97B326-MC+9 97B326U-2 97B327 -MC+9 97B384-MC+9 97B386-MC+9 97B388-MC+9 97B389-MC+9 97B391-MC+9 97B392-MC+9 97D108-MC+9 97D109-MC+9 97D109U-2 97D112U-1 97D114U-MC+ 97D408-MC+9 97EOO1-MC+ 97E001U 97E006-MC+9 97E008-MC+9 97E009-MC+9 97E494-MC+9 97E499-MC+9 97E500-MC+9 97E501-MC+9 97F099-MC+9 97F174-MC+9 97F175-MC+9 97F177 -MC+9 97F178-MC+9 97F179-MC+9 97F265-MC+9 97F266-MC+9 97F267 -MC+9 97F268-MC+9 97F271 U-1 97F272-MC+9 97F273-MC+9 97F275-MC+9 97J130-MC+9 97J131-MC+9 97 J 132-MC+9 97 J 134-MC+9 97 J 135-MC+9 97 J 136-MC+9 97 J 185-MC+9 97 J 186-MC+9 97J191-MC+9 97 J192-MC+9 97 J222-MC+9 97 J223-MC+9 97 J224-MC+9 97 J225-MC+9 97J227-1 97 J228-MC+9 98C134-MC+9 98F128-MC+9 98F129-MC+9 98F136U 98H043 98H044-MC+9 98H046-MC+9 98H112-MC+9 98H113-MC+9 98H114-MC+9 98H115-MC+9 98H116-MC+9 98H117-MC+9 98H118 99L136 99L137 99L 139-MC+9
Classification	Class III
Reason for Recall	Apheresis Collection Devices, with a possible pump encoder failure, were distributed.
Product Quantity	372 units
Recall Number	B-2193-12

Product Description	Haemonetics Cymbal Automated Blood Collection Model LN1900
Code Info	Serial Numbers: 07A180-1 07M111 06A252U-1 07B115-1 06A255 06K067-1 07B209-1 06K066-1 07B104-1 07B208-1 08K224 08K227 08K260 08K226 07B114-1 07B117-1 07B192-1 07A181-1 07A182-1 07B110-1 07B193-1 07M108 07M085 07M105 07M107 07M109 07M110-1 07M112 07M113 07B105U-1 07A172-1 07B109-1 06K075-1 07A178-1 07A183-1 07B200-1 07B206-1 07M341-1 07M342-1 07B211-1 07L040 07A175-1 07L183 06A261U-1 07A184-1 07B108-1 07B106-1 08K225 07M117 08K223 08K255 07M118 08K258 07M116 08K254 08K256 08K257 08K259 07M114 07B204-1 07A174-1 07B111-1 06K070-1 07L032 07C302-1 06K080-1 06K064-1 07M115 07B210-1 07M106-1 06K063-2 06K068-1 06K069-1 07B194-1 07B202-2 07B201-1 07B191-1 07B113-1 07B195-1 07B116-1 07B189-1 07A179-1 07B203-1 07B112-1 07B205-1 07B207-1 06K072-1
Classification	Class III
Reason for Recall	Apheresis Collection Devices, with a possible pump encoder failure, were distributed.
Product Quantity	93 units
Recall Number	B-2194-12

Class III Food/Cosmetics Event

Event ID	61467
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	22-Mar-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Defense Nutrition
City	Tarzana
State	CA
Country	US
Distribution Pattern	Distribution was made to IL, MI, MS, AL, CO, MD, TX, GA, NY, KS, AR, FL, NV, WA, CT, UT, VT, PA, LA, TN, NE, MN and OR. Foriegn distribution was made to Canada.

