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U.S. Department of Health and Human Services

Enforcement Report - Week of May 29, 2013

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Class I Food Event

Event ID63356
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Oct-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmWhole Foods Market
CityAustin
StateTX
CountryUS
Distribution PatternTX
 

Associated Products

Product DescriptionChicken Spring Rolls Dist. by Whole Foods Market, UPC 225757203997
Code InfoAll product with a sell by date of 10/1/12 or 10/2/12.
ClassificationClass I
Reason for RecallThe products were manufactured using peanuts supplied by Sunland, Inc. and have the potential to be contaminated with Salmonella.
Product Quantity
Recall NumberF-1446-2013
Product DescriptionPeanut Sesame Noodles Dist. by Whole Foods Market, UPC 222099604192
Code InfoAll product with either a sell by date of 10/1/12 or 10/2/12 or a sold on date of 09/27/12 or 9/28/12.
ClassificationClass I
Reason for RecallThe products were manufactured using peanuts supplied by Sunland, Inc. and have the potential to be contaminated with Salmonella.
Product Quantity
Recall NumberF-1447-2013

Class I Food Event

Event ID63418
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Oct-12
Initial Firm Notification of Consignee or Public Visit
Recalling FirmBrookshire Grocery Company Manufacturing
CityTyler
StateTX
CountryUS
Distribution PatternTX, Louisiana and Southern Arkansas
 

Associated Products

Product DescriptionGoldenbrook Farms Peanut Butter Bash Ice Cream, 1/2 gallon carton with UPC code 0009282530538
Code InfoAll Peanut Butter Bash Ice Cream distributed between May 2010 and September 2012 with UPC code 0009282530538.
ClassificationClass I
Reason for RecallThe product has the potential to be contaminated with Salmonella. The peanut butter used in the manufacturing of the ice cream was supplied by Sunland, Inc.
Product Quantity
Recall NumberF-1442-2013

Class I Veterinary Event

Event ID63745
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Nov-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmCarolina Prime Pet
CityMurphy
StateNC
CountryUS
Distribution PatternAZ, CA, CO, DC, DE, HI, IL, MD, NE, NJ, NV, NM, PA, SD, TX, VA and WY.
 

Associated Products

Product DescriptionPriority Total Pet Care, All Natural Bullstrips Dog Treats, 6 Bullstrip, Distributed by Lucerne Foods, Inc., P.O. Box 99, Pleasanton, CA 94566-0009.
Code InfoUPC 0-21130-42080-3, Lot #20082712 S 3195 and 20090312 S3195
ClassificationClass I
Reason for RecallProduct tested positive for Salmonella.
Product Quantity64 cases (28,800 pieces)
Recall NumberV-168-2013

Class I Veterinary Event

Event ID64411
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Feb-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmNutri-Vet, LLC
CityBoise
StateID
CountryUS
Distribution Patterndistributed nationwide and also to Hong Kong, Malaysia, Panama, and Singapore.
 

Associated Products

Product DescriptionNutriPet Natural Chicken Fillet Strips, Item # 76-0081, Net wt. 16oz. There is NO UPC for this product. Product is labeled in parts: "***NUTRIPET***Naturally Chicken Fillet Strips***95% Fat-Free Treats for Dogs***NET WT. 16 oz***76-0081***".
Code InfoLot 2095 and expiration date 07/2014.
ClassificationClass I
Reason for RecallNutri-Pet Chicken Jerky products are recalled because they may be contaminated with Salmonella.
Product Quantity672/16 oz. packages
Recall NumberV-173-2013
Product DescriptionNutri-Vet Natural Chicken Breast Treats with Glucosamine for Dogs Promotes Joint Health, has net weight 5 oz or 15 oz. The 5 oz. package, item 50704, has the UPC 6 69125 50704 9. The 15 oz package, item 50705, has the UPC 6 69125 50705 6. Product is labeled in parts: "***NUTRIVET***Naturally Chicken Breast Treats***with glucosamine for Dogs Promote Joint Health***".
Code Info5 oz packages have lot 072114 and expiration date 07/2014. 15 oz. packages have lot 061114 and 061514 and expiration date 06/2014.
ClassificationClass I
Reason for RecallNutri-Vet Chicken Jerky products are recalled because they may be contaminated with Salmonella.
Product Quantity1992/5 oz. Packages and 3576/15 oz. Packages
Recall NumberV-174-2013
Product DescriptionNutri-Vet Natural Chicken Breast Treats with Omega 3 for Dogs Promotes a Glossy Coat has a net weight 5 oz or 15 oz. The 5 oz. package, item 50706, has the UPC 6 69125 50706 3; The 15 oz package, item 50707, has the UPC 6 69125 50707 0; Product is labeled in parts: "***NUTRIVET***Natural Chicken Breast Treats*** with Omega 3 for Dogs Promotes a Glossy Coat***".
Code Info5 oz. packages have lot 072314 and expiration date 07/2014. 15 oz. packages have lot 061514 and expiration date 06/2014.
ClassificationClass I
Reason for RecallNutri-Vet Chicken Jerky products are recalled because they may be contaminated with Salmonella.
Product Quantity1992/5 oz. packages and 3600/15 oz. packages
Recall NumberV-175-2013
Product DescriptionNutri-Vet Natural Chicken Breast Treats with Chamomile and Ginger for Dogs Helps Reduce Stress and Anxiety, has a net weight 5 oz or 15 oz. The 5 oz. package, item 50708, has the UPC 6 69125 50708 7. The 15 oz package, item 50709, has the UPC 6 69125 50709 4. Product is labeled in parts: "***NUTRIVET*** Natural Chicken Breast Treats***with Chamomile and Ginger for Dogs Helps Reduce Stress and Anxiety***".
Code Info5 oz. packages have lot 072214 and expiration date 07/2014. 15 oz. packages have lot 060714 and 061514 and expiration date 06/2014.
ClassificationClass I
Reason for RecallNutri-Vet Chicken Jerky products are recalled because they may be contaminated with Salmonella.
Product Quantity1992/5 oz. packages and 3466/15 oz packages
Recall NumberV-176-2013
Product DescriptionNutri-Vet Natural Chicken Breast Treats with Rosemary and Parsley for Dogs Promotes Fresh Breath, has a net weight 5 oz or 15 oz. The 5 oz. package, item 50710, has the UPC 6 69125 50710 0. The 15 oz package, item 50711, has the UPC 6 69125 50711 7. Product is labeled in parts: "***NUTRIVET*** Natural Chicken Breast Treats*** with Rosemary and Parsley for Dogs Promotes Fresh Breath***".
Code Info5 oz. packages have lot 072314 and expiration date 07/2014. 15 oz. packages have lot 060714 and 060814 and expiration date 06/2014.
ClassificationClass I
Reason for RecallNutri-Vet Chicken Jerky products are recalled because they may be contaminated with Salmonella.
Product Quantity1992/5 oz Packages and 3095/15 oz. Packages
Recall NumberV-177-2013
Product DescriptionNutri-Vet Natural Chicken Breast Treats with Antioxidants for SENIOR Dogs Promotes Health and Vitality. Item number is 50712 and has net weight 5 oz. The UPC is 6 69125 50712 4 Product is labeled in parts: "***NUTRIVET*** Natural Chicken Breast Treats*** Antioxidants for SENIOR dogs Promotes Health and Vitality***".
Code InfoLot number 062914 and expiration date 06/2014
ClassificationClass I
Reason for RecallNutri-Vet Chicken Jerky products are recalled because they may be contaminated with Salmonella.
Product Quantity1992/5 oz. Packages
Recall NumberV-178-2013
Product DescriptionNutri-Vet Natural Chicken Breast Treats with Enzymes for Dogs Promotes Healthy Digestion. Item number is 50714, net weight 5 oz, and the UPC is 6 69125 50714 8. Product is labeled in parts: "***NUTRIVET*** Natural Chicken Breast Treats with Enzymes for Dogs Promotes Healthy Digestion***".
Code Infolot number 072614 and expiration date 07/2014
ClassificationClass I
Reason for RecallNutri-Vet Chicken Jerky products are recalled because they may be contaminated with Salmonella.
Product Quantity1992/5 oz. Packages
Recall NumberV-179-2013
Product DescriptionNutri-Vet Natural Chicken Breast Treats with L-Carnitine for Dogs Promotes Healthy Weight. The net weight is 5 oz, item number is 50716. The UPC is 6 69125 50716 2. Product is labeled in parts: "***NUTRIVET*** Natural Chicken Breast Treats*** with L-Carnitine for Dogs Promotes Healthy Weight.***".
Code Infolot number 072514 and expiration date 07/2014
ClassificationClass I
Reason for RecallNutri-Vet Chicken Jerky products are recalled because they may be contaminated with Salmonella.
Product Quantity1992/5 oz. Packages
Recall NumberV-180-2013
Product DescriptionNutri-Vet Natural Chicken Breast Treats for Dogs, 5 oz. package, Item 50701, has the UPC 6 69125 50701 8; Nutri-Vet K9 Natural Chicken Breast Treats, 8 oz. package, Item 50702, has the UPC 6 69125 50702 5; Nutri-Vet K9 Natural Chicken Breast Treats, 16 oz. package, Item 50703, has the UPC 6 69125 50703 2; Product is labeled in parts: "***NUTRIVET*** Natural Chicken Breast Treats for Dogs***VETERINARY FORMULATED***".
Code Info5 oz packages have lot code 072514 and expiration date 07/2014. 8 oz. packages have lot code 072514 and expiration date 07/2014. 16 oz. packages have lot code 061214 and 061414 and expiration date 06/2014/
ClassificationClass I
Reason for RecallNutri-Vet Chicken Jerky products are recalled because they may be contaminated with Salmonella.
Product Quantity1986/5 oz. Packages; 1992/8 oz. Packages; and 2016/16 oz. Packages
Recall NumberV-181-2013
Product DescriptionNutri-Vet Hip & Joint Natural Chicken Breast Strips, 100 mg glucosamine per oz. Product has item number 99044, net weight of 8 oz, and the UPC is 6 69125 99044 5. Product is labeled in parts: "***NUTRIVET*** Natural Chicken Breast STRIPS***Early care for dogs***100 mg glucosamine per oz***Hip & Joint***".
Code Infolot code 072714 and expiration date 07/2014
ClassificationClass I
Reason for RecallNutri-Vet Chicken Jerky products are recalled because they may be contaminated with Salmonella.
Product Quantity1728/8 oz. Packages
Recall NumberV-182-2013

Class I Veterinary Event

Event ID64476
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmUnited Pet Group Inc
CityCincinnati
StateOH
CountryUS
Distribution PatternProduct was shipped to the following states: AZ, CA, FL, GA, IL, IN, MI, MO, NC, NJ, NV, NY, OH, PA, SC, WA & WI. Product was also shipped to Canada.
 

Associated Products

Product DescriptionUltra Blend Gourmet, Food for Parakeets (80 oz bag), A Harvest Celebration FOOD FOR PARAKEETS, NET.WT 80 OZ (5 LBS) Eight In One Pet Products Distributed by United Pet Group, Inc., Cincinnati, OH 45230 (800) 645-5154 www.eightinonepet.com UPC 0 26851 00904
Code InfoItem # A904/056-0904-01 - USE BY dates: 07/20/15 and 10/20/15
ClassificationClass I
Reason for RecallThe firm received notification from one of their ingredient suppliers that parsley they purchased may be contaminated with Salmonella.
Product Quantity6,630/80 oz bags
Recall NumberV-169-2013
Product DescriptioneCotrition Grains & Greens, Nutritional Supplement for Parakeets A Diverse Blend of Garden Vegetables & Select Grains Vitamin & Mineral Enriched NEW WT. 8 OZ (226 g) Eight In One Pet Products Distributed by United Pet Group, Inc. Cincinnati, Ohio 45230 (800) 645-5154 www.eightinonepet.com UPC 0 26851 00505
Code InfoItem # A505/11-20700 USE BY dates: 10/23/15 and 11/14/15
ClassificationClass I
Reason for RecallThe firm received notification from one of their ingredient suppliers that parsley they purchased may be contaminated with Salmonella.
Product Quantity8,880/8 oz bags
Recall NumberV-170-2013
Product DescriptioneCotrition Grains & Greens, Nutritional Supplement for Canaries and Finches A Diverse Blend of Garden Fresh Vegetables & Select Grains Vitamin & Mineral Enriched NET WT. 8 OZ (226 g) Eight In One Pet Products Distributed by United Pet Group, Inc. Cincinnati, Ohio 45230 (800) 645-5154 www.eightinonepet.com UPC 0 26851 00546
Code InfoItem # C546/11-20712 - USE BY date: 10/16/15
ClassificationClass I
Reason for RecallThe firm received notification from one of their ingredient suppliers that parsley they purchased may be contaminated with Salmonella.
Product Quantity264/8 oz bags
Recall NumberV-171-2013
Product DescriptioneCotrition Grains & Greens, Nutritional Supplement for Cockatiels A Diverse Blend of Garden Fresh Vegetables & Select Grains Vitamin & Mineral Enriched NET WT. 6.5 OZ (184 g) Eight In One Pet Products Distributed by United Pet Group, Inc. Cincinnati, Ohio 45230 (800) 645-5154 www.eightinonepet.com UPC 0 26851 00512
Code InfoItem # B512/11-20711 USE BY date: 12/05/15
ClassificationClass I
Reason for RecallThe firm received notification from one of their ingredient suppliers that parsley they purchased may be contaminated with Salmonella.
Product Quantity96/6.5 oz bags
Recall NumberV-172-2013

