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U.S. Department of Health and Human Services

Safety

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Enforcement Report for September 15, 2010

September 15, 2010                                                                                        10-36

 

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I

___________________________________

PRODUCT

Apple slices distributed in within two different product labeling: 1) SIMPLY FRESH, FRUIT, Apple Slices, Net Wt 2 oz (57g), UPC 077554002279. This product is packaged as 72 count per box, and 100 count per box; 2) Miller's, ALEHOUSE, RESTAURANTS, A "Reel" Great place to Catch a Good Time..., APPLE SLICES, Net Wt 2 oz (57g), UPC 042947611406. This product is packaged as 24 count per box. Recall # F-2805-2010

CODE

1) Use by Date 7-20-10, and 7-21-10;

2) Use by Date 7-20-10

RECALLING FIRM/MANUFACTURER

Marjon Specialty Foods, Inc., Plant City, FL, by e-mail and telephone on July 6, 2010 and July 7, 2010 and by press release on July 9, 2010. Firm initiated recall is ongoing.

REASON

Product is potentially contaminated with Listeria.

VOLUME OF PRODUCT IN COMMERCE

119 cases (30 cases w/ 24 ct; 83 cases w/ 72 ct; 6 cases w/ 100 ct)

DISTRIBUTION

FL

 

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II

___________________________________

PRODUCT   

Beehive Botanicals, Propol Dent, Peppermint Flavor, 20 pieces, UPC: 80521-01242, Contents: Sorbitol, Guam Base, Glucose Syrup, Bee Propolis, Peppermint Oil, Lecithin, Resinous Glaze Chlorophyll. Item Number G550 Bulk Propol-Dent Chewing Gum, 33 lb & 1 lb bags. Item Number 123 Propol-Dent Chewing Gum Display Each display has 18/20ct individual packages Item Number 101 Propol-Dent Chewing Gum Pouch Individual 20ct pouch. Recall # F-2804-2010

CODE

Lot #6149

RECALLING FIRM/MANUFACTURER

Recalling Firm: Beehive Botanicals, Inc., Hayward, WI, by letter dated June 11, 2010 and by telephone between June 11, 2010 – June 17, 2010.

Manufacturer: Ford Gum & Machine Company Inc., Akron, NY. Firm initiated recall is ongoing.

REASON

Product contains undeclared Soy, therefore posing a potential health hazard. People who have an allergy or severe sensitivity to Soy run the risk of serious allergic reaction if they consume this product. The product contains Soy Lecithin and the label represents only Lecithin without stating the source of the lecithin as required.  

VOLUME OF PRODUCT IN COMMERCE

881.25 lbs (868.65 lbs bulk, Individual Package -20 pieces: 9 packages, Displays -18pks/20 pc: 10 displays)

DISTRIBUTION

IL, WA, OK, NC, UT, PA, CA, Canada, England

___________________________________

PRODUCT

Tampico Citrus Punch in Plastic jug, 6 jugs per case, sold at retail in 1 Gallon units. Identifying UPC Number on label: 9518802128, Plant Code: 04-17. Recall # F-2806-2010

CODE

Best Before November 23, 2010  

RECALLING FIRM/MANUFACTURER

Safeway Inc., Pleasanton, CA, by letter, e-mails and on-site visits on August 12, 2010. Firm initiated recall is ongoing.

REASON

The product contains undeclared Yellow #5 in the ingredient statement.

VOLUME OF PRODUCT IN COMMERCE

19, 560 gallons

DISTRIBUTION

AZ, NM

___________________________________

PRODUCT   

1) Mamusia's Pierogi Dinner Dumplings, cheese, 14 oz, UPC 3411300555. Recall # F-2807-2010;

 

2) Mamusia's Pierogi Dinner Dumplings, potato & onion, 14 oz, UPC 3411300444. Recall # F-2808-2010;

 

3) Mamusia's Pierogi Dinner Dumplings, sauerkraut & mushroom, 14 oz, UPC 3411300666. Recall # F-2809-2010;

 

4) Mamusia’s Pierogi Dinner Dumplings, sauerkraut, 14 oz, UPC 3411300222. Recall # F-2810-2010;

 

5) Mamusia's Pierogi Dinner Dumplings, potato & cottage cheese, 14 oz, UPC 3411300333. Recall # F-2811-2010;

 

6) Mamusia's Pierogi Dinner Dumplings, potato & cheddar cheese, 14 oz, UPC 3411300111. Recall # F-2812-2010

CODE

No Code

RECALLING FIRM/MANUFACTURER

Recalling Firm: Lipari Foods, Inc., Warren, MI, by e-mail on April 8, 2010. 

