Safety

Enforcement Report for January 4, 2012

January 4, 2012
12-01

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I


PRODUCT

20 pound bulk boxes labeled as TexRio Tomatoes. Recall # F-0503-2012

CODE

Lot 04S46

RECALLING FIRM/MANUFACTURER

Recalling Firm: Rio Queen Citrus, Inc., Mission, TX, by telephone on November 25, 2011.

Manufacturer: Empresas Karol, Altamira, Mexico. Firm initiated recall is ongoing.

REASON

The tomatoes have the potential to be contaminated with Salmonella.

VOLUME OF PRODUCT IN COMMERCE

243 boxes

DISTRIBUTION

TX, MO


PRODUCT

Whole grain white rice, garden vegetable flavor, brand Uncle Ben's. Retail stand up carton. Labeling reads in part: "Uncle Ben's ***Whole Grain WHITE RICE Garden Vegetable WHOLE GRAIN WHITE RICE WITH PEAS, CORN & CARROTS***Net wt 4.70 oz (133g). Recall # F-0504-2012

CODE

Units: 133BA4RP06 and 133BB4RP06

RECALLING FIRM/MANUFACTURER

Recalling Firm: Mars Food US, Rancho Dominguez, CA, by press release on December 6, 2011 and verbally and electronic beginning December 7, 2011.

Manufacturer: Rexpak Ltd, Scarborough, Canada. Firm initiated recall is ongoing.

REASON

Recall due to undeclared milk allergen in the product.

VOLUME OF PRODUCT IN COMMERCE

2,936 cases

DISTRIBUTION

Nationwide


PRODUCT

Farm Wey labeled cantaloupes, 15 count case, Farm Wey distributed by Four Seasons 11/3/2011 to 11/7/2011. Recall # F-0505-2012

CODE

Lot numbers: 32773301 & 32773302

RECALLING FIRM/MANUFACTURER

Recalling Firm: Four Seasons Produce, Inc., Ephrata, PA, by email, telephone and fax on November 19, 2011.

Manufacturer: Farm-Wey Produce, Inc., Lakeland, FL. New York initiated recall is ongoing.

REASON

Firm was informed the product has the potential to be contaminated with Salmonella due to NY Dept of Agriculture testing/finding.

VOLUME OF PRODUCT IN COMMERCE

1,064 cases

DISTRIBUTION

NY, PA, PR and Bermuda


PRODUCT

Brand: Pacific Product: Cilantro. The product is distributed in Pacific International Marketing cartons of: 1) 20/3 Sleeves (20-3 twist tie bunch sleeves; 2) 30, (30 twist tie bunch sleeves; 3) Carton 60, (60 twist tie bunch sleeves; 4) Carton RPC 60, (60 twist tie bunch sleeves; 1) UPC code: 33383 80104. (Twist ties) The UPC code for sleeves is 40695 80104; 2) UPC code: 33383 80104. (Twist ties) The UPC code for sleeves is 40695 80104; 3) UPC code: 33383 80104. (Twist ties) The UPC code for sleeves is 40695 80104; 4) UPC code: 33383 80104. (Twist ties) The UPC code for sleeves is 40695 80104. Recall #F-0567-2012

CODE

1) Harvest Date: November 14, 17, 18, 19, 2011; 2) Harvest Date: November 18, 19, 2011; 3) Harvest Date: November 18, 19, 21, 2011; 4) Harvest Date: November 19, 2011);

1) twist ties) sleeves. Harvest Date: Lot# 11/14/2011 11CILTAY01, 11/17/2011 11CILTAY01, 11/18/2011 11CILTAY01F, 11/19/2011 11CILTAY01F, 11/21/2011 11CILTAY01F;

2) Harvest Date: Lot # 11/18/2011 11CILTAY01F, 11/19/2011 11CILTAY01F;

 

3) Harvest Date: Lot # 11/18/2011 11CILTAY01F, 11/19/2011 11CILTAY01F, 11/21/2011 11CILTAY01F;

 

4) Harvest Date: Lot # 11/19/2011 11CILTAY01F

RECALLING FIRM/MANUFACTURER

Recalling Firm: Pacific International Marketing, Salinas, CA, by press release on December 9, 2011 and letter on December 11, 2011.

Manufacturer: Rousseau Farming Co., Tolleson, AZ. FDA initiated recall is ongoing.

REASON

The cilantro may be contaminated with salmonella.

VOLUME OF PRODUCT IN COMMERCE

6,333 cartons

DISTRIBUTION

CA, AZ, MA, NJ, IN, SC, MD

 

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III


PRODUCT

Heartland Mill Inc. Certified Organic Yellow Cornmeal, net weight a) 2-lbs. (UPC 011933-70102), packaged in a plastic bag within a cloth bag, and packaged in b)10-lb. (011933-70110), c) 25-lb. (011933-70425), and d) 50-lb. (011933-70450) bags. Recall # F-0502-2012

CODE

a) and b) 01041209; c) 01041Y5EL5209; and d) 01041Y4HMEL5209 and 01041Y4EL5209. The product expires on 9/4/11

RECALLING FIRM/MANUFACTURER

Heartland Mill, Inc., Marienthal, KS, via e-mail and telephone on June 23, 2011. North Carolina Initiated recall is complete.