Class I Food Event

Event ID64916
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmWin Luck Trading Inc
CityBayonne
StateNJ
CountryUS
Distribution PatternNew York
 

Associated Products

Product DescriptionLam Sheng Kee, Frozen White Fish Ball - Shrimp Ball Net Weight 7 oz (200 G) - Sheng Lin Mark Trade Co. LTD 4 F. No 89, Ln. 528 Heping Road, Bade City, Taoyuan County 334, Taiwan (ROC). Distributed by: Win Luck Trading Inc. 100 Pulaski Street, Bayonne, NJ 07002.
Code InfoAll lots
ClassificationClass I
Reason for RecallThe recall was initiated after it was discovered the label failed to list the common name Albumin as egg; also the species of fish was not declared in the ingredient statement.
Product QuantityUnknown
Recall NumberF-1437-2013
Product DescriptionLam Sheng Kee, Frozen White Fish Ball - Lobster Ball Net Weight 7 oz (200 G) - Sheng Lin Mark Trade Co. LTD 4 F. No 89, Ln. 528 Heping Road, Bade City, Taoyuan County 334, Taiwan (ROC). Distributed by: Win Luck Trading Inc. 100 Pulaski Street, Bayonne, NJ 07002.
Code InfoAll lots
ClassificationClass I
Reason for RecallThe recall was initiated after it was discovered the label failed to list the common name Albumin as egg; also the species of fish was not declared in the ingredient statement.
Product QuantityUnknown
Recall NumberF-1438-2013
Product DescriptionLam Sheng Kee, Frozen White Fish Ball - Fish Package Egg, Net Weight 7 oz (200 G) - Sheng Lin Mark Trade Co. LTD 4 F. No 89, Ln. 528 Heping Road, Bade City, Taoyuan County 334, Taiwan (ROC). Distributed by: Win Luck Trading Inc. 100 Pulaski Street, Bayonne, NJ 07002.
Code InfoAll lots
ClassificationClass I
Reason for RecallThe recall was initiated after it was discovered the label failed to list the common name Albumin as egg; also the species of fish was not declared in the ingredient statement.
Product QuantityUnknown
Recall NumberF-1439-2013
Product DescriptionLam Sheng Kee, Frozen White Fish Ball - Fresh Fish Cake, Net Weight 7 oz (200 G) - Sheng Lin Mark Trade Co. LTD 4 F. No 89, Ln. 528 Heping Road, Bade City, Taoyuan County 334, Taiwan (ROC). Distributed by: Win Luck Trading Inc. 100 Pulaski Street, Bayonne, NJ 07002.
Code InfoAll lots
ClassificationClass I
Reason for RecallThe recall was initiated after it was discovered the label failed to list the common name Albumin as egg; also the species of fish was not declared in the ingredient statement.
Product QuantityUnknown
Recall NumberF-1440-2013

Class I Food Event

Event ID64958
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Apr-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmGo Max Go Foods
CitySanta Fe
StateNM
CountryUS
Distribution PatternNationwide distribution to 14 distributors and 26 retailers. Products were distributed to Canada, UK, Germany, and Australia. No government or VA consignees.
 

Associated Products

Product DescriptionSnap! crisped rice in a rice-milk chocolatey coating, 1.75 oz, dairy-free, vegan, no trans fats, no hydrogenated oils, no cholesterol, nothing artificial. Distributed by Go Max Go Foods, LLC 57 Puye Road, Santa Fe, NM 87505.
Code InfoUPC 899033002097
ClassificationClass I
Reason for RecallGo Max Go Foods is recalling various lots of vegan candy bar products containing the statement "dairy-free" due to undeclared milk.
Product Quantity38,928 bars
Recall NumberF-1430-2013
Product DescriptionCleo's Peanut Butter Cups creamy peanut butter in a rice-milk chocolately coating, 1.5 oz, gluten-free, dairy-free & vegan, no trans fats, nothing artificial. Distributed by Go Max Go Foods, LLC 40 Paseo Del Antiope, Santa Fe, NM 87506.
Code InfoUPC 899033002040
ClassificationClass I
Reason for RecallGo Max Go Foods is recalling various lots of vegan candy bar products containing the statement "dairy-free" due to undeclared milk.
Product Quantity74,364 bars
Recall NumberF-1431-2013
Product DescriptionJokerz Candy Bar peanuts, caramel, & nougat in a a rice-milk chocolately coating, 2.1 oz, dairy-free, vegan, no trans fats, nothing artificial. Distributed by Go Max Go Foods, LLC 40 Paseo Del Antilope, Santa Fe, NM 87506.
Code InfoUPC 899033002002
ClassificationClass I
Reason for RecallGo Max Go Foods is recalling various lots of vegan candy bar products containing the statement "dairy-free" due to undeclared milk.
Product Quantity128,604 bars
Recall NumberF-1432-2013
Product DescriptionTwilight Candy Bar caramel & chocolatey nougat in a a rice-milk chocolately coating, 2.1 oz, dairy-free, vegan, no trans fats, nothing artificial. Distributed by Go Max Go Foods, LLC 40 Paseo Del Antilope, Santa Fe, NM 87506.
Code InfoUPC 899033002019
ClassificationClass I
Reason for RecallGo Max Go Foods is recalling various lots of vegan candy bar products containing the statement "dairy-free" due to undeclared milk.
Product Quantity100,308 bars
Recall NumberF-1433-2013
Product DescriptionBuccaneer Candy Bar chocolatey nougat in a a rice-milk chocolately coating, 2.0 oz, dairy-free, vegan, no trans fats, nothing artificial. Distributed by Go Max Go Foods, LLC 40 Paseo Del Antilope, Santa Fe, NM 87506.
Code InfoUPC 899033002026
ClassificationClass I
Reason for RecallGo Max Go Foods is recalling various lots of vegan candy bar products containing the statement "dairy-free" due to undeclared milk.
Product Quantity53,916 bars
Recall NumberF-1434-2013
Product DescriptionThumbs Up Candy Bar. A Crunchy, Peanut Buttery Center in a a rice-milk chocolately coating, 1.3 oz, gluten-free,dairy-free & vegan, no trans fats, nothing artificial. Distributed by Go Max Go Foods, LLC 40 Paseo Del Antilope, Santa Fe, NM 87506.
Code InfoUPC 899033002064
ClassificationClass I
Reason for RecallGo Max Go Foods is recalling various lots of vegan candy bar products containing the statement "dairy-free" due to undeclared milk.
Product Quantity16,236 bars
Recall NumberF-1435-2013
Product DescriptionMahalo Candy Bar. Coconut & almonds in a a rice-milk chocolately coating, 2.0 oz, gluten-free,dairy-free & vegan, no trans fats, nothing artificial. Distributed by Go Max Go Foods, LLC 40 Paseo Del Antilope, Santa Fe, NM 87506.
Code InfoUPC 899033002033
ClassificationClass I
Reason for RecallGo Max Go Foods is recalling various lots of vegan candy bar products containing the statement "dairy-free" due to undeclared milk.
Product Quantity106,908 bars
Recall NumberF-1436-2013

Class I Food Event

Event ID65035
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Apr-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmConagra Inc
CityOmaha
StateNE
CountryUS
Distribution PatternDistribution was made nationwide.
 

Associated Products

Product DescriptionOrville Redenbacher's Classic Kettle Korn, sweet and salty popcorn, ready-to-eat, packaged in 5-oz/plastic bags (Unit UPC code 027000523216) and 1.5-oz/plastic bags (Unit UPC code 027000523254).
Code Info5-oz bags: Batch Code 5486234100, Best by Date SEP 02 2013; Batch Code 5486234200, Best by Date SEP 03 2013; and Batch Code 5486234300, Best by Date SEP 04 2013. 1.5-oz bags: Batch Code 5486234200, Best by Date SEP 03 2013 and Batch Code 5486234300, Best by Date SEP 04 2013.
ClassificationClass I
Reason for RecallThe kettle korn flavored ready-to-eat popcorn product may contain ready-to-eat white cheddar flavored popcorn which may pose a hazard to health due to undeclared milk.
Product Quantity8,666/8/5-oz bag/cases and 5,707/8/1.5-oz bag/cases
Recall NumberF-1443-2013

Class I Food Event

Event ID65041
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Apr-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmKrinos Foods, Inc.
CityLong Island City
StateNY
CountryUS
Distribution PatternCA, CO, CT, FL, GA, IA, IL, IN, MA, MD, MI, NC, NH, NJ, NY, OH, OR, PA, RI, SC, TX, VA, VI and WI
 

Associated Products

Product DescriptionKrinos TAHINI ground sesame seeds, 1) Net. Wt. 1 lb (454g) in glass jars with gold lids packed 12 jars per case - UPC Code 0-75013-28500-3, 2) Net. Wt. 2 lb in glass jars with gold lids packed 12 jars per case - UPC Code 0-75013-28510-2 and 3) Net. Wt. 40 lb (18 kg) in plastic tub packed 1 tub per case-UPC Code 0-75013-04018-3.
Code InfoEXP JAN 01 2014 up to and including EXP JUN 08 2014 and EXP OCT 16 2014 up to and including EXP MAR 15 2015.
ClassificationClass I
Reason for RecallSalmonella contamination.
Product Quantity3, 667 cartons (3,501 ctns of 1 pound, 108 ctns of 2 pound and 58 ctns of 40 pound)
Recall NumberF-1441-2013

Class II Biologics Event

Event ID38596
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Apr-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (The)
CityWest Henrietta
StateNY
CountryUS
Distribution PatternPA, NY
 

Associated Products

Product DescriptionRed Blood Cells
Code Info01E91917
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity1 unit
Recall NumberB-1310-13

Class II Biologics Event

Event ID39050
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Apr-07
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmNorthwest Florida Blood Center, Inc.
CityPensacola
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced.
Code Info4092092
ClassificationClass II
Reason for RecallBlood products, collected from a donor who received a piercing within 12 months of donation, was distributed.
Product Quantity1 unit
Recall NumberB-1241-13

Class II Biologics Event

Event ID39052
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Mar-07
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmNorthwest Florida Blood Center, Inc.
CityPensacola
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionFresh Frozen Plasma
Code Info5212449
ClassificationClass II
Reason for RecallBlood products, which quality control and distribution/required testing not performed were distributed.
Product Quantity1 unit
Recall NumberB-1250-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info5212449
ClassificationClass II
Reason for RecallBlood products, which quality control and distribution/required testing not performed were distributed.
Product Quantity1 unit
Recall NumberB-1251-13

Class II Biologics Event

Event ID39053
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Jun-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmFlorida Georgia Blood Alliance, Inc.
CityJacksonville
StateFL
CountryUS
Distribution PatternFL
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info8604369
ClassificationClass II
Reason for RecallBlood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-1093-13

Class II Biologics Event

Event ID39188
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Jul-01
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmChildren's Hospital of Orange County: Blood & Donor Services
CityOrange
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoFE18334,PART1; FE18334,PART2
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who had taken aspirin prior to the donation, were distributed.
Product Quantity2 units
Recall NumberB-1312-13

Class II Biologics Event

Event ID39434
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Dec-04
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmLife Sera, Inc.
CityClarkston
StateGA
CountryUS
Distribution PatternGermany
 

Associated Products

Product DescriptionSource Plasma
Code InfoFT01233251; FT01233373; FT01233495; FT01233601
ClassificationClass II
Reason for RecallBlood products, which tested negative for the human immunodeficiency virus (HIV) but were collected from a donor who previously tested positive for HIV, were distributed.
Product Quantity4 units
Recall NumberB-1169-13

Class II Biologics Event

Event ID39864
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Mar-05
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityLauderhill
StateFL
CountryUS
Distribution PatternFL
 

Associated Products

Product DescriptionFresh Frozen Plasma
Code Info1506379
ClassificationClass II
Reason for RecallBlood product, labeled with an incorrect expiration date, was distributed.
Product Quantity1 unit
Recall NumberB-1165-13

Class II Biologics Event

Event ID40010
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Apr-05
Initial Firm Notification of Consignee or Public FAX
Recalling FirmDCI Biologicals Orlando LLC
CityGainesville
StateFL
CountryUS
Distribution PatternUnited Kingdom
 

Associated Products

Product DescriptionSource Plasma
Code InfoGN0034097; GN0034652; GN0034726; GN0035205; GN0035272; GN0035915; GN0036133
ClassificationClass II
Reason for RecallBlood products, collected from a donor who subsequently reported a tattoo, were distributed
Product Quantity7 units
Recall NumberB-1233-13

Class II Biologics Event

Event ID40204
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Jun-05
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityLauderhill
StateFL
CountryUS
Distribution PatternMI, FL
 

Associated Products

Product DescriptionPlatelets
Code Info1770441;1770439;1770438
ClassificationClass II
Reason for RecallBlood products, labeled with the incorrect expiration date, were distributed.
Product Quantity3 units
Recall NumberB-1172-13
Product DescriptionRed Blood Cells Frozen Rejuvenated
Code Info1770439
ClassificationClass II
Reason for RecallBlood products, labeled with the incorrect expiration date, were distributed.
Product Quantity1 unit
Recall NumberB-1173-13

Class II Biologics Event

Event ID41304
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Dec-05
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmNorthwest Florida Blood Center, Inc.
CityPensacola
StateFL
CountryUS
Distribution PatternFL
 

Associated Products

Product DescriptionPlatelets Leukocytes Reduced Irradiated
Code Info 4084307
ClassificationClass II
Reason for RecallBlood product, processed in a manner that may have compromised sterility, was distributed.
Product Quantity1 unit
Recall NumberB-1171-13

Class II Biologics Event

Event ID41489
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Jan-06
Initial Firm Notification of Consignee or Public FAX
Recalling FirmDCI Biologicals, Orlando LLC
CityClearwater
StateFL
CountryUS
Distribution PatternUnited Kingdom
 

Associated Products

Product DescriptionSource Plasma
Code InfoGN0045072; GN0045321; GN0046053; GN0048378; GN0049724; GN0049924; GN0050812; GN0051396; GN0051675; GN0053084; GN0053446; GN0054588; GN0055530; GN0055783; GN0057930; GN0058194; GN0058694; GN0059013; GN0059781; GN0060131; GN0061476; GN0061595; GN0062439; GN0063114; GN0063386; GN0063819; GN0064254; GN0064881; GN0065184.
ClassificationClass II
Reason for RecallBlood products, collected from a donor who received a piercing within 12 months of donation, were distributed.
Product Quantity29 units
Recall NumberB-1170-13

Class II Biologics Event

Event ID42577
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Jul-06
Initial Firm Notification of Consignee or Public FAX
Recalling FirmInternational BioResources, LLC
CityEl Paso
StateTX
CountryUS
Distribution PatternNC
 

Associated Products

Product DescriptionSource Plasma
Code Info372020203; 372018910; 372018366; 372017462; 372028422; 372016374; 372014846; 372013772; 372013335; 372007234; 372000364; 372000335
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 Quantity12 units
Recall NumberB-1167-13

Class II Biologics Event

Event ID42579
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Jul-06
Initial Firm Notification of Consignee or Public FAX
Recalling FirmInternational BioResources, LLC
CityEl Paso
StateTX
CountryUS
Distribution PatternNC
 

Associated Products

Product DescriptionSource Plasma
Code InfoI65076717; I65070365
ClassificationClass II
Reason for RecallBlood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Product Quantity2 units
Recall NumberB-1155-13

Class II Biologics Event

Event ID48481
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Feb-08
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmAmerican National Red Cross (The)
CitySalt Lake City
StateUT
CountryUS
Distribution PatternUT, CA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info20LP81716
ClassificationClass II
Reason for RecallBlood products, collected in a manner that may have compromised sterility, were distributed.
Product Quantity1 unit
Recall NumberB-1158-13

Class II Biologics Event

Event ID48774
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Aug-07
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmFlorida Blood Services, Inc.
CityPensacola
StateFL
CountryUS
Distribution PatternFL
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info4111626
ClassificationClass II
Reason for RecallBlood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-1157-13

Class II Biologics Event

Event ID48801
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Jun-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeSouth Community Blood Centers, Inc.
CityGainesville
StateFL
CountryUS
Distribution PatternFL
 

Associated Products

Product DescriptionPlatelets
Code Info72F887558
ClassificationClass II
Reason for RecallQuality Control and Distribution/Distribution of product that did not meet specifications. Product in which instrument QC or validation was unacceptable, incomplete, not performed, or not documented.
Product Quantity1 unit
Recall NumberB-1160-13

Class II Biologics Event

Event ID49806
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Jul-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeSouth Community Blood Centers
CityLecanto
StateFL
CountryUS
Distribution PatternFL
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info72H259365
ClassificationClass II
Reason for RecallBlood product, with a low platelet count, was distributed.
Product Quantity1 unit
Recall NumberB-1161-13

Class II Biologics Event

Event ID49948
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Aug-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeSouth Community Blood Centers, Inc.
CityBrooksville
StateFL
CountryUS
Distribution PatternFL
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info72H552220
ClassificationClass II
Reason for RecallBlood product, with a low platelet count, was distributed.
Product Quantity1 unit
Recall NumberB-1164-13

Class II Devices Event

Event ID56447
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Jul-10
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTechnidata S.A.
CityMontbonnot St Martin
State
CountryFR
Distribution PatternWorldwide Distribution-USA (nationwide) including Washington DC and the states of California, Nevada, Kentucky, Alabama, Rhode Island, Pennsylvania, and Louisiana and the country of Italy.
 

Associated Products

Product DescriptionTD-Synergy. Laboratory Information System.
Code InfoTD Lims product versions: LIS (ALLX)-21.041-_ML-5370, LIS (ALLX)-22.021-_ML-5374, TD-Synergy product versions: SYN (ALLX)- 03.13B-_ML-5368, SYN (ALLX)- 03.141-_ML-5369, SYN(LINUX)-06.011-_ML-5381, SYN (ALLX)-11.11B-_ML-5345, SYN (ALLX)-11.21B-_ML-5346 SYN (ALL)- 11.31C-_ML-5372, SYN (LINUX)-11.321-_FR-5382, SYN (ALL)-11.321-_ML-5373
ClassificationClass II
Reason for RecallTechnidata has discovered that using the F8 key in the ERM session to add a combined test can result in the modification of the value of a result that has already been entered for a test of the request.
Product Quantity10
Recall NumberZ-1345-2013

Class II Devices Event

Event ID61315
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Mar-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDePuy Orthopaedics, Inc.
CityWarsaw
StateIN
CountryUS
Distribution PatternWorldwide Distribution - USA Nationwide including the state of VA and the country of Ireland.
 

Associated Products

Product DescriptionPinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner, Ref 1221-36-452 Product Usage: An acetabular liner is used in combination with other implants for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
Code Infoproduct code1221-36-452, lot 187460.
ClassificationClass II
Reason for RecallDePuy Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of one lot of the AltrX" liner because the product was incorrectly labeled on the box. The box was labeled for a 36IDX52OD +4 Neutral Liner, but the product enclosed was a 36IDX56OD Neutral Liner. Three ( 3 ) complaints were received in January 2012.
Product Quantity20 liners
Recall NumberZ-1366-2013

Class II Biologics Event

Event ID64024
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Dec-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBlood Bank of Alaska, Inc.
CityAnchorage
StateAK
CountryUS
Distribution PatternAlaska
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated Washed
Code InfoW066512427602
ClassificationClass II
Reason for RecallBlood product, collected from a donor who received a tattoo, was distributed.
Product Quantity1 unit
Recall NumberB-0874-13

Class II Biologics Event

Event ID64067
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Dec-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBergen Comm Reg Blood Center
CityParamus
StateNJ
CountryUS
Distribution PatternNJ
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW065612049423
ClassificationClass II
Reason for RecallBlood product, which did not meet acceptable product specifications, was distributed.
Product Quantity1 unit
Recall NumberB-0922-13

Class II Biologics Event

Event ID64218
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Sep-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmOgden Medical Center, Inc.
CityOgden
StateUT
CountryUS
Distribution PatternNV
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW1165123178833
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity1 unit
Recall NumberB-1222-13

Class II Biologics Event

Event ID64237
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Dec-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmLifeSource
CityRosemont
StateIL
CountryUS
Distribution PatternIL
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW287012007860; W287012007860; W287012007897; W287012007897; W287012007912; W287012007936;
ClassificationClass II
Reason for RecallBlood products, which did not meet the acceptable product specifications, were distributed.
Product Quantity6 units
Recall NumberB-1229-13

Class II Biologics Event

Event ID64254
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Jan-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmVirginia Blood Services
CityRichmond
StateVA
CountryUS
Distribution PatternVA
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW087612063608
ClassificationClass II
Reason for RecallBlood products, which did not meet the acceptable product specifications, were distributed.
Product Quantity1 unit
Recall NumberB-1228-13

Class II Biologics Event

Event ID64255
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAurora Area Blood Bank Dba Heartland Blood Centers
CityAurora
StateIL
CountryUS
Distribution PatternIL
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW0397126194597
ClassificationClass II
Reason for RecallBlood product, collected from a donor who was at risk for HIV Group O, was distributed.
Product Quantity1 unit
Recall NumberB-1227-13

Class II Biologics Event

Event ID64280
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Dec-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMississippi Valley Reg Bld Ctr
CityDavenport
StateIA
CountryUS
Distribution PatternIA
 

Associated Products

Product DescriptionPlasma Frozen within 24 hours (FP24)
Code InfoW333612096391
ClassificationClass II
Reason for RecallBlood product, expired unit returned to the firm was inappropriately re-labeled, was distributed.
Product Quantity1 unit
Recall NumberB-1215-13

Class II Biologics Event

Event ID64296
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Nov-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBlood Center Hammond Laboratory (the)
CityHammond
StateLA
CountryUS
Distribution PatternLA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code InfoW067112078593; W067112060745
ClassificationClass II
Reason for RecallBlood products, which were incompletely irradiated, were distributed.
Product Quantity2 unit
Recall NumberB-1216-13

Class II Biologics Event

Event ID64299
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityLake Worth
StateFL
CountryUS
Distribution PatternTN, FL
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW036810186644
ClassificationClass II
Reason for RecallBlood products, which was collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-1217-13
Product DescriptionPlatelets Pooled Leukocytes Reduced
Code InfoW036810811695
ClassificationClass II
Reason for RecallBlood products, which was collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-1218-13
Product DescriptionFresh Frozen Plasma
Code InfoW036810186644
ClassificationClass II
Reason for RecallBlood products, which was collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-1219-13

Class II Devices Event

Event ID64512
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Feb-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmMolift Inc.
CityTampa
StateFL
CountryUS
Distribution PatternUS Nationwide Distribution: CA, FL, GA, ID, IL, KY, MA, ME, MI, MN, NC, NH, NJ, NM, NV, NY, OH, OK, PA, TN, TX, VT, WA and Hawaii. Foreign Distribution:: Australia, Austria; Belgium, Denmark, Finland, France, Germany, Iceland, Israel, Italy, Japan, Netherlands, New Zealand, Norway, Spain, Sverige, Switzerland, United Kingdom.
 

Associated Products

Product DescriptionMolift Smart SWL150 kg Product Usage: To lift and transport a patient in the horizontal or other required position from one place to another.
Code InfoArt #: 0920001 batch 1-62 and 0920002 batch 1-77; Serial Number ranges 022228 to 094103 and 100015 to 12058.
ClassificationClass II
Reason for RecallThe Molift Smart (now known as the Molift Smart 150) is a foldable, mobile hoist with a safe working load ("SWL") of 150 kg (approximately 330 lbs.) and is intended for lifting and transferring a disabled person. The hoist is made out of lightweight materials for ease of operation. It has castors and is battery-powered. The Molift Smart includes a leg spreading mechanism to give optimal functionality to the product. If not assembled correctly with the locking devices, failure of the hoist may result in collapsing.
Product Quantity7,555 units subject to review; US: 1,280 units - Foreign: 6,275 units
Recall NumberZ-1342-2013
Product DescriptionMolift Smart 150 Product Usage: To lift and transport a patient in the horizontal or other required position from one place to another.
Code InfoArt #: 0920008; Serial Number range 20941 to 27299.
ClassificationClass II
Reason for RecallThe Molift Smart 150 (formerly "Molift Smart") is a foldable, mobile, battery-powered hoist for lifting and transfer of disabled persons, with a safe working load ("SWL") of 150 kg (approximately 330 lbs.). The hoist includes a leg-spreading mechanism, equipped with a safety mechanism, to give optimal safety and functionality to the device.
Product QuantitySubject to recall 1,460 units; US: 175 units; Foreign: 1,285 units
Recall NumberZ-1343-2013

Class II Devices Event

Event ID64618
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmUnimed Surgical Products, Inc.
CityLargo
StateFL
CountryUS
Distribution PatternDistributed in the states of MO, TN, and PA.
 

Associated Products

Product DescriptionPROGRESSIVE MEDICAL Laparoscopic Electrode PTFE Coated L Hook 33cm. Intended for the cutting of soft tissue and coagulation.
Code InfoLot Numbers: 071212-02, 071212-03, 071212-05, 071212-01, 071212-06, 082712-02, 071212-04, 082712-04, 082712-05, 082712-13, 071212-07, 082712-07, 082712-09, 082712-03, 082712-15, 082712-14, 081712-06, 082712-01, 082712-10, 081512-06, 080612-01, 081512-07, 082712-12, 081512-04, 082712-11, 081012-01, 080612-03, 080612-02, 080612-04, 071612-05, 071612-04, 080612-05, 080612-07, 081312-11, 071612-03, 081312-10, 071912-01, 071912-02, 092812-02, 092812-03, 092812-04, 092812-05, 092812-06, 092812-07, 091312-01, 100812-02, 072312-01, 080612-08, 081312-01, 100112-01, 091312-04, 082312-04, 082312-03, 082312-06, 082312-05, 082812-02, 111212-01, 111212-03, 111212-02, 082312-02, 092812-02, 092812-07, 092812-06, 111212-19, 111212-18, 111212-18, 111212-19, 100212-01, 100312-06, 111212-11, 111212-07, 081512-05, 111212-04, 100312-01, 100312-03, 091312-02, 091312-03, 100312-08, 100312-09, 100312-10, 100312-01, 100312-03, 100312-04, 111212-14, 111212-10, 111212-08, 111212-07, 111212-17, 111212-20, 111212-21, 121012-03, 120612-01, 111212-12, 121012-01, 112112-01, 112112-02, 112112-03, 112112-04, 112112-06, 011113-04, 100312-02, 011013-10, 092812-01, 091912-02, 100312-05, 011013-12, 011013-05, 092812-02, 111212-16, 011013-04, 011013-07, 011013-08, 100312-13, 011013-02, 111212-09, 111212-11, 011013-11, 111212-13, 111212-15, 092812-03, 012213-02, 111212-12, 011013-13, 012213-01, 012213-04 011013-09, 011413-02, 012213-03, 011413-03, 011413-04, 111212-16, 011013-06, 012913-01, 012913-02, 111212-05, 012913-03, 012913-09, 012813-01.
ClassificationClass II
Reason for RecallFirm is recalling due to concerns regarding changes that were made to the PTFE coating materials.
Product Quantity120,416 units
Recall NumberZ-1347-2013

Class II Devices Event

Event ID64647
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Mar-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmLinvatec Corp. dba ConMed Linvatec
CityLargo
StateFL
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) including the Virgin Islands and the states of CA, CT, FL, GA, IN, KY, KS, LA, MD, MI, MN, MO, MS, MT, NE, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, and WI, and the countries of Austria, Belgium, Canada, Denmark, Hong Kong and Zambia.
 

Associated Products

Product DescriptionRef: VP1600 HD Still Capture System ConMed Linvatec . Captures, stores and transfers images generated by a medical endoscopic camera system during surgical procedures.
Code InfoVP1600
ClassificationClass II
Reason for RecallThe VP1600 HD Still Capture Image System is recalled due to an anomaly between the software code in the VP1600 console and the communications interface for various keyboard key strokes (Caps lock and Num Lock) which may lock up and requires the user to reboot to continue.
Product Quantity267 units
Recall NumberZ-1340-2013

Class II Devices Event

Event ID64713
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Medical Systems (Cleveland) Inc
CityCleveland
StateOH
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, VA, VT, WA, WI, WV and WY; countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Denmark, France, Germany, Gibraltar, India, Iraq, Ireland, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Philippines, Poland, Portugal, Singapore, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom and Venezuela.
 

Associated Products

Product DescriptionBrilliance CT 16-Slice Water, System Code: 728245; Brilliance CT 10-Slice Water, System Code: 728250; Brilliance CT 6-Slice Water, System Code: 728255; MX8000 IDT 16, System Code: 728120 & MX8000 IDT 10, System Code: 728125 Computed Tomography X-ray systems. Distributed by Philips Medical Systems (Cleveland), Inc., 595 Miner Road, Cleveland, OH 44143 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
Code InfoSystem Code #728255, Serial #: 9702, 9703, 9704, 9705, 9706, 9707, 9709, 9710, 9713, 9714, 9717, 9718, 9719, 9721, 9722, 9723, 9724, 9725, 9727, 9730, 9731, 9732, 9733, 9734, 9735, 9738, 9739, 9740, 9741, 9742, 9743, 9746, 9747, 9749, 9752, 9753, 9756, 9758, 9759, 9760, 9761, 9762, 9765, 9766, 9768, 9769, 9770, 9772, 9774, 9778, 9780, 9781, 9783, 9784, 9786, 9787, 9790, 9791, 9792, 9793, 9796, 9797, 9801, 9805, 9807, 9808 & 9810. System Code #728250, Serial #: 2556, 2557, 2560, 2562, 2563, 2565, 2567, 2568, 2569, 2570, 2571, 2574, 2576, 2577, 2579, 2580, 2581, 2584, 2585, 2587, 2588, 2590, 2591, 2592, 2593, 2594, 2595, 2597, 9738 & 9741. System Code #728245, Serial #: 2562, 2564, 2567, 2573, 2576, 2582, 2584, 2585, 2586, 2587, 2589, 2590, 2594, 2596, 2597, 3014, 3091, 3105, 3151, 3217, 3235, 3287, 3303, 3312, 3339, 3340, 3341, 3342, 3343, 3344, 3346, 3348, 3351, 3353, 3355, 3356, 3357, 3358, 3359, 3360, 3363, 3364, 3366, 3369, 3371, 3373, 3374, 3377, 3378, 3379, 3380, 3381, 3382, 3383, 3385, 3388, 3392, 3393, 3394, 3397, 3400, 3404, 3406, 3407, 3408, 3410, 3413, 3414, 3415, 3416, 3419, 3423, 3425, 3427, 3429, 3431, 3432, 3433, 3435, 3436, 3437, 3438, 3439, 3440, 3441, 3443, 3445, 3446, 3448, 3449, 3451, 3452, 3453, 3454, 3455, 3458, 3459, 3461, 3462, 3464, 3468, 3469, 3470, 3471, 3473, 3474, 3475, 3477, 3478, 3479, 3481, 3482, 3483, 3484, 3485, 3486, 3488, 3489, 3491, 3492, 3493, 3495, 3496, 3497, 3498, 3499, 3500, 3501, 3502, 3503, 3504, 3505, 3508, 3509, 3510, 3511, 3512, 3513, 3514, 3515, 3517, 9716, 9718, 9719, 9724, 9732, 9741, 9743, 9746, 9749, 9778, 9780, 9787, 9790, 9797, 9801, 9808 & 9810. System Code #728120, Serial #: 2502, 2510, 2513, 2516, 2517, 2518, 2525, 2528, 2531, 2533, 2535, 2539, 2546, 3006, 3008, 3013, 3014, 3021, 3025, 3026, 3027, 3028, 3029, 3030, 3035, 3037, 3039, 3040, 3043, 3044, 3047, 3049, 3050, 3051, 3053, 3054, 3056, 3059, 3061, 3062, 3063, 3064, 3068, 3069, 3070, 3072, 3073, 3075, 3076, 3077, 3078, 3079, 3081, 3082, 3084, 3085, 3087, 3088, 3089, 3091, 3093, 3094, 3095, 3097, 3099, 3100, 3103, 3104, 3105, 3106, 3107, 3108, 3110, 3111, 3112, 3113, 3114, 3116, 3117, 3118, 3119, 3120, 3121, 3122, 3124, 3125, 3126, 3127, 3129, 3130, 3131, 3132, 3135, 3136, 3137, 3138, 3141, 3143, 3144, 3146, 3148, 3149, 3150, 3151, 3152, 3153, 3154, 3155, 3156, 3157, 3159, 3160, 3161, 3162, 3163, 3164, 3165, 3167, 3168, 3169, 3171, 3172, 3174, 3176, 3177, 3178, 3179, 3180, 3182, 3183, 3185, 3187, 3188, 3189, 3190, 3192, 3194, 3195, 3196, 3198, 3199, 3202, 3203, 3204, 3205, 3206, 3207, 3208, 3209, 3211, 3212, 3213, 3214, 3216, 3217, 3218, 3219, 3220, 3221, 3222, 3223, 3224, 3225, 3229, 3230, 3232, 3233, 3234, 3235, 3236, 3237, 3238, 3239, 3240, 3245, 3246, 3247, 3248, 3250, 3251, 3252, 3253, 3254, 3255, 3258, 3261, 3262, 3264, 3265, 3266, 3268, 3269, 3270, 3271, 3273, 3274, 3277, 3279, 3280, 3281, 3283, 3284, 3285, 3287, 3289, 3290, 3293, 3294, 3295, 3296, 3297, 3298, 3299, 3300, 3302, 3303, 3304, 3305, 3307, 3308, 3310, 3311, 3312, 3315, 3316, 3318, 3319, 3320, 3321, 3322, 3324, 3328, 3329, 3330, 3367 & 9760. System Code #728125, Serial #: 2501, 2505, 2508, 2509, 2513, 2515, 2516, 2522, 2523, 2524, 2525, 2526, 2529, 2530, 2531, 2533, 2534, 2535, 2539, 2540, 2542, 2543, 2548 & 2549.
ClassificationClass II
Reason for RecallPhilips Healthcare received a report from the field stating when they viewed the CTDIVol information from the PACS system, the calculations were too high. Instead of storing the CTDIVol value for each slice in the DICOM tag, the system took the sum of all CTDIVol values from all the images in the dataset and stored this value in the DICOM tag, resulting in incorrect information.
Product Quantity515 units
Recall NumberZ-1338-2013

Class II Devices Event

Event ID64718
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSeparation Technology, Inc.
CitySanford
StateFL
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) including the states of PA, NC, IL, KS, and FL, and the countries Canada and Turkey.
 

Associated Products

Product DescriptionSLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGE. Produce a monolayer of cells onto a glass slide from any fluid suspension.
Code InfoSerial numbers: 0110, 0111, 0112, 0210, 0211, 0212, 0310, 0311, 0312, 0410, 0411, 0412, 0511, 0512, 0611, 0710, 0711, 0811, 0812, 0910, 0911, 0912, 1011, 1012, 1112, 1210, 1212.
ClassificationClass II
Reason for RecallSeparation Technology, Inc. recalled SlidePrep Plus Cytology Centrifuges manufactured prior to January 1, 2013 for having the potential to start up unexpectedly when encountering an electrostatic discharge.
Product Quantity102
Recall NumberZ-1367-2013

Class II Devices Event

Event ID64850
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Apr-13
Initial Firm Notification of Consignee or Public
Recalling FirmRoche Diagnostics Operations, Inc.
CityIndianapolis
StateIN
CountryUS
Distribution PatternUSA Nationwide Distribution
 

Associated Products

Product DescriptionCobas® 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module only. Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids. This analyzer is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes and photometric analysis modules
Code InfoPart Number 05990378001 Serial Numbers 1017-06, 1021-03, 1021-05, 1142-09, 1145-10, 1140-01, 1125-07, 1128-02, 1146-01, 1146-02, 1146-03, 1171-10, 1169-06, 1169-08, 1169-09, 1172-09, 1156-01, 1156-02, 1156-09, 1160-04, 1160-06, 1016-05, 1017-01, 1139-08, 1139-10, 1140-07, 1140-08, 1140-10, 1156-06, 1156-07, 1158-09, 1160-01, 1160-05, 1173-01, 1139-06, 1139-07, 2374-11, 1127-08, 1138-08, 1138-10, 1139-01, 1156-08, 1156-10, 1173-10, 1156-05, 1158-10, 1139-09, 1131-08, 1132-01, 1132-02, 1171-07, 1171-08, 1171-09, 1147-05, 1149-01, 1124-05, 1124-06, 1132-03, 1132-04, 1147-05, 1149-01, 1128-05, 1128-06, 1139-02, 1139-03, 1139-04, 1139-05, 1146-05, 1146-06, 1147-04, 1156-04, 1132-05, 1132-10, 1137-02, 1147-05, 1149-01, 1128-05, 1128-06, 1149-07, 1149-08, and 1167-02.
ClassificationClass II
Reason for RecallWhen using the cobas e 602 module, Diluent Multiassay may be used for autodilution of certain assays instead of Diluent Universal. This may cause incorrect results under specific circumstances if all of the following conditions are met simultaneously: More than a total of 2000 reagent kits or diluents have been registered on the cobas e 602 modules within one system core, and two different diluents are on board the module in parallel (i.e., Diluent Universal and Diluent MultiAssay), and Diluent Universal previously registered correctly is now being registered as Diluent MultiAssay, or vice versa.
Product Quantity72 units
Recall NumberZ-1368-2013

Class II Veterinary Event

Event ID64903
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBimeda MTC Animal Health Inc.
CityCambridge
State
CountryCA
Distribution PatternNationwide (KS and WI)
 

Associated Products

Product DescriptionHypertonic Saline Solution 7.2%; Sterile - Preservative Free; For Animal Use Only; Packaged in HDPE 1000 mL bottle with a grey 30mm chlorobutyl rubber (silicone) stopper and capped with a silver tear off aluminum seal.
Code InfoLot Number: 2J041; Item Number: 1HYP009 - VETONE; Expiry: 14 SEP
ClassificationClass II
Reason for RecallThe sterility of the recalled products cannot be assured.
Product Quantity8,447 bottles
Recall NumberV-192-2013
Product DescriptionCalcium Gluconate 23% Solution; Sterile Preservative Free; FOR ANIMAL USE ONLY; Packaged in HDPE 500 mL bottle with a grey 30mm chlorobutyl rubber (siliconized) stopper and capped with a red tear off aluminum seal.
Code InfoLot Number: 2J029A; Item Number: 1CAL028, 500 mL, Bimeda Inc.; Expiry: 14 SEP
ClassificationClass II
Reason for RecallThe sterility of the recalled products cannot be assured.
Product Quantity19,560 bottles
Recall NumberV-193-2013
Product Description50% Dextrose Injection, USP; Sterile Preservative Free; For Animal Use Only; Packaged in HDPE 500 mL bottle with a grey 30mm chlorobutyl rubber (siliconized) stopper and capped with a silver tear off aluminum seal.
Code InfoLot Number: 2J028; Item Number: 1DEX012; Expiry: 15 SEP
ClassificationClass II
Reason for RecallThe sterility of the recalled products cannot be assured.
Product Quantity6,702 bottles
Recall NumberV-194-2013

Class II Food Event

Event ID64914
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Apr-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmClement Pappas & Co., Inc.
CityCarneys Point
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionOrganics Nature's Promise Organic Cranberry Juice Blend UPC 688267036163 - 64 FL OZ (2 QT) 1.89L Distributed by Foodhold USA LLC Landover, MD 20785 1-877-846-9949
Code InfoLot number Exp. Date 1430230351 11/15/2013 1430230561 11/26/2013 1430230701 12/10/2013
ClassificationClass II
Reason for RecallOne of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb.
Product Quantity
Recall NumberF-1412-2013
Product DescriptionPublix Market Greenwise Organic Cranberry Flavored Juice Blend 64 FL OZ (2 QTS) 1.89 L UPC 041415049208 Distributed by Publix Supermarkets Inc. Lakeland, FL 33802 publix.com
Code InfoLot Number Exp Date 1430230152 10/13/2013 1430230292 10/30/2013
ClassificationClass II
Reason for RecallOne of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb.
Product Quantity
Recall NumberF-1413-2013
Product Descriptionwild harvest organic apple juice 64 FL OZ (2 QTS) 1.89L UPC 011535025567 Distributed by Supervalu Inc. Eden Prairie, MN 55344 USA
Code InfoLot Number Exp. Date 3690230281 1/28/2014 3690230351 2/4/2014 3690230491 2/18/2014 3690230561 2/25/2014 3690230771 3/18/2014
ClassificationClass II
Reason for RecallOne of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb.
Product Quantity
Recall NumberF-1414-2013
Product Descriptionwild harvest organic cranberry 64 FL OZ (2 QTS) 1.89L UPC 011535500408 Distributed by Supervalu Inc. Eden Prairie, MN 55344 USA
Code InfoLot Number Exp Date 1430230351 11/5/2013 1430230561 11/26/2013
ClassificationClass II
Reason for RecallOne of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb.
Product Quantity
Recall NumberF-1415-2013
Product DescriptionGreenway Organic Apple Juice From Concentrate 64 FL Oz (2 QTS) 1.89L UPC 70625348405 Distributed by OnPoint Inc. 2 Paragon Drive Montvale, NJ 07645
Code InfoLot Number Exp Date 3690230351 2/4/2014 3690230421 2/11/2014 3690230491 2/18/2014 3690230561 2/25/2014 3690230701 3/11/2014
ClassificationClass II
Reason for RecallOne of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb.
Product Quantity
Recall NumberF-1416-2013
Product DescriptionHarris Teeter Organics Apple Juice 64 FL OZ (2 QT) 1.89 L UPC 072036764324 Proudly distributed by Harris Teeters Mathews, NC 28105
Code InfoLot Number Exp Date 3690230152 1/15/2014 3690230292 1/29/2014 3690230432 2/12/2014 3690230582 2/27/2014 3690230842 3/25/2014
ClassificationClass II
Reason for RecallOne of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb.
Product Quantity
Recall NumberF-1417-2013
Product Descriptionsimple truth organic Apple Juice 100% 64 FL OZ (2 QT) 1.89 L UPC 011110834805 Distributed by The Kroger Co. Cincinnati OH 45202
Code InfoLot Number Exp Date 3690230152 1/15/2014 3690230292 1/29/2014 3690230432 2/12/2014 3690230582 2/27/2014 3690230351 2/4/2014 3690230621 3/3/2014
ClassificationClass II
Reason for RecallOne of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb.
Product Quantity
Recall NumberF-1418-2013
Product Descriptionmeijier Organics Cranberry Juice Net 64 FL OZ(2 QT) 1.89 L UPC 719283661562 Dist By Meijier Distribution Inc. Grand Rapids, MI 49544
Code InfoLot Number Exp Date 1430230701 12/10/2013
ClassificationClass II
Reason for RecallOne of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb.
Product Quantity
Recall NumberF-1419-2013
Product DescriptionFull Circle Organic 100% Apple Juice 64 FL OZ (2 QT) 1.89 L UPC 36800043114 Distributed by Topco Associates LLC 7711 Gross Point Road, Skokie, Illinois 60077 www.fullcirclefoods.com
Code InfoLot Number Exp Date 3690230281 1/28/2014 3690230351 2/4/2014 3690230551 2/25/2014 3690230631 3/4/2014 3690230491 2/18/2014
ClassificationClass II
Reason for RecallOne of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb.
Product Quantity
Recall NumberF-1420-2013
Product DescriptionGiant Eagle Nature's Basket Organic Apple Juice Net 64 FL OZ (2 QT) 1.89 L UPC 030034056063 Distributed by Giant Eagle Inc. Pittsburgh, PA 15238-2809
Code InfoLot Number Exp Date 3690230281 1/28/2014 3690230491 2/18/2014 3690230351 2/4/2014 3690230701 3/11/2014
ClassificationClass II
Reason for RecallOne of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb.
Product Quantity
Recall NumberF-1421-2013
Product DescriptionWegmans Organic Apple Juice 64 FL OZ (2 QT) 1.89 L UPC 077890206058 Distributed by: Wegmans Food Markets, Inc. Rochester, NY 14603
Code InfoLot Number Exp Date 3690230281 1/28/2014 3690230351 2/4/2014 3690230421 2/11/2014 3690230491 2/18/2014 3690230561 2/25/2014 3690230631 3/4/2014 3690230701 3/11/2014 3690230771 3/18/2014 3690230781 3/19/2014
ClassificationClass II
Reason for RecallOne of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb.
Product Quantity
Recall NumberF-1422-2013
Product DescriptionWegmans Organic Cranberry Juice Blend 64 FL OZ (2 QT) 1.89 L UPC 077890266892 Distributed by: Wegmans Food Markets, Inc. Rochester, NY 14603
Code InfoLot number Exp Date 1430230351 11/15/2013
ClassificationClass II
Reason for RecallOne of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb.
Product Quantity
Recall NumberF-1423-2013
Product DescriptionHeinen's organic 100% Apple Juice 64 FL. OZ. (2QT) 1.89L UPC 020601403031 Distributed by: Heinen's, Inc, Warrensville Heights, OH 44128
Code InfoLot number Exp Date 3690230432 2/12/2014
ClassificationClass II
Reason for RecallOne of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb.
Product Quantity187 units
Recall NumberF-1424-2013
Product DescriptionFull Circle Organic 100 % Cranberry Juice Blend 64 FL OZ (2 QT) 1.89 L UPC 03600079045 Distributed by Topco Associates LLC 7711 Gross Point Road, Skokie, Illinois 60077 www.fullcirclefoods.com
Code InfoLot number Exp Date 1430230491 11/18/2013
ClassificationClass II
Reason for RecallOne of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb.
Product Quantity
Recall NumberF-1425-2013
Product DescriptionBest Choice Clearly Organic Organic Apple Juice Net Wt 64 FL OZ (2 QT) 1.89 L UPC 070038614395 Proudly Distributed By : Associated Wholesale Grocers Inc., Kansas City, Kansas 66106
Code InfoLot number Exp Date 3690230152 1/15/2014 3690230292 1/29/2014
ClassificationClass II
Reason for RecallOne of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb.
Product Quantity
Recall NumberF-1426-2013
Product DescriptionTrader Joe's Apple Juice 64 FL OZ (2 QT) 1.89 L UPC 00746854 Dist. & Sold Exclusively By: Trader Joe's Monrovia, CA 91016
Code InfoLot number Exp Date 3690230281 5/25/2014 3690230351 6/5/2014 3690230421 6/13/2014 3690230491 6/20/2014 3690230561 6/27/2014 3690230631 7/3/2014 3690230701 7/11/2014
ClassificationClass II
Reason for RecallOne of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb.
Product Quantity
Recall NumberF-1427-2013
Product Description1) Organics Nature's Promise Organic Apple Juice 64 FL OZ (2 QT) 1.89L UPC 688267036156 Distributed by Foodhold USA LLC Landover, MD 20785 1-877-846-9949 2) Organics Nature's Promise Organic Apple Juice 6.75 FL OZ (200 mL) UPC 688267063107 Distributed by Foodhold USA LLC Landover, MD 20785 1-877-846-9949
Code Info64 fl oz. Lot number Exp. Date 3690630281 1/28/2014 3690630351 2/4/2014 3690630421 2/11/2014 3690630561 2/25/2014 3690630631 3/4/2014 3690630701 3/11/2014 3690630841 3/25/2014 6.75 fl oz. Lot number Exp. Date 8240030101 1/10/2014 82400.0111 1/11/2014 8240030451 2/14/2014
ClassificationClass II
Reason for RecallOne of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb.
Product Quantity
Recall NumberF-1428-2013
Product DescriptionGiant Eagle Nature's Basket Organic Cranberry Net 64 FL OZ (2 QT) 1.89 L UPC 030034056070 Distributed by Giant Eagle Inc. Pittsburgh, PA 15238-2809
Code InfoLot number Exp. Date 1430230351 11/5/2013 1430230701 12/10/2013
ClassificationClass II
Reason for RecallOne of this products ingredients, Organic Apple Juice Concentrate, was found to contain patulin levels between 57.4-100 ppb.
Product Quantity
Recall NumberF-1429-2013

Class II Devices Event

Event ID64930
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmRoche Molecular Systems, Inc.
CityBranchburg
StateNJ
CountryUS
Distribution PatternNationwide Distribution.
 

Associated Products

Product Descriptioncobas® 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.
Code InfoMaterial Number 05200881001 - all lot/serial numbers.
ClassificationClass II
Reason for RecallIn rare instances, channel shifted results have been generated with cobas® 4800 assays run on v1.1.1 of the cobas® 4800 system. Raw data review indicates that, in these cases, all signals are shifted by one channel: channel 1 results report as channel 2, channel 2 results report as channel 3, channel 3 results report as channel 4, and channel 4 results report as channel 1. In the reported cases, the results of the runs were either invalid or the preponderance of individual patient specimen showed to be invalid.
Product Quantity425 instruments
Recall NumberZ-1346-2013

Class II Devices Event

Event ID64931
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmProgressive Medical Inc
CitySaint Louis
StateMO
CountryUS
Distribution PatternNationwide Distribution including AR, AZ, CA, CO, FL, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, NE, OH, OK, OR, TN, TX, WA, and WI.
 