Associated Products

Product Description	Defense Nutrition Warrior Whey Natural Powder, dietary supplement, packaged in 14-oz. bottles and packed 6/14-oz bottles per case.
Code Info	Lot numbers SP1094A2, Exp 04/04/2013; SP1153B2, Exp 06/02/2013; SP1319C2, Exp 11/15/2013 and SP2013C2, Exp 01/13/2014
Classification	Class III
Reason for Recall	The products contain undeclared soy lecithin
Product Quantity	10,380/14-oz bottles
Recall Number	F-1813-2012

Product Description	Defense Nutrition Organic Warrior Whey Powder, Plain, dietary supplement, packaged in 14-oz. bottles and packed 6/14-oz bottles per case. Distributed by Defense Nutrition, Woodland Hills, CA.
Code Info	Lot number SP1332E2, Exp 12/28/2013
Classification	Class III
Reason for Recall	The products contain undeclared soy lecithin
Product Quantity	1,908/14-oz bottles
Recall Number	F-1814-2012

Product Description	Dr. Mercola Miracle Whey Protein Powder, dietary supplement, packaged in 1-lb. bottles and packed 6/1 lb-bottles per case. Distributed by Mercola Health Resources, LLC, Aurora, IL.
Code Info	Lot numbers SP1355B2, Exp. 12/21/2013 and SP2067A2, Exp 3/7/2014
Classification	Class III
Reason for Recall	The products contain undeclared soy lecithin
Product Quantity	17,916/1-lb bottles
Recall Number	F-1815-2012

Class III Biologics Event

Event ID	61783
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Mar-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	American Red Cross Blood Services
City	Farmington
State	CT
Country	US
Distribution Pattern	Connecticut; New York

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced Irradiated
Code Info	033FY66023; 033FY66024; 033FY66025; 033FY66026; 033FY66027; 033FY66028; 033FY66029; 033FY66030; 033FY66031; 033FY66032; 033FY66033; 033FY66034; 033FY66035; 033FY66037; 033FY66038; 033FY66039; 033FY66040; 033FY66041; 033FY66013; 033FY66014; 033FY66015; 033FY66016; 033FY66017; 033FY66018; 033FY66019; 033FY66020; 033FY66021; 033FY66022; 033FY66047; 033FY66048; 033FY66049; 033FY66050; 033FY66051; 033FY66042; 033FY66043; 033FY66044; 033FY66045; 033FY66046;
Classification	Class III
Reason for Recall	Blood products, collected using equipment for which quality control was not performed, were distributed.
Product Quantity	38 units
Recall Number	B-1528-12

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	033FY66036;
Classification	Class III
Reason for Recall	Blood products, collected using equipment for which quality control was not performed, were distributed.
Product Quantity	1 unit
Recall Number	B-1529-12

Class III Biologics Event

Event ID	61882
Status	Ongoing
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	10-May-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Immucor Inc
City	Norcross
State	GA
Country	US
Distribution Pattern	US/Nationwide; Canada, China, Denmark, India, Israel, Japan, Philippines, & Sweden

Associated Products

Product Description	Capture-R Ready Indicator Red Cells
Code Info	Lot/Serial Number 221812
Classification	Class III
Reason for Recall	Capture-R Ready Indicator Cells, with a rate of reported events for equivocal and unexpected positive reactions significantly higher than other lots, were distributed.
Product Quantity	747 units
Recall Number	B-2203-12

Class III Biologics Event

Event ID	61887
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	10-Jan-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Biomat USA, Inc.
City	Salt Lake City
State	UT
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	0630042647;
Classification	Class III
Reason for Recall	Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Product Quantity	1
Recall Number	B-2058-12

Class III Biologics Event

Event ID	62184
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160062308; 2160068966;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	2
Recall Number	B-1843-12

Class III Biologics Event

Event ID	62185
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160081036;
Classification	Class III
Reason for Recall	Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity	1
Recall Number	B-1883-12

Class III Biologics Event

Event ID	62186
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160063498;
Classification	Class III
Reason for Recall	Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity	1
Recall Number	B-1884-12

Class III Biologics Event

Event ID	62187
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160059814; 2160067375;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	2
Recall Number	B-1885-12

