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Enforcement Report - Week of October 17, 2012

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Biologics Devices Drugs Food / Cosmetics Veterinary

Class I Devices Event

Event ID	63059
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-Sep-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Baxter Healthcare Corp.
City	Round Lake
State	IL
Country	US
Distribution Pattern	Worldwide Distribution - US Nationwide and Internationally to Canada, Costa Rica, Australia, New Zealand, Hong Kong, and the United Kingdom.

Associated Products

Product Description	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Code Info	product code 2C7519, all lots
Classification	Class I
Reason for Recall	Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within the burette.
Product Quantity	278,420 units
Recall Number	Z-0012-2013

Product Description	Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Code Info	product code 2H7519, all lots
Classification	Class I
Reason for Recall	Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within the burette.
Product Quantity	1,995,040 units
Recall Number	Z-0013-2013

Product Description	Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Code Info	product code 2C8819, all lots
Classification	Class I
Reason for Recall	Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within the burette.
Product Quantity	2,265,453 units
Recall Number	Z-0014-2013

Product Description	Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Code Info	product code 2H8819, all lots
Classification	Class I
Reason for Recall	Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within the burette.
Product Quantity	488,504 units
Recall Number	Z-0015-2013

Class I Food/Cosmetics Event

Event ID	63074
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	31-Aug-12
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	Manna Organics Inc
City	Newark
State	NJ
Country	US
Distribution Pattern	NY, NJ, PA, MA, VA, MD, CT, GA, IL, and TX

Associated Products

Product Description	SooNyeoWon Soybean Sprouts (5 lbs., 10 lbs., and 16-ounce packages - all packaged in plastic bags). 16-oz bag UPC 0 28346 07121 8; Manna Organics Inc. 170 Avenue 'L', Newark, NJ 07105; MSB West, LLC 622 South Anderson Street, Los Angeles, CA 90023
Code Info	Unknown
Classification	Class I
Reason for Recall	Products have the potential to be contaminated with Listeria monocytogenes.
Product Quantity	10 pound bags (9207 units); 5 pound bags (1944 cases); 16 oz. - 2834 cases
Recall Number	F-0097-2013

Product Description	SooNyeoWon and Jinga brand Firm Tofu; Net Wt. 16 oz., in square white plastic container, UPC 0 28346 07812 5 and 0 28346 09112 4, respectively. Manna Organics Inc. 170 Avenue 'L', Newark, NJ 07105; MSB West, LLC 622 South Anderson Street, Los Angeles, CA 90023
Code Info	Exp date 9/8/2012 or later
Classification	Class I
Reason for Recall	Products have the potential to be contaminated with Listeria monocytogenes.
Product Quantity	SooNyeoWon Firm Tofu -3437 cases;Jinga Firm Tofu- 3518 cases
Recall Number	F-0098-2013

Product Description	Soy Milk, 1.3 gallon, packaged in a white plastic pail, UPC 0 28346 07140 9. Produced by Manna Organics Inc. 170 Avenue 'L', Newark, NJ 07105.
Code Info	Unknown
Classification	Class I
Reason for Recall	Products have the potential to be contaminated with Listeria monocytogenes.
Product Quantity	220 units
Recall Number	F-0099-2013

Product Description	SooNyeoWon Healthy Soybean Sprouts, 16 ounce package; Manna Organics Inc. 170 Avenue 'L', Newark, NJ 07105; MSB West, LLC 622 South Anderson Street, Los Angeles, CA 90023
Code Info	On or after July 18, 2012
Classification	Class I
Reason for Recall	Products have the potential to be contaminated with Listeria monocytogenes.
Product Quantity	16 ounce bags (2834 cases)
Recall Number	F-0100-2013

Product Description	SooNyeoWon and Jinga brand Soft Tofu 16 oz. in square, plastic containers, UPC 0 28346 07814 9 (SooNyeoWon). Manna Organics Inc. 170 Avenue 'L', Newark, NJ 07105; MSB West, LLC 622 South Anderson Street, Los Angeles, CA 90023
Code Info	9/8/2012 or later
Classification	Class I
Reason for Recall	Products have the potential to be contaminated with Listeria monocytogenes.
Product Quantity	2926 cases
Recall Number	F-0101-2013

Product Description	SooNyeoWon Silken Tofu; 14 oz. plastic container, UPC 0 28346 09113 1. Manna Organics Inc. 170 Avenue 'L', Newark, NJ 07105; MSB West, LLC 622 South Anderson Street, Los Angeles, CA 90023
Code Info	9/8/2012 or later
Classification	Class I
Reason for Recall	Products have the potential to be contaminated with Listeria monocytogenes.
Product Quantity	SooNyeoWon Silken Tofu - 140 cases; 697 units
Recall Number	F-0102-2013

Product Description	Labeled in Korean as Healthy Tofu, 5-pieces and 10 pieces, UPC 028346091292. Manna Organics Inc. Newark, NJ.
Code Info	7/25/2012 or later
Classification	Class I
Reason for Recall	Products have the potential to be contaminated with Listeria monocytogenes.
Product Quantity	3320 units
Recall Number	F-0103-2013

Product Description	Soon Tofu, 30-pieces packaged in large, white, plastic bucket. Manna Organics Inc. Newark, NJ
Code Info	7/24/2012 or later
Classification	Class I
Reason for Recall	Products have the potential to be contaminated with Listeria monocytogenes.
Product Quantity	Tofu Large Bucket -3356 units; Soon Tofu-3150 units
Recall Number	F-0104-2013

Class I Food/Cosmetics Event

Event ID	63099
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	29-Aug-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Spokane Produce, Inc.
City	Spokane
State	WA
Country	US
Distribution Pattern	Retail accounts in ID, MT and WA

Associated Products

Product Description	Pico De Gallo in a plastic container labeled: "Pineapple/Mango Pico De Gallo Roma Tomato, Pineapple, Mango, Red Onion, Green Bell Pepper, Anaheim Pepper, Cilantro Lime Juice, jalapeno Pepper, Salt 88694 83987 Keep Refrigerated Best used by: 09/10/12 Packed by Spokane Produce, Inc 1905 S Geiger Blvd Spokane, WA 16 oz (454g)"
Code Info	"Best used by: 09/10/12"
Classification	Class I
Reason for Recall	Daniella brand mangoes recalled because they may be contaminated with Salmonella. Mangoes were used to manufacture Pico De Gallo.
Product Quantity	128/16 oz. containers
Recall Number	F-0080-2013

Class I Food/Cosmetics Event

Event ID	63106
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Sep-12
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	Eco Health, Inc.
City	Newhall
State	CA
Country	US
Distribution Pattern	Nationwide in the US

Associated Products

Product Description	florAlign Prebiotic Formula, sizes: 90g, 180g, 270g
Code Info	UPC code #'s FA02-90GM, FA02-180GM, and FA02-270GM
Classification	Class I
Reason for Recall	Eco Health is recalling florAlign Prebiotic Formula because it has the potential to be contaminated with Salmonella.
Product Quantity	274 units
Recall Number	F-0084-2013

Class I Food/Cosmetics Event

Event ID	63151
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	10-Sep-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Forever Cheese Inc
City	Astoria
State	NY
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Marte brand Frescolina Ricotta Salata. Matured and packed by: Fattorie Chiarappa SRL VIA Dell'ulvio, 5 Conversano (BA) - Italy. --- Product is vacuum packaged and is labeled with a round label. Product may also be cut into smaller wedges, but will still have the same Frescolina Ricotta Salata label.
Code Info	all lots and all production codes. Includes T5086/440220, T5520/440315, T6048/440417, T6528/440519, T7012/440703, T7452/440601, T7939/440822, T8419/441003, T8899/441020, T9425/441202, T9962/441227, U1392/450126
Classification	Class I
Reason for Recall	Frescolina brand Ricotta Salata cheeses found positive for Listeria Monocytogenes resulting from CA state and FDA sampling.
Product Quantity	835 cases
Recall Number	F-0078-2013

Class I Food/Cosmetics Event

Event ID	63164
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Aug-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Newark Nut Stores, Inc.
City	Cranford
State	NJ
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Organic Pine Nuts (Raw, No Shell) 1 lb.Nuts.com NutsOnline, 125 Moen Street, Cranford, NJ 07016 800-558-8881
Code Info	Lot 97368
Classification	Class I
Reason for Recall	Pine nuts may contain peanuts
Product Quantity	870 lbs.
Recall Number	F-0028-2013

Class I Devices Event

Event ID	63174
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	29-Apr-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Accutron Inc
City	Phoenix
State	AZ
Country	US
Distribution Pattern	US Nationwide Distribution

Associated Products

Product Description	Flow Meter, CM Assembly, Model #27025, Serial # 13686, 13690, 13712, 13793. Flowmeter, CM Assembly, Model#31970, Serial#13692. Product Usage: Conscious Sedation Unit Analgesia Gas Machine.
Code Info	Model#27025: Lot # 73971, 74929. Model#31970: Lot#74142.
Classification	Class I
Reason for Recall	Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner.
Product Quantity	220 units total
Recall Number	Z-0017-2013

Product Description	Ultra PC% Cabinet Mount Package G, Model #36600, Serial # 13593, 13594, 13595, 13596, 13597, 13598, 13599, 13600, 13602, 13605, 13610, 13611, 13612, 13615, 13616, 13617, 13621, 13622, 13624, 13625, 13627, 13628, 13633, 13634, 13635, 13636, 13637, 13638, 13639, 13640, 13642, 13643, 13644, 13647, 13650, 13669, 13675, 13673, 13678, 13679, 13680, 13683, 13685, 13687, 13691, 13693, 13694, 13695, 13696, 13697, 13701, 13702, 13705, 13706, 13709, 13710, 13711, 13724, 13725, 13728, 13729, 13735, 13739, 13743, 13746, 13750, 13751, 13753, 13754, 13755, 13756, 13760, 13762, 13766, 13774, 13775, 13777, 13781, 13782, 13783, 13785, 13786, 13788, 13792, 13794, 13796, 13799, 13800, 13803, 13804, 13809, 13810, 28298, 28299, 28304, 28305, 28306, 28307, Ultra PC% Cabinet Mount Pkg I, Model #36800, Serial # 13601, 13603, 13607, 13608, 13609, 13613, 13618, 13620, 13623, 13626, 13629, 13630, 13631, 13632, 13641, 13645, 13646, 13648, 13649, 13651, 13652, 13653, 13654, 13655, 13656, 13657, 13658, 13659, 13660, 13661, 13665, 13666, 13667, 13668, 13671, 13672, 13674, 13676, 13677, 13684, 13688, 13689, 13698, 13700, 13707, 13723, 13727, 13730, 13732, 13734, 13741, 13742, 13757, 13758, 13759, 13761, 13762, 13763, 13764, 13765, 13767, 13769, 13789, 13790, 13791, 13795, 13797, 13801, 13802, 13806, 13808, 28300, 28302, 28303, Ultra PC% Cabinet Mount Pkg G, Model#36600-NS, Serial# 13805, 13807, 13811, 13812. Ultra PC% Cabinet Mount Pkg H, Model#36800-NS, Serial# 13744, 13745,13752, 13773, 13774, 13778, 13779, 13780 Product Usage: Conscious Sedation Unit Analgesia Gas Machine.
Code Info	Model #36600, Lot # 73778, 73740, 73851, 73920, 74475, 74035, 74012, 74219, 74118, 74471, 75583, 74372, 75049, 74745, 75049, 75283, 75616, 75299, 74926, 75767, 75344, 75311, 74513. Model #36800, Lot# 73739, 73852, 74011, 73921, 74470, 74032, 74011, 73969, 74139, 74125, 74204, 74220, 74143, 74617, 74573, 74746, 75584, 75449, 74927, 75617, 74568 Model#36600-NS, Lot#75328. Model#36800-NS, Lot#75286.
Classification	Class I
Reason for Recall	Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner.
Product Quantity	220 units total
Recall Number	Z-0018-2013

Product Description	CM Flowmeter Pkg H, Model #36700, Serial # 13749 Product Usage: Conscious Sedation Unit Analgesia Gas Machine.
Code Info	Lot # 75285
Classification	Class I
Reason for Recall	Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner.
Product Quantity	220 units total
Recall Number	Z-0019-2013

Product Description	Newport Portable Package, Model #50000, Serial # 13591, 13592, 13604, 13606, 13614, 13662, 13663, 13664, 13726, 13731, 13733, 13736, 13737, 13738, 13740, 13768, 13770, 13771, 13772, 13784, 13787. Product Usage: Portable Analgesia Gas Machine.
Code Info	Lot # 73656, 74139, 75209, 74689, 75515, 74858.
Classification	Class I
Reason for Recall	Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner.
Product Quantity	220 units total
Recall Number	Z-0020-2013

Class I Food/Cosmetics Event

Event ID	63202
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	11-Sep-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	GM Distributing Co, Inc
City	Hidalgo
State	TX
Country	US
Distribution Pattern	AZ, GA, IL, MN, NY, and TX

Associated Products

Product Description	Marathon brand- 4 kilo boxes, label on the mango says "MARATHON...PRODUCE OF MEXICO", 952 ctns. of number 6 mangos, 714 ctns. of number 7's, 1186 ctns. of number 8's, 952 ctns. of number 9's, 714 ctns. of number 10's, 476 ctns. of number 12's.
Code Info	DH80 is lot code of recalling firm
Classification	Class I
Reason for Recall	GM Produce Sales is voluntarily recalling 4994 cartons of Marathon Brand mangos packed at Agricola Daniella, in Los Mochis, Sinaloa, because it has the potential to be contaminated with Salmonella gaminara, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
Product Quantity	4994 CARTONS
Recall Number	F-0027-2013

Class I Food/Cosmetics Event

Event ID	63208
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	15-Sep-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	United Salad Company
City	Portland
State	OR
Country	US
Distribution Pattern	Distributed to wholesale and retail customers in Alaska, Idaho, Montana, Oregon and Washington

Associated Products

Product Description	Fruit Medley - 1) Zupan's brand Island Medley 12 oz UPC 92504723497 2) Mary's Select brand Island Fruit Medley - 12 oz UPC 9250473497 3) Mary's Select brand Fruit Mix Ensalada - 12 oz UPC 9250473216 4) Trader Joe's Plant Code: P-002 brand - Tropical Fruit Medley - 1 lb UPC 0094-9361
Code Info	1) Best if Sold By 09/02/12 - 09/17/12 2) Best if Sold By 09/02/12 - 09/17/12 3) Best if Sold By 09/02/12 - 09/17/12 4) Best By: 09/02/12 - 09/18/12
Classification	Class I
Reason for Recall	The mangos used to manufacturer the products may be contaminated with Salmonella.
Product Quantity
Recall Number	F-0081-2013