Manufacturer: Sawa Restaurant, Taylor, MI. Firm initiated recall is ongoing.

REASON

All products have undeclared wheat ingredients. Products labeled as "cheese" have undeclared milk ingredients.

VOLUME OF PRODUCT IN COMMERCE

Unknown

DISTRIBUTION

MI, PA, WI, OH, IL, KY

___________________________________

PRODUCT   

Ferrous Gluconate Tablets USP, 324 mg, Dietary Supplement, Contains: Each tablet contains 324 mg of ferrous gluconate, equivalent to 38 mg of elemental iron, providing 208% of the US recommended daily intake (RDI) of iron for adults and children 4 and older, Net Contents 100 tablets. NDC 0574-0508-01, UPC Codes 305740508114. Recall # F-2813-2010

CODE

Lot number on bottle: 2009176722

RECALLING FIRM/MANUFACTURER

Recalling Firm: Paddock Laboratories, Inc., Minneapolis, MN, by letter dated June 15, 2010.   

Manufacturer: Lomapharm Rudolf Lohmann GmbH KG, Emmerthal, Germany. Firm initiated recall is ongoing.

REASON

Presence of Foreign Tablets; bottle of Ferrous Gluconate Tablets, USP 324 mg contained Ferrous Sulfate Tablets, USP, (red) instead of Ferrous Gluconate Tablets, USP (green).

VOLUME OF PRODUCT IN COMMERCE

39,048 bottles

DISTRIBUTION

Nationwide, Guam, Japan

 

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS I

___________________________________

PRODUCT   

1) Liposyn III Intravenous Fat Emulsion, 10%, a) 250 mL vial (NDC 0409-9790-02); b) 500 mL vial (NDC 0409-9790-03); Rx only. Recall # D-876-2010;

 

2) Liposyn III Intravenous Fat Emulsion, 20%, a) 250 mL bottle (NDC 0409-9791-02); b) 500 mL botlle (NDC 0409-9791-03); Rx only. Recall # D-877-2010;

 

3) Liposyn III Intravenous Fat Emulsion, 30%, 500 mL bottle, Rx only, NDC 0409-6892-03. Recall # D-878-2010;

 

4) Liposyn II Intravenous Fat Emulsion, 10%, 500 mL bottle, Rx only, NDC 0409-9786-03. Recall # D-880-2010;

 

5) Liposyn II Intravenous Fat Emulsion, 20%, a) 250 mL bottle (NDC 0409-9789-02), b) 500 mL botlle (NDC 0409-9789-03), Rx only. Recall # D-881-2010

CODE

1) Lot numbers: a) 75010DW; 75011DW; 75012DW; 75013DW; 75014DW; 75015DW; 75079DW; 75970DW; 75971DW, Exp 09/01/10; 82380DW; 82381DW, Exp 04/01/11; 83558DW, Exp 05/01/11; 84724DW; 84725DW, Exp 06/01/11; 85032DW; 85033DW, Exp 07/01/11; b) 72397DW; 72398DW; 72399DW; 72400DW; 72401DW, Exp 06/01/10; 74825DW; 74826DW; 74827DW; 74828DW; 74829DW; 74830DW; 74831DW; 74833DW; 74834DW; 74835DW; 74836DW; 74837DW, Exp 08/01/10; 77376DW; 77377DW; 77378DW; 77379DW; 77380DW; 77381DW; 77382DW; 77383DW; 77384DW; 77385DW; 77386DW; 77387DW; 77388DW, Exp 11/01/10; 82404DW; 82405DW; 82406DW; 82407DW; 82408DW; 82409DW; 82410DW; 82411DW; 82412DW; 82414DW; 82415DW; 82416DW, Exp 04/01/11; 83571DW; 83572DW; 83573DW; 83574DW; 83575DW; 83576DW; 83577DW; 83578DW; 83579DW; 83580DW; 83581DW; 83582DW; 83583DW, Exp 05/01/11; 84748DW; 84749DW; 84750DW; 84751DW; 84752DW; 84753DW; 84754DW; 84755DW; 84756DW; 84757DW; 84758DW; 84759DW; 84760DW, Exp 06/01/11; 85045DW; 85046DW; 85047DW; 85048DW; 85049DW; 85050DW; 85051DW; 85052DW; 85053DW; 85054DW; 85055DW; 85056DW; 85057DW, Exp 07/01/11;