Class III Biologics Event

Event ID	62188
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160058180; 2160062907;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	2
Recall Number	B-1886-12

Class III Biologics Event

Event ID	62189
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160073430;
Classification	Class III
Reason for Recall	Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity	1
Recall Number	B-1887-12

Class III Biologics Event

Event ID	62190
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160062987; 2160074078;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	2
Recall Number	B-1888-12

Class III Biologics Event

Event ID	62191
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160063042; 2160063876;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	2
Recall Number	B-1889-12

Class III Biologics Event

Event ID	62192
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160078137;
Classification	Class III
Reason for Recall	Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity	1
Recall Number	B-1890-12

Class III Biologics Event

Event ID	62193
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160064991; 2160069116; 2160070885;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	3
Recall Number	B-1891-12

Class III Biologics Event

Event ID	62194
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160058966; 2160059586;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	2
Recall Number	B-1892-12

Class III Biologics Event

Event ID	62196
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160079822; 2160080589;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	2
Recall Number	B-1894-12

Class III Biologics Event

Event ID	62197
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160063733; 2160065091; 2160066720; 2160068524; 2160069915; 2160083083;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	6
Recall Number	B-1895-12

Class III Biologics Event

Event ID	62198
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160069116; 2160070885; 2160064991;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	3
Recall Number	B-1896-12

Class III Biologics Event

Event ID	62199
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160063963;
Classification	Class III
Reason for Recall	Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity	1
Recall Number	B-1897-12

Class III Biologics Event

Event ID	62221
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160066587; 2160071412;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	2
Recall Number	B-1833-12

Class III Biologics Event

Event ID	62223
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160081922;
Classification	Class III
Reason for Recall	Blood Product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity	1
Recall Number	B-1835-12

Class III Drugs Event

Event ID	62407
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	05-Jun-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Watson Laboratories Inc
City	Corona
State	CA
Country	US
Distribution Pattern	Nationwide.

Associated Products

Product Description	Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125 mg/0.025 mg, 0.15 mg/0.025 mg, 28-count tablets per dispenser (NDC 52544-959-28), packaged in 3-count Tablet Dispensers per carton (NDC 52544-959-31), Rx only Manufactured by: Watson Laboratories, Inc., Corona, CA 92880; Distributed by: Watson Pharma, Inc., Corona, CA 92880.
Code Info	Lot #s: 412572A, 412572B, Exp 11/12
Classification	Class III
Reason for Recall	Impurities/Degradation Products: High Out-of-specification results were obtained for both known and unknown impurities.
Product Quantity	18,938 cartons
Recall Number	D-1436-2012

Class III Food/Cosmetics Event

Event ID	62472
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	29-Jun-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Itoen (USA) Inc
City	Honolulu
State	HI
Country	US
Distribution Pattern	Product was released for distribution in HI.

Associated Products

Product Description	Aloha Maid Natural brand Coconut Water with Pineapple in 11.5 fl oz (340mL) Can; UPC Code: 8-35146-00818-3; 24 cans per case (4 packs X 6 cans each) Product is processed and packaged by ITO EN (USA) INC., Honolulu, Hi
Code Info	The drink can is stamped on the underside with the code: IHMAY0913XXXX; [XXXX = military time of the day; IH = ITO EN HAWAII; MAY0913 = Expiry code presenting product was produced on May 9, 2012 and will expire on May 9, 2013]
Classification	Class III
Reason for Recall	Product has off-smell and off-taste and should not be consumed.
Product Quantity	8,340 cases
Recall Number	F-1817-2012