Product Description	Fruit Mango diced, peeled halves or spears 1) United Salad Co. brand Mango Diced 5 lb no UPC 2) United Salad Co brand Mango Peeled Halves 1 lb not UPC 3) Garden Highway Plant Code: P-002 Mango Spears 24 oz UPC 826766-214068
Code Info	1) Packed on 8/28/12- 9/7/12 2) Packed on 8/28/12 - 9/7/12 3) Best if Sold By: 09/02/12 - 9/17/12
Classification	Class I
Reason for Recall	The mangos used to manufacturer the products may be contaminated with Salmonella.
Product Quantity
Recall Number	F-0082-2013

Product Description	Mango Salsa 1) Garden Highway Plant Code: P-002 brand Mango Salsa 9 oz UPC 826766-422005 2) Mary's Select brand Tropical Salsa 16 oz UPC 9250474578 3) Mary's Select brand Tropical Salsa 16 oz UPC 9250474569 4) Garden Highway Plant Code: P-002 brand Salsa Tropical Fresh 11 oz UPC 826766-422104
Code Info	1) Best if Sold By: 09/02/12 - 09/17/12 2) Best if Sold By: 09/02/12 - 09/17/12 3) Best if Sold By: 09/02/12 - 09/17/12 4) Best if Sold By: 09/02/12 - 09/17/12
Classification	Class I
Reason for Recall	The mangos used to manufacturer the products may be contaminated with Salmonella.
Product Quantity
Recall Number	F-0083-2013

Class I Food/Cosmetics Event

Event ID	63210
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Sep-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Cut Fruit Express, Inc.
City	Inver Grove Heights
State	MN
Country	US
Distribution Pattern	MI, MN, WI

Associated Products

Product Description	CANTALOUPE, HONEY DEW, PINEAPPLE AND GRAPES (CHPG) UNDER THE FOLLOWING BRANDS: Indianhead Foods 13105 FRUIT MIX CHPG 5# Manufactured by Cut Fruit Express Mpls, MN 55076 Following products Distributed by H. Brooks & Co. Mpls, MN 55112: H.Brooks & Company 31165 MIXED FRUIT CHPG 4/16OZ 16oz 4 per case UPC# 0 3823231165 6. Festival Foods-Best Of The Season 31165 MIXED FRUIT CHPG 4/16OZ 16oz 4 per case UPC# 0 3823231165 6. Kitchen Cravings Kwik Trip #1 31595 FRUIT CUP MIX Chunks 5.5oz 24 per case UPC# 0 3977955262 5. Kitchen Cravings Kwik Trip #31616 Fruit Tray 16 oz 12 per case UPC#0 3977955265 6. Supermom's /Super America-Goodies-to go! 31595 FRUIT MIX CHPG 5.5 oz 24 per case UPC# 76391390250 1. H.Brooks 34382 MIXED FRUIT CHPG Net Wt 8 oz(227g) 6 per case 19 UPC# 0 3823234382 4. H.Brooks 37663 FRUIT MIXED CHPG Net Wt 12oz(340g) 4 per case 175 UPC# 0 3823237663 1.
Code Info	Use by 9/11 - 9/14
Classification	Class I
Reason for Recall	Cut Fruit Express, Inc processed cantaloupe that was later recalled by the supplier DFI Marketing due to a positive Salmonella sample.
Product Quantity	372 Cases total
Recall Number	F-0029-2013

Product Description	CANTALOUPE: UPPER LAKES Foods 142901 CANTALOUPE CHUNK 2/3# UPPER LAKES Foods 142800 CANTALOUPE HALVED/PEELED 2/5# & 5# USF 4259982 CANTALOUPE DICED 1/2" X 1/2" 2/5# CCP USF 4384418 CANTALOUPE CHUNKS 25# USF 8138646 CANTALOUPE CHUNK 4/5# USF 5985015 CANTALOUPE CHUNK 5# USF 0900001 CANTALOUPE PLD & HALVED 10# Manufactured by Cut Fruit Express, Mpls MN 55076. The following products Distributed by H Brooks & Co Mpls MN 55112: H.Brooks 37575 CANTALOUPE CHUNK Net WT 16 oz (454g) 4 per case 57 UPC# 03823237575 7. H.Brooks 33326 CANTALOUPE CHUNK 5# Net Wt 80 oz (2268g) 1 per case 02 UPC# 0383233326 9. Festival Foods-Best Of The Season H.Brooks 33326 CANTALOUPE CHUNK 5# Net Wt 80 oz (2268g) 1 per case 02 UPC# 0383233326 9. H.Brooks 31931 CANTALOUPE FRUIT CUP 6/5.5 Net Wt 5.5oz(16g) 6 per case 164 UPC# 03823231931 7. Festival Foods-Best of the Season 31931 H.Brooks 31931 CANTALOUPE FRUIT CUP 6/5.5 Net Wt 5.5oz(16g) 6 per case 164 UPC# 03823231931 7. H.Brooks 37567 CANTALOUPE CHUNK 4/12OZ Net Wt 12oz(340g) 4 per case 46 UPC# 0 3823237567 2. H.Brooks 26868 CANTALOUPE SLICES Net Wt 10 oz (284g) 3 per case 214 UPC# 0 3823226868 4. Reinhart Marshall 32774 CANTALOUPE DICE 40/1/2Cup Net Wt 3 oz (85g) 40 per case 360 CCP. Holiday Pantry 31561 Cantaloupe Chunks Net Wt 5.5oz (156g) 24 per case 309 UPC# 0 3823231561 6. Kitchens Cravings Cantaloupe Kwik Trip 31561 CANTALOUPE Chunks 5.5oz 24 per case UPC# 03977955259 5.
Code Info	Use-by 9/11 to 9/14
Classification	Class I
Reason for Recall	Cut Fruit Express, Inc processed cantaloupe that was later recalled by the supplier DFI Marketing due to a positive Salmonella sample.
Product Quantity
Recall Number	F-0030-2013

Product Description	CANTALOUPE, HONEY DEW, GRAPES (CHG) UNDER THE FOLLOWING BRANDS: USF 0811125 FRUIT MIX CHG RECEPTION 25# Manufactured by Cut Fruit Express Mpls., MN 55076. The following products Distributed By H. Brooks & Co. Mpls MN 55112: Festival Best of the Season Medley Fruit Cup H.Brooks 31907 Net Wt 5.5 oz. (156g) 6 units per case 158 UPC# 0 3823231907 2. H.Brooks 31907 Medley Fruit Cup Net Wt 5.5 oz. (156g) 6 units per case 158 UPC# 0 3823231907 2. Holiday Pantry 32096 Fruit Medley Mix Net Wt 5.5 OZ (1256G) 24 units per case UPC# 0 3823232096 2. H.Brooks 37647 MIXED FRUIT CHG Net Wt 12oz( 340g) 4 per case 173 UPC# 0 3823237647 1. Festival Foods-Best Of The Season H. Brooks 37655 MIXED FRUIT CHG Net Wt 16oz(454g) 4 per case 174 UPC# 0 3823237655 6.
Code Info	Use-by 9/11 to 9/14
Classification	Class I
Reason for Recall	Cut Fruit Express, Inc processed cantaloupe that was later recalled by the supplier DFI Marketing due to a positive Salmonella sample.
Product Quantity	372 cases total.
Recall Number	F-0031-2013

Product Description	CANTALOUPE, WATERMELON, HONEY DEW, RED GRAPES: Festival Foods-Best Of The Season 30787 H.Brooks Melon Mix Slices Net Wt. 12 oz. (340g) 3 units per case 331 UPC# 0 3823230787 1.
Code Info	Use-by 9/11 to 9/14
Classification	Class I
Reason for Recall	Cut Fruit Express, Inc processed cantaloupe that was later recalled by the supplier DFI Marketing due to a positive Salmonella sample.
Product Quantity	372 cases total
Recall Number	F-0032-2013

Product Description	CANTALOUPE, HONEYDEW, GRAPE, PINEAPPLE, STRAWBERRY: Festival Foods-Best Of The Season 32299 H. Brooks FRUIT BOWL CHPGS 3# Net Wt 48 oz (1362g) K280 2 per case UPC# 0 3823232299 7. Distributed by H.Brooks & Co Mpls MN 55112
Code Info	Use-by 9/11 to 9/14
Classification	Class I
Reason for Recall	Cut Fruit Express, Inc processed cantaloupe that was later recalled by the supplier DFI Marketing due to a positive Salmonella sample.
Product Quantity	372 cases total
Recall Number	F-0033-2013

Product Description	CANTALOUPE, HONEYDEW, PINEAPPLE AND RED GRAPE, DIP: H.Brooks 33478 FRUIT TRAY w/dip 2.5# Net Wt 40 oz (1134 g) 292 2 per case UPC# 0 3823233478 5. H.Brooks 38279 FRUIT TRAY w/Dip 3# Net Wt 48 oz (1361g) 2 per case 101 UPC# 03823238279 3. H.Brooks 38287 FRUIT TRAY w/Dip 2# DIP Net Wt 32 oz (907g) 4 per case 17 UPC# 0 3823238287 8. Distributed By H. Brooks & Co. Mpls MN 55112
Code Info	Use-by 9/11 to 9/14
Classification	Class I
Reason for Recall	Cut Fruit Express, Inc processed cantaloupe that was later recalled by the supplier DFI Marketing due to a positive Salmonella sample.
Product Quantity	372 cases total.
Recall Number	F-0034-2013

Product Description	CANTALOUPE, PINEAPPLE AND WATERMELON: H.Brooks & Company 33531 FRUIT MIX CPW SPEARS 15oz (425g) 4 per case UPC# 0 3823233531 7. Distributed by H. Brooks & Co Mpls. MN55112.
Code Info	Use-by 9/11 to 9/14
Classification	Class I
Reason for Recall	Cut Fruit Express, Inc processed cantaloupe that was later recalled by the supplier DFI Marketing due to a positive Salmonella sample.
Product Quantity	372 cases total.
Recall Number	F-0035-2013

Product Description	CANTALOUPE, HONEYDEW: Festival Foods-Best Of The Season 46981 H. Brooks Fruit Mix CH Net Wt 5.5 oz (156g) 6 per case 384 UPC# 0 3823246981 4. H.Brooks 46981 46981 H. Brooks Fruit Mix CH Net Wt 5.5 oz (156g) 6 per case 384 UPC# 0 3823246981 4. Distributed by H. Brooks & Co. Mpls. MN 55112.
Code Info	Use-by 9/11 to 9/14
Classification	Class I
Reason for Recall	Cut Fruit Express, Inc processed cantaloupe that was later recalled by the supplier DFI Marketing due to a positive Salmonella sample.
Product Quantity	372 cases total.
Recall Number	F-0036-2013

Product Description	CANTALOUPE, HONEYDEW, WATERMELON: Festival Foods-Best Of The Season 37461 H. Brooks Melon Medley Chunk Net Wt 16 oz (454g) 4 per case 135 UPC 0 3823237461 3. H. Brooks Melon Medley Chunk Net Wt 16 oz (454g) 4 per case 135 UPC 0 3823237461 3.. Distributed by H. Brooks & Co. Mpls. MN 55112.
Code Info	Use-by 9/11 to 9/14
Classification	Class I
Reason for Recall	Cut Fruit Express, Inc processed cantaloupe that was later recalled by the supplier DFI Marketing due to a positive Salmonella sample.
Product Quantity	372 cases total.
Recall Number	F-0037-2013

Class I Food/Cosmetics Event

Event ID	63216
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	18-Sep-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Kroger Co
City	Cincinnati
State	OH
Country	US
Distribution Pattern	Product was shipped to the following states: AL, GA, IL, IN, KS, KY, MI, MO, NC, NE, OH, SC, TN, VA & WV.

Associated Products

Product Description	FRESH SELECTIONS by Kroger" Tender Spinach NET WT 10 OZ (283g) BEST IF USED BY 09/16/12 Product of USA 10:09 HarvestMark.com, 1104 A244 0105 KN01 INGREDIENTS: SPINACH DISTRIBUTED BY THE KROGER COM. CINCINNATI OHIO 45202
Code Info	BEST IF USED BY 09/16/12 Product of USA 10:09 HarvestMark.com, 1104 A244 0105 KN01
Classification	Class I
Reason for Recall	The firm was notified by the Ohio Department of Agriculture of positive Listeria Monocytogenes in their Fresh Selection Tender Spinach.
Product Quantity	910 cs/12/10 oz bags
Recall Number	F-0085-2013

Class I Food/Cosmetics Event

Event ID	63222
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-Sep-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	3fish Inc.
City	Gastonia
State	NC
Country	US
Distribution Pattern	NC and SC

Associated Products

Product Description	Maryland Crab Cake Bulk (fresh), #81868, 4oz @2x8ct, Net Wt. 4 lbs, Packed by 3fish, Inc.
Code Info	Item #79003, Lot #22YAW1A1235 (Diced Yellow Onions)
Classification	Class I
Reason for Recall	Products were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination.
Product Quantity	65 cases (16/4oz pkgs per case)
Recall Number	F-0038-2013

Product Description	Charl Crab Cake Bulk (fresh), #81873, 2x8ct, 4 oz, Net Wt. 4 lbs, Packed by 3fish, Inc.
Code Info	Item #79009, Lot #22YAW1A1235 (Diced Yellow Onions)
Classification	Class I
Reason for Recall	Products were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination.
Product Quantity	152 cases (16/4oz pkgs per case)
Recall Number	F-0039-2013

Product Description	Crab Stuffing Bucket (fresh and frozen), #84480, 5 lb Tub, Net St: 5 lbs, Packed by 3fish, Inc.
Code Info	Item #79011, Lot #22YAW1A1235 (Diced Yellow Onions)
Classification	Class I
Reason for Recall	Products were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination.
Product Quantity	46 cases (5 lb tub)
Recall Number	F-0040-2013

Product Description	HT Signature Lump Crab Cake (Fresh), #81791, 4 oz @ 2x8ct, Net wt. 4 lbs, Packed by 3fish, Inc.
Code Info	Item #79018, Lot #22YAW1A1235 (Diced Yellow Onions)
Classification	Class I
Reason for Recall	Products were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination.
Product Quantity	677 cases (16/4oz pkgs per case)
Recall Number	F-0041-2013