 

2) Lot numbers: a) 73619DW; 73620DW; 73621DW; 73622DW; 73623DW; 73624DW; 73625DW; 73626DW, Exp 07/01/10; 75001DW; 75017DW; 75018DW; 75019DW; 75024DW; 75025DW; 75026DW; 75027DW; 75028DW; 75029DW; 75030DW; 75031DW; 75032DW; 75033DW; 75972DW; 75973DW; 75974DW; 75975DW; 75976DW; 75977DW, Exp 09/01/10; 76155DW; 76156DW; 76157DW; 76158DW; 76159DW; 76160DW; 76161DW, Exp 10/01/10; 77496DW; 77497DW; 77498DW; 77499DW; 77500DW; 77501DW; 77502DW; 77503DW; 77504DW; 77505DW; 77506DW, Exp 11/01/10; 78657DW; 78658DW; 78659DW; 78660DW; 78661DW; 78662DW; 78663DW; 78664DW; 78665DW; 78666DW; 78667DW, Exp 12/01/10; 82382DW; 82383DW; 82384DW; 82385DW; 82386DW; 82387DW; 82388DW; 82389DW; 82390DW; 82393DW; 82394DW; 82395DW; 82396DW; 82397DW; 82398DW; 82399DW; 82400DW; 82401DW; 82402DW; 82403DW, Exp 04/01/11; 83560DW; 83561DW; 83562DW; 83565DW; 83566DW; 83567DW; 83568DW, Exp 05/01/11; 84726DW; 84727DW; 84728DW; 84729DW; 84730DW; 84731DW; 84732DW; 84733DW; 84734DW; 84735DW; 84736DW; 84737DW; 84738DW; 84739DW; 84740DW; 84741DW; 84742DW; 84743DW; 84744DW; 84745DW, Exp 06/01/11; 85035DW; 85037DW; 85038DW; 85039DW; 85040DW; 85041DW; 85042DW, Exp 07/01/11; b) 72409DW; 72410DW; 72411DW; 72412DW; 72413DW; 72414DW; 72415DW; 72416DW; 72417DW; 72418DW; 72419DW; 72420DW; 72421DW; 72422DW; 72423DW; 72427DW; 72428DW; 72429DW; 72430DW; 72431DW; 72432DW; 72433DW; 72434DW; 72435DW; 72436DW; 72437DW; 72438DW; 72439DW; 72440DW; 72441DW, Exp 06/01/10; 74840DW; 74841DW; 74842DW; 74843DW; 74844DW; 74845DW, Exp 08/01/10; 75036DW; 75037DW; 75038DW; 75039DW; 75040DW; 75041DW; 75042DW; 75043DW; 75044DW; 75045DW; 75046DW; 75047DW; 75048DW, Exp 09/01/10; 77391DW; 77392DW; 77393DW; 77394DW; 77395DW; 77396DW; 77397DW; 77398DW; 77399DW; 77400DW; 77401DW; 77402DW; 77403DW; 77507DW; 77508DW; 77509DW; 77510DW; 77511DW; 77512DW; 77513DW; 77514DW; 77515DW; 77516DW; 77517DW; 77518DW; 77519DW, Exp 11/01/10; 78670DW; 78671DW; 78672DW; 78673DW; 78674DW; 78675DW; 78676DW; 78677DW; 78678DW; 78679DW; 78680DW; 78681DW; 78682DW, Exp 12/01/10; 82417DW; 82418DW; 82419DW; 82420DW; 82421DW; 82422DW; 82424DW; 82425DW; 82426DW; 82427DW; 82428DW; 82429DW; 82430DW; 82431DW; 82432DW; 82433DW; 82434DW; 82435DW; 82436DW; 82437DW; 82438DW; 82439DW; 82440DW; 82441DW; 82442DW, Exp 04/01/11; 83586DW; 83587DW; 83588DW; 83589DW; 83590DW; 83591DW; 83592DW; 83593DW; 83594DW; 83595DW; 83596DW; 83597DW; 83598DW; 83601DW; 83602DW; 83603DW; 83604DW; 83605DW; 83606DW; 83607DW; 83608DW; 83609DW; 83610DW; 83611DW; 83612DW; 83613DW; 83616DW; 83617DW; 83618DW; 83619DW; 83620DW; 83621DW; 83622DW; 83623DW; 83624DW; 83625DW; 83626DW, Exp 05/01/11; 84763DW; 84764DW; 84765DW; 84766DW; 84767DW; 84768DW; 84769DW; 84770DW; 84771DW; 84772DW; 84773DW; 84774DW; 84775DW, Exp 06/01/11; 85060DW; 85061DW; 85062DW; 85063DW; 85064DW; 85065DW; 85066DW; 85067DW; 85068DW; 85069DW; 85070DW; 85071DW; 85072DW; 85075DW; 85076DW; 85077DW; 85078DW; 85079DW; 85080DW; 85081DW; 85082DW; 85083DW; 85084DW; 85085DW; 85086DW, Exp 07/01/11;