Class III Biologics Event

Event ID	62501
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	14-Dec-09
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Sunquest Information Systems, Inc.
City	Tucson
State	AZ
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Sunquest Laboratory Blood Bank and Blood Donor
Code Info	Sunquest Blood Bank and Blood Donor versions: Sunquest Blood Bank and Blood Donor versions 6.0.1 Distributed with Sunquest Laboratory 6.1; 6.0.1 Distributed with Sunquest Laboratory 6.2; 6.0.2 Distributed with Sunquest Laboratory 6.3; 6.4 Distributed with Sunquest Laboratory 6.4
Classification	Class III
Reason for Recall	Software, with a glitch or defect, was distributed.
Product Quantity	4 products
Recall Number	B-2202-12

Class III Devices Event

Event ID	62555
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Iris Diagnostics
City	Chatsworth
State	CA
Country	US
Distribution Pattern	Nationwide Distribution

Associated Products

Product Description	IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. Intended Use: IRISpec CA/CB is an assayed QC material for monitoring of the urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) use only.
Code Info	Iris Diagnostics part number 800-0074, lot number 131-12.
Classification	Class III
Reason for Recall	The firm recalled after it received complaints of IRISpec CA/CB two part Urine Chemistry Control, 101131-12, where the nitrite results read negative for the part B control, which should be positive.
Product Quantity	862
Recall Number	Z-2124-2012

Class III Drugs Event

Event ID	62628
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Jul-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Axcentria Pharmaceuticals LLC
City	Telford
State	PA
Country	US
Distribution Pattern	Michigan

Associated Products

Product Description	Major brand Infants' Mapap, Acetaminophen Concentrated Drops, 1 FL. OZ. (30 mL.) 80 mg. per 0.8 mL, Cherry Flavor, Distributed by MAJOR PHARMACEUTICALS, Livonia, MI --- NDC 0904-5255-30,
Code Info	Lot D12044, Exp 4/2014, NDC 0904-5255-30
Classification	Class III
Reason for Recall	Labeling; labeled with incorrect EXP Date; Incorrect expiration date printed on the outer packaging. Package incorrectly states 5/2014 should correctly state 4/2014
Product Quantity	13,128 bottles
Recall Number	D-1441-2012

Mixed Classification Food/Cosmetics Event

Event ID	62622
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	20-Jul-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Spillson's, Ltd.
City	Monroe
State	MI
Country	US
Distribution Pattern	Retail stores, truck stops, Vending facilities in the Monroe Michigan Area.

Associated Products

Product Description	Spillson's Texas BBQ Beef Sandwich, 4 oz.
Code Info	Best By July 20, 2012 - August 3, 2012
Classification	Class I
Reason for Recall	Undeclared soy and wheat found in the flour ingredient of the Texas BBQ Beef sandwich. People with an allergy or sensitivity to soy or wheat run the risk of a serious or life threatening reaction if they consume this product.
Product Quantity	18
Recall Number	F-1818-2012

Product Description	Spillson's Ltd. Bologna & Cheese Sandwich, Nt. Wt. 4 oz
Code Info	Best By July 20-August 3, 2012
Classification	Class II
Reason for Recall	Undeclared wheat found in the flour ingredient, undeclared soy lecithin in cheese product. People with an allergy or sensitivity to wheat or soy run the risk of a serious or life threatening reaction if they consume this product.
Product Quantity	5
Recall Number	F-1819-2012

Product Description	Spillson's Ltd. The Big Sicilian Sandwich Nt. Wt. 7oz
Code Info	Best By July 20-August 3, 2012
Classification	Class II
Reason for Recall	Undeclared yellow # 5 found in the sandwich pepper ingredient. People with a sensitivity to yellow # 5 run the risk of a serious or life threatening reaction if they consume this product.
Product Quantity	17
Recall Number	F-1820-2012

Product Description	Spillson's Ltd. Ham Sandwich Nt. Wt. 7 oz
Code Info	Best By July 20-August 3, 2012
Classification	Class II
Reason for Recall	Undeclared wheat found in the sandwich flour ingredient and undeclared soy lecithin in the cheese ingredient. People with an allergy or sensitivity to wheat or soy run the risk of a serious or life threatening reaction if they consume this product.
Product Quantity	42
Recall Number	F-1821-2012