Product Description	Carolina Style Crab Cakes (Frozen), 2 x 8ct INGLES, Net Wt 4 lbs, Packed by 3fish, Inc.
Code Info	Item #79035, Lot #22YAW1A1235 (Diced Yellow Onions)
Classification	Class I
Reason for Recall	Products were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination.
Product Quantity	314 cases (16/4oz pkgs per case)
Recall Number	F-0042-2013

Product Description	Frozen Crab Bites, ½ oz, Bulk 100 x 0.5oz, Net Wt: 50 oz, Packed by 3fish, Inc.
Code Info	Item #79037, Lot #22YAW1A1235 (Diced Yellow Onions)
Classification	Class I
Reason for Recall	Products were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination.
Product Quantity	77 cases (100/5 oz units per case)
Recall Number	F-0043-2013

Product Description	MD Crab Cakes - Value Tray Pack (Frozen), 6 4x3oz, Customer Item: 504583, Packed by 3fish, Inc.
Code Info	Item #79048, Lot #22YAW1A1235 (Diced Yellow Onions)
Classification	Class I
Reason for Recall	Products were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination.
Product Quantity	24 cases (24/3 oz pkgs per case)
Recall Number	F-0044-2013

Product Description	Harris Teeter, Atlantic Stuffed Salmon 8ct (Fresh)
Code Info	Item #79202, Lot #22YAW1A1235 (Diced Yellow Onions)
Classification	Class I
Reason for Recall	Products were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination.
Product Quantity	347 lbs (8 ct/lb)
Recall Number	F-0045-2013

Product Description	Harris Teeter, Stuffed Tilapia 8ct (Fresh)
Code Info	Item #79203, Lot #22YAW1A1235 (Diced Yellow Onions)
Classification	Class I
Reason for Recall	Products were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination.
Product Quantity	234 lbs (8ct/lb)
Recall Number	F-0046-2013

Product Description	Harris Teeter, Stuffed Flounder 8ct (Fresh).
Code Info	Item #79204, Lot #22YAW1A1235 (Diced Yellow Onions)
Classification	Class I
Reason for Recall	Products were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination.
Product Quantity	196 lbs (8ct/lb)
Recall Number	F-0047-2013

Product Description	HT Premium Lobster Cake (fresh), 3 oz @ 2x8ct, Net Wt: 3 lbs, Packed by 3fish, Inc.
Code Info	Item #79420, Lot #22YAW1A1235 (Diced Yellow Onions)
Classification	Class I
Reason for Recall	Products were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination.
Product Quantity	18 cases (16/3oz. per case)
Recall Number	F-0048-2013

Product Description	Jalapeno Salmon Cake 3oz (Fresh), 4 oz @ 2x8ct, Net Wt: 3 lbs, Packed by 3fish, Inc.
Code Info	Item #79103, Lot #22YAW1A1235 (Diced Yellow Onions)
Classification	Class I
Reason for Recall	Products were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination.
Product Quantity	8 cases (16/3oz pkgs per case)
Recall Number	F-0049-2013

Class I Food/Cosmetics Event

Event ID	63256
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	22-Sep-12
Initial Firm Notification of Consignee or Public	Press Release

Recalling Firm	Fresh Express Incorporated
City	Salinas
State	CA
Country	US
Distribution Pattern	Initial distribution to: IL, MI, MN, ND, NY, NJ, SD, WI, IA, IN, OH and PA. Waiting for distribution information from firm.

Associated Products

Product Description	Fresh Express Leafy Green Romaine; Crunchy Romaine Lettuce & Tender Green Leaf Lettuce 9 oz. bag, Keep refrigerated, no preservatives. UPC 71279-26112. Fresh Express Incorporated Salinas, CA.
Code Info	Code: I246A5BMG, Use-By-Date: September 16, 2012.
Classification	Class I
Reason for Recall	USDA MDP program had a positive sample result for Listeria Monocytogenes.
Product Quantity	xx
Recall Number	F-0026-2013

Class I Food/Cosmetics Event

Event ID	63267
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Sep-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	G.O. Fresh
City	Minneapolis
State	MN
Country	US
Distribution Pattern	Minnesota, Iowa, North Dakota and Wisconsin

Associated Products

Product Description	Cut Cantaloupe: G.O Fresh: 0379729 4/5# CANTALOUPE CHUNKS (PACKER) 130250 BEST BY 9/16/12. SYSCO Imperial: 2229268 4/5# MELON CANTALOUPE 3/4" 130249 & 130250 BEST BY 9/15/12 & 9/16/12 UPC# 1007 4865593455. SYSCO Imperial: 6520878 1/5# PAIL CANTALOUPE CHUNK 3/4" 130249 & 130250 BEST BY 9/15/12 & 9/16/12 UPC# 1007 4865393345. SYSCO Imperial 8628554 1/5# CANTALOUPE DICE 1/2" HC 130250 BEST BY 09/16/12, UPC # 0007 4865537049. SYSCO Imperial O325852 1/10# CANTALOUPE W/P & HALVED 130249 & 130250, BEST BY 9/15/12 & 9/16/12, UPC# 0007 4865941983. SYSCO Imperial O325852 1/10# WHOLE/HALVED
Code Info	BEST BY 9/15/12 & 9/16/12
Classification	Class I
Reason for Recall	G.O. Fresh in Minnesota is voluntarily recalling specific cut items that contain cantaloupe, which has been recalled by DFI Marketing, Inc. due to potential Salmonella contamination.
Product Quantity	721 TOTAL CASES FOR ALL PRODUCTS
Recall Number	F-0086-2013

Product Description	Mixed Fruit w/ Grapes: SYSCO Imperial 1210321 4/5# FRUIT MIX CHUNK W/GRAPES 130250 BEST BY 9/16/12. SYSCO Imperial 2665156 4/5# MIX MELON W/ REDGRAPES 130249 & 130250 BEST BY 9/15/12 & 9/16/12, UPC# 1007 4865599914. SYSCO Imperial 3278165 1/5# FRUIT MIX CHUNK WI/GRAPE 130249 & 130250, BEST BY 9/15/12 & 9/16/12, UPC# 1007 4865618960.
Code Info	BEST BY 9/15/12 & 9/16/12
Classification	Class I
Reason for Recall	G.O. Fresh in Minnesota is voluntarily recalling specific cut items that contain cantaloupe, which has been recalled by DFI Marketing, Inc. due to potential Salmonella contamination.
Product Quantity	721 TOTAL CASES FOR ALL PRODUCTS
Recall Number	F-0087-2013

Product Description	SYSCO Imperial 2232734 4/5# FRUIT VARIETY CHUNK 3/4" 130249 & 130250 BEST BY 9/15/12 & 9/16/12, UPC# 1007 4865593493.
Code Info	BEST BY 9/15/12 & 9/16/12
Classification	Class I
Reason for Recall	G.O. Fresh in Minnesota is voluntarily recalling specific cut items that contain cantaloupe, which has been recalled by DFI Marketing, Inc. due to potential Salmonella contamination.
Product Quantity	721 TOTAL CASES FOR ALL PRODUCTS
Recall Number	F-0088-2013

Product Description	SYSCO Imperial 47340104/5# FRUIT MIX W/ORANGE WEDGES 130250 BEST BY 9/16/12, UPC# 0007 4865498029.
Code Info	BEST BY 9/16/12
Classification	Class I
Reason for Recall	G.O. Fresh in Minnesota is voluntarily recalling specific cut items that contain cantaloupe, which has been recalled by DFI Marketing, Inc. due to potential Salmonella contamination.
Product Quantity	721 TOTAL CASES FOR ALL PRODUCTS
Recall Number	F-0089-2013

Product Description	SYSCO Imperial 4835718 30/4.5 OZ FRUIT MIX CANT/PINE/REDGRAPES 130249 & 130250 BEST BY 9/15/12 & 9/16/12. SYSCO Imperial 7068657 4/5# FRUIT MIX CANT/PINE/RED GRAPE 130250 BEST BY 9/16/12.
Code Info	BEST BY 9/15/12 & 9/16/12.
Classification	Class I
Reason for Recall	G.O. Fresh in Minnesota is voluntarily recalling specific cut items that contain cantaloupe, which has been recalled by DFI Marketing, Inc. due to potential Salmonella contamination.
Product Quantity	721 TOTAL CASES FOR ALL PRODUCTS
Recall Number	F-0090-2013

Product Description	SYSCO Imperial 6520795 1/5# FRUIT MIX CHUNKS 3/4" 130249 & 130250 BEST BY 9/15/12 & 9/16/12, UPC# 1007 4865393314.
Code Info	BEST BY 9/15/12 & 9/16/12,
Classification	Class I
Reason for Recall	G.O. Fresh in Minnesota is voluntarily recalling specific cut items that contain cantaloupe, which has been recalled by DFI Marketing, Inc. due to potential Salmonella contamination.
Product Quantity	721 TOTAL CASES FOR ALL PRODUCTS
Recall Number	F-0091-2013

Product Description	SYSCO Imperial 5370204 30/4.5 OZ/ ,30# FRUIT VARIETY GARDEN-TO-GO 130249 & 130250 BEST BY 9/15/12 & 9/16/12 .
Code Info	BEST BY 9/15/12 & 9/16/12
Classification	Class I
Reason for Recall	G.O. Fresh in Minnesota is voluntarily recalling specific cut items that contain cantaloupe, which has been recalled by DFI Marketing, Inc. due to potential Salmonella contamination.
Product Quantity	721 TOTAL CASES FOR ALL PRODUCTS
Recall Number	F-0092-2013

Product Description	SYSCO Imperial 9498072 FRUIT W/GOLD PINEAPPLE KIT 4/1.5# 130250 BEST BY 9/16/12, UPC# 1007 4865871287.
Code Info	BEST BY 9/16/12
Classification	Class I
Reason for Recall	G.O. Fresh in Minnesota is voluntarily recalling specific cut items that contain cantaloupe, which has been recalled by DFI Marketing, Inc. due to potential Salmonella contamination.
Product Quantity	721 TOTAL CASES FOR ALL PRODUCTS
Recall Number	F-0093-2013

Product Description	SYSCO Imperial 1/5# PAIL MELON MIX HONEY-CANT W/ GRAPE 7225071 1/5#MELON W/GRAPE 130249 BEST BY 9/15/12, UPC# 0007 4865448475.
Code Info	BEST BY 9/15/12
Classification	Class I
Reason for Recall	G.O. Fresh in Minnesota is voluntarily recalling specific cut items that contain cantaloupe, which has been recalled by DFI Marketing, Inc. due to potential Salmonella contamination.
Product Quantity	721 TOTAL CASES FOR ALL PRODUCTS
Recall Number	F-0094-2013

Class II Biologics Event

Event ID	40178
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Jun-05
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Mary Greeley Medical Center
City	Ames
State	IA
Country	US
Distribution Pattern	FL, IA, NY

Associated Products

Product Description	Source Plasma
Code Info	4714157; 4714753; 4715411
Classification	Class II
Reason for Recall	Blood products, collected from a donor who previously tested positive for Hepatitis B surface antigen (HBsAg), were distributed.
Product Quantity	3 units
Recall Number	B-2271-12

Class II Biologics Event

Event ID	42230
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	05-May-06
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	American Red Cross Blood Services
City	Saint Louis
State	MO
Country	US
Distribution Pattern	MO, TN, IL, TX, AR

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	11LG02923; 11LG03004, 11LG02926(P1); 11LG02926 (P2); 11LG02932(P1); 11LG02932(P2), 11LG02945; 11LG02949(P1), 11LG02949(P2); 11LG02951(P1); 11LG02951(P2), 11LG02953; 11LG02957(P1); 11LG02957(P2), 11LG02953, 11LG02960(P1), 11LG02960(P2); 11LG02965; 11LG02970(P1); 11LG02970(P2), 11LG03030(P1); 11LG03030(P2); 11LG03018(P1), 11LG03018(P2), 11LG03040(P1); 11LG03040(P2); 11LG03054; 11LG03013 11LG03034(P1); 11LG03034(P2), 11LG03074, 11LG03067(P1) 11LG03024; 11LG03013; 11LG03026; 11LG03074; 11LG03048; 11LG02980; 11LG02995; 11LG02999; 11LG02978; 11LG03057; 11LG03067(P2); 11LG03046; 11LG02932; 11LG03060; 11LG03062; 11LG03004, 11LG02975,
Classification	Class II
Reason for Recall	Blood products, which was labeled as leukoreduced, but exceeded the White Blood Cell count limit, were distributed.
Product Quantity	49 units
Recall Number	B-2614-12

Class II Biologics Event

Event ID	42262
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	15-May-06
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	BioLife Plasma Services LP
City	Independence
State	MO
Country	US
Distribution Pattern	IL

Associated Products

Product Description	Source Plasma
Code Info	06IMOA7790; 06IMOA7228; 06IMOA6898; 06IMOA6322; 06IMOA6048
Classification	Class II
Reason for Recall	Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity	5 units
Recall Number	B-2615-12

Class II Biologics Event

Event ID	47258
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	25-Jan-08
Initial Firm Notification of Consignee or Public	Other

Recalling Firm	CSL Plasma, Inc
City	Columbia
State	SC
Country	US
Distribution Pattern	IL, Switzerland & Germany

Associated Products

Product Description	Source Plasma
Code Info	6120145076, 6120137847, 6120137155, 6120136578, 6120135921, 6120134073, 6120133601, 6120131975, 6120131234, 6120130349, 6120129914, 6120129048, 6120128622, 6120127750, 6120127426, 6120126564, 6120126172, 6120125365, 6120124432, 6120123695, 6120123015, 6120122632, 6120121734, 6120121330, 6120120787, 6120119923, 6120119289, 6120118949, 6120118310, 6120117939, 6120117289, 6120116914, 6120116170, 6120115650, 6120114822, 6120114177, 6120113833, 6120113148, 6120112749, 6120112062
Classification	Class II
Reason for Recall	Blood products, collected from a donor whose physical examination was incomplete, were distributed.
Product Quantity	40 units
Recall Number	B-2170-12

Class II Biologics Event

Event ID	47296
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	22-Feb-08
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Mississippi Valley Reg Bld Ctr
City	Davenport
State	IA
Country	US
Distribution Pattern	Missouri