 

3) Lot numbers: 73665DW; 73666DW; 73667DW; 73668DW; 73669DW; 73671DW; 73672DW; 73673DW; 73674DW, Exp 07/01/10; 76164DW; 76165DW; 76166DW; 76167DW; 76168DW; 76169DW; 76170DW; 76171DW; 76172DW, Exp 10/01/10; 77522DW; 77523DW; 77524DW; 77525DW; 77526DW; 77527DW; 77528DW; 77529DW; 77530DW, Exp 11/01/10; 82445DW; 82446DW; 82447DW; 82448DW; 82449DW; 82450DW; 82451DW; 82452DW, Exp 04/01/11; 83631DW; 83632DW; 83633DW; 83634DW; 83635DW; 83636DW; 83637DW; 83638DW; 83639DW, Exp 05/01/11; 84779DW; 84780DW; 84781DW; 84782DW; 84783DW; 84784DW; 84785DW; 84786DW; 84787DW; 84788DW, Exp 06/01/11;

 

4) Lot numbers: 73629DW; 73630DW; 73631DW; 73632DW; 73633DW; 73634DW; 73635DW; 73637DW; 73638DW; 73639DW; 73640DW; 73647DW, Exp 07/01/10; 74855DW; 74856DW; 74857DW; 74858DW; 74859DW; 74860DW; 74862DW; 74863DW; 74864DW; 74865DW; 74866DW; 74867DW, Exp 08/01/10; 75052DW; 75053DW; 75054DW; 75055DW; 75056DW; 75057DW; 75105DW; 75106DW; 75107DW; 75108DW; 75109DW; 75110DW; 75111DW; 75112DW; 75113DW; 75114DW, Exp 09/01/10; 77344DW; 77406DW; 77407DW; 77409DW; 77410DW; 77411DW; 77412DW; 77413DW; 77414DW, Exp 11/01/10; 78685DW; 78686DW; 78687DW; 78688DW; 78689DW; 78690DW; 78691DW; 78692DW; 78693DW; 78694DW; 78695DW; 78696DW; 78697DW, Exp 12/01/10;

 