REASON

High insect fragment level.

VOLUME OF PRODUCT IN COMMERCE

a) 30, b) 225, c) 240, and d) 573 bags

DISTRIBUTION

MO, GA, CO, SD, IL, MI, CO, IN, IA, and MD


PRODUCT

1) Shirakiku Brand Dried Shiitake Whole Mushrooms, 3 oz is packed in a plastic rectangular package with gold and black border. The red and white Shirakiku Brand logo is in the top border. The whole dried mushrooms are visible through a clear panel on the front of the package. SHII-TA-KE in red lettering is at the top of the clear panel. SHIITAKE MUSHROOM 3OZ SK 30 Unit/Case; UPC 0 74410 56016 4. Recall # F-0568-2012;

2) Shirakiku Brand Dried Shiitake Sliced Mushrooms, 2 oz is packed in a plastic rectangular package with gold and black border. The red and white Shirakiku Brand logo is in the top border. The whole dried mushrooms are visible through a clear panel on the front of the package. SHII-TA-KE in red lettering is at the top of the clear panel. SHIITAKE MUSHROOM SLICED 2 OZ SK 50 Unit/Case. UPC 0 74410 56016 4. Recall # F-0569-2012

CODE

1) Lot#06/09/2012; Lot#09/19/2012; Lot#08/16/2012; Lot#10/11/2012;

2) Lot#08/16/2012; Lot#07/27/2012; Lot#09/19/2012

RECALLING FIRM/MANUFACTURER

Recalling Firm: Nishimoto Trading Co., Ltd., Santa Fe Springs, CA, by letter on December 5, 2011.

Manufacturer: Zhejiang Dashan Import & Export Trade Co., Ltd., Zhejiang, China. Firm initiated recall is ongoing.

REASON

Mushrooms have undeclared sulfites.

VOLUME OF PRODUCT IN COMMERCE

413 units

DISTRIBUTION

Nationwide

The FDA begins a pilot program seeking to expedite notifications of human drug product recalls to the public. The agency will modify the drug product section of the Enforcement Report17, published every Wednesday, to include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action. Such recalls will be listed under the heading, “Recalls Pending Classification: DRUGS.” They will be reposted with their classification once that determination has been made. Send comments or suggestions to CDERRecallPilot@fda.hhs.gov.

 

RECALLS PENDING CLASSIFICATION: DRUGS

 

None for this week.

 

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II


PRODUCT

Squeeze Pod, Alcohol-Free, Moisturizing Hand Sanitizer with 0.13% BKC (0.75 mL). Recall # D-1131-2012

CODE

Lot #: A32122, Exp. 06/13-A

RECALLING FIRM/MANUFACTURER

Recalling Firm: K. W. Griffen Company, DBA Biomed Packaging Systems, Norwalk, CT, by letter on December 15, 2011.

Manufacturer: Bentley Laboratories LLC, Edison, NJ. Firm initiated recall is ongoing.

REASON

Microbial contamination of Non-Sterile Products: Product contaminated with bacteria-Burkholderia cepacia.

VOLUME OF PRODUCT IN COMMERCE

194, 040 pods

DISTRIBUTION

CT


PRODUCT

Lantus (insulin glargine [rDNA origin] injection) 10 mL Vial, 100 units/mL, Rx only, in cartons of 1 vial each; NDC 0088-2220-33. Recall # D-1132-2012

CODE

A1259, 1/31/2013 A1271, 2/28/2013 A1295, 3/31/2013

RECALLING FIRM/MANUFACTURER

Recalling Firm: Sanofi-aventis US, Inc., Bridgewater, NJ, by letters dated September 19, 2011.

Manufacturer: Gruppo Lepetit Srl, Anagni, Italy. Firm initiated recall is ongoing.

REASON

Lack of Assurance of Sterility.

VOLUME OF PRODUCT IN COMMERCE

226,880 cartoon boxes (1 vial/box)

DISTRIBUTION

Nationwide


PRODUCT

Super Soft Sanitizer (benzalkonium chloride), 0.13%, 0.5 fl. oz. (15 mL) HDPE bottles, distributed under the following labels: a) Allstate.; b) NTMA; and c) Got Room for More?. Recall # D-1133-2012

CODE

Lot #: A32122

RECALLING FIRM/MANUFACTURER

Recalling Firm: Humphreyline Inc., Florence, KY, by telephone on December 6, 2011, and letters, dated December 7, 2011.

Manufacturer: Bentley Laboratories LLC, Edison, NJ. Firm initiated recall is ongoing.

REASON

Microbial Contamination of Non-Sterile Products: Samples of the recalled OTC product were laboratory tested and found to be contaminated with Burkholderia cepacia.

VOLUME OF PRODUCT IN COMMERCE

1,798 bottles

DISTRIBUTION

Nationwide


PRODUCT

Glenmark Clotrimazole Cream USP, 1%, 30g, Rx only, NDC 68462-181-35. Recall #D-1134-2012

CODE

Batch #02111245, exp March 2013

RECALLING FIRM/MANUFACTURER

Recalling Firm: Glenmark Generics Inc., USA, Mahwah, NJ, by letters on December 6, 2011.

Manufacturer: Glenmark Generics Limited, Colvale Bardez, India. Firm initiated recall is ongoing.

REASON

Label Mix Up; Products immediate container (tube) is labeled as Ciclopirox Cream but actually contains Clotrimazole Cream. The outer carton is correctly labeled as Clotrimazole Cream

VOLUME OF PRODUCT IN COMMERCE

16,116 tubes

DISTRIBUTION

Nationwide


PRODUCT

1) Chlorpap PEH DM, IMMEDIATE-RELEASE TABLET, 100 tablets, NDC 29273-0104-01. Recall #D-1135-2012;

 

2) Chlorpap PSE, IMMEDIATE-RELEASE TABLET, 100 tablets, NDC 29273-0101-01. Recall # D-1136-2012;

 

3) Chlorpap PSE DM, IMMEDIATE-RELEASE TABLET, 100 tablets, NDC 29273-0102-01 Recall # D-1137-2012;

 

4) Maxichlor DM, IMMEDIATE-RELEASE TABLET, 100 tablets, NDC 29273-0448-01. Recall # D-1138-2012;

 

5) Maxichlor PEH, IMMEDIATE-RELEASE TABLET, 100 tablets, NDC 29273-0444-01. Recall #D-1139-2012;

 

6) Maxichlor PEH DM, IMMEDIATE-RELEASE TABLET, 100 tablets, NDC 29273-0445-01. Recall # D-1140-2012;

 

7) Maxichlor PSE, IMMEDIATE-RELEASE TABLET, 100 tablets, NDC 29273-0442-01. Recall # D-1141-2012;

 

8) Maxichlor PSE DM, IMMEDIATE-RELEASE TABLET, 100 tablets, NDC 29273-0443-01. Recall # D-1142-2012;

 

9) Chlorpap, IMMEDIATE-RELEASE TABLET, 100 tablets, NDC 29273-0100-01. Recall # D-1143-2012

CODE

1) Lot 09G009;

2) Lot 09G002;

3) Lot 09G005;

4) Lot 09M009;

5) Lot 09M011;

6) Lot 09M010;

7) Lots 09F023, 09F024 09F025;

8) Lots 09F028, 09F029, 09F030;

9) Lot 09G001

RECALLING FIRM/MANUFACTURER

TG United, Inc., Brooksville, FL, by letter on December 17, 2011. Firm Initiated recall is ongoing.

REASON

CGMP Deviations: TG United, Inc. is recalling Chlorpap and Maxichlor tablet drug products for blending problems.

VOLUME OF PRODUCT IN COMMERCE

8,089 bottles and 659,660 professional samples

DISTRIBUTION

Nationwide


PRODUCT

1) Amlodipine Besylate Tablets, 2.5 mg, 90 count bottle, NDC 60505-0193-03, and 1000 count bottle, NDC 60505-0193-02, Rx Only. Recall # D-1144-2012;

2) Amlodipine Besylate Tablets, 5 mg, 90 count bottle, NDC 60505-0194-02, and 1000 count bottle, NDC 60505-0194-03. Recall # D-1145-2012;

3) Amlodipine Besylate Tablets, 10 mg, 90 count bottle, NDC 60505-0195-02 and 1000 count bottle, NDC 60505-0195-03. Recall # D-1146-2012

CODE

1) JD0780 Exp 02/2011, JE3558 Exp 03/2011, JF5111 Exp 05/2011, JE3555 Exp 03/2011, JF5110 Exp 05/2011, JG6578 Exp 07/2011;

2) JD0787 Exp 02/2011, JD4612 Exp 02/2011, JD4613 Exp 02/2011, JF5172 Exp 06/2011, JD0872 Exp 02/2011, JD4611 Exp 02/2011, JF5171 Exp 06/2011, JG6592 Exp 07/2011;

3) JD0788 Exp 02/2011, JD4614 Exp 03/2011, JD4615 Exp 03/2011, JE7873 Exp 04/2011, JE7876 Exp 04/2011 JF1994 Exp 04/2011, JD0789 Exp 02/2011, JE7881 Exp 04/2011, JE7882 Exp 04/2011, JF5173 Exp 06/2011, JF5174 Exp 07/2011, JG6603 Exp 07/2011

RECALLING FIRM/MANUFACTURER

Apotex Inc., Toronto Ontario, Canada, by letter dated Feb 28, 2011, with a follow up fax. Firm initiated recall is ongoing.

REASON

Impurities/Degradation Products: tablets failed routine stability studies.

VOLUME OF PRODUCT IN COMMERCE

569,228 bottles

DISTRIBUTION

Nationwide and to Haiti & Saudi Arabia

 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II


PRODUCT

Cryoprecipitated AHF. Recall # B-0234-12

CODE

Units: W067111028696, W067111028688, W067111022117, W067111023872, W067111022119, W067111028692, W067111028689, W067111028687, W067111028693, W067111023871

RECALLING FIRM/MANUFACTURER

The Blood Center, New Orleans, LA, by telephone on April 4, 2011. Firm initiated recall is complete.

REASON

Blood products, not prepared in accordance with specifications, were distributed.

VOLUME OF PRODUCT IN COMMERCE

10 units

DISTRIBUTION

MS


PRODUCT

Source Plasma. Recall # B-0240-12

CODE

Units: 372682804, 0411119080, 0411118068, 0411116780, 0411116240, 0411091655, 0411091073, 0411087479, 0411084365, 0411083573, 0411082504, 0411082108, 0411080944, 0411080569, 0411079707, 0411079125, 0411078313, 0411077989, 0411074630, 0411071192, 0411069998, 0411068291, 0411067425, 0411063477, 0411063056, 0411178134, 0411176648, 0411174723, 374601417, 0411119080, 0411118068, 0411116780, 0411116240, 0411091655, 0411091073, 0411087479, 0411084365, 0411083573, 0411082504, 0411082108, 0411080944, 0411080569, 0411079707, 0411079125, 0411078313, 0411077989, 0411074630, 0411071192, 0411069998, 0411068291, 0411067425, 0411063477, 0411063056

RECALLING FIRM/MANUFACTURER

CSL Plasma, Inc., Oak Park, MI, by fax on February 11, 2010. Firm initiated recall is complete.

REASON

Blood products, collected from donors who were previously deferred for high risk behavior, were distributed.

VOLUME OF PRODUCT IN COMMERCE

53 units

DISTRIBUTION

NC and Germany


PRODUCT

Cryoprecipitated AHF, Pooled. Recall # B-0323-12

CODE

Unit: 4600407

RECALLING FIRM/MANUFACTURER

Northern California Community Blood Bank, Eureka, CA, by telephone on June 26, 2007. Firm initiated recall is complete.

REASON

Blood product, not prepared in accordance with specifications, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

CA


PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-0451-12

CODE

Unit: W043211073244

RECALLING FIRM/MANUFACTURER

Blood Assurance Inc., Chattanooga, TN, by facsimile on November 25, 2011. Firm initiated recall is complete,

REASON

Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

TN, IN


PRODUCT

1) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0452-12;

2) Platelets Pheresis Leukocytes Reduced. Recall # B-0453-12

CODE

1) Units: W1170115030731 (3 units), W1170115030811;

2) Units: W1170115030811 (2 units), W117011503104J (3 units)

RECALLING FIRM/MANUFACTURER

Recalling Firm: Blood Centers of the Pacific – Irwin Center, San Francisco, CA, by telephone on September 26, 2011 and by letter dated October 10, 2011.

Manufacturer: Blood Centers of the Pacific – Santa Rosa Center, Santa Rosa, CA. Firm initiated recall is complete.

REASON

Blood products, for which quality control testing was not performed, were distributed.

VOLUME OF PRODUCT IN COMMERCE

9 units

DISTRIBUTION

CA


PRODUCT

Source Plasma. Recall # B-0454-12

CODE

Units: 3330191690, 3330191052, 3330190171, 3330189544, 3330188749, 3330188119, 3330187290, 3330186604, 3330185807, 3330183718, 3330180243, 3330185194, 3330184363, 3330182818, 3330182244, 3330179437, 3330178954, 3330180890

RECALLING FIRM/MANUFACTURER

Talecris Plasma Resources, Inc., El Paso, TX, by facsimile on November 10, 2011. Firm initiated recall is complete.

REASON

Blood products, collected from a donor who did not have a complete physical examination, were distributed.

VOLUME OF PRODUCT IN COMMERCE

18 units

DISTRIBUTION

NC

 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III


PRODUCT

Source Plasma. Recall # B-0217-12

CODE

Units: 3530033072, 3530032514, 3530030209, 3530029269, 3530027418, 3530026146, 3530025644, 3530024361, 3530023809, 3530022566, 3530022098, 3530020743, 3530020183, 3530018633, 3530018067, 3530016676, 3530016108, 3530015093, 3530014475, 3530013342, 3530012792, 3530011715, 3530011123, 3530010121, 3530009584, 3530008514, 3530008010, 3530007068, 3530006534, 3530005197, 3530004751, 3530003758, 3530003354, 3530001791

RECALLING FIRM/MANUFACTURER

Recalling Firm: Talecris Plasma Resources, Inc., Research Triangle Park, NC, by e-mail on April 24, 2009 and July 8, 2009.

Manufacturer: Talecris Plasma Resources, Inc., Flint, MI. Firm initiated recall is complete.

REASON

Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.

VOLUME OF PRODUCT IN COMMERCE

34 units

DISTRIBUTION

NC


PRODUCT

Platelets Pheresis Leukocytes Reduced. Recall # B-0239-12

CODE

Units: W036511110451; W036511087883

RECALLING FIRM/MANUFACTURER

LifeShare Blood Centers, Shreveport, LA, by letter dated November 2, 2011. Firm initiated recall is complete.

REASON

Blood products, collected from a donor who reported travel to a leishmania risk area, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

LA


PRODUCT

Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0362-12

CODE

Unit: W036811241038

RECALLING FIRM/MANUFACTURER

Community Blood Centers Laboratory Services, Inc., Lauderhill, FL, by telephone and facsimile on October 20, 2011. Firm initiated recall is complete.

REASON

Blood product, labeled with an incorrect volume, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

FL


PRODUCT

Recovered Plasma. Recall # B-0450-12

CODE

Unit: W043211073244

RECALLING FIRM/MANUFACTURER

Blood Assurance Inc., Chattanooga, TN, by facsimile on November 25, 2011. Firm initiated recall is complete,

REASON

Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

TN, IN


PRODUCT

Bone. Recall # B-0459-12

CODE

Units: 030527779, 030567547, 030566864, 030512563

RECALLING FIRM/MANUFACTURER

DCI Donor Services Tissue Services Division, Nashville, TN, by telephone and e-mail on September 26, 2011. Firm initiated recall is complete.

REASON

Bone allografts with positive post-processing swab cultures were distributed.

VOLUME OF PRODUCT IN COMMERCE

4 units

DISTRIBUTION

CA


PRODUCT

Fluzone(R), Influenza Virus Vaccine, Single-Dose Vials, 0.5 mL, NDC 49281-011-10. Recall # B-0460-12

CODE

Lot numbers U4114DA, exp 6/30/12; U4118AA, exp 6/30/12; U4118BA, exp 6/30/12; U4118BB, exp 6/30/12; U4122AA, exp 6/30/12; U4122BA, exp 6/30/12; U4122CA, exp 6/30/12; U4124AA, exp 6/30/12; U4124BA, exp 6/30/12; U4124CA, exp 6/30/12; U4147AA, exp 6/30/12; U4147BA, exp 6/30/12; U4147CA, exp 6/30/12; U4149AA, exp 6/30/12; U4159DA, exp 6/30/12; U4178AA, exp 6/30/12; U4178BA, exp 6/30/12; U4184AA, exp 6/30/12; and U4197AB, exp 6/30/12

RECALLING FIRM/MANUFACTURER

Sanofi Pasteur, Inc., Swiftwater, PA, by letter on November 14, 2011. Firm initiated recall is ongoing.

REASON

Fluzone(R), Influenza Virus Vaccine, Single-Dose Vials, 0.5mL, misbranded due to an error in the Prescribing Information (PI) included in packages of 10 single-dose vials of Fluzone vaccine, was distributed.

VOLUME OF PRODUCT IN COMMERCE

2,832,810 units

DISTRIBUTION

Nationwide


PRODUCT

Limulus Amebocyte Lysate. Recall # B-0485-12

CODE

Lot A1482L

RECALLING FIRM/MANUFACTURER

Charles River Endosafe, a Division of Charles River Laboratories, Inc., Charleston, SC, were notified of the recall on February 23, 2011 and continued through March 2, 2011. Firm initiated recall is complete.

REASON

Limulus Amebocyte Lysate, possibly misbranded with missing lot number and expiration date, was distributed.

VOLUME OF PRODUCT IN COMMERCE

7,774 units

DISTRIBUTION

Nationwide and Internationally

 

RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS I


PRODUCT

INOmax DS (Delivery System) Model 10003 & 10007. The INOMAX DS Delivery System delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators. The INOMAX DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. Recall # Z-0583-2012

CODE

Serial Number DS20070005 DS20070006 DS20070007 DS20070008 DS20070009 DS20070010 DS20070011 DS20070012 DS20070013 DS20070014 DS20070015 DS20070016 DS20070017 DS20070018 DS20070019 DS20070020 DS20070021 DS20070022 DS20070023 DS20070024 DS20070025 DS20070026 DS20070027 DS20070028 DS20070029 DS20070030 DS20070031 DS20070032 DS20070033 DS20070034 DS20070035 DS20070036 DS20070037 DS20070038 DS20070039 DS20070040 DS20070041 DS20070042 DS20070043 DS20070044 DS20070045 DS20070046 DS20070047 DS20070048 DS20070049 DS20070050 DS20070051 DS20070052 DS20070053 DS20070054 DS20070055 DS20070056 DS20070057 DS20070058 DS20070059 DS20070060 DS20070061 DS20070062 DS20070063 DS20070064 DS20070065 DS20070066 DS20070067 DS20070068 DS20070069 DS20070070 DS20070071 DS20070072 DS20070073 DS20070074 DS20070075 DS20070076 DS20070077 DS20070078 DS20070079 DS20070080 DS20070081 DS20070082 DS20070083 DS20070084 DS20070085 DS20070086 DS20070087 DS20070091 DS20070092 DS20070093 DS20070094 DS20070095 DS20070096 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DS20100784 DS20100785 DS20100786 DS20100787 DS20100788 DS20100789 DS20100790 DS20100791 DS20100792 DS20100793 DS20100794 DS20100795 DS20100796 DS20100797 DS20100798 DS20100799 DS20100800 DS20100801 DS20100802 DS20100803 DS20100804 DS20100805 DS20100806 DS20100807 DS20100808 DS20100809 DS20100810 DS20100811 DS20100812 DS20100813 DS20100814 DS20100815 DS20100816 DS20100817 DS20100818 DS20100819 DS20100820 DS20100821 DS20100822 DS20100823 DS20100824 DS20100825 DS20100826 DS20100827 DS20100828 DS20100829 DS20100830 DS20100831 DS20100832 DS20100833 DS20100834 DS20100835 DS20100836 DS20100837 DS20100838 DS20100839 DS20100840 DS20100841 DS20100842 DS20100843 DS20100844 DS20100845 DS20100846 DS20100847 DS20100848 DS20100849 DS20100850 DS20100851 DS20100852 DS20100853 DS20100854 DS20100855 DS20100856 DS20100857 DS20100858 DS20100859 DS20100860 DS20100861 DS20100862 DS20100863 DS20100864 DS20100865

RECALLING FIRM/MANUFACTURER

Ino Therapeutics. Madison WI, by letter dated December 22, 2011. Firm initiated recall is ongoing.

REASON

Through the review and monitoring of its complaint data, Ikaria identified a product anomaly with the INOmax DS Model 1003. Ikaria concluded the anomaly risk to the patient safety was low and non reportable (4/23/10). During a subsequent Level 3 inspection by FDA, it was concluded that the action should have been reported under 21 CFR & 806.10.

VOLUME OF PRODUCT IN COMMERCE

2446 units

DISTRIBUTION

Nationwide and Malaysia

 

RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS II


PRODUCT

Rapid Strand Rx; the RAPID Strand Rx kit consists of custom loaded absorbable seeding spacers and I-125 radionuclide brachytherapy sources (seeds) spaced at prescribed distance and configuration within a sleeve (tube) made of absorbable suture material, stiffened, loaded into prostate seeding needles, packaged and then sterilized by Gamma sterilization method, accompanied by a calibration strand, a sealed source calibration certificate (100% assay report), a radiograph of the loaded needles in the needle-holding card, and a source certification technical data sheet.; Products Provided by: Oncura, Prescription Filled by: AnazaoHealth,; product identifier: I125RSRX, model 7000. RA PID Strand Rx is indicated for permanent interstitial implantation of selected localized tumors that are of low to moderate radio sensitivity. It may be used either as primary treatment (such as prostate cancer or unresectable tumors) or for the treatment of residual disease after excision of the primary tumor. RAPID Strand Rx may be indicated for use concurrent with or at the completion of other treatment modalities such as external beam radiation therapy. Recall # Z-0266-2012

CODE

Oncura order numbers 85342, 85778, 85897, 87430, 87433, 87479, 87547, 87801, 87849, 87851, 87992, 87993, 88070, 88081, 88093, 88426, 88562, 88690, 88798, 88819, 88823, 88830 and 88844

RECALLING FIRM/MANUFACTURER

Medi-Physics Inc. dba GE Healthcare, Arlington Heights, IL, by letter dated September 20, 2011. Firm initiated recall is ongoing.

REASON

There is a potential brachytherapy over or under dose with the RAPID Strand Rx kit that may impact patient therapy.

VOLUME OF PRODUCT IN COMMERCE

23 units

DISTRIBUTION

Nationwide, Canada and the UK


PRODUCT

Suction Handle (Sterile) Part Number: 1990S. For use in open heart procedures, Autologus blood recovery or blood suction. Product is a component of Blood Recovery Systems. Recall # Z-0273-2012

CODE

Lot # IBC 041811-2065, Exp date: 18/APR/2015

RECALLING FIRM/MANUFACTURER

International Biophysics Corp., Austin, TX, by letter dated October 5, 2011. Firm initiated recall is ongoing.

REASON

Potential for the sterility to be compromised.

VOLUME OF PRODUCT IN COMMERCE

1,200 units

DISTRIBUTION

Nationwide


PRODUCT

cobas c 311 Analyzer, Part Number: 04826876001 In-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically; the analyzer also has an optional ISE module for measuring sodium, potassium and chloride. Recall # Z-0310-2012

CODE

Serial Numbers:1050-16, 1040-08, 1041-06, 0927-16, 0918-05, 1048-02, 0812-12, 1058-09, 0925-20, 1044-19, 1041-05, 1043-15, 1056-18, 0812-09, 1038-07, 0814-10, 1041-19, 1170-04, 0929-08, 0919-16, 0814-03, 0926-11, 1035-01, 1034-19, 1035-10, 1174-19, 1176-03, 1067-02, 0919-17, 0920-05, 0927-13, 1060-17, 1060-05, 0927-17, 1044-18, 0812-10, 0811-20, 1041-20, 1174-04, 0925-05, 1060-01, 1062-09, 1066-20, 1174-07, 0814-15, 0814-17, 1053-16, 1054-02, 1034-02, 1052-16, 1052-19, 0918-06, 1052-13, 1052-20, 1052-15, 1034-07, 1043-10, 0811-15, 1054-03, 1061-08, 1043-06, 0926-10, 1044-06, 1034-03, 1052-09, 1043-12, 1055-01, 0929-09, 1038-05, 1034-01, 0810-19, 1054-20, 1062-07, 1059-20, 0814-16, 1043-14, 1062-08, 1054-01, 0929-07, 1038-06, 1056-19, 1057-03, 1169-20, 0926-19, 1067-01, 1038-04, 0925-06, 1043-08, 1043-13, 0812-11, 1057-05, 1060-06, 0926-16, and 1034-06

RECALLING FIRM/MANUFACTURER

Recalling Firm: Roche Diagnostics Operations, Inc., Indianapolis, IN, by letter on October 26, 2011.

Manufacturer: MHitachi High-Technologies Corp., Tokyo, Japan. Firm initiated recall is ongoing.

REASON

The cobas c 311 analyzer software may incorrectly calculate the volume of the ISE Reference Electrolyte solution remaining on the analyzer. In some cases the incorrect results obtained will not be flagged with any data alarms.

VOLUME OF PRODUCT IN COMMERCE

940 units

DISTRIBUTION

Nationwide and Internationally


PRODUCT

SoftMic GUI versions: 4.0.3.0-4.0.3.15, 4.0.4.1-4.0.4.7. SoftMic is a laboratory information system to be used in medical research, clinical, and public health laboratories by knowledgeable, trained, and experienced personnel. SoftMic enables the user to handle data processing and laboratory activities for microbiology and serology testing, for the purpose of storing, managing, querying, and reporting laboratory data. Recall # Z-0466-2012

CODE

SoftMic GUI versions: 4.0.3.0-4.0.3.15, 4.0.4.1-4.0.4.7.

RECALLING FIRM/MANUFACTURER

SCC Soft Computer, Clearwater, FL, by a Field Correction dated August 25, 2011. Firm initiated recall is ongoing.

REASON

When a certain series of keystrokes on the test grid are performed while entering results and statusing a test, the test status may not be maintained upon saving. The status may be removed or copied from another test on the order upon saving.

VOLUME OF PRODUCT IN COMMERCE

144 units

DISTRIBUTION

Nationwide and Canada


PRODUCT

Siemens Healthcare Diagnostics, Dimension Vista(R) Cardiac Troponin I Calibrator (KC678), in vitro diagnostic. Recall # Z-0513-2012

CODE

Lot # 1DD085

RECALLING FIRM/MANUFACTURER

Siemens Healthcare Diagnostics, Inc., Newark, DE, by letter on November 17, 2011. Firm initiated recall is ongoing.

REASON

Siemens Healthcare Diagnostics has confirmed positive bias on QC and Patients.

VOLUME OF PRODUCT IN COMMERCE

2,281 units

DISTRIBUTION

Nationwide and Internationally


PRODUCT

Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Product Code: 2M8161. Recall # Z-0598-2012

CODE

Serial Number 12050019CC

RECALLING FIRM/MANUFACTURER

Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by visit on May 9, 2011.

Manufacturer: Baxter Healthcare SA, Singapore, Singapore. Firm initiated recall is complete.

REASON

There was no documentation to show the required tests were performed following the replacement of the battery and battery harness.

VOLUME OF PRODUCT IN COMMERCE

1 pump

DISTRIBUTION

PR


PRODUCT

1) Coulter LH500 Series Analyzer, Part number: 178832, 178833, 178834. LH 500 Series System Instructions for Use, PN 624602 Rev BA. The COULTER LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter For In Vitro Diagnostic Use in clinical laboratories. The LH500 Analyzer also provides a semi-automated reticulocyte analysis. Recall # Z-0599-2012;

2) Coulter HmX Hematology Analyzer, Part number: 6605522, 6605523, 6605524. HmX Hematology Analyzer / HmX Hematology Analyzer with Autoloader PN 4237523 Rev C. The COULTER HmX Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter for In Vitro Diagnostic Use in clinical laboratories. Recall # Z-0600-2012;

3) Coulter HmX Hematology Analyzer with Autoloader, Part number: 6605525, 6605526, 6605527. HmX Hematology Analyzer / HmX Hematology Analyzer with Autoloader PN 4237523 Rev C. The COULTER HmX Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter for In Vitro Diagnostic Use in clinical laboratories. Recall # Z-0601-2012;

4) COULTER MAXM Hematology Analyzer/MAXM Hematology Analyzer with Autoloader Part number: 6705995, 6705996, 6705997/ Part number: 6705998, 67059999, 6706000. HmX Hematology Analyzer / HmX Hematology Analyzer with Autoloader PN 4237523 Rev C. The COULTER HmX Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter for In Vitro Diagnostic Use in clinical laboratories. Recall # Z-0602-2012

CODE

N/A

RECALLING FIRM/MANUFACTURER

Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated October 13, 2011.

Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.

REASON

The recall was initiated because Beckman has identified a problem with Integrated Circuit chips used in different boards throughout the analyzer.

VOLUME OF PRODUCT IN COMMERCE

222 units

DISTRIBUTION

Nationwide and Internationally


PRODUCT

The GSP 2021-0010 (Genetic Screening Processor) instrument is a fully automated, high throughput batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The chemistries running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders. Recall # Z-0603-2012

CODE

None

RECALLING FIRM/MANUFACTURER

Recalling Firm: PerkinElmer LAS, Inc., Waltham, MA, by letters on October 24, 2011.

Manufacturer: PerkinElmer Life and Analytical Sciences, Wallac, OY, Turku, Finland. Firm initiated recall is ongoing.

REASON

Malfunction of the GSP disk remover unit may cause a punched disc to remain in the well during the measurement of the plate. This may cause a false negative screening result being reported for 17-OHP, resulting in failure to identify cases of congenital adrenal hyperplasia (CAH).

VOLUME OF PRODUCT IN COMMERCE

52

DISTRIBUTION

Nationwide and Internationally


PRODUCT

CDI 101 Hematocrit/Oxygen Saturation Monitoring System. The CDI 101 Hematocrit/Oxygen Saturation Monitoring System is intended for use during cardiopulmonary bypass procedures where continuous monitoring of the blood's oxygen saturation, hematocrit and hemoglobin levels is needed. Recall # Z-0604-2012

CODE

Serial Numbers: 1070, 1071, 1076, 1077, 1080, 1083, 1104, 1107, 1108, 1115-1117, 1124, 1127, 1128, 1132-1134, 1136, 1137, 1139-1144, 1148, 1151, 1152, 1154-1156, 1160-1162, 1166, 1168-1173, 1182,1185,1186,1190,1192, 1193, 1195, 1239-1241, 1243-1245, 1247, 1249-1257,1261, 1264-1266, 1268-1277,1279, 1280, 1282-1289, 1297,1299-1301, 1306-1311, 1313-1318, 1321-1324, 1337-1339, 1350-1355, 1357-1363, 1365-1377, 1382, 1386, 1406-1409, 1411, 1413,1414, 1417-1422, 1428-1436, 1440, 1441, 1443-1447, 1450-1453, 1455-1458, 1460, 1463, 1469-1482, 1484, 1486, 1488, 1492,1503-1511 ,1513, 1515-1520, 1532-1534, 1537, 1540, 1542, 1543, 1547, 1548, 1550, 1551, 1555, 1560-1563, 1568-1574, 1578, 1579, 1585-1596, 1598, 1614, 1615, 1617-1622, 1625-1629, 1632-1647, 1653, 1655, 1660, 1666, 1667, 1669-1676, 1679, 1681, 1682, 1690, 1693, 1694, 1696, 1699, 1705-1709, 1713, 1714, 1726, 1729-1734,1738, 1745-1750,1752-1756,1760, 1764-1768, 1771, 1773-1777,1785,1787,1788,1790-1794,1797-1799,1801-1808,1816,1818-1821, 1823, 1826, and 1839

RECALLING FIRM/MANUFACTURER

Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letter dated December 4, 2011. FDA initiated recall is ongoing.

REASON

Terumo is recalling the CDI 101 Hematocrit/Oxygen Saturation Monitoring System because they have not yet submitted a 510(k) to FDA to market the device.

VOLUME OF PRODUCT IN COMMERCE

366 units

DISTRIBUTION

Nationwide

 

RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS III


PRODUCT

Curix Opthos H, size 35x43 cm A radiographic medical x-ray film designed to optimize diagnostic chest imaging by providing complete diagnostic information including superbly visualized lung detail along with a high level of retro-cardiac, sub-diaphragmatic and mediastinal information. Recall # Z-0285-2012

CODE

Unit: 79890049

RECALLING FIRM/MANUFACTURER

Recalling Firm: AGFA Corp., Greenville, SC, by letter on October 7, 2011.

Manufacturer: Agfa Materials Corp., Goose Creek, SC. Firm initiated recall is ongoing.

REASON

The film notch was located in the wrong position.

VOLUME OF PRODUCT IN COMMERCE

125 units

DISTRIBUTION

IN, KS, MI, MN, MO, NC, NE, NY, OH, TN and Canada

 

END OF ENFORCEMENT REPORT FOR JANUARY 4, 2012.

 
#

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