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	GH21702
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 Unit
Recall Number	B-2171-12

Class II Biologics Event

Event ID	47550
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	22-Jan-08
Initial Firm Notification of Consignee or Public	Other

Recalling Firm	CSL Plasma, Inc
City	Charlotte
State	NC
Country	US
Distribution Pattern	IL

Associated Products

Product Description	Source Plasma
Code Info	4180273037,4180270764, 4180266853, 4180262108, 4180261397, 4180256862, 4180253172, 4180250494, 4180245124, 4180243722, 4180242872, 4180236288, 4180233903, 4180233565, 4180231839, 4180231448
Classification	Class II
Reason for Recall	Blood products, collected from a donor who had not had an annual physical performed, were distributed.
Product Quantity	16 units
Recall Number	B-2159-12

Class II Biologics Event

Event ID	47551
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	17-Jan-08
Initial Firm Notification of Consignee or Public	Other

Recalling Firm	CSL Plasma, Inc
City	Charlotte
State	NC
Country	US
Distribution Pattern	IL

Associated Products

Product Description	Source Plasma
Code Info	4180253928, 4180250655, 4180245270, 4180242777, 4180242324, 4180229226, 4180224003, 4180210306
Classification	Class II
Reason for Recall	Blood products, collected from a donor whose routine physical examination was inadequately documented, were distributed.
Product Quantity	8 units
Recall Number	B-2160-12

Class II Biologics Event

Event ID	47613
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	26-Feb-08
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Mississippi Valley Reg Bld Ctr
City	Davenport
State	IA
Country	US
Distribution Pattern	Missouri and Illinois

Associated Products

Product Description	Platelets Pheresis Leukocytes Reduced Irradiated
Code Info	K47096
Classification	Class II
Reason for Recall	Blood products, manufactured from an apheresis unit with platelet yield that did not meet the criteria to be split unit, were distributed.
Product Quantity	1 Unit
Recall Number	B-2167-12

Product Description	Platelets Pheresis Leukocytes Reduced
Code Info	K47096
Classification	Class II
Reason for Recall	Blood products, manufactured from an apheresis unit with platelet yield that did not meet the criteria to be split unit, were distributed.
Product Quantity	1 Unit
Recall Number	B-2168-12

Class II Biologics Event

Event ID	48850
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	20-May-08
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Csl Plasma Inc
City	Boca Raton
State	FL
Country	US
Distribution Pattern	Illinois, Switzerland, Germany

Associated Products

Product Description	Source Plasma/Liquid Plasma
Code Info	4240203191; 4240202188; 4240201501; 4240200163; 4240199668; 4240198041; 4240196915; 4240196219; 4240195380; 4240194609; 4240193795; 4240193268; 4240192176; 4240191692; 4240190721; 4240190268; 4240189306; 4240189065; 4240188195; 4240187586; 4240186387; 4240185611; 4240184951; 4240183873; 4240183517; 4240182263; 4240181724; 4240180641; 4240180206; 4240179162; 4240178951; 4240177911; 4240177729; 4240176805; 4240176099; 4240175018; 4240174624; 4240173554; 4240172999; 4240172073; 4240171396; 4240170548; 4240169885; 4240168756; 4240168208; 4240167150; 4240166625; 4240165560; 4240165043; 4240164097; 4240163516; 4240162425; 4240161746; 4240160819
Classification	Class II
Reason for Recall	Blood products, collected from a donor whose physical examination was incomplete, were distributed.
Product Quantity	54 units
Recall Number	B-2169-12

Class II Biologics Event

Event ID	49237
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-Mar-08
Initial Firm Notification of Consignee or Public	Other

Recalling Firm	CSL Plasma, Inc
City	Charlotte
State	NC
Country	US
Distribution Pattern	IL & Switzerland

Associated Products

Product Description	Source Plasma
Code Info	4180282178, 4180279745, 4180278491, 4180277760, 4180276178, 4180275396, 4180273178, 4180272494, 4180270143, 4180266525, 4180265593, 4180264046, 4180263285, 4180261076, 4180260046, 4180258914. 4180257745, 4180256429, 4180254112, 4180252830, 4180252090
Classification	Class II
Reason for Recall	Blood products, collected from a donor whose physical examination was incomplete, were distributed.
Product Quantity	21 units
Recall Number	B-2165-12

Class II Biologics Event

Event ID	49260
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	30-May-08
Initial Firm Notification of Consignee or Public	Other

Recalling Firm	CSL Plasma, Inc
City	Charlotte
State	NC
Country	US
Distribution Pattern	IL & Switzerland

Associated Products

Product Description	Source Plasma
Code Info	4180295780, 4180294894, 4180293744, 4180283593, 4180282892, 4180281202, 4180280604, 4180278570, 4180277820, 4180276612, 4180274515, 4180263406, 4180260842, 4180260079, 4180256240, 4180253464, 4180249029, 4180247557, 4180246771, 4180244936, 4180242533, 4180239378, 4180238122, 4180234049, 4180232196, 4180230162, 4180228498, 4180201425, 4180199340, 4180196842, 4180195554, 4180194508, 4180192034, 4180189396, 4180188420, 4180187221, 4180186479, 4180185283, 4180184637, 4180183187, 4180182484
Classification	Class II
Reason for Recall	Blood products, collected from a donor whose physical examination was incomplete, were distributed.
Product Quantity	41 units
Recall Number	B-2164-12

Class II Biologics Event

Event ID	49669
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	10-Jul-07
Initial Firm Notification of Consignee or Public	Other

Recalling Firm	CSL Plasma, Inc
City	Columbia
State	SC
Country	US
Distribution Pattern	IL, Switzerland & Germany

Associated Products

Product Description	Source Plasma
Code Info	6120184788, 6120182116, 6120180703, 6120180227, 6120179225, 6120178892, 6120177790, 6120177421, 6120176492, 6120175940, 6120171979, 6120170348, 6120169880, 6120168751, 6120168260, 6120167205, 6120166856, 6120165421, 6120164349, 6120164013, 6120162997, 6120162589, 6120161584, 6120161290, 6120160353, 6120155898, 6120154062, 6120152803, 6120152113, 6120151111, 6120150127. 6120149367, 6120148504, 6120147824, 6120147361, 6120146516, 6120139832, 6120139116, 6120137303, 6120136101, 6120134209, 6120133758, 6120133064, 6120131872, 6120131360, 6120130744, 6120139584, 6120129144, 6120128029, 6120127480, 6120126302, 6120125851, 6120125246, 6120124655, 6120124156, 6120123633, 6120123134, 6120122603, 6120121993, 6120121432, 6120120916, 6120119877
Classification	Class II
Reason for Recall	Blood products, collected from a donor whose physical examination was incomplete, were distributed.
Product Quantity	62 units
Recall Number	B-2163-12

Class II Biologics Event

Event ID	49676
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	16-Jul-08
Initial Firm Notification of Consignee or Public	Other

Recalling Firm	CSL Plasma, Inc
City	Charlotte
State	NC
Country	US
Distribution Pattern	Switzerland

Associated Products

Product Description	Source Plasma
Code Info	4180331755; 4180331283
Classification	Class II
Reason for Recall	Blood products, collected from a donor who had not had an annual physical performed, were distributed.
Product Quantity	2 units
Recall Number	B-2162-12

Class II Biologics Event

Event ID	49950
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	29-Aug-08
Initial Firm Notification of Consignee or Public	Other

Recalling Firm	CSL Plasma, Inc
City	Columbia
State	SC
Country	US
Distribution Pattern	Switzerland

Associated Products

Product Description	Source Plasma
Code Info	6120191445
Classification	Class II
Reason for Recall	Blood product, collected from a donor whose physical examination was incomplete, was distributed.
Product Quantity	1 unit
Recall Number	B-2161-12

Class II Biologics Event

Event ID	51349
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	09-Jan-09
Initial Firm Notification of Consignee or Public	Other

Recalling Firm	CSL Plasma, Inc
City	Charlotte
State	NC
Country	US
Distribution Pattern	IL & Switzerland

Associated Products

Product Description	Source Plasma
Code Info	4180357508, 4180356223, 4180355586, 4180354295, 4180353710, 4180352509, 4180351968, 4180350287, 4180349041, 4180348511, 4180347274, 4180345499, 4180344657, 4180343823, 4180343000, 4180341053, 4180340360, 4180337642, 4180336133, 4180335468, 4180334421, 4180333841, 4180332742, 4180332015, 4180330994, 4180330361, 4180328295, 4180326367, 4180324587, 4180318627, 4180317614, 4180316239, 4180315098, 4180313340, 4180311686, 4180309998, 4180307699, 4180306098, 4180304902, 4180304275, 4180303246, 4180299690, 4180299081, 4180296193, 4180295467, 4180294037, 4180293389, 4180292056
Classification	Class II
Reason for Recall	Blood products, collected from a donor whose routine physical examination was inadequately documented, were distributed.
Product Quantity	48 units
Recall Number	B-2157-12

Class II Biologics Event

Event ID	51350
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	29-Jan-09
Initial Firm Notification of Consignee or Public	Other

Recalling Firm	CSL Plasma, Inc
City	Charlotte
State	NC
Country	US
Distribution Pattern	IL & Switzerland

Associated Products

Product Description	Source Plasma
Code Info	4180290407, 4180287036, 4180284294, 4180281212, 4180280707, 4180277252, 4180272579, 4180268036, 4180265765, 4180264824, 4180263294, 4180262150, 4180261123, 4180260114, 4180258969, 4180257127, 4180256375, 4180254940, 4180254305
Classification	Class II
Reason for Recall	Blood products, collected from a donor whose routine physical examination was inadequately documented, were distributed.
Product Quantity	19 units
Recall Number	B-2156-12

Class II Devices Event

Event ID	54725
Status	Completed
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	29-Jan-10
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Orthohelix Surgical Designs Inc
City	Medina
State	OH
Country	US
Distribution Pattern	Nationwide distribution: USA including the states of CA, CO, FL, GA, IL, MO, NC, NH, NJ, NM, NY, OH, OR, PA, SD, TN, TX, VA, WA, and WI.

Associated Products

Product Description	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Code Info	HSC-056-32-1067051
Classification	Class II
Reason for Recall	The tips of the drivers are breaking while being used to drive the screws into patients.
Product Quantity	47 Pieces
Recall Number	Z-0026-2013

Product Description	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Code Info	HSC-056-38-1067061
Classification	Class II
Reason for Recall	The tips of the drivers are breaking while being used to drive the screws into patients.
Product Quantity	120 Pieces
Recall Number	Z-0027-2013

Class II Biologics Event

Event ID	54937
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	02-Nov-09
Initial Firm Notification of Consignee or Public	Telephone

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

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	004KM20447; 004KM20488; 004KM20496; 004KM20520; 004KS42753; 004KM20450; 004KM20453; 004KS42776
Classification	Class II
Reason for Recall	Blood products, collected from donors whose arm preparation was inadequate, were distributed.
Product Quantity	8
Recall Number	B-2154-12

Class II Biologics Event

Event ID	54950
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	29-Jan-10
Initial Firm Notification of Consignee or Public	Other

Recalling Firm	CSL Plasma, Inc.
City	Boca Raton
State	FL
Country	US
Distribution Pattern	IL, Switzerland, Germany

Associated Products

Product Description	Source Plasma
Code Info	4140613225; 4140612523; 4140581482; 4140580782; 4140578837; 4140577908; 4140575951; 4140575036; 4140572923; 4140572023; 4140570304; 4140569645; 4140567576; 4140566265; 4140564698; 4140563245; 4140561679; 4140560376; 4140557425; 4140554999; 4140553972; 4140526449; 4140497533; 4140496378; 4140493098; 4140490859; 4140489881; 4140485193; 4140483573; 4140481484; 4140479914; 4140477740; 4140476696; 4140473287; 4140471125; 4140470089; 4140467939; 4140466345; 4140464890; 4140450547; 4140446540; 4140445479; 4140443871; 4140441426; 4140440699; 4140437662; 4140428864; 4140426883; 4140425978; 4140421489; 4140420581; 4140418186; 4140417609; 4140415423; 4140414696; 4140412624; 4140411954; 4140407551; 4140406574; 4140404641; 4140403233; 4140401772; 4140396726; 4140395141; 4140393701; 4140392195; 4140390838; 4140388946; 4140384411; 4140382992; 4140381378; 4140379502; 4140378027; 4140372101; 4140371139; 4140369324; 4140367440; 4140366542; 4140364365; 4140363574; 4140280861; 4140278756; 4140277773; 4140275407; 4140274524; 4140272672; 4140271809; 4140269889; 4140268100; 4140267275; 4140263303; 4140261905; 4140260453; 4140258970; 4140257679; 4140255588; 4140254264; 4140250919; 4140249596; 4140248130; 4140246765; 4140245406; 4140244065; 4140225325; 4140223493; 4140221844; 4140221072; 4140217378; 4140216493; 4140214814; 4140214030; 4140212214; 4140211478; 4140209774; 4140209001; 4140205337; 4140204469; 4140202914; 4140202111; 4140196246; 4140194848; 4140193691; 4140192470; 4140190797; 4140190016; 4140164810; 4140163986; 4140160621; 4140159164; 4140156438; 4140154970; 4140152719; 4140151909; 4140150500; 4140149432; 4140148224; 4140146839; 4140145321; 4140143399; 4140142605; 4140140678; 4140139919; 4140136502; 4140135390; 4140134026; 4140132464; 4140130969; 4140130258; 4140119613; 4140117241; 4140116168; 4140115037; 4140113992; 4140112986; 4140111846; 4140110755; 4140107327; 4140106209; 4140105241; 4140104023; 4140102679; 4140101997; 4140099247; 4140097860; 4140097129; 4140095718; 4140095099; 4140093901; 4140093053; 4140092135; 4140090007; 4140089126; 4140087789; 4140087212; 4140086061; 4140085472; 4140081408; 4140080632; 4140079501; 4140078702; 4140077848; 4140076758; 4140075734; 4140075023; 4140074324; 4140073742; 4140072670; 4140072092; 4140054330; 4140053881; 4140052807; 4140052261; 4140051221; 4140050170; 4140049582; 4140048233; 4140047761; 4140046724; 4140046278; 4140045354; 4140044856; 4140043873; 4140043449; 4140042171; 4140041556; 4140040598; 4140040076; 4140039174; 4140038586; 4140037748; 4140037331; 4140036303; 4140035806; 4140034671; 4140034195; 4140033318; 4140032865; 4140032049; 4140031663; 4140024779; 4140024261; 4140023308; 4140022789; 4140021629; 4140021160; 4140020324; 4140008740;
Classification	Class II
Reason for Recall	Blood products, collected from donors who were previously deferred for high risk behavior, were distributed.
Product Quantity	227
Recall Number	B-1993-12