5) Lot numbers: a) 74900DW; 74901DW; 74902DW; 74903DW; 74904DW; 74905DW; 74906DW; 74907DW; 74908DW; 74909DW; 74910DW, Exp 08/01/10; b) 72461DW; 72462DW; 72464DW; 72465DW; 72466DW; 72467DW; 72468DW; 72469DW; 72470DW; 72471DW; 72472DW; 72473DW; 72474DW; 72475DW, Exp 06/01/10; 73677DW; 73678DW; 73679DW; 73680DW; 73681DW; 73682DW; 73683DW; 73684DW; 73685DW; 73686DW; 73687DW, Exp 07/01/10; 74870DW; 74871DW; 74872DW; 74873DW; 74874DW; 74875DW; 74876DW; 74877DW; 74878DW; 74879DW; 74880DW; 74881DW; 74882DW; 74885DW; 74886DW; 74887DW; 74888DW; 74889DW; 74890DW; 74891DW; 74892DW; 74893DW; 74894DW; 74895DW; 74896DW; 74897DW, Exp 08/01/10; 75058DW; 75059DW; 75060DW; 75061DW; 75062DW; 75063DW; 75066DW; 75067DW; 75068DW; 75069DW; 75070DW; 75071DW; 75072DW; 75073DW; 75074DW; 75075DW; 75076DW; 75077DW; 75122DW; 75123DW; 75124DW; 75125DW; 75126DW; 75127DW; 75128DW; 75129DW; 75130DW; 75131DW, Exp 09/01/10; 76297DW; 76298DW; 76299DW; 76300DW; 76301DW, Exp 10/01/10; 77324DW; 77325DW; 77326DW; 77327DW; 77328DW; 77329DW; 77330DW; 77331DW; 77332DW; 77333DW; 77334DW; 77335DW; 77336DW; 77533DW; 77534DW; 77535DW; 77536DW; 77537DW; 77538DW; 77539DW; 77540DW; 77541DW; 77542DW; 77543DW; 77544DW; 77545DW, Exp 11/01/10; 78700DW; 78701DW; 78702DW; 78703DW; 78704DW; 78705DW; 78706DW; 78707DW; 78708DW; 78710DW; 78711DW; 78712DW; 78715DW; 78716DW; 78717DW; 78718DW; 78719DW; 78720DW; 78721DW; 78722DW; 78723DW; 78724DW; 78725DW; 78726DW, Exp 12/01/10

RECALLING FIRM/MANUFACTURER

Recalling Firm: Hospira, Inc., Lake Forest, IL, by letters dated March 31, 2010 and June 3, 2010, and by press release on May 27, 2010. 

Manufacturer: Hospira, Inc., Clayton, NC. Firm initiated recall is ongoing.

REASON

Presence of Particulate Matter: The product may contain stainless steel particulate matter.

VOLUME OF PRODUCT IN COMMERCE

1,197,825 vials

DISTRIBUTION

Nationwide

___________________________________

PRODUCT   

Nzu (Natural) clay substance, 4-oz. plastic bags and 5-lb plastic bags. Recall # D-882-2010

CODE

No Codes

RECALLING FIRM/MANUFACTURER

Recalling Firm: Tropical Foods Warehouse, College Park, GA, by telephone on May 7, 2010 and letter dated May 10, 2010. 
Manufacturer: Martana Nigeria Limited, Isolo, Nigeria. Firm initiated recall is ongoing.

REASON

Chemical Contamination: This product is sold in ethnic stores and is intended to treat, cure or mitigate morning sickness in pregnant women, FDA analyses found the product to contain high levels of lead and arsenic.

VOLUME OF PRODUCT IN COMMERCE

40 bags

DISTRIBUTION

GA, NC

___________________________________

PRODUCT   

Nitrogen, Compressed NF, size 300 cylinder, Rx only, Airgas Puritan Medical; H92 Chattanooga Plant; Part # NI NF300. Recall # D-883-2010

CODE

Lot # WC01X153A, Exp 06/02/15

RECALLING FIRM/MANUFACTURER

Recalling Firm: Airgas South, Kennesaw, GA, by visit on June 17, 2010 and by letter dated July 9, 2010.

Manufacturer: Airgas South Inc., Chattanooga, TN. Firm initiated recall is complete.

REASON

Chemical Contamination: Nitrogen NF cylinder had a pungent chlorine/solvent like odor, the cylinder was tested and contained several halogenated organics believed to be soil fumigants.

VOLUME OF PRODUCT IN COMMERCE

30 cylinders

DISTRIBUTION

GA, TN

___________________________________

PRODUCT   

Magic Power Coffee (powder), 100% Natural, Dietary Supplement. The product is sold in a 2-serving box containing 2 sealed foil packets, Net Weight 32 g (2 x 16 g, 2 Servings), UPC 7 18122 68687 2. Each foil packet has one serving, Net Weight 16 g, UPC 7 18122 68697 1. