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U.S. Department of Health and Human Services

Enforcement Report - Week of October 17, 2012

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Class I Devices Event

Event ID63059
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBaxter Healthcare Corp.
CityRound Lake
StateIL
CountryUS
Distribution PatternWorldwide Distribution - US Nationwide and Internationally to Canada, Costa Rica, Australia, New Zealand, Hong Kong, and the United Kingdom.
 

Associated Products

Product DescriptionBaxter 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 Infoproduct code 2C7519, all lots
ClassificationClass I
Reason for RecallBaxter 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 Quantity278,420 units
Recall NumberZ-0012-2013
Product DescriptionBaxter 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 Infoproduct code 2H7519, all lots
ClassificationClass I
Reason for RecallBaxter 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 Quantity1,995,040 units
Recall NumberZ-0013-2013
Product DescriptionBaxter 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 Infoproduct code 2C8819, all lots
ClassificationClass I
Reason for RecallBaxter 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 Quantity2,265,453 units
Recall NumberZ-0014-2013
Product DescriptionBaxter 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 Infoproduct code 2H8819, all lots
ClassificationClass I
Reason for RecallBaxter 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 Quantity488,504 units
Recall NumberZ-0015-2013

Class I Food Event

Event ID63074
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Aug-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmManna Organics Inc
CityNewark
StateNJ
CountryUS
Distribution PatternNY, NJ, PA, MA, VA, MD, CT, GA, IL, and TX
 

Associated Products

Product DescriptionSooNyeoWon 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 InfoUnknown
ClassificationClass I
Reason for RecallProducts have the potential to be contaminated with Listeria monocytogenes.
Product Quantity10 pound bags (9207 units); 5 pound bags (1944 cases); 16 oz. - 2834 cases
Recall NumberF-0097-2013
Product DescriptionSooNyeoWon 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 InfoExp date 9/8/2012 or later
ClassificationClass I
Reason for RecallProducts have the potential to be contaminated with Listeria monocytogenes.
Product QuantitySooNyeoWon Firm Tofu -3437 cases;Jinga Firm Tofu- 3518 cases
Recall NumberF-0098-2013
Product DescriptionSoy 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 InfoUnknown
ClassificationClass I
Reason for RecallProducts have the potential to be contaminated with Listeria monocytogenes.
Product Quantity220 units
Recall NumberF-0099-2013
Product DescriptionSooNyeoWon 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 InfoOn or after July 18, 2012
ClassificationClass I
Reason for RecallProducts have the potential to be contaminated with Listeria monocytogenes.
Product Quantity16 ounce bags (2834 cases)
Recall NumberF-0100-2013
Product DescriptionSooNyeoWon 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 Info9/8/2012 or later
ClassificationClass I
Reason for RecallProducts have the potential to be contaminated with Listeria monocytogenes.
Product Quantity2926 cases
Recall NumberF-0101-2013
Product DescriptionSooNyeoWon 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 Info9/8/2012 or later
ClassificationClass I
Reason for RecallProducts have the potential to be contaminated with Listeria monocytogenes.
Product QuantitySooNyeoWon Silken Tofu - 140 cases; 697 units
Recall NumberF-0102-2013
Product DescriptionLabeled in Korean as Healthy Tofu, 5-pieces and 10 pieces, UPC 028346091292. Manna Organics Inc. Newark, NJ.
Code Info7/25/2012 or later
ClassificationClass I
Reason for RecallProducts have the potential to be contaminated with Listeria monocytogenes.
Product Quantity3320 units
Recall NumberF-0103-2013
Product DescriptionSoon Tofu, 30-pieces packaged in large, white, plastic bucket. Manna Organics Inc. Newark, NJ
Code Info7/24/2012 or later
ClassificationClass I
Reason for RecallProducts have the potential to be contaminated with Listeria monocytogenes.
Product QuantityTofu Large Bucket -3356 units; Soon Tofu-3150 units
Recall NumberF-0104-2013

Class I Food Event

Event ID63099
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Aug-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmSpokane Produce, Inc.
CitySpokane
StateWA
CountryUS
Distribution PatternRetail accounts in ID, MT and WA
 

Associated Products

Product DescriptionPico 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"
ClassificationClass I
Reason for RecallDaniella brand mangoes recalled because they may be contaminated with Salmonella. Mangoes were used to manufacture Pico De Gallo.
Product Quantity128/16 oz. containers
Recall NumberF-0080-2013

Class I Food Event

Event ID63106
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Sep-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmEco Health, Inc.
CityNewhall
StateCA
CountryUS
Distribution PatternNationwide in the US
 

Associated Products

Product DescriptionflorAlign Prebiotic Formula, sizes: 90g, 180g, 270g
Code InfoUPC code #'s FA02-90GM, FA02-180GM, and FA02-270GM
ClassificationClass I
Reason for RecallEco Health is recalling florAlign Prebiotic Formula because it has the potential to be contaminated with Salmonella.
Product Quantity274 units
Recall NumberF-0084-2013

Class I Food Event

Event ID63151
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Sep-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmForever Cheese Inc
CityAstoria
StateNY
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionMarte 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 Infoall 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
ClassificationClass I
Reason for RecallFrescolina brand Ricotta Salata cheeses found positive for Listeria Monocytogenes resulting from CA state and FDA sampling.
Product Quantity835 cases
Recall NumberF-0078-2013

Class I Food Event

Event ID63164
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Aug-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmNewark Nut Stores, Inc.
CityCranford
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionOrganic Pine Nuts (Raw, No Shell) 1 lb.Nuts.com NutsOnline, 125 Moen Street, Cranford, NJ 07016 800-558-8881
Code InfoLot 97368
ClassificationClass I
Reason for RecallPine nuts may contain peanuts
Product Quantity870 lbs.
Recall NumberF-0028-2013

Class I Devices Event

Event ID63174
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Apr-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAccutron Inc
CityPhoenix
StateAZ
CountryUS
Distribution PatternUS Nationwide Distribution
 

Associated Products

Product DescriptionFlow 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 InfoModel#27025: Lot # 73971, 74929. Model#31970: Lot#74142.
ClassificationClass I
Reason for RecallAccutron 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 Quantity220 units total
Recall NumberZ-0017-2013
Product DescriptionUltra 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 InfoModel #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.
ClassificationClass I
Reason for RecallAccutron 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 Quantity220 units total
Recall NumberZ-0018-2013
Product DescriptionCM Flowmeter Pkg H, Model #36700, Serial # 13749 Product Usage: Conscious Sedation Unit Analgesia Gas Machine.
Code InfoLot # 75285
ClassificationClass I
Reason for RecallAccutron 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 Quantity220 units total
Recall NumberZ-0019-2013
Product DescriptionNewport 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 InfoLot # 73656, 74139, 75209, 74689, 75515, 74858.
ClassificationClass I
Reason for RecallAccutron 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 Quantity220 units total
Recall NumberZ-0020-2013

Class I Food Event

Event ID63202
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Sep-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmGM Distributing Co, Inc
CityHidalgo
StateTX
CountryUS
Distribution PatternAZ, GA, IL, MN, NY, and TX
 

Associated Products

Product DescriptionMarathon 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 InfoDH80 is lot code of recalling firm
ClassificationClass I
Reason for RecallGM 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 Quantity4994 CARTONS
Recall NumberF-0027-2013

Class I Food Event

Event ID63208
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Sep-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmUnited Salad Company
CityPortland
StateOR
CountryUS
Distribution PatternDistributed to wholesale and retail customers in Alaska, Idaho, Montana, Oregon and Washington
 

Associated Products

Product DescriptionFruit 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 Info1) 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
ClassificationClass I
Reason for RecallThe mangos used to manufacturer the products may be contaminated with Salmonella.
Product Quantity
Recall NumberF-0081-2013
Product DescriptionFruit 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 Info1) 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
ClassificationClass I
Reason for RecallThe mangos used to manufacturer the products may be contaminated with Salmonella.
Product Quantity
Recall NumberF-0082-2013
Product DescriptionMango 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 Info1) 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
ClassificationClass I
Reason for RecallThe mangos used to manufacturer the products may be contaminated with Salmonella.
Product Quantity
Recall NumberF-0083-2013

Class I Food Event

Event ID63210
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Sep-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmCut Fruit Express, Inc.
CityInver Grove Heights
StateMN
CountryUS
Distribution PatternMI, MN, WI
 

Associated Products

Product DescriptionCANTALOUPE, 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 InfoUse by 9/11 - 9/14
ClassificationClass I
Reason for RecallCut Fruit Express, Inc processed cantaloupe that was later recalled by the supplier DFI Marketing due to a positive Salmonella sample.
Product Quantity372 Cases total
Recall NumberF-0029-2013
Product DescriptionCANTALOUPE: 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 InfoUse-by 9/11 to 9/14
ClassificationClass I
Reason for RecallCut Fruit Express, Inc processed cantaloupe that was later recalled by the supplier DFI Marketing due to a positive Salmonella sample.
Product Quantity
Recall NumberF-0030-2013
Product DescriptionCANTALOUPE, 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 InfoUse-by 9/11 to 9/14
ClassificationClass I
Reason for RecallCut Fruit Express, Inc processed cantaloupe that was later recalled by the supplier DFI Marketing due to a positive Salmonella sample.
Product Quantity372 cases total.
Recall NumberF-0031-2013
Product DescriptionCANTALOUPE, 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 InfoUse-by 9/11 to 9/14
ClassificationClass I
Reason for RecallCut Fruit Express, Inc processed cantaloupe that was later recalled by the supplier DFI Marketing due to a positive Salmonella sample.
Product Quantity372 cases total
Recall NumberF-0032-2013
Product DescriptionCANTALOUPE, 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 InfoUse-by 9/11 to 9/14
ClassificationClass I
Reason for RecallCut Fruit Express, Inc processed cantaloupe that was later recalled by the supplier DFI Marketing due to a positive Salmonella sample.
Product Quantity372 cases total
Recall NumberF-0033-2013
Product DescriptionCANTALOUPE, 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 InfoUse-by 9/11 to 9/14
ClassificationClass I
Reason for RecallCut Fruit Express, Inc processed cantaloupe that was later recalled by the supplier DFI Marketing due to a positive Salmonella sample.
Product Quantity372 cases total.
Recall NumberF-0034-2013
Product DescriptionCANTALOUPE, 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 InfoUse-by 9/11 to 9/14
ClassificationClass I
Reason for RecallCut Fruit Express, Inc processed cantaloupe that was later recalled by the supplier DFI Marketing due to a positive Salmonella sample.
Product Quantity372 cases total.
Recall NumberF-0035-2013
Product DescriptionCANTALOUPE, 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 InfoUse-by 9/11 to 9/14
ClassificationClass I
Reason for RecallCut Fruit Express, Inc processed cantaloupe that was later recalled by the supplier DFI Marketing due to a positive Salmonella sample.
Product Quantity372 cases total.
Recall NumberF-0036-2013
Product DescriptionCANTALOUPE, 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 InfoUse-by 9/11 to 9/14
ClassificationClass I
Reason for RecallCut Fruit Express, Inc processed cantaloupe that was later recalled by the supplier DFI Marketing due to a positive Salmonella sample.
Product Quantity372 cases total.
Recall NumberF-0037-2013

Class I Food Event

Event ID63216
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmKroger Co
CityCincinnati
StateOH
CountryUS
Distribution PatternProduct was shipped to the following states: AL, GA, IL, IN, KS, KY, MI, MO, NC, NE, OH, SC, TN, VA & WV.
 

Associated Products

Product DescriptionFRESH 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 InfoBEST IF USED BY 09/16/12 Product of USA 10:09 HarvestMark.com, 1104 A244 0105 KN01
ClassificationClass I
Reason for RecallThe firm was notified by the Ohio Department of Agriculture of positive Listeria Monocytogenes in their Fresh Selection Tender Spinach.
Product Quantity910 cs/12/10 oz bags
Recall NumberF-0085-2013

Class I Food Event

Event ID63222
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Sep-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling Firm3fish Inc.
CityGastonia
StateNC
CountryUS
Distribution PatternNC and SC
 

Associated Products

Product DescriptionMaryland Crab Cake Bulk (fresh), #81868, 4oz @2x8ct, Net Wt. 4 lbs, Packed by 3fish, Inc.
Code InfoItem #79003, Lot #22YAW1A1235 (Diced Yellow Onions)
ClassificationClass I
Reason for RecallProducts were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination.
Product Quantity65 cases (16/4oz pkgs per case)
Recall NumberF-0038-2013
Product DescriptionCharl Crab Cake Bulk (fresh), #81873, 2x8ct, 4 oz, Net Wt. 4 lbs, Packed by 3fish, Inc.
Code InfoItem #79009, Lot #22YAW1A1235 (Diced Yellow Onions)
ClassificationClass I
Reason for RecallProducts were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination.
Product Quantity152 cases (16/4oz pkgs per case)
Recall NumberF-0039-2013
Product DescriptionCrab Stuffing  Bucket (fresh and frozen), #84480, 5 lb Tub, Net St: 5 lbs, Packed by 3fish, Inc.
Code InfoItem #79011, Lot #22YAW1A1235 (Diced Yellow Onions)
ClassificationClass I
Reason for RecallProducts were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination.
Product Quantity46 cases (5 lb tub)
Recall NumberF-0040-2013
Product DescriptionHT Signature Lump Crab Cake (Fresh), #81791, 4 oz @ 2x8ct, Net wt. 4 lbs, Packed by 3fish, Inc.
Code InfoItem #79018, Lot #22YAW1A1235 (Diced Yellow Onions)
ClassificationClass I
Reason for RecallProducts were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination.
Product Quantity677 cases (16/4oz pkgs per case)
Recall NumberF-0041-2013
Product DescriptionCarolina Style Crab Cakes (Frozen), 2 x 8ct  INGLES, Net Wt 4 lbs, Packed by 3fish, Inc.
Code InfoItem #79035, Lot #22YAW1A1235 (Diced Yellow Onions)
ClassificationClass I
Reason for RecallProducts were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination.
Product Quantity314 cases (16/4oz pkgs per case)
Recall NumberF-0042-2013
Product DescriptionFrozen Crab Bites, ½ oz, Bulk 100 x 0.5oz, Net Wt: 50 oz, Packed by 3fish, Inc.
Code InfoItem #79037, Lot #22YAW1A1235 (Diced Yellow Onions)
ClassificationClass I
Reason for RecallProducts were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination.
Product Quantity77 cases (100/5 oz units per case)
Recall NumberF-0043-2013
Product DescriptionMD Crab Cakes - Value Tray Pack (Frozen), 6  4x3oz, Customer Item: 504583, Packed by 3fish, Inc.
Code InfoItem #79048, Lot #22YAW1A1235 (Diced Yellow Onions)
ClassificationClass I
Reason for RecallProducts were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination.
Product Quantity24 cases (24/3 oz pkgs per case)
Recall NumberF-0044-2013
Product DescriptionHarris Teeter, Atlantic Stuffed Salmon 8ct (Fresh)
Code InfoItem #79202, Lot #22YAW1A1235 (Diced Yellow Onions)
ClassificationClass I
Reason for RecallProducts were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination.
Product Quantity347 lbs (8 ct/lb)
Recall NumberF-0045-2013
Product DescriptionHarris Teeter, Stuffed Tilapia 8ct (Fresh)
Code InfoItem #79203, Lot #22YAW1A1235 (Diced Yellow Onions)
ClassificationClass I
Reason for RecallProducts were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination.
Product Quantity234 lbs (8ct/lb)
Recall NumberF-0046-2013
Product DescriptionHarris Teeter, Stuffed Flounder 8ct (Fresh).
Code InfoItem #79204, Lot #22YAW1A1235 (Diced Yellow Onions)
ClassificationClass I
Reason for RecallProducts were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination.
Product Quantity196 lbs (8ct/lb)
Recall NumberF-0047-2013
Product DescriptionHT Premium Lobster Cake (fresh), 3 oz @ 2x8ct, Net Wt: 3 lbs, Packed by 3fish, Inc.
Code InfoItem #79420, Lot #22YAW1A1235 (Diced Yellow Onions)
ClassificationClass I
Reason for RecallProducts were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination.
Product Quantity18 cases (16/3oz. per case)
Recall NumberF-0048-2013
Product DescriptionJalapeno Salmon Cake 3oz (Fresh), 4 oz @ 2x8ct, Net Wt: 3 lbs, Packed by 3fish, Inc.
Code InfoItem #79103, Lot #22YAW1A1235 (Diced Yellow Onions)
ClassificationClass I
Reason for RecallProducts were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination.
Product Quantity8 cases (16/3oz pkgs per case)
Recall NumberF-0049-2013

Class I Food Event

Event ID63256
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Sep-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmFresh Express Incorporated
CitySalinas
StateCA
CountryUS
Distribution PatternInitial distribution to: IL, MI, MN, ND, NY, NJ, SD, WI, IA, IN, OH and PA. Waiting for distribution information from firm.
 

Associated Products

Product DescriptionFresh 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 InfoCode: I246A5BMG, Use-By-Date: September 16, 2012.
ClassificationClass I
Reason for RecallUSDA MDP program had a positive sample result for Listeria Monocytogenes.
Product Quantityxx
Recall NumberF-0026-2013

Class I Food Event

Event ID63267
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmG.O. Fresh
CityMinneapolis
StateMN
CountryUS
Distribution PatternMinnesota, Iowa, North Dakota and Wisconsin
 

Associated Products

Product DescriptionCut 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 InfoBEST BY 9/15/12 & 9/16/12
ClassificationClass I
Reason for RecallG.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 Quantity721 TOTAL CASES FOR ALL PRODUCTS
Recall NumberF-0086-2013
Product DescriptionMixed 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 InfoBEST BY 9/15/12 & 9/16/12
ClassificationClass I
Reason for RecallG.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 Quantity721 TOTAL CASES FOR ALL PRODUCTS
Recall NumberF-0087-2013
Product DescriptionSYSCO Imperial 2232734 4/5# FRUIT VARIETY CHUNK 3/4" 130249 & 130250 BEST BY 9/15/12 & 9/16/12, UPC# 1007 4865593493.
Code InfoBEST BY 9/15/12 & 9/16/12
ClassificationClass I
Reason for RecallG.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 Quantity721 TOTAL CASES FOR ALL PRODUCTS
Recall NumberF-0088-2013
Product DescriptionSYSCO Imperial 47340104/5# FRUIT MIX W/ORANGE WEDGES 130250 BEST BY 9/16/12, UPC# 0007 4865498029.
Code InfoBEST BY 9/16/12
ClassificationClass I
Reason for RecallG.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 Quantity721 TOTAL CASES FOR ALL PRODUCTS
Recall NumberF-0089-2013
Product DescriptionSYSCO 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 InfoBEST BY 9/15/12 & 9/16/12.
ClassificationClass I
Reason for RecallG.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 Quantity721 TOTAL CASES FOR ALL PRODUCTS
Recall NumberF-0090-2013
Product DescriptionSYSCO Imperial 6520795 1/5# FRUIT MIX CHUNKS 3/4" 130249 & 130250 BEST BY 9/15/12 & 9/16/12, UPC# 1007 4865393314.
Code InfoBEST BY 9/15/12 & 9/16/12,
ClassificationClass I
Reason for RecallG.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 Quantity721 TOTAL CASES FOR ALL PRODUCTS
Recall NumberF-0091-2013
Product DescriptionSYSCO Imperial 5370204 30/4.5 OZ/ ,30# FRUIT VARIETY GARDEN-TO-GO 130249 & 130250 BEST BY 9/15/12 & 9/16/12 .
Code InfoBEST BY 9/15/12 & 9/16/12
ClassificationClass I
Reason for RecallG.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 Quantity721 TOTAL CASES FOR ALL PRODUCTS
Recall NumberF-0092-2013
Product DescriptionSYSCO Imperial 9498072 FRUIT W/GOLD PINEAPPLE KIT 4/1.5# 130250 BEST BY 9/16/12, UPC# 1007 4865871287.
Code InfoBEST BY 9/16/12
ClassificationClass I
Reason for RecallG.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 Quantity721 TOTAL CASES FOR ALL PRODUCTS
Recall NumberF-0093-2013
Product DescriptionSYSCO 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 InfoBEST BY 9/15/12
ClassificationClass I
Reason for RecallG.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 Quantity721 TOTAL CASES FOR ALL PRODUCTS
Recall NumberF-0094-2013

Class II Biologics Event

Event ID40178
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Jun-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMary Greeley Medical Center
CityAmes
StateIA
CountryUS
Distribution PatternFL, IA, NY
 

Associated Products

Product DescriptionSource Plasma
Code Info4714157; 4714753; 4715411
ClassificationClass II
Reason for RecallBlood products, collected from a donor who previously tested positive for Hepatitis B surface antigen (HBsAg), were distributed.
Product Quantity3 units
Recall NumberB-2271-12

Class II Biologics Event

Event ID42230
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-May-06
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican Red Cross Blood Services
CitySaint Louis
StateMO
CountryUS
Distribution PatternMO, TN, IL, TX, AR
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info11LG02923; 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,
ClassificationClass II
Reason for RecallBlood products, which was labeled as leukoreduced, but exceeded the White Blood Cell count limit, were distributed.
Product Quantity49 units
Recall NumberB-2614-12

Class II Biologics Event

Event ID42262
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-May-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBioLife Plasma Services LP
CityIndependence
StateMO
CountryUS
Distribution PatternIL
 

Associated Products

Product DescriptionSource Plasma
Code Info06IMOA7790; 06IMOA7228; 06IMOA6898; 06IMOA6322; 06IMOA6048
ClassificationClass II
Reason for RecallBlood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity5 units
Recall NumberB-2615-12

Class II Biologics Event

Event ID47258
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Jan-08
Initial Firm Notification of Consignee or Public Other
Recalling FirmCSL Plasma, Inc
CityColumbia
StateSC
CountryUS
Distribution PatternIL, Switzerland & Germany
 

Associated Products

Product DescriptionSource Plasma
Code Info6120145076, 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
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose physical examination was incomplete, were distributed.
Product Quantity40 units
Recall NumberB-2170-12

Class II Biologics Event

Event ID47296
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Feb-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMississippi Valley Reg Bld Ctr
CityDavenport
StateIA
CountryUS
Distribution PatternMissouri
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoGH21702
ClassificationClass II
Reason for RecallBlood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Product Quantity1 Unit
Recall NumberB-2171-12

Class II Biologics Event

Event ID47550
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Jan-08
Initial Firm Notification of Consignee or Public Other
Recalling FirmCSL Plasma, Inc
CityCharlotte
StateNC
CountryUS
Distribution PatternIL
 

Associated Products

Product DescriptionSource Plasma
Code Info4180273037,4180270764, 4180266853, 4180262108, 4180261397, 4180256862, 4180253172, 4180250494, 4180245124, 4180243722, 4180242872, 4180236288, 4180233903, 4180233565, 4180231839, 4180231448
ClassificationClass II
Reason for RecallBlood products, collected from a donor who had not had an annual physical performed, were distributed.
Product Quantity16 units
Recall NumberB-2159-12

Class II Biologics Event

Event ID47551
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Jan-08
Initial Firm Notification of Consignee or Public Other
Recalling FirmCSL Plasma, Inc
CityCharlotte
StateNC
CountryUS
Distribution PatternIL
 

Associated Products

Product DescriptionSource Plasma
Code Info4180253928, 4180250655, 4180245270, 4180242777, 4180242324, 4180229226, 4180224003, 4180210306
ClassificationClass II
Reason for Recall Blood products, collected from a donor whose routine physical examination was inadequately documented, were distributed.
Product Quantity8 units
Recall NumberB-2160-12

Class II Biologics Event

Event ID47613
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Feb-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMississippi Valley Reg Bld Ctr
CityDavenport
StateIA
CountryUS
Distribution PatternMissouri and Illinois
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code InfoK47096
ClassificationClass II
Reason for RecallBlood products, manufactured from an apheresis unit with platelet yield that did not meet the criteria to be split unit, were distributed.
Product Quantity1 Unit
Recall NumberB-2167-12
Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoK47096
ClassificationClass II
Reason for RecallBlood products, manufactured from an apheresis unit with platelet yield that did not meet the criteria to be split unit, were distributed.
Product Quantity1 Unit
Recall NumberB-2168-12

Class II Biologics Event

Event ID48850
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-May-08
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmCsl Plasma Inc
CityBoca Raton
StateFL
CountryUS
Distribution PatternIllinois, Switzerland, Germany
 

Associated Products

Product DescriptionSource Plasma/Liquid Plasma
Code Info4240203191; 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
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose physical examination was incomplete, were distributed.
Product Quantity54 units
Recall NumberB-2169-12

Class II Biologics Event

Event ID49237
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Mar-08
Initial Firm Notification of Consignee or Public Other
Recalling FirmCSL Plasma, Inc
CityCharlotte
StateNC
CountryUS
Distribution PatternIL & Switzerland
 

Associated Products

Product DescriptionSource Plasma
Code Info4180282178, 4180279745, 4180278491, 4180277760, 4180276178, 4180275396, 4180273178, 4180272494, 4180270143, 4180266525, 4180265593, 4180264046, 4180263285, 4180261076, 4180260046, 4180258914. 4180257745, 4180256429, 4180254112, 4180252830, 4180252090
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose physical examination was incomplete, were distributed.
Product Quantity21 units
Recall NumberB-2165-12

Class II Biologics Event

Event ID49260
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-May-08
Initial Firm Notification of Consignee or Public Other
Recalling FirmCSL Plasma, Inc
CityCharlotte
StateNC
CountryUS
Distribution PatternIL & Switzerland
 

Associated Products

Product DescriptionSource Plasma
Code Info4180295780, 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
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose physical examination was incomplete, were distributed.
Product Quantity41 units
Recall NumberB-2164-12

Class II Biologics Event

Event ID49669
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Jul-07
Initial Firm Notification of Consignee or Public Other
Recalling FirmCSL Plasma, Inc
CityColumbia
StateSC
CountryUS
Distribution PatternIL, Switzerland & Germany
 

Associated Products

Product DescriptionSource Plasma
Code Info6120184788, 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
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose physical examination was incomplete, were distributed.
Product Quantity62 units
Recall NumberB-2163-12

Class II Biologics Event

Event ID49676
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Jul-08
Initial Firm Notification of Consignee or Public Other
Recalling FirmCSL Plasma, Inc
CityCharlotte
StateNC
CountryUS
Distribution PatternSwitzerland
 

Associated Products

Product DescriptionSource Plasma
Code Info4180331755; 4180331283
ClassificationClass II
Reason for RecallBlood products, collected from a donor who had not had an annual physical performed, were distributed.
Product Quantity2 units
Recall NumberB-2162-12

Class II Biologics Event

Event ID49950
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Aug-08
Initial Firm Notification of Consignee or Public Other
Recalling FirmCSL Plasma, Inc
CityColumbia
StateSC
CountryUS
Distribution PatternSwitzerland
 

Associated Products

Product DescriptionSource Plasma
Code Info6120191445
ClassificationClass II
Reason for RecallBlood product, collected from a donor whose physical examination was incomplete, was distributed.
Product Quantity1 unit
Recall NumberB-2161-12

Class II Biologics Event

Event ID51349
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Jan-09
Initial Firm Notification of Consignee or Public Other
Recalling FirmCSL Plasma, Inc
CityCharlotte
StateNC
CountryUS
Distribution PatternIL & Switzerland
 

Associated Products

Product DescriptionSource Plasma
Code Info4180357508, 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
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose routine physical examination was inadequately documented, were distributed.
Product Quantity48 units
Recall NumberB-2157-12

Class II Biologics Event

Event ID51350
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Jan-09
Initial Firm Notification of Consignee or Public Other
Recalling FirmCSL Plasma, Inc
CityCharlotte
StateNC
CountryUS
Distribution PatternIL & Switzerland
 

Associated Products

Product DescriptionSource Plasma
Code Info4180290407, 4180287036, 4180284294, 4180281212, 4180280707, 4180277252, 4180272579, 4180268036, 4180265765, 4180264824, 4180263294, 4180262150, 4180261123, 4180260114, 4180258969, 4180257127, 4180256375, 4180254940, 4180254305
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose routine physical examination was inadequately documented, were distributed.
Product Quantity19 units
Recall NumberB-2156-12

Class II Devices Event

Event ID54725
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Jan-10
Initial Firm Notification of Consignee or Public Letter
Recalling FirmOrthohelix Surgical Designs Inc
CityMedina
StateOH
CountryUS
Distribution PatternNationwide 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 DescriptionOrthoHelix 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 InfoHSC-056-32-1067051
ClassificationClass II
Reason for RecallThe tips of the drivers are breaking while being used to drive the screws into patients.
Product Quantity47 Pieces
Recall NumberZ-0026-2013
Product DescriptionOrthoHelix 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 InfoHSC-056-38-1067061
ClassificationClass II
Reason for RecallThe tips of the drivers are breaking while being used to drive the screws into patients.
Product Quantity120 Pieces
Recall NumberZ-0027-2013

Class II Biologics Event

Event ID54937
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Nov-09
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (The)
CityDedham
StateMA
CountryUS
Distribution PatternCA, MA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info004KM20447; 004KM20488; 004KM20496; 004KM20520; 004KS42753; 004KM20450; 004KM20453; 004KS42776
ClassificationClass II
Reason for RecallBlood products, collected from donors whose arm preparation was inadequate, were distributed.
Product Quantity8
Recall NumberB-2154-12

Class II Biologics Event

Event ID54950
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Jan-10
Initial Firm Notification of Consignee or Public Other
Recalling FirmCSL Plasma, Inc.
CityBoca Raton
StateFL
CountryUS
Distribution PatternIL, Switzerland, Germany
 

Associated Products

Product DescriptionSource Plasma
Code Info4140613225; 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;
ClassificationClass II
Reason for RecallBlood products, collected from donors who were previously deferred for high risk behavior, were distributed.
Product Quantity227
Recall NumberB-1993-12

Class II Biologics Event

Event ID58339
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Jan-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDelta Blood Bank
CityStockton
StateCA
CountryUS
Distribution PatternCA.
 

Associated Products

Product DescriptionFresh Frozen Plasma
Code InfoW128709421812
ClassificationClass II
Reason for RecallBlood products, collected from a donor who may be at increased risk for Creutzfeldt-Jakob Disease (CJD), were distributed.
Product Quantity1
Recall NumberB-1991-12
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW128709421812
ClassificationClass II
Reason for RecallBlood products, collected from a donor who may be at increased risk for Creutzfeldt-Jakob Disease (CJD), were distributed.
Product Quantity1
Recall NumberB-1992-12

Class II Biologics Event

Event ID58340
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Feb-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDelta Blood Bank
CityStockton
StateCA
CountryUS
Distribution PatternCA.
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW128710018949
ClassificationClass II
Reason for RecallBlood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Product Quantity1
Recall NumberB-1990-12

Class II Biologics Event

Event ID58499
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Mar-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDelta Blood Bank
CityStockton
StateCA
CountryUS
Distribution PatternCA.
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW128710020715 (part I, part II)
ClassificationClass II
Reason for RecallBlood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
Product Quantity2 units
Recall NumberB-1989-12

Class II Biologics Event

Event ID59133
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Apr-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDelta Blood Bank
CityStockton
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW128711100317
ClassificationClass II
Reason for RecallBlood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Product Quantity1 unit
Recall NumberB-1988-12

Class II Biologics Event

Event ID59337
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-May-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDelta Blood Bank
CityStockton
StateCA
CountryUS
Distribution PatternCA.
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code InfoW128710142210
ClassificationClass II
Reason for RecallBlood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
Product Quantity1
Recall NumberB-1986-12
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW128710142210
ClassificationClass II
Reason for RecallBlood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
Product Quantity1
Recall NumberB-1987-12

Class II Biologics Event

Event ID59338
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-May-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDelta Blood Bank
CityStockton
StateCA
CountryUS
Distribution PatternCA.
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW128710142209
ClassificationClass II
Reason for RecallBlood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Product Quantity1 unit
Recall NumberB-1985-12