Product Description	Spillson's Ltd. Meatball Sub Sandwich Nt. Wt. 10 oz
Code Info	Best By July 20-August 3, 2012
Classification	Class II
Reason for Recall	Undeclared wheat found in the sandwich flour ingredient. People with an allergy or sensitivity to wheat run the risk of a serious or life threatening reaction if they consume this product.
Product Quantity	13
Recall Number	F-1822-2012

Product Description	Spillson's Ltd.Greek Pita Sandwich Nt. Wt. 7oz.
Code Info	Best By July 20-August 3, 2012
Classification	Class II
Reason for Recall	Undeclared wheat found in the sandwich flour ingredient. People with an allergy or sensitivity to wheat run the risk of a serious or life threatening reaction if they consume this product.
Product Quantity	51
Recall Number	F-1823-2012

Product Description	Spillson's Ltd. Smoked Turkey & Swiss Pita Sandwich, 7 oz.
Code Info	Best By July 20-August 3, 2012
Classification	Class II
Reason for Recall	Undeclared wheat found in the sandwich flour ingredient. Undeclared soy lecithin in the Cheese ingredient. People with an allergy or sensitivity to wheat run the risk of a serious or life threatening reaction if they consume this product.
Product Quantity	76
Recall Number	F-1824-2012

Product Description	Spillson's Ltd. Ham & Swiss Pita Sandwich, 7 oz.
Code Info	Best By July 20-August 3, 2012
Classification	Class II
Reason for Recall	Undeclared wheat. People with an allergy or sensitivity to wheat or soy run the risk of a serious or life threatening reaction if they consume this product.
Product Quantity	58
Recall Number	F-1825-2012

Product Description	Spillson's Ltd. Ham & Turkey Combo Sandwich, 9 oz.
Code Info	Best By July 20-August 3, 2012
Classification	Class II
Reason for Recall	Undeclared wheat and soy not declared as source of the lecithin ingredient. People with an allergy or sensitivity to wheat or soy run the risk of a serious or life threatening reaction if they consume this product.
Product Quantity	42
Recall Number	F-1826-2012

Product Description	Spillson's Ltd. Sausage & Egg Muffin Sandwich, 6oz.
Code Info	Best By July 20-August 3, 2012
Classification	Class II
Reason for Recall	Sandwich contains undeclared wheat in flour ingredient and undeclared soy lecithin in cheese ingredient. People with an allergy or sensitivity to wheat or soy run the risk of a serious or life threatening reaction if they consume this product.
Product Quantity	34
Recall Number	F-1827-2012

Product Description	Spillson's Ltd. Club Sub Sandwich, 7oz.
Code Info	Best By July 20-August 3, 2012
Classification	Class II
Reason for Recall	Sandwich contains undeclared wheat in flour ingredient . People with an allergy or sensitivity to wheat run the risk of a serious or life threatening reaction if they consume this product.
Product Quantity	33
Recall Number	F-1828-2012

Product Description	Spillson's Ltd. Roast Beef Sandwich 97% Fat Free, 7oz.
Code Info	Best By July 20-August 3, 2012
Classification	Class II
Reason for Recall	Sandwich contains undeclared wheat in flour ingredient and undeclared soy lecithin in the cheese ingredient. People with an allergy or sensitivity to wheat or soy run the risk of a serious or life threatening reaction if they consume this product.
Product Quantity	8
Recall Number	F-1829-2012

Product Description	Spillson's Ltd. Super Italian Sandwich , 10 oz.
Code Info	Best By July 20-August 3, 2012
Classification	Class II
Reason for Recall	Sandwich contains undeclared wheat in flour ingredient, undeclared yellow #5 in the pepper ingredient. People with an allergy or sensitivity to wheat or soy run the risk of a serious or life threatening reaction if they consume this product.
Product Quantity	69
Recall Number	F-1830-2012

Product Description	Spillson's Ltd. Pizza Boat, 4 oz.
Code Info	Best By July 20-August 3, 2012
Classification	Class II
Reason for Recall	Sandwich contains undeclared wheat in flour ingredient. People with an allergy or sensitivity to wheat run the risk of a serious or life threatening reaction if they consume this product.
Product Quantity	4
Recall Number	F-1831-2012

Product Description	Spillson's Ltd. Cheeseburger Sandwich.
Code Info	Best By July 20-August 3, 2012
Classification	Class II
Reason for Recall	Sandwich contains undeclared soy lecithin found in the cheese ingredient. People with an allergy or sensitivity to wheat run the risk of a serious or life threatening reaction if they consume this product.
Product Quantity	8
Recall Number	F-1832-2012

Product Description	Spillson's Ltd. Double Cheeseburger Sandwich.
Code Info	Best By July 20-August 3, 2012
Classification	Class II
Reason for Recall	Sandwich contains undeclared soy lecithin found in the cheese ingredient. People with an allergy or sensitivity to wheat run the risk of a serious or life threatening reaction if they consume this product.
Product Quantity	20
Recall Number	F-1833-2012

Product Description	Spillson's Ltd. Breakfast Muffin Sandwich, 6 oz Ham
Code Info	Best By July 20-August 3, 2012
Classification	Class II
Reason for Recall	Sandwich contains undeclared wheat found in the flour ingredient and undeclared soy lecithin found in the cheese ingredient. People with an allergy or sensitivity to wheat run the risk of a serious or life threatening reaction if they consume this product.
Product Quantity	31
Recall Number	F-1834-2012

Mixed Classification Biologics Event

Event ID	61799
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	30-Mar-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	Blood Assurance Inc
City	Chattanooga
State	TN
Country	US
Distribution Pattern	Tennessee; Indiana

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W043211063102; W043210098418; W043210058610;
Classification	Class II
Reason for Recall	Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity	3
Recall Number	B-1534-12

Product Description	Recovered Plasma
Code Info	W043211063102; W043210098418; W043210058610;
Classification	Class III
Reason for Recall	Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity	3
Recall Number	B-1535-12

Product Description	Platelets Pooled
Code Info	W043210058610;
Classification	Class II
Reason for Recall	Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Product Quantity	1
Recall Number	B-1536-12

Mixed Classification Drugs Event

Event ID	61967
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	25-May-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Mallinckrodt Inc.
City	Hobart
State	NY
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mallinckrodt Inc., Hazelwood, MO 63042 USA, NDC 0406-0375-16, UPC 3 0406-0375-16 1.
Code Info	Lot #: 0375T79384, Exp 05/13; 0375T81348, Exp 09/13; 0375U82277, Exp 01/14
Classification	Class III
Reason for Recall	Subpotent (Multiple Ingredient) Drug: Low out of specification assay results for the hydrocodone bitartrate ingredient was found.
Product Quantity	41,100 bottles
Recall Number	D-1430-2012

Product Description	Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mallinckrodt Inc., Hazelwood, MO 63042 USA, NDC 0406-0375-16, UPC 3 0406-0375-16 1.
Code Info	Lot #: 0375P76192, Exp 07/12; 0375T80512, Exp 08/13; 0375T81209, Exp 09/13
Classification	Class II
Reason for Recall	CGMP Deviations: This product is being recalled because expired flavoring was used in the manufacturing of these lots.
Product Quantity	44,330 bottles
Recall Number	D-1431-2012

Mixed Classification Biologics Event

Event ID	62195
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Plasmacare Inc
City	Cleveland
State	OH
Country	US
Distribution Pattern	California

Associated Products

Product Description	Source Plasma
Code Info	2160082085; 2160070284; 2160069890; 2160073365;
Classification	Class III
Reason for Recall	Blood Products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Product Quantity	4
Recall Number	B-1893-12

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