Associated Products

Product DescriptionProgressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Modified Coated Needle 2.75" (6.99cm) Length, Product number P0013M, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries
Code InfoLot number 071212-02
ClassificationClass II
Reason for RecallProduct coatings require 510K approval.
Product Quantity28 boxes with 12 units each.
Recall NumberZ-1348-2013
Product DescriptionProgressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated Blade 6.5" (16.51cm) Length, Product number P0014, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries
Code InfoLot number 071212-03
ClassificationClass II
Reason for RecallProduct coatings require 510K approval.
Product Quantity19 boxes with 12 units each.
Recall NumberZ-1349-2013
Product DescriptionProgressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated L Hook 33cm Length, Product number P0020, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries
Code InfoLot numbers 071212-05 and 081712-06
ClassificationClass II
Reason for RecallProduct coatings require 510K approval.
Product Quantity173 boxes with 6 units each.
Recall NumberZ-1350-2013
Product DescriptionProgressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated Blade 2.50" (6.40) Length, Product number P0012, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries
Code InfoLot numbers 071212-01, 082712-01 and 111212-04
ClassificationClass II
Reason for RecallProduct coatings require 510K approval.
Product Quantity150 boxes with 12 units each.
Recall NumberZ-1351-2013
Product DescriptionProgressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated Wire L Hook 33cm Length, Product number P0100 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries
Code InfoLot numbers 071212-06 and 082712-13
ClassificationClass II
Reason for RecallProduct coatings require 510K approval.
Product Quantity59 boxes with 6 units each.
Recall NumberZ-1352-2013
Product DescriptionProgressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated L Hook 44cm Length, Product number P0020X Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries
Code InfoLot number 082712-08
ClassificationClass II
Reason for RecallProduct coatings require 510K approval.
Product Quantity20 boxes with 6 units each.
Recall NumberZ-1353-2013
Product DescriptionProgressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Modified Coated Blade 2.50" (6.40cm) Length, Product number P0012M Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries
Code InfoLot number 082712-02
ClassificationClass II
Reason for RecallProduct coatings require 510K approval.
Product Quantity20 boxes with 12 units each.
Recall NumberZ-1354-2013
Product DescriptionProgressive Medical PTFE Coated Disposable Electrosurgical Electrodes -Laparoscopic Electrode PTFE Coated Curved Blade 33cm Length, Product number P0019 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries
Code InfoLot number 071212-04
ClassificationClass II
Reason for RecallProduct coatings require 510K approval.
Product Quantity38 boxes with 6 units each.
Recall NumberZ-1355-2013
Product DescriptionProgressive Medical PTFE Coated Disposable Electrosurgical Electrodes -NON-STICK CAUTERY TIP PTFE Modified Coated Blade 6.5" (16.51cm) Length, Product number P0014M Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries
Code InfoLot number 082712-04
ClassificationClass II
Reason for RecallProduct coatings require 510K approval.
Product Quantity27 boxes with 12 units each.
Recall NumberZ-1356-2013
Product DescriptionProgressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated Spatula 33cm Length, Product number P0018 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries
Code InfoLot number 082712-05
ClassificationClass II
Reason for RecallProduct coatings require 510K approval.
Product Quantity16 boxes with 6 units each.
Recall NumberZ-1357-2013
Product DescriptionProgressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated Wire L Hook 44cm Length, Product number P0100X Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries
Code InfoLot numbers 071212-07 and 082712-14
ClassificationClass II
Reason for RecallProduct coatings require 510K approval.
Product Quantity60 boxes with 6 units each.
Recall NumberZ-1358-2013
Product DescriptionProgressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated Wire L Hook Split 33cm Length,Product number P0020S Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries
Code InfoLot number 082712-07
ClassificationClass II
Reason for RecallProduct coatings require 510K approval.
Product Quantity20 boxes with 6 units each.
Recall NumberZ-1359-2013
Product DescriptionProgressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated J Hook 33cm Length, Product number P0021, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries
Code InfoLot number 082712-09
ClassificationClass II
Reason for RecallProduct coatings require 510K approval.
Product Quantity19 boxes with 6 units each.
Recall NumberZ-1360-2013
Product DescriptionProgressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated Needle 2.75" (6.99cm) Length, Product number P0013 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries
Code InfoLot number 082712-03
ClassificationClass II
Reason for RecallProduct coatings require 510K approval.
Product Quantity39 boxes with 12 units each.
Recall NumberZ-1361-2013
Product DescriptionProgressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated Sharp Needle 2.00" (5.08cm) Length, Product number P0118 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries
Code InfoLot number 082712-15
ClassificationClass II
Reason for RecallProduct coatings require 510K approval.
Product Quantity18 boxes with 12 units each.
Recall NumberZ-1362-2013
Product DescriptionProgressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated J- Hook 44cm Length, Product number P0021X Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries
Code InfoLot number 082712-10
ClassificationClass II
Reason for RecallProduct coatings require 510K approval.
Product Quantity4 boxes containing 6 individually packaged pieces each
Recall NumberZ-1363-2013
Product DescriptionProgressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Push Button Pencil With PTFE Blade and Holster, Product number P0035H Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Rx Only Electrodes used in Electrosurgeries
Code InfoLot number 082712-12
ClassificationClass II
Reason for RecallProduct coatings require 510K approval.
Product Quantity11 boxes with 25 units each.
Recall NumberZ-1364-2013

Class II Devices Event

Event ID64941
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmStryker Howmedica Osteonics Corp.
CityMahwah
StateNJ
CountryUS
Distribution PatternNationwide distribution: USA including states of: HI, IN, MS, NC, NJ, OK, TX, and WI.
 

Associated Products

Product DescriptionStryker Orthopaedics Triathlon Femoral Distal Augment- Left; 1 single unit per package Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA Stryker France, ZAC Satolas Green Pusignan, Av de Satoles Green 69881 Meyzieu, Cedex, France This device is used when there is a deficiency in the bone present during femoral preparation these devices are used to "fill the gap" between the implant and the bone
Code InfoCatalog Number 5541-A-501 Lot Codes HALY, HAOO, HANG
ClassificationClass II
Reason for RecallStryker Orthopaedics received a report that a label on the external packaging (box) of a Triathalon Femoral Distal Augment 10mm- Size 5 Left depicted a glyph of an acetabular shell rather than a femoral distal augment. In addition the label was missing a reference to the "10mm" augment thickness which per the label print is required to appear below the size reference.
Product Quantity11 units
Recall NumberZ-1370-2013

Class II Devices Event

Event ID64943
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmColoplast Manufacturing US, LLC
CityMinneapolis
StateMN
CountryUS
Distribution PatternNationwide Distribution including AL, CA, CO, DC, IL, IN, KY, MD, MA, MO, NH, OH, RI, and VA.
 

Associated Products

Product DescriptionRostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark.
Code Info3483171
ClassificationClass II
Reason for RecallColoplast is recalling one lot of Restorelle L prosthesis because it is mislabeled. The incorrect Instructions For Use (IFU) pamphlet is included in the packaging.
Product Quantity111
Recall NumberZ-1341-2013

Class II Devices Event

Event ID65018
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmChicago X-Ray Systems, Inc.
CityProspect Heights
StateIL
CountryUS
Distribution PatternWorldwide Distribution- USA (nationwide) and Latin America.
 

Associated Products

Product DescriptionFona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.
Code InfoModel IntraOs 70
ClassificationClass II
Reason for RecallThe IntraOs 70 system was found to have missing or incomplete system labels as required by 21 CFR 1010.2 & 1010.3. Also, the user's manual was found to have missing or improperly labeled information as required by 21 CFR 1020.30(h).
Product Quantity1960 units
Recall NumberZ-1179-2013

Class II Devices Event

Event ID65036
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCEFLA DENTAL GROUP
CityIMOLA, BO
State
CountryIT
Distribution PatternUS Nationwide Distribution
 

Associated Products

Product DescriptionMyRay RXDC dental unit x-ray unit
Code InfoModel - MyRay RX DC
ClassificationClass II
Reason for RecallThe RX DC dental x-ray unit was found to be noncompliant with 21CFR 1010,2, 1020.30(e) & 1020.30(h). Specifically, 1. The tube housing did not contain a Certification label. 2. The collimator did not contain an identification label. 3. The user's manual did not contain leakage technique factors, tube housing cooling curves and rating charts, and technique factors which lead to operation at maximum line current.
Product Quantity173 shipped to US
Recall NumberZ-1217-2013

Class II Devices Event

Event ID65096
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Apr-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBoston Scientific CRM Corp
CitySaint Paul
StateMN
CountryUS
Distribution PatternNationwide Distribution including DC and PR
 

Associated Products

Product DescriptionLATITUDE® Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.
Code Infon/a
ClassificationClass II
Reason for RecallBoston Scientific CRM is conducting a recall on the LATITUDE Patient Management System Model 6488 Version 7.3 because between March 4 and 27, 2013, a Siebel release caused ~5000 distributed PMR clinic faxes to display with illegible characters and not the required, Patient non-compliance information that was intended.
Product Quantity1
Recall NumberZ-1339-2013

Class II Drugs Event

Event ID65154
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLloyd Inc. of Iowa
CityShenandoah
StateIA
CountryUS
Distribution PatternThe firm distributed the bulk product to Forest Laboratories, Inc, St. Louis, MO who repackaged the product into 100-tablet bottles and distribution was made to 75 customers Nationwide and Puerto Rico.
 

Associated Products

Product DescriptionLevothroid (levothyroxine sodium tablets, USP) , 50 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1321-01
Code InfoLot #: 1098751, Exp. Mar-13
ClassificationClass II
Reason for RecallcGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Product Quantity4,440 Bottles
Recall NumberD-432-2013
Product DescriptionLloyd Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
Code InfoLot #: HB04712, Exp. Mar-13, HB08112, HC08112, Exp Apr-13, and HC11112 May-13.
ClassificationClass II
Reason for RecallcGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Product Quantity7,681,277 tablets
Recall NumberD-433-2013
Product DescriptionLevothroid (levothyroxine sodium tablets, USP) , 75 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1322-01
Code InfoLot #: 1098752, Exp. Mar-13; 1099890, Exp Apr-13.
ClassificationClass II
Reason for RecallcGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Product Quantity19,787 Bottles
Recall NumberD-434-2013
Product DescriptionLloyd Thyro-Tab 0.075 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
Code InfoLot #: HC04712, Exp. Mar-13; HD08112, Exp. Apr-13; HE08112, HD11112, Exp May-13.
ClassificationClass II
Reason for RecallcGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Product Quantity9,545,718 tablets
Recall NumberD-435-2013
Product DescriptionLevothroid (levothyroxine sodium tablets, USP), 88 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1329-01
Code InfoLot #: 1098967, Exp. Mar-13.
ClassificationClass II
Reason for RecallcGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Product Quantity12,156 Bottles
Recall NumberD-436-2013
Product DescriptionLloyd Thyro-Tab 0.088 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
Code InfoLot #: HD04712, Exp. Mar-13; HF08112, Exp Apr-13; HF11112, Exp May-13.
ClassificationClass II
Reason for RecallcGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Product Quantity5,767,711 tablets
Recall NumberD-437-2013
Product DescriptionLloyd Thyro-Tab 0.100 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
Code InfoLot #: HA27211, HB27211, HC27211, HD27211, Exp Apr-13; HB31411, Exp May-13; HD35511, HA35511, HB35511, HC35511, Exp Jul-13; HA06212, HB06212, Exp Sep-13.
ClassificationClass II
Reason for RecallcGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Product Quantity21,019,909 tablets
Recall NumberD-438-2013
Product DescriptionLloyd Thyro-Tab 0.112 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
Code InfoLot #: HE27211, Exp Apr-13; HE35511, Exp Jul-13; HA04112, Exp Aug-13; HC06212, Exp Sep-12.
ClassificationClass II
Reason for RecallcGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Product Quantity7,614,709 tablets
Recall NumberD-439-2013
Product DescriptionLloyd Thyro-Tab 0.125 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
Code InfoLot #: HA27811, HC27811, Exp Apr-13; HD35311, HA00512, HB00512, exp Jul-13; HA04412, Exp Aug-13; HD06212, Exp Sep-13.
ClassificationClass II
Reason for RecallcGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Product Quantity13,460,920 tablets
Recall NumberD-440-2013
Product DescriptionLloyd Thyro-Tab 0.137 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
Code InfoLot #: HD31411, Exp May-13; HC04112, Exp Aug-13.
ClassificationClass II
Reason for RecallcGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Product Quantity3,844,402 tablets
Recall NumberD-441-2013
Product DescriptionLloyd Thyro-Tab 0.150 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
Code InfoLot #: HE27811, HD27811, Exp Apr-13; HC00512, Exp Jul-13; HD04112, HE06212, Exp Sep-13.
ClassificationClass II
Reason for RecallcGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Product Quantity9,575,108 tablets
Recall NumberD-442-2013
Product DescriptionLloyd Thyro-Tab 0.175 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
Code InfoLot #: HC29411, Exp May-13; HD00512, Exp Jul-13; HA08912, Exp Oct-13.
ClassificationClass II
Reason for RecallcGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Product Quantity5,768,782 tablets
Recall NumberD-443-2013
Product DescriptionLloyd Thyro-Tab 0.200 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
Code InfoLot #: HD29411, Exp May-13; HE00512, Exp Jul-13; HF062122, Exp Sep-13.
ClassificationClass II
Reason for RecallcGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Product Quantity5,771,989 tablets
Recall NumberD-444-2013
Product DescriptionLevothroid (levothyroxine sodium tablets, USP), 100 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1323-01
Code InfoLot #: 1095184, 1095185, 1095186, 1095187, Exp Apr-13; 1096370, Exp May-13; 1097547, 1097588, 1097589, Exp Jul-13.
ClassificationClass II
Reason for RecallcGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Product Quantity142,103 Bottles
Recall NumberD-445-2013
Product DescriptionLevothroid (levothyroxine sodium tablets, USP), 112 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1330-01
Code InfoLot #: 1095208, Exp Apr-13; 1097177, Exp Jul-13; 1098537 , Exp Aug-13.
ClassificationClass II
Reason for RecallcGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Product Quantity40,311 Bottles
Recall NumberD-446-2013
Product DescriptionLevothroid (levothyroxine sodium tablets, USP) , 125 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1324-01
Code InfoLot #: 1095209,1095211, Exp Apr-13; 1097408, 1097731, 1097732, Exp Jul-13.
ClassificationClass II
Reason for RecallcGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Product Quantity77,471 Bottles
Recall NumberD-447-2013
Product DescriptionLevothroid (levothyroxine sodium tablets, USP), 137 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1331-01.
Code InfoLot #: 1096372, Exp May-13.
ClassificationClass II
Reason for RecallcGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Product Quantity12,911 Bottles
Recall NumberD-448-2013
Product DescriptionLevothroid (levothyroxine sodium tablets, USP), 150 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1325-01.
Code InfoLot #: 1095213, 1095214, Exp Apr-13; 1097733, Exp Jul-13; 1098540, Exp Aug-13.
ClassificationClass II
Reason for RecallcGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Product Quantity61,347 Bottles
Recall NumberD-449-2013
Product DescriptionLevothroid (levothyroxine sodium tablets, USP), 175 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1326-01
Code InfoLot #r: 1095922, Exp May-13; 1097735, Exp Jul-13; 1099892, Exp Oct-13.
ClassificationClass II
Reason for RecallcGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Product Quantity32,345 Bottles
Recall NumberD-450-2013
Product DescriptionLevothroid (levothyroxine sodium tablets, USP), 200 mcg, RX only, 100 tablets per bottle. Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1327-01
Code InfoLot #: 1095923, Exp May-13; 1097828, Exp Jul-13.
ClassificationClass II
Reason for RecallcGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
Product Quantity29,489 Bottles
Recall NumberD-451-2013

Class II Devices Event

Event ID65158
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMedical Information Technology, Inc.
CityWestwood
StateMA
CountryUS
Distribution PatternWorldwide Distribution - USA, including Puerto Rico and the country of Canada.
 

Associated Products

Product DescriptionMEDITECH Bi-Directional interactive Communication Analyzer Interface; Integrates with MEDITECH's Laboratory Information System (LIS) with Other Vendor systems to manage the transfer of patient results and demographic information.
Code InfoMagic Releases 5.41, 5.52. 5.53, 5.62, 5.63, 5.64 and Client Server Releases 5.64, 5.65, 6.05, 6.06, 6.07
ClassificationClass II
Reason for RecallIncorrect transmission of laboratory results.
Product Quantity56 devices
Recall NumberZ-1365-2013

Class II Drugs Event

Event ID65172
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmKing Legacy, a wholly owned subsidiary of Pfizer
CityBristol
StateTN
CountryUS
Distribution PatternNationwide and Puerto Rico
 

Associated Products

Product DescriptionLevoxyl (levothyroxine sodium) tablets, USP, 25 mcg, packaged in a) 100-count bottles (NDC 60793-850-01) and b) 1000-count bottles (NDC 60793-850-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
Code InfoLot # a) 65228, Exp. 06/13; 65636, Exp. 08/13; b) 65180, Exp. 05/13; 65769, Exp. 07/13
ClassificationClass II
Reason for RecallSubpotent Drug: The products were below specification for potency at the expiry stability point.
Product Quantity51,591 bottles
Recall NumberD-421-2013
Product DescriptionLevoxyl (levothyroxine sodium) tablets, USP, 50 mcg, packaged in a) 100-count bottles (NDC 60793-851-01) and b) 1000-count bottles (NDC 60793-851-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
Code InfoLot # a) 64934, Exp. 4/13; 65059, Exp. 5/13; 65179, Exp. 4/13; 65630, Exp. 7/13; 65916, Exp. 8/13; 66367, Exp. 10/13; and 66718, Exp. 11/13; b) 64338, Exp. 4/13; 64932, Exp. 4/13; 65060, Exp. 5/13; 65235, Exp. 6/13; 65853, Exp. 6/13; and 65962, Exp. 7/13
ClassificationClass II
Reason for RecallSubpotent Drug: The products were below specification for potency at the expiry stability point.
Product Quantity195,699 bottles
Recall NumberD-422-2013
Product DescriptionLevoxyl (levothyroxine sodium) tablets, USP, 75 mcg, packaged in a) 100-count bottles (NDC 60793-852-01) and b) 1000-count bottles (NDC 60793-852-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
Code InfoLot # a) 64197, Exp. 4/13; 64339, Exp. 4/13; 65061, Exp. 5/13; 65236, Exp. 6/13; 65917, Exp. 8/13; 66122, Exp. 8/13; and 66427, Exp. 9/13; b) 64340, Exp. 4/13; 64933, Exp. 4/13; 65062, Exp. 5/13; 65237, Exp. 6/13; 65238, Exp. 6/13; and 66121, Exp. 8/13
ClassificationClass II
Reason for RecallSubpotent Drug: The products were below specification for potency at the expiry stability point.
Product Quantity194,142 bottles
Recall NumberD-423-2013
Product DescriptionLevoxyl (levothyroxine sodium) tablets, USP, 88 mcg, packaged in a) 100-count bottles (NDC 60793-853-01) and b) 1000-count bottles (NDC 60793-853-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
Code InfoLot # a) 64935, Exp. 5/13; 65239, Exp. 6/13; 65900, Exp. 8/13; 66370, Exp. 10/13; and 66391, Exp. 9/13; b) 64927, Exp. 5/13; and 65240, Exp. 6/13
ClassificationClass II
Reason for RecallSubpotent Drug: The products were below specification for potency at the expiry stability point.
Product Quantity112,914 bottles
Recall NumberD-424-2013
Product DescriptionLevoxyl (levothyroxine sodium) tablets, USP, 100 mcg, packaged in a) 100-count bottles (NDC 60793-854-01) and b) 1000-count bottles (NDC 60793-854-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
Code InfoLot # a) 64341, Exp 04/13; 64928, Exp. 5/13; 65064, Exp. 5/13; 65233, Exp. 7/13; 66162, Exp. 8/13; 66365, Exp. 10/13; and 66677, Exp. 11/13; b) 64342, Exp. 4/13; 64929, Exp. 5/13; 65065, Exp. 5/13; 65234, Exp. 7/13; 65539, Exp. 7/13; 65901, Exp. 8/13; and 66163, Exp. 8/13
ClassificationClass II
Reason for RecallSubpotent Drug: The products were below specification for potency at the expiry stability point.
Product Quantity195,201 bottles
Recall NumberD-425-2013
Product DescriptionLevoxyl (levothyroxine sodium) tablets, USP, 112 mcg, packaged in a) 100-count bottles (NDC 60793-855-01) and b) 1000-count bottles (NDC 60793-855-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
Code InfoLot # a) 64936, Exp. 5/13; 65634, Exp. 7/13; 66295, Exp. 9/13; 66669, Exp. 11/13; b) 65063, Exp. 5/13 and 65767, Exp. 7/13
ClassificationClass II
Reason for RecallSubpotent Drug: The products were below specification for potency at the expiry stability point.
Product Quantity107,236 bottles
Recall NumberD-426-2013
Product DescriptionLevoxyl (levothyroxine sodium) tablets, USP, 125 mcg, packaged in a) 100-count bottles (NDC 60793-856-01) and b) 1000-count bottles (NDC 60793-856-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
Code InfoLot # a) 64333, Exp. 5/13; 64937, Exp. 6/13; 65629, Exp. 7/13; and 66296, Exp. 9/13; b) 64931, Exp. 5/13 and 65766, Exp. 7/13
ClassificationClass II
Reason for RecallSubpotent Drug: The products were below specification for potency at the expiry stability point.
Product Quantity103,796 bottles
Recall NumberD-427-2013
Product DescriptionLevoxyl (levothyroxine sodium) tablets, USP, 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count bottles (NDC 60793-857-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
Code InfoLot # a) 64190, Exp. 4/13; 64331, Exp. 6/13; 65642, Exp. 7/13; and 66297, Exp. 9/13; b) 64326, Exp. 4/13; 64332, Exp. 6/13; and 65771, Exp. 7/13
ClassificationClass II
Reason for RecallSubpotent Drug: The products were below specification for potency at the expiry stability point.
Product Quantity77,272 bottles
Recall NumberD-428-2013
Product DescriptionLevoxyl (levothyroxine sodium) tablets, USP, 150 mcg, packaged in a) 100-count bottles (NDC 60793-858-01) and b) 1000-count bottles (NDC 60793-858-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
Code InfoLot # a) 65066, Exp. 5/13 and 65644, Exp. 7/13; b) 64327, Exp. 4/13 and 65772, Exp. 7/13
ClassificationClass II
Reason for RecallSubpotent Drug: The products were below specification for potency at the expiry stability point.
Product Quantity56,405 bottles
Recall NumberD-429-2013
Product DescriptionLevoxyl (levothyroxine sodium) tablets, USP, 175 mcg, packaged in a) 100-count bottles (NDC 60793-859-01) and b) 1000-count bottles (NDC 60793-859-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
Code InfoLot # a) 64329, Exp. 5/13; 65229, Exp. 6/13; and 65913, Exp. 9/13; b) 64330, Exp. 5/13; 65230, Exp. 6/13; and 65915, Exp. 9/13
ClassificationClass II
Reason for RecallSubpotent Drug: The products were below specification for potency at the expiry stability point.
Product Quantity51,438 bottles
Recall NumberD-430-2013
Product DescriptionLevoxyl (levothyroxine sodium) tablets, USP, 200 mcg, packaged in a) 100-count bottles (NDC 60793-860-01) and b) 1000-count bottles (NDC 60793-860-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
Code InfoLot # a) 64301, Exp. 4/13 and 65628, Exp. 7/13; b) 64300, Exp. 4/13 and 65765, Exp. 7/13
ClassificationClass II
Reason for RecallSubpotent Drug: The products were below specification for potency at the expiry stability point.
Product Quantity33,227 bottles
Recall NumberD-431-2013

Class III Biologics Event

Event ID39047
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Dec-06
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmNorthwest Florida Blood Center, Inc.
CityPensacola
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code Info4565963A; 4565963B; 4565953A; 4565953B
ClassificationClass III
Reason for RecallBlood products, which were labeled with an incorrect volume, were distributed.
Product Quantity4 units
Recall NumberB-1311-13

Class III Biologics Event

Event ID39432
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Oct-04
Initial Firm Notification of Consignee or Public Other
Recalling FirmLifeSouth Community Blood Centers, Inc.
CityDunwoody
StateGA
CountryUS
Distribution PatternGA
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info71X077426
ClassificationClass III
Reason for RecallBlood product, for which the quality control testing was incomplete, was distributed.
Product Quantity1 unit
Recall NumberB-1065-13

Class III Biologics Event

Event ID39654
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jan-05
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican National Red Cross
CitySalt Lake City
StateUT
CountryUS
Distribution PatternUT and CA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info020 S75093
ClassificationClass III
Reason for RecallBlood products, collected using expired blood collection sets, were distributed.
Product Quantity1 unit
Recall NumberB-0892-13
Product DescriptionFresh Frozen Plasma
Code Info020 S75093
ClassificationClass III
Reason for RecallBlood products, collected using expired blood collection sets, were distributed.
Product Quantity1 unit
Recall NumberB-0893-13

Class III Biologics Event

Event ID39704
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Feb-05
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityLauderhill
StateFL
CountryUS
Distribution PatternFL
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis)
Code Info1553291A, 1553291B
ClassificationClass III
Reason for RecallBlood products, with an unacceptable hematocrit, were distributed.
Product Quantity2 units
Recall NumberB-1176-13

Class III Biologics Event

Event ID42325
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-May-06
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityLauderhill
StateFL
CountryUS
Distribution PatternFL
 

Associated Products

Product DescriptionRed Blood Cells
Code Info1718381
ClassificationClass III
Reason for RecallBlood product, stored at the incorrect temperature, was distributed.
Product Quantity1 unit
Recall NumberB-1166-13

Class III Devices Event

Event ID49026
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAlere San Diego, Inc.
CitySan Diego
StateCA
CountryUS
Distribution PatternNationwide distribution: USA including states of: AL, AK, AR, AZ, CA, CO, CT, DE, HI, IA, ID, IL, IN, FL, GA, KY, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, UT, TN, TX, VA, WA, WI, WV AND WY.
 

Associated Products

Product DescriptionCardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026) The SP hCG Cassette Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in the early detection of pregnancy. This test is for professional use.
Code InfoLot: hCG2080330
ClassificationClass III
Reason for RecallAlere San Diego Inc. is recalling the Cardinal Health hCG Cassette Rapid Test because some of them were incorrectly packaged into Cardinal Health hCG Combo Rapid test kit boxes. The kit box incorrectly indicates the product may be used for both urine and serum sample types.
Product Quantity2,167 kits
Recall NumberZ-1344-2013

Class III Biologics Event

Event ID49757
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Aug-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmSuncoast Communities Blood Bank, Inc.
CitySarasota
StateFL
CountryUS
Distribution PatternFL
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW038608281767
ClassificationClass III
Reason for RecallBlood product, collected from a donor with no documentation of an arm inspection, was distributed.
Product Quantity1 unit
Recall NumberB-1162-13
Product DescriptionFresh Frozen Plasma
Code InfoW038608281767
ClassificationClass III
Reason for RecallBlood product, collected from a donor with no documentation of an arm inspection, was distributed.
Product Quantity1 unit
Recall NumberB-1163-13

Class III Drugs Event

Event ID52863
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAaron Industries Inc
CityLynwood
StateCA
CountryUS
Distribution PatternNationwide in the US: MD, MI, AL, NC, CT, NY, PA, OR, WV.
 

Associated Products

Product DescriptionRite Aid brand Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg and phenylephrine HCl 5 mg), 4 oz. package size, Distributed by: Rite Aid, Camp Hill, PA --- UPC Code: 0 11822 57307 8.
Code InfoLot # 82507 and 82720.
ClassificationClass III
Reason for RecallPresence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Product Quantity27,144 bottles
Recall NumberD-419-2013

Class III Biologics Event

Event ID52877
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-May-09
Initial Firm Notification of Consignee or Public FAX
Recalling FirmTalecris Plasma Resources, Inc.
CityEl Paso
StateTX
CountryUS
Distribution PatternNC
 

Associated Products

Product DescriptionSource Plasma
Code Info3740083441; 3740082841; 3740080126; 3740079058; 3740078680; 3740077894; 3740077329; 3740076349; 3740075984; 3740074225; 3740073916; 3740072958; 3740072504; 3740071276; 3740070953; 3740069648; 3740086734; 3740086219; 3740075209; 3740069079; 3740068171
ClassificationClass III
Reason for RecallBlood products, collected from a donor who failed arm inspection and/or general appearance, were distributed.
Product Quantity21 units
Recall NumberB-1156-13

Class III Biologics Event

Event ID64238
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Dec-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmONEBLOOD Inc DBA: Southeastern Comm. Blood Center
CityTallahassee
StateFL
CountryUS
Distribution PatternFL
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW12701283116500
ClassificationClass III
Reason for RecallBlood product, collected from a therapeutic donor, was distributed.
Product Quantity1 unit
Recall NumberB-1220-13

Class III Biologics Event

Event ID64241
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Dec-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Center Of Gtr KC
CityKansas City
StateMO
CountryUS
Distribution PatternKS
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW045011067606-part 1; W045011067606-part 2
ClassificationClass III
Reason for RecallBlood products, collected from a donor who was at risk for Leishmaniasis, were distributed.
Product Quantity2 units
Recall NumberB-1225-13

Class III Biologics Event

Event ID64252
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jan-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeServe Blood Center
CityDes Moines
StateIA
CountryUS
Distribution PatternFL
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW037912183934; W037912163660; W037912139385
ClassificationClass III
Reason for RecallBlood products, which was collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity3 unit
Recall NumberB-1226-13

Class III Biologics Event

Event ID64277
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Jan-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmLifeServe Blood Center
CityDes Moines
StateIA
CountryUS
Distribution PatternIA
 

Associated Products

Product DescriptionPlatelets Pooled Leukocytes Reduced
Code InfoW037912556178
ClassificationClass III
Reason for RecallBlood product, collected from a donor with no documentation on the donor record of an arm inspection or general appearance, was distributed.
Product Quantity1 unit
Recall NumberB-1210-13

Class III Biologics Event

Event ID64278
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Jan-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmLifeServe Blood Center
CityDes Moines
StateIA
CountryUS
Distribution PatternIA
 

Associated Products

Product DescriptionPlatelets Pooled Leukocytes Reduced Irradiated
Code InfoW037912556179
ClassificationClass III
Reason for RecallBlood product, collected from a donor with no documentation on the donor record of an arm inspection or general appearance, was distributed.
Product Quantity1 unit
Recall NumberB-1211-13

Class III Biologics Event

Event ID64279
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Jan-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmInland Northwest Blood Center
CitySpokane
StateWA
CountryUS
Distribution PatternWA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code InfoW068512202667; W068512382308
ClassificationClass III
Reason for RecallBlood products, manufactured from Whole Blood units that were stored at an incorrect temperature, were distributed.
Product Quantity2 units
Recall NumberB-1212-13
Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW068511031449
ClassificationClass III
Reason for RecallBlood products, manufactured from Whole Blood units that were stored at an incorrect temperature, were distributed.
Product Quantity1 unit
Recall NumberB-1213-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW068512601781; W068512022191; W068512103816; W068512210571; W068512022307; W068512103830; W068512322177; W068512382313; W068512501917; W068512501915; W068511106868; W068512200074; W068511106838; W068511323195;
ClassificationClass III
Reason for RecallBlood products, manufactured from Whole Blood units that were stored at an incorrect temperature, were distributed.
Product Quantity14 units
Recall NumberB-1214-13

Class III Biologics Event

Event ID64301
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Jan-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmBio-Blood Components, Inc.
CityHammond
StateIN
CountryUS
Distribution PatternTN
 

Associated Products

Product DescriptionSource Plasma
Code Info12HINC1435; 12HINC0838
ClassificationClass III
Reason for RecallBlood products, collected from a donor who was listed as a permanent deferral, were distributed.
Product Quantity2 units
Recall NumberB-1224-13

Class III Biologics Event

Event ID64302
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Dec-12
Initial Firm Notification of Consignee or Public Other
Recalling FirmThe American National Red Cross South Carolina Region
CityColumbia
StateSC
CountryUS
Distribution PatternSC
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code Info36FP39434
ClassificationClass III
Reason for RecallBlood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Product Quantity1 unit
Recall NumberB-1223-13

Class III Veterinary Event

Event ID64757
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Mar-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAbbott Animal Health
CityAbbott Park
StateIL
CountryUS
Distribution PatternNationwide (CA, GA, IA, IN, KY, MN, OR, TX, VA, WA)
 

Associated Products

Product DescriptionIsoflo; Isoflurane, USP; Nonflammable, Nonexplosive; Inhalation Anesthetic; 250 mL; For Use in Horses and Dogs; packaged in amber bottles; Product expires 8/23/14
Code InfoProduct Code: 5260-13-05; Lot: 24-002E
ClassificationClass III
Reason for RecallCanadian labeled Isoflurane was shipped to US customers.
Product Quantity5,898 cases (35,388 bottles)
Recall NumberV-195-2013

Class III Devices Event

Event ID64901
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmOrtho-Clinical Diagnostics
CityRochester
StateNY
CountryUS
Distribution PatternWorldwide Distribution - Nationwide including Puerto Rico, and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.
 

Associated Products

Product DescriptionVITROS Immunodiagnostic Products CK-MB Calibrators, REF 128 6293, IVD, Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of CK-MB in human serum and plasma (EDTA or heparin).
Code InfoLots 1400 (exp. 22 April 2013), 1410 (exp. 20 May 2013), 1420 (exp. 12 July 2013), 1430 (exp. 5 August 2013) , 1440 (exp. 10 September 2013), 1450 (exp. 18 November 2013), 1460 (exp. 18 November 2013), 1465 (exp. 13 November 2013), 1480 (exp. 3 January 2014)
ClassificationClass III
Reason for RecallInternal testing demonstrated that opened-reconstituted VITROS CK-MB Calibrators stored at -20 degrees Celsius (-4 degrees Farenheit) generated invalid calibrations that were detected by positively biased quality control results.
Product QuantityDomestic: 3019 units, Foreign: 905 units
Recall NumberZ-1337-2013

Class III Veterinary Event

Event ID65020
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Apr-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmNora Apothecary and Alternative Therapies, Inc.
CityIndianapolis
StateIN
CountryUS
Distribution PatternIN, OH, IL, FL, TN
 

Associated Products

Product DescriptionCyclosporine Opth Oint 0.2%: 3 gm, 6 gm Opthalmic, 30 day expiration
Code Infoproducts within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013
ClassificationClass III
Reason for RecallThe firm announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection.
Product Quantity3
Recall NumberV-183-2013
Product DescriptionCyclosporine Opth Oint 0.2%, 6 gm Opthalmic, 30 day expiration
Code Infoproducts within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013
ClassificationClass III
Reason for RecallThe firm announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection.
Product Quantity2
Recall NumberV-184-2013
Product DescriptionCyclosporine Opth Soln 0.2%,10 ml Opthalmic, 30 day expiration
Code Infoproducts within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013
ClassificationClass III
Reason for RecallThe firm announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection.
Product Quantity5
Recall NumberV-185-2013
Product DescriptionCyclosporine Opth Soln 1%,10 ml Opthalmic, 30 day expiration
Code Infoproducts within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013
ClassificationClass III
Reason for RecallThe firm announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection.
Product Quantity4
Recall NumberV-186-2013
Product DescriptionCyclosporine Opth Soln 2%,10 ml Opthalmic, 30 day expiration
Code Infoproducts within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013
ClassificationClass III
Reason for RecallThe firm announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection.
Product Quantity2
Recall NumberV-187-2013
Product DescriptionEDTA Opth Soln 1%,10 ml Opthalmic, 30 day expiration
Code Infoproducts within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013
ClassificationClass III
Reason for RecallThe firm announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection.
Product Quantity1
Recall NumberV-188-2013
Product DescriptionTacrolimus Opth Soln 0.01%,10 ml Opthalmic, 30 day expiration
Code Infoproducts within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013
ClassificationClass III
Reason for RecallThe firm announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection.
Product Quantity
Recall NumberV-189-2013
Product DescriptionTacrolimus Opth Soln 0.02%,10 ml Opthalmic, 30 day expiration
Code Infoproducts within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013
ClassificationClass III
Reason for RecallThe firm announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection.
Product Quantity2
Recall NumberV-190-2013
Product DescriptionIdoxuridine Opth Soln 0.1%,5 ml Opthalmic, 30 day expiration
Code InfoProducts within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013.
ClassificationClass III
Reason for RecallThe firm announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The compounded products that are subject to the recall are those products within their expiration date that were compounded and dispensed by the pharmacy on or before Friday, April 19, 2013. The recall is being initiated due to concerns associated with quality control processes that present a lack of sterility assurance and were observed during a recent FDA inspection.
Product Quantity1
Recall NumberV-191-2013

Class III Drugs Event

Event ID65021
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmNovartis Consumer Health
CityLincoln
StateNE
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionLamisil AT (terbinafine hydrochloride cream 1% antifungal), 24 g (.85 oz) tube, Novartis Consumer Health, Parsippany, NJ 07054, NDC 0067-6171-85
Code InfoLot #: 10118124, Exp: Sept 2013
ClassificationClass III
Reason for RecallLabeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
Product Quantity3,828 Tubes
Recall NumberD-420-2013

Class III Drugs Event

Event ID65115
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMylan Institutional, Inc. (d.b.a. UDL Laboratories)
CityRockford
StateIL
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionBudesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit dose (3 x 10 capsules blister packaged) per box, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed by: UDL Laboratories, Inc., Rockford, IL 61103, NDC 51079-020-03.
Code InfoLot No: 3037382, Exp 09/13
ClassificationClass III
Reason for RecallFailed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing.
Product Quantity1,621 boxes
Recall NumberD-452-2013

Mixed Classification Food Event

Event ID64967
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Apr-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmAlfred Louie Inc
CityBakersfield
StateCA
CountryUS
Distribution PatternCA, ID, AZ, NV.
 

Associated Products

Product DescriptionBean Sprouts: Keep Refrigerated: Ingredients: Mung Beans Net WT: 10 lbs (4.54 KG); Alfred Louis Inc., Bakersfield, CA 93309 Product of the USA. UPC 00000 20001
Code Infono codes on products
ClassificationClass I
Reason for RecallFDA environmental samples found Listeria Monocytogenes on product in packing line and on food contact surfaces in the facility.
Product Quantity
Recall NumberF-1444-2013
Product DescriptionSoy Bean Sprouts: Keep Refrigerated: Ingredients:Soy Beans Net WT: 5 lbs (2.27 KG); Alfred Louis Inc., Bakersfield, CA 93309 Product of the USA.
Code Infono codes on products
ClassificationClass II
Reason for RecallFDA environmental samples found Listeria Monocytogenes on product in packing line and on food contact surfaces in the facility.
Product Quantityxx
Recall NumberF-1445-2013

Mixed Classification Biologics Event

Event ID39441
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Aug-04
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmNorthwest Florida Blood Center, Inc.
CityPensacola
StateFL
CountryUS
Distribution PatternFlorida, Switzerland
 

Associated Products

Product DescriptionPlatelets
Code Info4050499
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity1 unit
Recall NumberB-1238-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info4050499
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity1 unit
Recall NumberB-1239-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info4050499
ClassificationClass III
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity1 unit
Recall NumberB-1240-13

Mixed Classification Biologics Event

Event ID39991
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Mar-05
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmAmerican National Red Cross (The)
CitySalt Lake City
StateUT
CountryUS
Distribution PatternCA, OK, TX, UT, and NV
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info20E34887, 20E34890, 20E34899, 20E34906, 20J98100, 20J98716, 20M38841, 20M38847, 20M38849, 20M3B852, 20M38854, 20M38872, 20VB3505, 20V83514, 20V83516, 20V83519, 20E34908, 20E34910, 20J98110, 20J98713, 20J98723, 20M38831, 20M38838, 20M38857, 20M38862, 20V83510, 20M38834, 20J98721, 20M38840, 20J98684, 20E34879, 20J98698, 20J98103, 20M38870, 20V83S21, 20J98718, 20E34885, 20E34894, 20M38856, 20M38858, 20M38866, 20J98677, 20M38864, 20M38869, 20J98688, 20E34901.
ClassificationClass II
Reason for RecallBlood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Product Quantity46 units
Recall NumberB-0941-13
Product DescriptionFresh Frozen Plasma
Code Info20M38857, 20M38862, 20M38872, 20V83519, 20E34679, 20E34885, 20E34890, 20E34901, 20V83521.
ClassificationClass II
Reason for RecallBlood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Product Quantity9 units
Recall NumberB-0942-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info20E34894, 20E34899, 20E34906, 20E34908, 20E34910, 20J98677, 20J98684, 20J98688, 20J9B698, 20J98700, 20J98703, 20J98710, 20J98713 , 20J98716, 20J98718, 20J98721, 20J98723, 20M38831, 20M38834, 20M38838, 20M38840, 20M38841, 20M38847, 20M38849, 20M38852, 20M38854, 20M38856, 20M38858, 20M38861, 20M38864, 20M38866, 20M38869, 20M38870, 20V83505, 20V83510, 20V83514, 20V83516, 20M40659, 20M40662, 20M40664, 20M40674.
ClassificationClass III
Reason for RecallBlood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Product Quantity41 units
Recall NumberB-0943-13
Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code Info20M38861
ClassificationClass II
Reason for RecallBlood products, collected from donors whose suitability to donate was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-0944-13
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