Class II Devices Event

Event ID62059
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTerumo Cardiovascular Systems Corporation
CityAnn Arbor
StateMI
CountryUS
Distribution PatternWorldwide 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 DescriptionSarns Centrifugal System Control module, 100/115V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Code InfoCatalog 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.
ClassificationClass II
Reason for RecallTerumo 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 Quantity847 units
Recall NumberZ-0051-2013
Product DescriptionSarns Centrifugal System Control module, 220/240V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Code InfoCatalog number: 6380 and serial numbers: 5007, 5028-5030, 5032, 5075, 5076, 5135,6010,6013,6025,6030,6116, 7000-7197,7372, and 7373.
ClassificationClass II
Reason for RecallTerumo 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 Quantity213 units
Recall NumberZ-0052-2013
Product DescriptionSarns Centrifugal System Control module System 9000 The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Code InfoCatalog number: 6381 and serial numbers: 1003-1006, 1020, 1026, 1045, 2001, 2017,2018,2036,7000-7113, and 7381.
ClassificationClass II
Reason for RecallTerumo 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 Quantity126 units
Recall NumberZ-0053-2013

Class II Biologics Event

Event ID62445
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Jun-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeSouth Community Blood Centers Inc - Birmingham Region
CityBirmingham
StateAL
CountryUS
Distribution PatternAlabama
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW115112166840A;
ClassificationClass II
Reason for RecallBlood product, with platelet count below the specified minimum requirement, was distributed.
Product Quantity1
Recall NumberB-2155-12

Class II Biologics Event

Event ID62446
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-May-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmOctapharma Plasma, Inc.
CityNorfolk
StateVA
CountryUS
Distribution PatternAustria
 

Associated Products

Product DescriptionSource Plasma
Code Info5080238043; 5080237145; 5080235642; 5080235128; 5080234049; 5080233479; 5080232406; 5080225818; 5080224961; 5080223129; 5080221982; 5080215743; 5080214633; 5080213587;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose physical examination was incomplete, were distributed.
Product Quantity14
Recall NumberB-1996-12

Class II Biologics Event

Event ID62517
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Jun-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmCentral California Blood Center
CityFresno
StateCA
CountryUS
Distribution PatternCalifornia; Florida
 

Associated Products

Product DescriptionPlasma Frozen within 24 hours (FP24)
Code InfoW115912230409;
ClassificationClass II
Reason for RecallBlood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity1
Recall NumberB-2301-12
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW115911273251;
ClassificationClass II
Reason for RecallBlood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity1
Recall NumberB-2302-12
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW115912230409; W115911273251;
ClassificationClass II
Reason for RecallBlood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity2
Recall NumberB-2303-12

Class II Biologics Event

Event ID62523
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-May-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmFlorida's Blood Centers, Inc.
CityOrlando
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW038112074744;
ClassificationClass II
Reason for RecallBlood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Product Quantity1
Recall NumberB-2299-12

Class II Biologics Event

Event ID62524
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-May-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmThe American National Red Cross - Southern Region
CityDouglasville
StateGA
CountryUS
Distribution PatternGeorgia
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info003GR02571; 003LC53425;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who reported living in a malarial endemic area within the past three years, were distributed.
Product Quantity2
Recall NumberB-2298-12

Class II Biologics Event

Event ID62532
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-May-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmInterstate Blood Bank Inc. of Wisconsin
CityMilwaukee
StateWI
CountryUS
Distribution PatternGermany, Israel
 

Associated Products

Product DescriptionSource Plasma
Code InfoFP126179; FP125079; FP124605; FP124360; FP124182; FP123934; FP123311; FP122993; FP122782; FP122470; FP121845; FP121621; FP121096; FP120997; FP120475; FP120431; FP119845; FP119766; FP119762;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who had been permanently deferred, were distributed.
Product Quantity19
Recall NumberB-2297-12

Class II Biologics Event

Event ID62752
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Dec-09
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSunquest Information Systems, Inc.
CityTucson
StateAZ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionSunquest Laboratory. Sunquest Application Interfacing Outbound Department of Health Interface.
Code InfoSunquest Application Interfacing. The standard Department of Health Template (conception date of 2/9/2005).
ClassificationClass II
Reason for RecallSoftware, with a defect or glitch, was distributed.
Product Quantity1
Recall NumberB-2584-12

Class II Devices Event

Event ID62832
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Healthcare Diagnostics, Inc.
CityNewark
StateDE
CountryUS
Distribution PatternUnited 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 DescriptionEmit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) Product Usage: Enzyme n Immunoassay, Phenobarbital
Code InfoEmit(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
ClassificationClass II
Reason for RecallFirm 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 Quantity79,744 cartons
Recall NumberZ-0030-2013

Class II Biologics Event

Event ID62921
StatusOngoing
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGreer Laboratories Inc
CityLenoir
StateNC
CountryUS
Distribution PatternCA, IL, IA, NM, TN
 

Associated Products

Product DescriptionProduct 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 InfoLot Number: 200795
ClassificationClass II
Reason for RecallMislabeled vials of Allergenic Extract were distributed.
Product Quantity1 Lot
Recall NumberB-2498-12

Class II Devices Event

Event ID62968
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Aug-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmImmunodiagnostics Systems Ltd
CityBoldon Tyne & Wear
State
CountryGB
Distribution PatternNationwide Distribution including NY, CA, ME and CT.
 

Associated Products

Product DescriptionIDS 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 InfoLot 14541, EXP Nov 2012
ClassificationClass II
Reason for RecallIt 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 Quantity1
Recall NumberZ-0039-2013
Product DescriptionIDS-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 InfoLot 1184, EXP Aug 2012
ClassificationClass II
Reason for RecallIt 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 Quantity3
Recall NumberZ-0040-2013
Product DescriptionIDS-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 InfoLot 1177, EXP Aug 2012
ClassificationClass II
Reason for RecallIt 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 Quantity3
Recall NumberZ-0041-2013
Product DescriptionIDS-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 InfoLot 948 and 1145, EXP Aug 2012 and Jan 2013 respectively
ClassificationClass II
Reason for RecallIt 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 Quantity5
Recall NumberZ-0042-2013
Product DescriptionIDS-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 InfoLot 958, EXP Sep 2012
ClassificationClass II
Reason for RecallIt 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 Quantity5
Recall NumberZ-0043-2013
Product DescriptionIDS-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 InfoLot 1170, EXP Feb 2013
ClassificationClass II
Reason for RecallIt 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 Quantity10
Recall NumberZ-0044-2013
Product DescriptionIDS-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 InfoLot 975, EXP Sep 2012
ClassificationClass II
Reason for RecallIt 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 Quantity29
Recall NumberZ-0045-2013

Class II Food Event

Event ID62981
StatusCompleted
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Aug-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmPacific Northwest Tofu, LLC
CityPortland
StateOR
CountryUS
Distribution PatternProduct distributed in Oregon
 

Associated Products

Product DescriptionGourmet 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 InfoUSE BY 08/22/12, USE BY 10/01/12, and USE BY 11/22/12
ClassificationClass II
Reason for RecallSoy was partially declared on the label because the ingredient list is cut off at the right side of the label.
Product QuantityUndetermined amount for Gourmet Tofu
Recall NumberF-0050-2013
Product DescriptionHot & 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 InfoUSE BY 08/22/12, USE BY 10/01/12, and USE BY 11/22/12
ClassificationClass II
Reason for RecallWheat 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 Quantity10 packages
Recall NumberF-0051-2013
Product DescriptionTeriyaki 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 InfoUSE BY 08/22/12, USE BY 10/01/12, and USE BY 11/22/12
ClassificationClass II
Reason for RecallSoy was partially declared on the label because the ingredient list is cut off at the right side of the label.
Product Quantity32 packages
Recall NumberF-0052-2013
Product DescriptionStir 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 InfoUSE BY 08/22/12, USE BY 10/01/12, and USE BY 11/22/12
ClassificationClass II
Reason for RecallSoy was partially declared on the label because the ingredient list is cut off at the right side of the label.
Product Quantityundetermined amount
Recall NumberF-0053-2013

Class II Food Event

Event ID62990
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Aug-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmCinnabar Specialty Foods Inc
CityPrescott
StateAZ
CountryUS
Distribution PatternNationwide to following states: MT, CA, AZ, PA, NC, TX, VA, IL, MI, CO, UT, GA, WA, WY, AK, FL, MO, ID.
 

Associated Products

Product DescriptionNeera'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 mL***Manufactured by Cinnabar Specialty Foods, Inc. Prescott, AZ 86305 866 293 6433 www.cinnabarfoods.com***".
Code InfoUPC: 7-3778516002-4 EXPIRATION NUMBERS: 09/06/12, 11/28/12, 02/07/13, 04/26/13 and 05/05/13
ClassificationClass II
Reason for RecallThe product was recalled due to undeclared sub-ingredients of milk and soy.
Product Quantity79 cases
Recall NumberF-0024-2013

Class II Food Event

Event ID62998
StatusCompleted
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-May-11
Initial Firm Notification of Consignee or Public Visit
Recalling FirmMothers' Milk Bank at Austin
CityAustin
StateTX
CountryUS
Distribution PatternTX
 

Associated Products

Product DescriptionMother'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 InfoBatch # 8638-1
ClassificationClass II
Reason for RecallThe product had the potential to contain foreign materials.
Product Quantity22-3 oz. bottles.
Recall NumberF-0106-2013
Product DescriptionMother'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 InfoBatch # 78501-1
ClassificationClass II
Reason for RecallThe product had the potential to contain foreign materials.
Product Quantity52-3 oz bottles
Recall NumberF-0107-2013

Class II Devices Event

Event ID63019
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBiomerieux Inc
CityHazelwood
StateMO
CountryUS
Distribution PatternWorldwide 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 DescriptionPREVI 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 InfoSerial numbers AS180-00001 to AS180-00376.
ClassificationClass II
Reason for RecallThe instrument may not dispense the specimen onto the pre-poured media resulting in a false negative result.
Product Quantity350 systems
Recall NumberZ-0023-2013

Class II Biologics Event

Event ID63020
StatusOngoing
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Healthcare Diagnostics Inc.
CityBerkeley
StateCA
CountryUS
Distribution PatternNationwide; Also to Thailand, South Africa, Chile, Peru, Belgium, Bolivia, Ecuador, Uruguay. Mexico, China, Spain, Italy, Australia, France and Brazil.
 

Associated Products

Product DescriptionMicroCel 500 Buffer Chamber Mfg by: Siemens Healthcare Diagnostics Inc., Berkeley, CA.
Code InfoCatalog number 10312319/VG 42115 Product will have the letter R after the manufacture date.
ClassificationClass II
Reason for RecallTrugene MicroCel 500 buffer chambers, with the potential to leak buffer and could cause electrical arcing posing a hazard to the operator, were distributed.
Product Quantity1 Unit
Recall NumberB-2519-12

Class II Devices Event

Event ID63045
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Medical Solutions USA, Inc
CityMalvern
StatePA
CountryUS
Distribution PatternNationwide Distribution including the states of MO, FL, MA, NY, WI, GA, CA and WA.
 

Associated Products

Product DescriptionSiemens syngo.plaza radiological image processing system.
Code InfoModel number 10592457, serial numbers 100263, 100401, 100177, 100138, 100174, 100406, 100249, 100201, 100198, 100181, 100146.
ClassificationClass II
Reason for RecallSiemens 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 Quantity11
Recall NumberZ-0048-2013

Class II Devices Event

Event ID63070
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmRemington Medical Inc.
CityAlpharetta
StateGA
CountryUS
Distribution PatternNationwide distribution: USA including states of: AL, AZ, CA, FL, IN, MA, NC, NY, OH, PA and TX.
 

Associated Products

Product DescriptionAutomatic 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 InfoNAC-1820M, Lot number: 121003
ClassificationClass II
Reason for RecallSterility of the product may be compromised.
Product Quantity800 needles
Recall NumberZ-0028-2013

Class II Biologics Event

Event ID63072
StatusOngoing
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmImmucor Inc
CityNorcross
StateGA
CountryUS
Distribution PatternNationwide, Bahrain, Canada, China, Columbia, Germany, South Africa, Ireland, Japan, New Zealand, Norway, Peru, and South Korea
 

Associated Products

Product DescriptionCapture-R Ready Indicator Red Cells
Code InfoLot 221861, Exp. 2012-09-06
ClassificationClass II
Reason for RecallSingle 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 Quantity1 Lot
Recall NumberB-2585-12

Class II Devices Event

Event ID63079
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTerumo Cardiovascular Systems Corporation
CityAnn Arbor
StateMI
CountryUS
Distribution PatternWorldwide distribution: USA including AK, AL, AR, AZ, CA, CO, CT, DC
 

Associated Products

Product DescriptionBattery, 100/115V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Code InfoCatalog 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
ClassificationClass II
Reason for RecallTerumo 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 Quantity1076
Recall NumberZ-0049-2013
Product DescriptionBattery, 220V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Code InfoCatalog number: 9491; and lot numbers: 1001-1187, 1101, 1193-1286, 2083-2085, 2018, 2288, 2289, 2447-2451, 2634, 2635, and 2884.
ClassificationClass II
Reason for RecallTerumo 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 Quantity289 units
Recall NumberZ-0050-2013

Class II Devices Event

Event ID63085
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Jul-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmWinco Mfg., LLC
CityOcala
StateFL
CountryUS
Distribution PatternWorldwide Distribution - USA including Arkansas, California, Maryland, Mississippi, New York, Pennsylvania and the country of Saudi Arabia
 

Associated Products

Product DescriptionCaremor Cliner"***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 536 Serial No. 536A-101475***" Literature: "***Caremor Cliner 5351/5361***Winco***ISO 9001-2008 Certified***Our most comfortable and versatile recliner***Ease 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'S***Infinite positioning back***Padded armrests w/arm guard***Webbed elastic suspension back and seat***Removable side panels**Continuous seat & legrest cushion***5351 w/tray***5361 w/out tray***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 34474***www.wincomfg.com***Proudly Made in the USA***" Patient recliner chair
Code InfoModel Number 5361
ClassificationClass II
Reason for RecallWinco 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 Quantity23 chairs
Recall NumberZ-0031-2013
Product DescriptionCaremor Cliner is labeled in part: "***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 535 Serial No. 535A-104522***" Literature: "***Caremor Cliner 5351/5361***Winco***ISO 9001-2008 Certified***Our most comfortable and versatile recliner***Ease 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'S***Infinite positioning back***Padded armrests w/arm guard***Webbed elastic suspension back and seat***Removable side panels**Continuous seat & legrest cushion***5351 w/tray***5361 w/out tray***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 34474***www.wincomfg.com***Proudly Made in the USA***" Patient recliner chair
Code InfoModel Number 5351
ClassificationClass II
Reason for RecallWinco 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 Quantity20 chairs
Recall NumberZ-0032-2013

Class II Devices Event

Event ID63111
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Aug-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmKardium
CityRichmond
StateBC
CountryCA
Distribution PatternNationwide Distribution-including the states of FL, GA, IL, and NH.
 

Associated Products

Product DescriptionTORQ 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 InfoLot No. 062711. Expiry date is June 2014.
ClassificationClass II
Reason for RecallThe TORQ Sternal Closure Device, Lot 062711, is being recalled due to probability one of the metal parts may be dislodged during use.
Product Quantity480 units
Recall NumberZ-0054-2013

Class II Devices Event

Event ID63140
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Jan-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBeckman Coulter Inc.
CityBrea
StateCA
CountryUS
Distribution PatternWorldwide 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 DescriptionActive 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 InfoLot # 110919D, 111017C, 111017D, 111114C, 111212C.
ClassificationClass II
Reason for RecallThe 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 Quantity216 units total (6 units in the US)
Recall NumberZ-0016-2013

Class II Devices Event

Event ID63154
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAdvanced Neuromodulation Systems Inc.
CityPlano
StateTX
CountryUS
Distribution PatternUS Nationwide Distribution
 

Associated Products

Product DescriptionThe 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 InfoEon Mini - 3788 (IPG), Multiple Serial Numbers
ClassificationClass II
Reason for RecallEon 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 Quantity56 units
Recall NumberZ-0025-2013

Class II Devices Event

Event ID63157
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Aug-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmMedtronic Sofamor Danek USA Inc
CityMemphis
StateTN
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) and the countries of India, Netherlands, Hong Kong, S. L Korea, Singapore, Canada, Australia, Japan, and Mexico.
 

Associated Products

Product DescriptionATLANTIS(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 InfoAll lots except those starting with SY
ClassificationClass II
Reason for RecallLines 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 Quantity1047 units
Recall NumberZ-0036-2013
Product DescriptionATLANTIS(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 InfoAll lots except those starting with SY
ClassificationClass II
Reason for RecallLines 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 Quantity1014 units
Recall NumberZ-0037-2013
Product DescriptionPREMIER(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 InfoAll lots except those starting with SY
ClassificationClass II
Reason for RecallLines 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 Quantity247 units
Recall NumberZ-0038-2013

Class II Devices Event

Event ID63158
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Apr-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBeckman Coulter Inc.
CityBrea
StateCA
CountryUS
Distribution PatternWorldwide 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 DescriptionUnicel 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 Infoall serial numbers
ClassificationClass II
Reason for RecallBeckman 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 Quantity1281 units total (693 units in the US)
Recall NumberZ-0021-2013

Class II Devices Event

Event ID63161
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBeckman Coulter Inc.
CityBrea
StateCA
CountryUS
Distribution PatternWorldwide 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 DescriptionCYTO-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 InfoAll tetraCHROME lots manufactured
ClassificationClass II
Reason for RecallThe 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 Quantity137,445 units total (26,155 units in US)
Recall NumberZ-0033-2013
Product DescriptionCYTO-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 InfoAll tetraCHROME lots manufactured
ClassificationClass II
Reason for RecallThe 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 Quantity33,259 units total (8,458 units in US)
Recall NumberZ-0034-2013
Product DescriptionTetraCXP 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 InfoAll tetraCHROME lots manufactured
ClassificationClass II
Reason for RecallThe 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 Quantity146 units total (37 units in US)
Recall NumberZ-0035-2013

Class II Food Event

Event ID63168
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Sep-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmSpringside Cheese Corp
CityOconto Falls
StateWI
CountryUS
Distribution PatternWI, CO
 

Associated Products

Product DescriptionColor Cheddar Cheese Curds: Springside Cheese, Color Curd, 55-0172, V1, August 27, 2012,
Code Info8.21.1 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
ClassificationClass II
Reason for RecallSpringside 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 Quantity41,616.53 lbs total
Recall NumberF-0054-2013
Product DescriptionSpringside Cheese, Color Cheddar, 55-0172, V1, August 21, 2012,
Code Info8.22.1 8.25.3 8.31.2 9.1.3
ClassificationClass II
Reason for RecallSpringside 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 Quantity41,616.53 lbs total
Recall NumberF-0055-2013
Product DescriptionSpringside Cheese, Black Pepper Color Cheddar, 55-0172, V2, August 24, 2012,
Code Info8.24.2 8.27.2 9.1.3
ClassificationClass II
Reason for RecallSpringside 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 Quantity41,616.53 lbs total
Recall NumberF-0056-2013
Product DescriptionSpringside Cheese, Blue Cheese Color Cheddar, 55-0172, V2, August 24, 2012,
Code Info8.24.2
ClassificationClass II
Reason for RecallSpringside 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 Quantity41,616.53 lbs total
Recall NumberF-0057-2013
Product DescriptionSpringside Cheese, Color Cheddar Horseradish Cheese, 55-0172, V2, August 24, 2012,
Code Info8.24.2
ClassificationClass II
Reason for RecallSpringside 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 Quantity41,616.53 lbs total
Recall NumberF-0058-2013
Product DescriptionSpringside Cheese, Color Cheddar Tomato Basil , 55-0172, V1, August 21, 2012,
Code Info8.21.1
ClassificationClass II
Reason for RecallSpringside 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 Quantity41,616.53 lbs total
Recall NumberF-0059-2013
Product DescriptionSpringside Cheese, Monterey Jack Caribbean Red Hot , 55-0172, V3, August 28, 2012,
Code Info8.28.3
ClassificationClass II
Reason for RecallSpringside 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 Quantity41,616.53 lbs total
Recall NumberF-0060-2013
Product Description Springside Cheese, Monterey Jack Chipotle Cheese, 55-0172, V3, August 21, 2012.
Code Info8.21.3 8.28.3
ClassificationClass II
Reason for RecallSpringside 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 Quantity41,616.53 lbs total
Recall NumberF-0061-2013
Product DescriptionSpringside Cheese, Cranberry Monterey Jack Cheese, 55-0172, V3, August 28, 2012,
Code Info8.28.3
ClassificationClass II
Reason for RecallSpringside 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 Quantity41,616.53 lbs total
Recall NumberF-0062-2013
Product DescriptionSpringside Cheese, Monterey Jack Dill Cheese, 55-0172, V3, August 21, 2012,
Code Info8.21.3 8.28.3
ClassificationClass II
Reason for RecallSpringside 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 Quantity41,616.53 lbs total
Recall NumberF-0063-2013
Product DescriptionSpringside Cheese, Monterey Jack Habanero Cheese, 55-0172, V3, August 21, 2012,
Code Info8.21.3
ClassificationClass II
Reason for RecallSpringside 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 Quantity41,616.53 lbs total
Recall NumberF-0064-2013
Product DescriptionSpringside Cheese, Monterey Jack Jalapeno Cheese, 55-0172, V3, August 21, 2012,
Code Info8.21.3
ClassificationClass II
Reason for RecallSpringside 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 Quantity41,616.53 lbs total
Recall NumberF-0065-2013
Product DescriptionWhite Cheddar Cheese Curds: Springside Cheese, White Curds, 55-0172, V2, August 22, 2012, NET WEIGHT___.
Code Info8.22.2 8.22.4 8.29.3 8.29.4
ClassificationClass II
Reason for RecallSpringside 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 Quantity41,616.53 lbs total
Recall NumberF-0066-2013
Product Description Springside Cheese, Maple White Cheddar, 55-0172, V3, August 22, 2012.
Code Info8.22.3
ClassificationClass II
Reason for RecallSpringside 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 Quantity41,616.53 lbs total
Recall NumberF-0067-2013
Product Description Springside Cheese, Black & Green Olive White Cheddar Midget, 55-0172, V3, August 22, 2012.
Code Info8.22.3
ClassificationClass II
Reason for RecallSpringside 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 Quantity41,616.53 lbs total
Recall NumberF-0068-2013
Product DescriptionSpringside Cheese, Reduced Fat Farmers Cheese, 55-0172, V2, August 21, 2012.
Code Info8.21.2
ClassificationClass II
Reason for RecallSpringside 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 Quantity41,616.53 lbs total
Recall NumberF-0069-2013
Product DescriptionSpringside Cheese, Reduced Fat Caraway Farmers, 55-0172, V2, August 21, 2012.
Code Info8.21.2
ClassificationClass II
Reason for RecallSpringside 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 Quantity41,616.53 lbs total
Recall NumberF-0070-2013
Product DescriptionSpringside Cheese, Colby Cheese, 55-0172, V3, August 27, 2012.
Code Info8.27.3
ClassificationClass II
Reason for RecallSpringside 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 Quantity41,616.53 lbs total
Recall NumberF-0071-2013
Product DescriptionSpringside Cheese, Bacon Colby Cheese, 55-0172, V3, August 27, 2012.
Code Info8.27.3
ClassificationClass II
Reason for RecallSpringside 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 Quantity41,616.53 lbs total
Recall NumberF-0072-2013
Product DescriptionSpringside Cheese, Morel & Leek Monterey Jack, 55-0172, V3, August 28, 2012.
Code Info8.28.3
ClassificationClass II
Reason for RecallSpringside 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 Quantity41,616.53 lbs total
Recall NumberF-0073-2013
Product DescriptionSpringside Cheese, Monterey Jack Peppercorn Ranch , 55-0172, V3, August 28, 2012.
Code Info8.28.3
ClassificationClass II
Reason for RecallSpringside 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 Quantity41,616.53 lbs total
Recall NumberF-0074-2013
Product DescriptionSpringside Cheese, Monterey Jack Roasted Red Pepper Cheese, 55-0172, V3, August 28, 2012.
Code Info8.28.3
ClassificationClass II
Reason for RecallSpringside 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 Quantity41,616.53 lbs total
Recall NumberF-0075-2013
Product DescriptionSpringside Cheese, Monterey Jack Salsa Cheese, 55-0172, V3, August 28, 2012.
Code Info8.28.3
ClassificationClass II
Reason for RecallSpringside 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 Quantity41,616.53 lbs total
Recall NumberF-0076-2013
Product DescriptionSpringside Cheese, rBGH Free White Cheddar, 55-0172, V32 August 22, 2012.
Code Info8.22.3 8.29.3
ClassificationClass II
Reason for RecallSpringside 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 Quantity41,616.53 lbs
Recall NumberF-0077-2013

Class II Devices Event

Event ID63169
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBeckman Coulter Inc.
CityBrea
StateCA
CountryUS
Distribution PatternWorldwide 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 DescriptionAccess 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 InfoLot# 112788, 115741, 118917
ClassificationClass II
Reason for RecallBeckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevated results that could mask a folate deficiency.
Product Quantity4,635 units total (3,214 units in US)
Recall NumberZ-0046-2013
Product DescriptionAccess Folate WHO Calibrators, Part Number: A98033. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems
Code InfoLot# 122651, 123635, 219962
ClassificationClass II
Reason for RecallBeckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevated results that could mask a folate deficiency.
Product Quantity5,266 units total (3,214 units in US)
Recall NumberZ-0047-2013

Class II Devices Event

Event ID63175
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-May-09
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAlere San Diego, Inc.
CitySan Diego
StateCA
CountryUS
Distribution PatternWorldwide 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 DescriptionTriage 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 InfoLot 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
ClassificationClass II
Reason for RecallBiosite is recalling the Triage TOX Drug Screen kits where the box containing test devices because it was mislabeled.
Product Quantity45,638 units
Recall NumberZ-0029-2013

Class II Food Event

Event ID63200
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-May-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmWorld Finer Foods, Inc.
CityBloomfield
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionDa 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 InfoE18911 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
ClassificationClass II
Reason for RecallDa 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 Quantity1953 cases (24 jars per case)
Recall NumberF-0096-2013

Class II Food Event

Event ID63205
StatusCompleted
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Aug-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPepsi Bottling Group Nashville
CityNashville
StateTN
CountryUS
Distribution PatternGA, TN, KY, and IN
 

Associated Products

Product Descriptiondiet Orange Crush, no calorie orange soda, 2 L (2.1 QT), UPC 078000013979
Code InfoLot Codes: AUG 27 12 NT05242, SEP 17 12 NY06142, OCT 01 12 NT06252, and OCT 22 12 NY07272.
ClassificationClass II
Reason for RecallDiet Orange Soda contains undeclared high fructose corn syrup.
Product Quantity9011 cases of 8 units
Recall NumberF-0095-2013

Class II Devices Event

Event ID63211
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmOptovue Inc.
CityFremont
StateCA
CountryUS
Distribution PatternWorldwide distribution -- USA (nationwide) and Internationally.
 

Associated Products

Product DescriptionReference 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 InfoAll units of these models.
ClassificationClass II
Reason for RecallDevices 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 Quantity795 units
Recall NumberZ-0024-2013

Class II Devices Event

Event ID63214
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling Firm3M Company - Health Care Business
CitySaint Paul
StateMN
CountryUS
Distribution PatternWorldwide 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 Description3M 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 InfoModel 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
ClassificationClass II
Reason for Recall3M 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 Quantity707 units (61 US, 646 OUS)
Recall NumberZ-0022-2013

Class II Drugs Event

Event ID63354
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPaddock Laboratories, LLC
CityMinneapolis
StateMN
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionMoexipril HCl Tablets 7.5mg, 100 tabs, Rx Only, Paddock Laboratories, Inc., Minneapolis, MN 55427, NDC 0574-0110-01 ,
Code Info2012028142 exp. 1/2014
ClassificationClass II
Reason for RecallPaddock 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 Quantity2267 bottles
Recall NumberD-007-2013

Class II Devices Event

Event ID63362
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmICU Medical, Inc.
CitySan Clemente
StateCA
CountryUS
Distribution PatternNationwide distribution: Virginia only.
 

Associated Products

Product Description3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod®, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.
Code InfoPart Number (Item #) AG8049-NS, Lot # 2528655.
ClassificationClass II
Reason for RecallICU 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 Quantity60
Recall NumberZ-0055-2013

Class III Biologics Event

Event ID39813
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Mar-05
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Center of Greater Kansas City
CityKansas City
StateMO
CountryUS
Distribution PatternMissouri and Kansas
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW045005017417; W045005017418; W045005017426; W045005017430; W045005017437; W045005017438
ClassificationClass III
Reason for RecallBlood products, with invalid HIV/HCV nucleic acid testing (NAT) results, were distributed.
Product Quantity6 units
Recall NumberB-1948-12

Class III Biologics Event

Event ID42897
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Jul-06
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross, The
CityPomona
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info006FS04297
ClassificationClass III
Reason for RecallBlood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-1692-12

Class III Biologics Event

Event ID50634
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Nov-08
Initial Firm Notification of Consignee or Public Other
Recalling FirmCSL Plasma, Inc
CityColumbia
StateSC
CountryUS
Distribution PatternSwitzerland
 

Associated Products

Product DescriptionSource Plasma
Code Info6120207155, 6120209576, 6120209315, 6120208409, 6120208457
ClassificationClass III
Reason for RecallBlood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Product Quantity5 units
Recall NumberB-2158-12

Class III Biologics Event

Event ID61565
StatusOngoing
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Feb-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMedImmune, LLC
CityPhiladelphia
StatePA
CountryUS
Distribution PatternProduct was distributed within the US to CA, FL and TX. Government account: Department of Defense, Camp Pendleton, CA.
 

Associated Products

Product DescriptionFluMist, Influenza Virus Vaccine, Live, Intranasal, each 0.2mL dose is a suspension supplied in a single-dose pre-filled intranasal sprayer
Code InfoLot YL2077
ClassificationClass III
Reason for RecallFluMist, Influenza Virus Vaccine, Live Intranasal, lacking assurance of proper temperature manintenance during shipment, was distributed.
Product Quantity1 Lot
Recall NumberB-2586-12

Class III Food Event

Event ID61778
StatusCompleted
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Oct-11
Initial Firm Notification of Consignee or Public Visit
Recalling FirmMothers' Milk Bank at Austin
CityAustin
StateTX
CountryUS
Distribution PatternAustin,TX
 

Associated Products

Product DescriptionMother'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 InfoBatch 9429-1
ClassificationClass III
Reason for RecallThe product had the potential to contain foreign materials.
Product Quantity54 - 3 oz. bottles
Recall NumberF-0105-2013

Class III Biologics Event

Event ID62570
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Jun-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Center
CityDayton
StateOH
CountryUS
Distribution PatternOhio
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code InfoW035412039602; W035412037992;
ClassificationClass III
Reason for RecallBlood products, labeled with extended expiration dates, were distributed.
Product Quantity2
Recall NumberB-2306-12

Class III Drugs Event

Event ID62827
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmActavis Mid Atlantic LLC
CityLincolnton
StateNC
CountryUS
Distribution PatternNationwide & Puerto Rico
 

Associated Products

Product DescriptionPrometh 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 InfoX111001, X111008, X111030, Exp 10/13
ClassificationClass III
Reason for RecallImpurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Product Quantity14,868 Bottles
Recall NumberD-005-2013
Product DescriptionPrometh 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 InfoX110042, X110051, X110064, Exp 09/13
ClassificationClass III
Reason for RecallImpurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
Product Quantity19,980 Bottles
Recall NumberD-006-2013

Class III Biologics Event

Event ID62969
StatusOngoing
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAssociates of Cape Cod, Inc.
CityEast Falmouth
StateMA
CountryUS
Distribution PatternCA, IA, FL, MN, NC, NY, SC, TX Foreign: Canada, Columbia, Brazil, Ecuador, Guatemala, Hong Kong, Indonesia, Korea, Russian Federation, UK, Taiwan
 

Associated Products

Product DescriptionAssociates 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 InfoLot number: 51006539
ClassificationClass III
Reason for RecallOne lot of mislabeled Pyrotell gel clot LAL reagent was distributed.
Product Quantity217 (5 vial Packs) and 37 (25 vial Packs)
Recall NumberB-2565-12

Class III Food Event

Event ID63182
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmChang Jiang Seafood Ca Inc
CitySouth El Monte
StateCA
CountryUS
Distribution PatternAZ, CA, UT
 

Associated Products

Product DescriptionFrozen IQF PND Shrimp (Farm Raised), size 61/70 and size 71/90, 30 lbs (6bgsx5lbs)
Code InfoProduct has no lot numbers. Product date: 15-11-2011.
ClassificationClass III
Reason for RecallChang Jiang Seafood CA Inc. is recalling Frozen Shrimp because it contains nitrofuran which is an unapproved antibiotic.
Product Quantity719 cartons
Recall NumberF-0025-2013
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