Class II Biologics Event

Event ID	58339
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Jan-11
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	Fresh Frozen Plasma
Code Info	W128709421812
Classification	Class II
Reason for Recall	Blood products, collected from a donor who may be at increased risk for Creutzfeldt-Jakob Disease (CJD), were distributed.
Product Quantity	1
Recall Number	B-1991-12

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W128709421812
Classification	Class II
Reason for Recall	Blood products, collected from a donor who may be at increased risk for Creutzfeldt-Jakob Disease (CJD), were distributed.
Product Quantity	1
Recall Number	B-1992-12

Class II Biologics Event

Event ID	58340
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	04-Feb-11
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	W128710018949
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-1990-12

Class II Biologics Event

Event ID	58499
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	11-Mar-11
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	Platelets Pheresis Leukocytes Reduced
Code Info	W128710020715 (part I, part II)
Classification	Class II
Reason for Recall	Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
Product Quantity	2 units
Recall Number	B-1989-12

Class II Biologics Event

Event ID	59133
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	22-Apr-11
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	W128711100317
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 unit
Recall Number	B-1988-12

Class II Biologics Event

Event ID	59337
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-May-11
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 Irradiated
Code Info	W128710142210
Classification	Class II
Reason for Recall	Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
Product Quantity	1
Recall Number	B-1986-12

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W128710142210
Classification	Class II
Reason for Recall	Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
Product Quantity	1
Recall Number	B-1987-12

Class II Biologics Event

Event ID	59338
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-May-11
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	W128710142209
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 unit
Recall Number	B-1985-12

Class II Devices Event

Event ID	62059
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	24-Sep-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Terumo Cardiovascular Systems Corporation
City	Ann Arbor
State	MI
Country	US
Distribution Pattern	Worldwide Distribution - USA (nationwide) and the countries of Bangladesh, Seoul Korea, Chile, Brazil, Venesuela, Thailand, Mexico, India, Taiwan, Canada, Dominican Republic, Guatemala, Ecuador, Germany, Republic of Georgia, Hong Kong, Japan, United Arab Emirates (UAE), Japan, Belgium, Phillipines, Singapore, and South Africa.

Associated Products

Product Description	Sarns Centrifugal System Control module, 100/115V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Code Info	Catalog number: 6379 and serial numbers: 942,1003-1006,1034,1039,1051,1056,1087,1914,3030,4019,4344, 5009,5012,5013,5030,5048,5059, 5062, 5080, 5096, 5111, 5112, 5122, 5140, 5713, 6003, 6005, 6023, 6024, 6027, 6033, 6034, 6054, 6055, 6060, 6066, 6068, 6069, 6073, 6079, 6081, 6082, 6086, 6089, 6090-6092, 6097, 6107, 6109, 6112, 6119, 6126-6128, 6236, 6379, 7000-7785, and R7051.
Classification	Class II
Reason for Recall	Terumo Cardiovascular Systems (Terumo CVS) received one report of loss of power to the control module and subsequently the drive motor for the Sarns centrifugal system during cardiopulmonary bypass.
Product Quantity	847 units
Recall Number	Z-0051-2013

Product Description	Sarns Centrifugal System Control module, 220/240V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Code Info	Catalog number: 6380 and serial numbers: 5007, 5028-5030, 5032, 5075, 5076, 5135,6010,6013,6025,6030,6116, 7000-7197,7372, and 7373.
Classification	Class II
Reason for Recall	Terumo Cardiovascular Systems (Terumo CVS) received one report of loss of power to the control module and subsequently the drive motor for the Sarns centrifugal system during cardiopulmonary bypass.
Product Quantity	213 units
Recall Number	Z-0052-2013

Product Description	Sarns Centrifugal System Control module System 9000 The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Code Info	Catalog number: 6381 and serial numbers: 1003-1006, 1020, 1026, 1045, 2001, 2017,2018,2036,7000-7113, and 7381.
Classification	Class II
Reason for Recall	Terumo Cardiovascular Systems (Terumo CVS) received one report of loss of power to the control module and subsequently the drive motor for the Sarns centrifugal system during cardiopulmonary bypass.
Product Quantity	126 units
Recall Number	Z-0053-2013

Class II Biologics Event

Event ID	62445
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	19-Jun-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	W115112166840A;
Classification	Class II
Reason for Recall	Blood product, with platelet count below the specified minimum requirement, was distributed.
Product Quantity	1
Recall Number	B-2155-12

Class II Biologics Event

Event ID	62446
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	16-May-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Octapharma Plasma, Inc.
City	Norfolk
State	VA
Country	US
Distribution Pattern	Austria

Associated Products

Product Description	Source Plasma
Code Info	5080238043; 5080237145; 5080235642; 5080235128; 5080234049; 5080233479; 5080232406; 5080225818; 5080224961; 5080223129; 5080221982; 5080215743; 5080214633; 5080213587;
Classification	Class II
Reason for Recall	Blood products, collected from a donor whose physical examination was incomplete, were distributed.
Product Quantity	14
Recall Number	B-1996-12

Class II Biologics Event

Event ID	62517
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	12-Jun-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Central California Blood Center
City	Fresno
State	CA
Country	US
Distribution Pattern	California; Florida

Associated Products

Product Description	Plasma Frozen within 24 hours (FP24)
Code Info	W115912230409;
Classification	Class II
Reason for Recall	Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity	1
Recall Number	B-2301-12

Product Description	Blood and Blood Products for Reprocessing
Code Info	W115911273251;
Classification	Class II
Reason for Recall	Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity	1
Recall Number	B-2302-12

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W115912230409; W115911273251;
Classification	Class II
Reason for Recall	Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity	2
Recall Number	B-2303-12

Class II Biologics Event

Event ID	62523
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	31-May-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Florida's Blood Centers, Inc.
City	Orlando
State	FL
Country	US
Distribution Pattern	Florida

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	W038112074744;
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-2299-12

Class II Biologics Event

Event ID	62524
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	16-May-12
Initial Firm Notification of Consignee or Public	FAX

Recalling Firm	The American National Red Cross - Southern Region
City	Douglasville
State	GA
Country	US
Distribution Pattern	Georgia

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced
Code Info	003GR02571; 003LC53425;
Classification	Class II
Reason for Recall	Blood products, collected from a donor who reported living in a malarial endemic area within the past three years, were distributed.
Product Quantity	2
Recall Number	B-2298-12

Class II Biologics Event

Event ID	62532
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	Interstate Blood Bank Inc. of Wisconsin
City	Milwaukee
State	WI
Country	US
Distribution Pattern	Germany, Israel

Associated Products

Product Description	Source Plasma
Code Info	FP126179; FP125079; FP124605; FP124360; FP124182; FP123934; FP123311; FP122993; FP122782; FP122470; FP121845; FP121621; FP121096; FP120997; FP120475; FP120431; FP119845; FP119766; FP119762;
Classification	Class II
Reason for Recall	Blood products, collected from a donor who had been permanently deferred, were distributed.
Product Quantity	19
Recall Number	B-2297-12

Class II Biologics Event

Event ID	62752
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. Sunquest Application Interfacing Outbound Department of Health Interface.
Code Info	Sunquest Application Interfacing. The standard Department of Health Template (conception date of 2/9/2005).
Classification	Class II
Reason for Recall	Software, with a defect or glitch, was distributed.
Product Quantity	1
Recall Number	B-2584-12

Class II Devices Event

Event ID	62832
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	30-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Siemens Healthcare Diagnostics, Inc.
City	Newark
State	DE
Country	US
Distribution Pattern	United States Nationwide Distribution in the states of: CA, FL, KS, MA, MN, MS, NM, NY, NC, OR, PA, TN, TX, UT, VA, and WA.

Associated Products

Product Description	Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) Product Usage: Enzyme n Immunoassay, Phenobarbital
Code Info	Emit(R) 2000 Phenobarbital Assay (OSR4D229), lots 1151, 1167, 1191, and/or 1212 and Syva(R) Emit(R) Phenobarbital Assay (4D019UL), lots D4, D5, D6, and D7
Classification	Class II
Reason for Recall	Firm has confirmed highter imprecision with the recalled lots on Beckman Coulter AU(R) Systems. Also, if the Syva(R) Emit(R) 2000 Phenobartbital Assay (4D019UL) lots D4, D5, D6, and/or D7 as an application on AU(R) Systems is used, the issue may be experienced. Firm has found that within-run imprecison of the recalled lots when run on an AU(R) System may be higher that what would normally be observed. Firm has observed a low frequency of outliers that differ from the expected value by 20%.
Product Quantity	79,744 cartons
Recall Number	Z-0030-2013

Class II Biologics Event

Event ID	62921
Status	Ongoing
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	15-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Greer Laboratories Inc
City	Lenoir
State	NC
Country	US
Distribution Pattern	CA, IL, IA, NM, TN

Associated Products

Product Description	Product is a 50% glycerinated Aspergillus niger (Human) Allergenic Extract in liquid form. Product is vialed in 10 mL type 1 glass vials,stoppered with latex stoppers and sealed with a 13 mm aluminum crimped cap.
Code Info	Lot Number: 200795
Classification	Class II
Reason for Recall	Mislabeled vials of Allergenic Extract were distributed.
Product Quantity	1 Lot
Recall Number	B-2498-12

Class II Devices Event

Event ID	62968
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	10-Aug-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Immunodiagnostics Systems Ltd
City	Boldon Tyne & Wear
State
Country	GB
Distribution Pattern	Nationwide Distribution including NY, CA, ME and CT.

Associated Products

Product Description	IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box containing plastic bottles. The Urine BETA CrossLaps® ELISA is an enzyme immunological test for the quantification of degradation products of C-terminal telopeptides of Type-I collagen in human urine. The Urine BETA CrossLaps® ELISA assay is intended for in vitro diagnostic use as an indication of human bone resorption as an aid in A. Monitoring bone resorption changes of 1) Anti-resorptive therapies in postmenopausal women: a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs b) Bisphosphonate therapies B. Predicting skeletal response (Bone Mineral Density) in postmenopausal women undergoing anti-resorptive therapies a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs b) Bisphosphonate therapies
Code Info	Lot 14541, EXP Nov 2012
Classification	Class II
Reason for Recall	It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sale as IVDs in the United States. The products should have been labeled as Research Use Only or Investigational use only dependent on their usage.
Product Quantity	1
Recall Number	Z-0039-2013

Product Description	IDS-iSYS Ostase® BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase® BAP Assay (IDS-iSYS BAP) is intended for the quantitative determination of bone-specific alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum or plasma on the IDS-iSYS Multi- Discipline Automated Analyser (Analyser). Results are to be used in conjunction with other clinical and laboratory data to aid the clinician in the management of post menopausal osteoporosis and Pagets disease.
Code Info	Lot 1184, EXP Aug 2012
Classification	Class II
Reason for Recall	It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sale as IVDs in the United States. The products should have been labeled as Research Use Only or Investigational use only dependent on their usage.
Product Quantity	3
Recall Number	Z-0040-2013

Product Description	IDS-iSYS Ostase® BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number IS-2830. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase® BAP (IDS-iSYS BAP) Control Set is used for quality control of the IDS-iSYS Ostase® BAP (Bone Alkaline Phosphatase) Assay on the IDS-iSYS Multi-Discipline Automated Analyser.
Code Info	Lot 1177, EXP Aug 2012
Classification	Class II
Reason for Recall	It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sale as IVDs in the United States. The products should have been labeled as Research Use Only or Investigational use only dependent on their usage.
Product Quantity	3
Recall Number	Z-0041-2013

Product Description	IDS-iSYS N-Mid® Osteocalcin, Catalog Number IS-2900. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid® Osteocalcin Assay is intended for the quantitative determination of Osteocalcin in human serum or plasma on the IDS-iSYS Multi-Discipline Automated Analyser (Analyser). Results are to be used in conjunction with other clinical and laboratory data to assist the clinician. Osteocalcin is an indicator of osteoblastic activity in human serum and plasma and is intended to be used as an aid in the prevention of osteoporosis.
Code Info	Lot 948 and 1145, EXP Aug 2012 and Jan 2013 respectively
Classification	Class II
Reason for Recall	It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sale as IVDs in the United States. The products should have been labeled as Research Use Only or Investigational use only dependent on their usage.
Product Quantity	5
Recall Number	Z-0042-2013

Product Description	IDS-iSYS N-Mid® Osteocalcin, Catalog Number IS-2930. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid® Osteocalcin Control Set is used for quality control of the IDS-iSYS N-Mid® Osteocalcin Assay on the IDS-iSYS Multi-Discipline Automated Analyser.
Code Info	Lot 958, EXP Sep 2012
Classification	Class II
Reason for Recall	It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sale as IVDs in the United States. The products should have been labeled as Research Use Only or Investigational use only dependent on their usage.
Product Quantity	5
Recall Number	Z-0043-2013

Product Description	IDS-iSYS Intact PINP, Catalog Number IS-4000. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) assay is intended for the quantitative determination of intact PINP in human serum or plasma on the IDS-iSYS Multi-Discipline Automated Analyser.
Code Info	Lot 1170, EXP Feb 2013
Classification	Class II
Reason for Recall	It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sale as IVDs in the United States. The products should have been labeled as Research Use Only or Investigational use only dependent on their usage.
Product Quantity	10
Recall Number	Z-0044-2013

Product Description	IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) Control Set is used for quality control of the IDS-iSYS Intact PINP Assay on the IDS-iSYS Multi-Discipline Automated Analyser.
Code Info	Lot 975, EXP Sep 2012
Classification	Class II
Reason for Recall	It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sale as IVDs in the United States. The products should have been labeled as Research Use Only or Investigational use only dependent on their usage.
Product Quantity	29
Recall Number	Z-0045-2013

Class II Food/Cosmetics Event

Event ID	62981
Status	Completed
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	21-Aug-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Pacific Northwest Tofu, LLC
City	Portland
State	OR
Country	US
Distribution Pattern	Product distributed in Oregon

Associated Products

Product Description	Gourmet Firm Tofu is packaged in a retail vacuum plastic package and each has net wt. 7.5 oz.. The product is sold under the Dae Han Tofu Soya Select brand. The UPC is 0 34199 718903;
Code Info	USE BY 08/22/12, USE BY 10/01/12, and USE BY 11/22/12
Classification	Class II
Reason for Recall	Soy was partially declared on the label because the ingredient list is cut off at the right side of the label.
Product Quantity	Undetermined amount for Gourmet Tofu
Recall Number	F-0050-2013

Product Description	Hot & Spicy Tofu is packaged in a retail vacuum plastic package and each has net wt. 7.5 oz.. The product is sold under the Dae Han Tofu Soya Select brand. Hot & Spicy Tofu has the UPC 0 34199 719191.
Code Info	USE BY 08/22/12, USE BY 10/01/12, and USE BY 11/22/12
Classification	Class II
Reason for Recall	Wheat or Sesame Seed Oil was partially declared on the label because the ingredient list is cut off at the right side of the label.
Product Quantity	10 packages
Recall Number	F-0051-2013

Product Description	Teriyaki Tofu is packaged in a retail vacuum plastic package and each has net wt. 7.5 oz.. The product is sold under the Dae Han Tofu Soya Select brand. The Teriyaki Tofu has the UPC 0 34199 718965.
Code Info	USE BY 08/22/12, USE BY 10/01/12, and USE BY 11/22/12
Classification	Class II
Reason for Recall	Soy was partially declared on the label because the ingredient list is cut off at the right side of the label.
Product Quantity	32 packages
Recall Number	F-0052-2013

Product Description	Stir Fried Tofu is packaged in a retail vacuum plastic package and each has net wt. 7.5 oz.. The product is sold under the Dae Han Tofu Soya Select brand. Stir Fried Tofu has the UPC 0 31499 003283.
Code Info	USE BY 08/22/12, USE BY 10/01/12, and USE BY 11/22/12
Classification	Class II
Reason for Recall	Soy was partially declared on the label because the ingredient list is cut off at the right side of the label.
Product Quantity	undetermined amount
Recall Number	F-0053-2013

Class II Food/Cosmetics Event

Event ID	62990
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	25-Aug-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Cinnabar Specialty Foods Inc
City	Prescott
State	AZ
Country	US
Distribution Pattern	Nationwide to following states: MT, CA, AZ, PA, NC, TX, VA, IL, MI, CO, UT, GA, WA, WY, AK, FL, MO, ID.

Associated Products

Product Description	Neera's Tikka Curry Rich and Creamy All Natural Simmering Sauce, 16 fluid ounces/ 473 ml. Packaged in jar. Packaged at 12/16oz units/case. Product labeling reads in part:" NEERA'S TIKKA CURRY Rich and Creamy All Natural Simmering Sauce*Just add meat, fish or vegetables!16 Fluid Ounces / 473 mLManufactured by Cinnabar Specialty Foods, Inc. Prescott, AZ 86305 866 293 6433 www.cinnabarfoods.com*".
Code Info	UPC: 7-3778516002-4 EXPIRATION NUMBERS: 09/06/12, 11/28/12, 02/07/13, 04/26/13 and 05/05/13
Classification	Class II
Reason for Recall	The product was recalled due to undeclared sub-ingredients of milk and soy.
Product Quantity	79 cases
Recall Number	F-0024-2013

Class II Food/Cosmetics Event

Event ID	62998
Status	Completed
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	02-May-11
Initial Firm Notification of Consignee or Public	Visit

Recalling Firm	Mothers' Milk Bank at Austin
City	Austin
State	TX
Country	US
Distribution Pattern	TX

Associated Products

Product Description	Mother's Milk Bank at Austin, Batch # 8638-1, 3 oz.(100 mL), Pasteurized, Exp: 02/19/2012, Kcal/Oz: 24, Protein: 0.9 g/dl.
Code Info	Batch # 8638-1
Classification	Class II
Reason for Recall	The product had the potential to contain foreign materials.
Product Quantity	22-3 oz. bottles.
Recall Number	F-0106-2013

Product Description	Mother's Milk Bank at Austin, Batch # 78501-1, 3 oz.(100 mL), Pasteurized, Exp: 06/28/2011, Kcal/Oz: 22, Protein: 1.0 g/dl.
Code Info	Batch # 78501-1
Classification	Class II
Reason for Recall	The product had the potential to contain foreign materials.
Product Quantity	52-3 oz bottles
Recall Number	F-0107-2013

Class II Devices Event

Event ID	63019
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Biomerieux Inc
City	Hazelwood
State	MO
Country	US
Distribution Pattern	Worldwide Distribution-USA (nationwide)-including DC and the states of CA, CO, CT, FL, GA, IL, IN, KY, LA, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TX, and WI, and the country of Canada.

Associated Products

Product Description	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
Code Info	Serial numbers AS180-00001 to AS180-00376.
Classification	Class II
Reason for Recall	The instrument may not dispense the specimen onto the pre-poured media resulting in a false negative result.
Product Quantity	350 systems
Recall Number	Z-0023-2013

Class II Biologics Event

Event ID	63020
Status	Ongoing
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	27-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Siemens Healthcare Diagnostics Inc.
City	Berkeley
State	CA
Country	US
Distribution Pattern	Nationwide; Also to Thailand, South Africa, Chile, Peru, Belgium, Bolivia, Ecuador, Uruguay. Mexico, China, Spain, Italy, Australia, France and Brazil.

Associated Products

Product Description	MicroCel 500 Buffer Chamber Mfg by: Siemens Healthcare Diagnostics Inc., Berkeley, CA.
Code Info	Catalog number 10312319/VG 42115 Product will have the letter R after the manufacture date.
Classification	Class II
Reason for Recall	Trugene MicroCel 500 buffer chambers, with the potential to leak buffer and could cause electrical arcing posing a hazard to the operator, were distributed.
Product Quantity	1 Unit
Recall Number	B-2519-12

Class II Devices Event

Event ID	63045
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	06-Jun-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Siemens Medical Solutions USA, Inc
City	Malvern
State	PA
Country	US
Distribution Pattern	Nationwide Distribution including the states of MO, FL, MA, NY, WI, GA, CA and WA.

Associated Products

Product Description	Siemens syngo.plaza radiological image processing system.
Code Info	Model number 10592457, serial numbers 100263, 100401, 100177, 100138, 100174, 100406, 100249, 100201, 100198, 100181, 100146.
Classification	Class II
Reason for Recall	Siemens became aware of an unintended behavior when using syngo.plaza. In syngo.plaza within the online "Short Time Storage" (STS), some studies are marked with an archived icon, however, the entry in the Archive Database referring to the physical file may be missing.
Product Quantity	11
Recall Number	Z-0048-2013

Class II Devices Event

Event ID	63070
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	29-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Remington Medical Inc.
City	Alpharetta
State	GA
Country	US
Distribution Pattern	Nationwide distribution: USA including states of: AL, AZ, CA, FL, IN, MA, NC, NY, OH, PA and TX.

Associated Products

Product Description	Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle biopsies of the prostate. The needles are compatible with the Bard Magnum biopsy instrument. The needles have an echogenic tip for accurate placement under ultrasound guidance and centimeter markings along the cannula to facilitate depth placement.
Code Info	NAC-1820M, Lot number: 121003
Classification	Class II
Reason for Recall	Sterility of the product may be compromised.
Product Quantity	800 needles
Recall Number	Z-0028-2013

Class II Biologics Event

Event ID	63072
Status	Ongoing
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	27-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Immucor Inc
City	Norcross
State	GA
Country	US
Distribution Pattern	Nationwide, Bahrain, Canada, China, Columbia, Germany, South Africa, Ireland, Japan, New Zealand, Norway, Peru, and South Korea

Associated Products

Product Description	Capture-R Ready Indicator Red Cells
Code Info	Lot 221861, Exp. 2012-09-06
Classification	Class II
Reason for Recall	Single lot of Capture-R Ready Indicator Red Cells, which may result in higher rates for equivocal and unexpected positive reactions compared to other in-date or previously released lots, was distributed.
Product Quantity	1 Lot
Recall Number	B-2585-12

Class II Devices Event

Event ID	63079
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	25-Sep-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Terumo Cardiovascular Systems Corporation
City	Ann Arbor
State	MI
Country	US
Distribution Pattern	Worldwide distribution: USA including AK, AL, AR, AZ, CA, CO, CT, DC

Associated Products

Product Description	Battery, 100/115V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Code Info	Catalog number: 9490; and lot numbers: 0101,1001-1025,1188-1192,1997, 2000-2017, 2019- 2082, 2086-2287, 2290-2446, 2452-2633, 2636-2938, and 2946-3063
Classification	Class II
Reason for Recall	Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2004 of various malfunctions of the battery backup system for the Sarns" Centrifugal System. The reports can be broadly categorized as follows: " Failure to charge " Failure to hold charge " Failure to operate In the most severe case, a battery malfunction could result in an unexpected loss of arterial flow. In this case, if the user doesn't clamp the venous line quickly enough, the patient could experience hypovolemia. In the event of a backflow condition, air could become entrained in the arterial line, which if not detected, could be passed to the patient.
Product Quantity	1076
Recall Number	Z-0049-2013

Product Description	Battery, 220V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Code Info	Catalog number: 9491; and lot numbers: 1001-1187, 1101, 1193-1286, 2083-2085, 2018, 2288, 2289, 2447-2451, 2634, 2635, and 2884.
Classification	Class II
Reason for Recall	Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2004 of various malfunctions of the battery backup system for the Sarns" Centrifugal System. The reports can be broadly categorized as follows: " Failure to charge " Failure to hold charge " Failure to operate In the most severe case, a battery malfunction could result in an unexpected loss of arterial flow. In this case, if the user doesn't clamp the venous line quickly enough, the patient could experience hypovolemia. In the event of a backflow condition, air could become entrained in the arterial line, which if not detected, could be passed to the patient.
Product Quantity	289 units
Recall Number	Z-0050-2013

Class II Devices Event

Event ID	63085
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	10-Jul-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Winco Mfg., LLC
City	Ocala
State	FL
Country	US
Distribution Pattern	Worldwide Distribution - USA including Arkansas, California, Maryland, Mississippi, New York, Pennsylvania and the country of Saudi Arabia

Associated Products

Product Description	Caremor Cliner"*Manufactured By WincoOcala, FL 34474 www.wincomfg.comModel No. 536 Serial No. 536A-101475" Literature: "Caremor Cliner 5351/5361WincoISO 9001-2008 CertifiedOur most comfortable and versatile reclinerEase of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.KEY FEATURE'SInfinite positioning backPadded armrests w/arm guardWebbed elastic suspension back and seatRemovable side panelsContinuous seat & legrest cushion5351 w/tray5361 w/out tray1.800.237.33775516 SW 1st LaneOcala, Florida 34474www.wincomfg.comProudly Made in the USA*" Patient recliner chair
Code Info	Model Number 5361
Classification	Class II
Reason for Recall	Winco Mfg., LLC in Ocala, FL is recalling the Caremor Cliner model numbers 5351 and 5361. The recall was initiated due to a report that a back frame did not "snap" onto a chair frame properly.
Product Quantity	23 chairs
Recall Number	Z-0031-2013

Product Description	Caremor Cliner is labeled in part: "*Manufactured By WincoOcala, FL 34474 www.wincomfg.comModel No. 535 Serial No. 535A-104522" Literature: "Caremor Cliner 5351/5361WincoISO 9001-2008 CertifiedOur most comfortable and versatile reclinerEase of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.KEY FEATURE'SInfinite positioning backPadded armrests w/arm guardWebbed elastic suspension back and seatRemovable side panelsContinuous seat & legrest cushion5351 w/tray5361 w/out tray1.800.237.33775516 SW 1st LaneOcala, Florida 34474www.wincomfg.comProudly Made in the USA*" Patient recliner chair
Code Info	Model Number 5351
Classification	Class II
Reason for Recall	Winco Mfg., LLC in Ocala, FL is recalling the Caremor Cliner model numbers 5351 and 5361. The recall was initiated due to a report that a back frame did not "snap" onto a chair frame properly.
Product Quantity	20 chairs
Recall Number	Z-0032-2013

Class II Devices Event

Event ID	63111
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Aug-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Kardium
City	Richmond
State	BC
Country	CA
Distribution Pattern	Nationwide Distribution-including the states of FL, GA, IL, and NH.

Associated Products

Product Description	TORQ Sternal Closure Device. The common name is TWISTER, WIRE. The model number is TQ01A. The Catalog numbers are: 17-00001: TORQ Sternal Closure Device Shipping Carton (6-10 packs), Sterile and, 15-00001 (or 17-00002): TORQ Sternal Closure Device 10-pack - Sterile. The device is supplied double-pouched, inside a shelf box containing 10 devices each. Shelf boxes are shipped to customers in either a small shipping carton containing one (1) shelf box (for a total of 10 devices), or large shipping carton containing six (6) shelf boxes (for a total of 6 x 10 = 60 devices). This product is used to close the sternal wires during cardiac surgery, and it is not an implantable device. The TORQ Sternal Closure device is used during sternal closure to tension and twist standard stainless steel surgical sutures of USP size 6 or 7 (metric size 8.0 or 9.0). The TORQ device is designed for use as a standard surgical suture wire twister for sternal closure. (Surgical sutures are not provided with the device.) The TORQ device is disposable, single-use, non-implantable and supplied sterile.
Code Info	Lot No. 062711. Expiry date is June 2014.
Classification	Class II
Reason for Recall	The TORQ Sternal Closure Device, Lot 062711, is being recalled due to probability one of the metal parts may be dislodged during use.
Product Quantity	480 units
Recall Number	Z-0054-2013

Class II Devices Event

Event ID	63140
Status	Terminated
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	20-Jan-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Beckman Coulter Inc.
City	Brea
State	CA
Country	US
Distribution Pattern	Worldwide Distribution - US Natiowide including the state of: OH, CT, CA and the state of Argentina, Austria, Belgium, Brazil, Canada, China, Columbia, Czech Republic, France, Germany, Greece, Hungary, Italy, Kuwait, Netherlands, Poland, Portugal, Slovakia, Spain, Switzerland, Turkey, and United Kingdom.

Associated Products

Product Description	Active Renin IRMA Kit, Part Number DSL25100 Product Usage: The Renin IRMA; DSL25100 immunoradiometric assay kit provides materials for the quantitative measurement of Renin in plasma. This assay is intended for in vitro diagnostic use.
Code Info	Lot # 110919D, 111017C, 111017D, 111114C, 111212C.
Classification	Class II
Reason for Recall	The recall was initiated because Beckman Coulter has confirmed that the Active Renin IRMA Test Kit may exhibit a decrease in stability of the coated tubes. As a result, quality control and patient sample results may be falsely elevated by up to 72%.
Product Quantity	216 units total (6 units in the US)
Recall Number	Z-0016-2013

Class II Devices Event

Event ID	63154
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	04-Sep-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Advanced Neuromodulation Systems Inc.
City	Plano
State	TX
Country	US
Distribution Pattern	US Nationwide Distribution

Associated Products

Product Description	The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode leads. It is powered by a hermetically sealed battery within a titanium case. It uses microelectronic circuitry to generate constant current electrical stimulation. Stimulation programs can be delivered as either single stimulation or MultiStim programs depending on patients need. Product Usage: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
Code Info	Eon Mini - 3788 (IPG), Multiple Serial Numbers
Classification	Class II
Reason for Recall	Eon Mini IPGs manufactured in April 2012 could potentially exhibit a sudden, brief surge in stimulation that would be felt by the patient as uncomfortable or painful. SJMs routine testing, monitoring, and analysis of manufacturing processes identified three lots of Eon Mini IPGs that the internal battery has the potential to come into contact with the internal microcontroller board.
Product Quantity	56 units
Recall Number	Z-0025-2013

Class II Devices Event

Event ID	63157
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	30-Aug-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Medtronic Sofamor Danek USA Inc
City	Memphis
State	TN
Country	US
Distribution Pattern	Worldwide Distribution-USA (nationwide) and the countries of India, Netherlands, Hong Kong, S. L Korea, Singapore, Canada, Australia, Japan, and Mexico.

Associated Products

Product Description	ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Code Info	All lots except those starting with SY
Classification	Class II
Reason for Recall	Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length.
Product Quantity	1047 units
Recall Number	Z-0036-2013

Product Description	ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Code Info	All lots except those starting with SY
Classification	Class II
Reason for Recall	Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length.
Product Quantity	1014 units
Recall Number	Z-0037-2013

Product Description	PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Code Info	All lots except those starting with SY
Classification	Class II
Reason for Recall	Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length.
Product Quantity	247 units
Recall Number	Z-0038-2013

Class II Devices Event

Event ID	63158
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	03-Apr-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Beckman Coulter Inc.
City	Brea
State	CA
Country	US
Distribution Pattern	Worldwide Distribution-USA (nationwide) and the counties of Australia, Belgium, Canada, Colombia, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Republic of Kuwait, Macao, Malaysia, Mexico, Netherlands, Norway, Oman, Panama, Philippines, Puerto Rico, Qatar, Romania, Russian, Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.

Associated Products

Product Description	Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: " Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood. " Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF).
Code Info	all serial numbers
Classification	Class II
Reason for Recall	Beckman Coulter is recalling the UniCel DxH 800 Coulter Cellular Analysis System because the NRBC, Differential or Reticulocyte mix chamber drain ports may become plugged by rubber pieces from specimen tube caps, and result in biohazard or chemical exposure and/or the potential for generating incorrect results.
Product Quantity	1281 units total (693 units in the US)
Recall Number	Z-0021-2013

Class II Devices Event

Event ID	63161
Status	Terminated
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	22-May-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Beckman Coulter Inc.
City	Brea
State	CA
Country	US
Distribution Pattern	Worldwide Distribution - USA (nationwide) and the following countries: Albania Australia Austria Bahrain Bangladesh Barbados Belarus Belgium Bosnia and Herzegovina Bulgaria Burundi Canada Chile China Colombia Croatia Czech Republic Denmark Ecuador El Salvador Finland France French Guiana French Polynesia Germany Greece Guadeloupe Hong Kong India Indonesia Iraq Ireland Israel Italy Japan Kenya Korea, Republic of Kuwait Libyan Arab Jamahiriya Lithuania Macao Malaysia Mexico Monaco Morocco Namibia Netherlands New Zealand Nigeria Norway Oman Pakistan Panama Poland Puerto Rico Qatar Reunion Romania Russian Federation Saudi Arabia Singapore Slovakia Slovenia South Africa Spain Sudan Sweden Switzerland Taiwan Turkey United Arab Emirates United Kingdom Uruguay

Associated Products

Product Description	CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.
Code Info	All tetraCHROME lots manufactured
Classification	Class II
Reason for Recall	The recall was initiated because Beckman Coulter has determined that the specimen and prepared sample stability claims stated in the product labeling for tetraCXP software and CYTO-STAT reagents (CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5) need to be updated for alignment with current standards and clinical decision-making associated with lymphocyte immunophenotyping results.
Product Quantity	137,445 units total (26,155 units in US)
Recall Number	Z-0033-2013

Product Description	CYTO-STAT tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number 6607073. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.
Code Info	All tetraCHROME lots manufactured
Classification	Class II
Reason for Recall	The recall was initiated because Beckman Coulter has determined that the specimen and prepared sample stability claims stated in the product labeling for tetraCXP software and CYTO-STAT reagents (CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5) need to be updated for alignment with current standards and clinical decision-making associated with lymphocyte immunophenotyping results.
Product Quantity	33,259 units total (8,458 units in US)
Recall Number	Z-0034-2013

Product Description	TetraCXP Software System, Part Number A40051. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.
Code Info	All tetraCHROME lots manufactured
Classification	Class II
Reason for Recall	The recall was initiated because Beckman Coulter has determined that the specimen and prepared sample stability claims stated in the product labeling for tetraCXP software and CYTO-STAT reagents (CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5) need to be updated for alignment with current standards and clinical decision-making associated with lymphocyte immunophenotyping results.
Product Quantity	146 units total (37 units in US)
Recall Number	Z-0035-2013

Class II Food/Cosmetics Event

Event ID	63168
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-Sep-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	Springside Cheese Corp
City	Oconto Falls
State	WI
Country	US
Distribution Pattern	WI, CO

Associated Products

Product Description	Color Cheddar Cheese Curds: Springside Cheese, Color Curd, 55-0172, V1, August 27, 2012,
Code Info	8.21.1 8.22.1 8.24.1 8.24.2 8.24.3 8.25.1 8.25.2 8.25.3 8.27.1 8.27.2 8.28.1 8.28.2 8.29.1 8.29.2 8.31.1 8.31.2 9.1.1 9.1.2 9.1.3
Classification	Class II
Reason for Recall	Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness.
Product Quantity	41,616.53 lbs total
Recall Number	F-0054-2013

Product Description	Springside Cheese, Color Cheddar, 55-0172, V1, August 21, 2012,
Code Info	8.22.1 8.25.3 8.31.2 9.1.3
Classification	Class II
Reason for Recall	Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness.
Product Quantity	41,616.53 lbs total
Recall Number	F-0055-2013

Product Description	Springside Cheese, Black Pepper Color Cheddar, 55-0172, V2, August 24, 2012,
Code Info	8.24.2 8.27.2 9.1.3
Classification	Class II
Reason for Recall	Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness.
Product Quantity	41,616.53 lbs total
Recall Number	F-0056-2013

Product Description	Springside Cheese, Blue Cheese Color Cheddar, 55-0172, V2, August 24, 2012,
Code Info	8.24.2
Classification	Class II
Reason for Recall	Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness.
Product Quantity	41,616.53 lbs total
Recall Number	F-0057-2013

Product Description	Springside Cheese, Color Cheddar Horseradish Cheese, 55-0172, V2, August 24, 2012,
Code Info	8.24.2
Classification	Class II
Reason for Recall	Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness.
Product Quantity	41,616.53 lbs total
Recall Number	F-0058-2013

Product Description	Springside Cheese, Color Cheddar Tomato Basil , 55-0172, V1, August 21, 2012,
Code Info	8.21.1
Classification	Class II
Reason for Recall	Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness.
Product Quantity	41,616.53 lbs total
Recall Number	F-0059-2013

Product Description	Springside Cheese, Monterey Jack Caribbean Red Hot , 55-0172, V3, August 28, 2012,
Code Info	8.28.3
Classification	Class II
Reason for Recall	Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness.
Product Quantity	41,616.53 lbs total
Recall Number	F-0060-2013

Product Description	Springside Cheese, Monterey Jack Chipotle Cheese, 55-0172, V3, August 21, 2012.
Code Info	8.21.3 8.28.3
Classification	Class II
Reason for Recall	Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness.
Product Quantity	41,616.53 lbs total
Recall Number	F-0061-2013

Product Description	Springside Cheese, Cranberry Monterey Jack Cheese, 55-0172, V3, August 28, 2012,
Code Info	8.28.3
Classification	Class II
Reason for Recall	Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness.
Product Quantity	41,616.53 lbs total
Recall Number	F-0062-2013

Product Description	Springside Cheese, Monterey Jack Dill Cheese, 55-0172, V3, August 21, 2012,
Code Info	8.21.3 8.28.3
Classification	Class II
Reason for Recall	Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness.
Product Quantity	41,616.53 lbs total
Recall Number	F-0063-2013

Product Description	Springside Cheese, Monterey Jack Habanero Cheese, 55-0172, V3, August 21, 2012,
Code Info	8.21.3
Classification	Class II
Reason for Recall	Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness.
Product Quantity	41,616.53 lbs total
Recall Number	F-0064-2013

Product Description	Springside Cheese, Monterey Jack Jalapeno Cheese, 55-0172, V3, August 21, 2012,
Code Info	8.21.3
Classification	Class II
Reason for Recall	Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness.
Product Quantity	41,616.53 lbs total
Recall Number	F-0065-2013

Product Description	White Cheddar Cheese Curds: Springside Cheese, White Curds, 55-0172, V2, August 22, 2012, NET WEIGHT___.
Code Info	8.22.2 8.22.4 8.29.3 8.29.4
Classification	Class II
Reason for Recall	Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness.
Product Quantity	41,616.53 lbs total
Recall Number	F-0066-2013

Product Description	Springside Cheese, Maple White Cheddar, 55-0172, V3, August 22, 2012.
Code Info	8.22.3
Classification	Class II
Reason for Recall	Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness.
Product Quantity	41,616.53 lbs total
Recall Number	F-0067-2013

Product Description	Springside Cheese, Black & Green Olive White Cheddar Midget, 55-0172, V3, August 22, 2012.
Code Info	8.22.3
Classification	Class II
Reason for Recall	Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness.
Product Quantity	41,616.53 lbs total
Recall Number	F-0068-2013

Product Description	Springside Cheese, Reduced Fat Farmers Cheese, 55-0172, V2, August 21, 2012.
Code Info	8.21.2
Classification	Class II
Reason for Recall	Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness.
Product Quantity	41,616.53 lbs total
Recall Number	F-0069-2013

Product Description	Springside Cheese, Reduced Fat Caraway Farmers, 55-0172, V2, August 21, 2012.
Code Info	8.21.2
Classification	Class II
Reason for Recall	Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness.
Product Quantity	41,616.53 lbs total
Recall Number	F-0070-2013

Product Description	Springside Cheese, Colby Cheese, 55-0172, V3, August 27, 2012.
Code Info	8.27.3
Classification	Class II
Reason for Recall	Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness.
Product Quantity	41,616.53 lbs total
Recall Number	F-0071-2013

Product Description	Springside Cheese, Bacon Colby Cheese, 55-0172, V3, August 27, 2012.
Code Info	8.27.3
Classification	Class II
Reason for Recall	Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness.
Product Quantity	41,616.53 lbs total
Recall Number	F-0072-2013

Product Description	Springside Cheese, Morel & Leek Monterey Jack, 55-0172, V3, August 28, 2012.
Code Info	8.28.3
Classification	Class II
Reason for Recall	Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness.
Product Quantity	41,616.53 lbs total
Recall Number	F-0073-2013

Product Description	Springside Cheese, Monterey Jack Peppercorn Ranch , 55-0172, V3, August 28, 2012.
Code Info	8.28.3
Classification	Class II
Reason for Recall	Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness.
Product Quantity	41,616.53 lbs total
Recall Number	F-0074-2013

Product Description	Springside Cheese, Monterey Jack Roasted Red Pepper Cheese, 55-0172, V3, August 28, 2012.
Code Info	8.28.3
Classification	Class II
Reason for Recall	Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness.
Product Quantity	41,616.53 lbs total
Recall Number	F-0075-2013

Product Description	Springside Cheese, Monterey Jack Salsa Cheese, 55-0172, V3, August 28, 2012.
Code Info	8.28.3
Classification	Class II
Reason for Recall	Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness.
Product Quantity	41,616.53 lbs total
Recall Number	F-0076-2013

Product Description	Springside Cheese, rBGH Free White Cheddar, 55-0172, V32 August 22, 2012.
Code Info	8.22.3 8.29.3
Classification	Class II
Reason for Recall	Springside Cheese Corp. is recalling cheese produced on August 21, 2012 through September 1, 2012. This voluntary recall has been initiated because the cheese has the potential to be contaminated with Giardia, a parasite, from an employee illness.
Product Quantity	41,616.53 lbs
Recall Number	F-0077-2013

Class II Devices Event

Event ID	63169
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	24-Jul-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Beckman Coulter Inc.
City	Brea
State	CA
Country	US
Distribution Pattern	Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Australia, Bangladesh, Belgium, Botswana, Brazil, Canada, China, Colombia, Czech Republic, Croatia, Ecuador, Ethiopia, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Malaysia, Mexico, Morocco, Namibia, Netherlands, New Zealand, Oman, Pakistan, Panama, Philippines, Poland, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Sweden, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, and Zimbabwe.

Associated Products

Product Description	Access Folate Calibrators, Part Number: A14207. The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) or red blood cells using the Access Immunoassay Systems. The serum folate level is an indicator of recent folate intake. A low RBC folate value can indicate a prolonged folate deficiency. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems.
Code Info	Lot# 112788, 115741, 118917
Classification	Class II
Reason for Recall	Beckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevated results that could mask a folate deficiency.
Product Quantity	4,635 units total (3,214 units in US)
Recall Number	Z-0046-2013

Product Description	Access Folate WHO Calibrators, Part Number: A98033. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems
Code Info	Lot# 122651, 123635, 219962
Classification	Class II
Reason for Recall	Beckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevated results that could mask a folate deficiency.
Product Quantity	5,266 units total (3,214 units in US)
Recall Number	Z-0047-2013

Class II Devices Event

Event ID	63175
Status	Terminated
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-May-09
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Alere San Diego, Inc.
City	San Diego
State	CA
Country	US
Distribution Pattern	Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Brazil, Canada, Colombia, Czech Republic, Finlind, France, Germany, Great Britian, Greece, Guatemala, Hong Kong, India, Indonesia, Italy, Lebanon, Mexico, Netherlands, Norway, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Switzerland, Taiwan, Tunisia, Turkey, United Arab Emirates, and Uruguay.

Associated Products

Product Description	Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine.
Code Info	Lot Numbers: W42932B W42933B W42934B W42935B W43279B W43281B W43282B W43283B W43284B W43285B W43286B W43287B W43288B W43637B W43638B W43640B W43646B W43648B W43649B W43650B W43652B W43653B W43655B W43657B W43659B W43660B W43661B W43663B W43664B W43665B W43692B W43693B W43694B W43695B W43696B W43697B W43698B W43699B W43700B W43701B W43702B W43703B W43704B W43705B W43706B W43707B W43708B W43709B W43710B W43711B W43712B W43713B W43714B W43715B W43716B W43717B W43718B W43983B W43984B W43985B W43986B W43987B W43988B W43989B W43990B W43991B W43992B W43993B W43994B W43995B W43996B W43997B W43998B W43999B W44000B W44001B W44002B W44003B W44004B W44005B W44006B W44007B W44008B W44009B W44010B W44011B W44012B W44013B W44014B W44015B W44016B W44017B W44018B W44019B W44020B W44021B W44022B W44023B W44024B W44025B W44026B W44027B W44028B W44029B W44030B W44031B W44032B W44033B W44034B W44036B W44037B W44038B W44039B W44040B W44041B W44042B W44043B W44044B W44045B W44046B W44047B W44048B W44049B W44050B W44051B W44052B W44053B W44054B W44055B W44056B W44057B W44058B W44059B W44060B W44061B W44062B W44063B W44064B W44065B W44066B W44067B W44068B W44246B W44269B W44628B W44665B W44666B W44667B W44668B W44669B W44670B W44671B W44672B W44673B W44675B W44676B W44677B W44678B W44679B W44680B W44681B W44682B W44683B W44684B W44686B W44687B W44688B W44690B W44692B W44693B W44697B W44698B W44699B W44700B W44703B W44704B W44708B W44709B W44710B W44712B W44713B W44715B W44716B W44717B W44718B W44719B W44723B W44988B
Classification	Class II
Reason for Recall	Biosite is recalling the Triage TOX Drug Screen kits where the box containing test devices because it was mislabeled.
Product Quantity	45,638 units
Recall Number	Z-0029-2013

Class II Food/Cosmetics Event

Event ID	63200
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	22-May-12
Initial Firm Notification of Consignee or Public	Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recalling Firm	World Finer Foods, Inc.
City	Bloomfield
State	NJ
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Da Vinci Pesto Genovese with basil and pine nuts Net Wt. 10 oz. (283 g) Distributed by World Finer Foods, Inc. Bloomfield, NJ 07003 Product is packaged in a glass jar with lid. www.worldfiner.com Product of Italy UPC: 0 70670-00822 4
Code Info	E18911 Best by: 07-08-2013 E19311 Best by: 07-12-2013 E31311 Best by: 11-09-2013 E31411 Best by: 11-10-2013 E03212 Best by: 02-01-2014 E03812 Best by: 02-07-2014
Classification	Class II
Reason for Recall	Da Vinci Pesto Genovese with Basil and Pine Nuts 10 oz. is mislabeled as the front of the label indicates pine nuts which was inadvertently omitted from the ingredient statement.
Product Quantity	1953 cases (24 jars per case)
Recall Number	F-0096-2013

Class II Food/Cosmetics Event

Event ID	63205
Status	Completed
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	14-Aug-12
Initial Firm Notification of Consignee or Public	E-Mail

Recalling Firm	Pepsi Bottling Group Nashville
City	Nashville
State	TN
Country	US
Distribution Pattern	GA, TN, KY, and IN

Associated Products

Product Description	diet Orange Crush, no calorie orange soda, 2 L (2.1 QT), UPC 078000013979
Code Info	Lot Codes: AUG 27 12 NT05242, SEP 17 12 NY06142, OCT 01 12 NT06252, and OCT 22 12 NY07272.
Classification	Class II
Reason for Recall	Diet Orange Soda contains undeclared high fructose corn syrup.
Product Quantity	9011 cases of 8 units
Recall Number	F-0095-2013

Class II Devices Event

Event ID	63211
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	07-Sep-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Optovue Inc.
City	Fremont
State	CA
Country	US
Distribution Pattern	Worldwide distribution -- USA (nationwide) and Internationally.

Associated Products

Product Description	Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.
Code Info	All units of these models.
Classification	Class II
Reason for Recall	Devices labeled for an intended use not included in the existing 510(k) or PMA. Specifically, "The Retina" poster provided with the systems, and the book "RETINAL OCT Analysis and Interpretation Method" by Bruno Lumbroso and Marco Rispoli which are not labeled within 51O(k) cleared product description.
Product Quantity	795 units
Recall Number	Z-0024-2013

Class II Devices Event

Event ID	63214
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Sep-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	3M Company - Health Care Business
City	Saint Paul
State	MN
Country	US
Distribution Pattern	Worldwide Distribution--USA (nationwide) including the states of AL, CO, CT, GA, IN, KY, MA, MI, MN, MO, MS, NJ, OH, PA, SC, TN, VA, WA and WI., and the countries of Argentina, Barbados, Chile, China, Colombia, Costa Rica, Ecuador, Germany, India, Indonesia, Japan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Morocco, Pakistan, Paraguay, Peru, Philippines, Poland, Republic of Guinea, Russia, South Africa, Taiwan, Thailand, Trinidad, UAE, Venezuela, Vietnam and Zimbabwe.

Associated Products

Product Description	3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. 3M Steri-Vac Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for indoor use only.
Code Info	Model 5XL 1-door, serial numbers from 721799 - 722166. Model 5XL 2-door, serial numbers from 820248 - 820285. Model 8XL 1-door, serial numbers from 350608 - 350887. Model 8XL 2-door, serial numbers from 450073 - 450105
Classification	Class II
Reason for Recall	3M determined that the electrical grounding mechanism for the Steri-Vac 5XL and 8XL gas Sterilizer/Aerator did not meet all of the requirements of the standard in that the electrical wiring, which is insulated and contained within the sealed door should have a stronger connection to the protective electrical grounding mechansim.
Product Quantity	707 units (61 US, 646 OUS)
Recall Number	Z-0022-2013

Class II Drugs Event

Event ID	63354
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	03-Oct-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Paddock Laboratories, LLC
City	Minneapolis
State	MN
Country	US
Distribution Pattern	Nationwide

Associated Products

Product Description	Moexipril HCl Tablets 7.5mg, 100 tabs, Rx Only, Paddock Laboratories, Inc., Minneapolis, MN 55427, NDC 0574-0110-01 ,
Code Info	2012028142 exp. 1/2014
Classification	Class II
Reason for Recall	Paddock Laboratories, LLC are recalling one lot (2012028142) of Moexipril HCl Tablets 7.5mg (expiration 1/2014) because of a non-conformity dissolution failure result found during routine stability testing at the 6 month test interval.
Product Quantity	2267 bottles
Recall Number	D-007-2013

Class II Devices Event

Event ID	63362
Status	Ongoing
Product Type	Devices
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Sep-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: Virginia only.

Associated Products

Product Description	3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod®, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.
Code Info	Part Number (Item #) AG8049-NS, Lot # 2528655.
Classification	Class II
Reason for Recall	ICU Medical, Inc. has identified a potential comingling of components where a 60 drop micro drip chamber may have been included on a 20 drop macro drip set.
Product Quantity	60
Recall Number	Z-0055-2013

Class III Biologics Event

Event ID	39813
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	15-Mar-05
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Community Blood Center of Greater Kansas City
City	Kansas City
State	MO
Country	US
Distribution Pattern	Missouri and Kansas

Associated Products

Product Description	Red Blood Cells
Code Info	W045005017417; W045005017418; W045005017426; W045005017430; W045005017437; W045005017438
Classification	Class III
Reason for Recall	Blood products, with invalid HIV/HCV nucleic acid testing (NAT) results, were distributed.
Product Quantity	6 units
Recall Number	B-1948-12

Class III Biologics Event

Event ID	42897
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Jul-06
Initial Firm Notification of Consignee or Public	Telephone

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	006FS04297
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 unit
Recall Number	B-1692-12

Class III Biologics Event

Event ID	50634
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	13-Nov-08
Initial Firm Notification of Consignee or Public	Other

Recalling Firm	CSL Plasma, Inc
City	Columbia
State	SC
Country	US
Distribution Pattern	Switzerland

Associated Products

Product Description	Source Plasma
Code Info	6120207155, 6120209576, 6120209315, 6120208409, 6120208457
Classification	Class III
Reason for Recall	Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Product Quantity	5 units
Recall Number	B-2158-12

Class III Biologics Event

Event ID	61565
Status	Ongoing
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	28-Feb-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	MedImmune, LLC
City	Philadelphia
State	PA
Country	US
Distribution Pattern	Product was distributed within the US to CA, FL and TX. Government account: Department of Defense, Camp Pendleton, CA.

Associated Products

Product Description	FluMist, Influenza Virus Vaccine, Live, Intranasal, each 0.2mL dose is a suspension supplied in a single-dose pre-filled intranasal sprayer
Code Info	Lot YL2077
Classification	Class III
Reason for Recall	FluMist, Influenza Virus Vaccine, Live Intranasal, lacking assurance of proper temperature manintenance during shipment, was distributed.
Product Quantity	1 Lot
Recall Number	B-2586-12

Class III Food/Cosmetics Event

Event ID	61778
Status	Completed
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	11-Oct-11
Initial Firm Notification of Consignee or Public	Visit

Recalling Firm	Mothers' Milk Bank at Austin
City	Austin
State	TX
Country	US
Distribution Pattern	Austin,TX

Associated Products

Product Description	Mother's Milk Bank at Austin, Batch # 9429-1, 3 oz. (100 mL), Pasteurized, Exp: 3/25/2012, KCal/Oz: 20, Protein: .9 g/dl
Code Info	Batch 9429-1
Classification	Class III
Reason for Recall	The product had the potential to contain foreign materials.
Product Quantity	54 - 3 oz. bottles
Recall Number	F-0105-2013

Class III Biologics Event

Event ID	62570
Status	Terminated
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	04-Jun-12
Initial Firm Notification of Consignee or Public	Telephone

Recalling Firm	Community Blood Center
City	Dayton
State	OH
Country	US
Distribution Pattern	Ohio

Associated Products

Product Description	Red Blood Cells Leukocytes Reduced Irradiated
Code Info	W035412039602; W035412037992;
Classification	Class III
Reason for Recall	Blood products, labeled with extended expiration dates, were distributed.
Product Quantity	2
Recall Number	B-2306-12

Class III Drugs Event

Event ID	62827
Status	Ongoing
Product Type	Drugs
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	14-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Actavis Mid Atlantic LLC
City	Lincolnton
State	NC
Country	US
Distribution Pattern	Nationwide & Puerto Rico

Associated Products

Product Description	Prometh VC Plain, Each 5mL contains: Promethazine Hydrochloride 6.25mg & Phenylephrine Hydrochloride 5mg, One Pint Bottles (473mL), Rx Only, Manufactured by: Actavis Mid Atlantic, LLC., 1877 Kawaii Road, Lincolnton, NC, 28092, USA, NDC 0472-1628-16.
Code Info	X111001, X111008, X111030, Exp 10/13
Classification	Class III
Reason for Recall	Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Product Quantity	14,868 Bottles
Recall Number	D-005-2013

Product Description	Prometh VC with Codeine Cough Syrup, CV, Each 5mL contains: Codeine phosphate 10mg; promethazine hydrochloride 6.25mg; phenylephrine hydrochloride 5mg, One Pint Bottles (473mL), Rx Only, Manufactured by: Actavis Mid Atlantic LLC., 1877 Kawaii Road, Lincolnton, NC 28092 USA, NDC 0472-1629-16
Code Info	X110042, X110051, X110064, Exp 09/13
Classification	Class III
Reason for Recall	Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Product Quantity	19,980 Bottles
Recall Number	D-006-2013

Class III Biologics Event

Event ID	62969
Status	Ongoing
Product Type	Biologics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	25-Jun-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Associates of Cape Cod, Inc.
City	East Falmouth
State	MA
Country	US
Distribution Pattern	CA, IA, FL, MN, NC, NY, SC, TX Foreign: Canada, Columbia, Brazil, Ecuador, Guatemala, Hong Kong, Indonesia, Korea, Russian Federation, UK, Taiwan

Associated Products

Product Description	Associates of Cape Cod Pyrotell Limulus Amebocyte Lysate (LAL) . In vitro diagnostic use to detect and quantify endotoxin gel-clot method Catalog Number: G5250-5: 5 vial Packs; Catalog Number: G5250-25: 25 vial Packs
Code Info	Lot number: 51006539
Classification	Class III
Reason for Recall	One lot of mislabeled Pyrotell gel clot LAL reagent was distributed.
Product Quantity	217 (5 vial Packs) and 37 (25 vial Packs)
Recall Number	B-2565-12

Class III Food/Cosmetics Event

Event ID	63182
Status	Ongoing
Product Type	Food/Cosmetics
Voluntary/Mandated	Voluntary: Firm Initiated
Recall Initiation Date	27-Aug-12
Initial Firm Notification of Consignee or Public	Letter

Recalling Firm	Chang Jiang Seafood Ca Inc
City	South El Monte
State	CA
Country	US
Distribution Pattern	AZ, CA, UT

Associated Products

Product Description	Frozen IQF PND Shrimp (Farm Raised), size 61/70 and size 71/90, 30 lbs (6bgsx5lbs)
Code Info	Product has no lot numbers. Product date: 15-11-2011.
Classification	Class III
Reason for Recall	Chang Jiang Seafood CA Inc. is recalling Frozen Shrimp because it contains nitrofuran which is an unapproved antibiotic.
Product Quantity	719 cartons
Recall Number	F-0025-2013

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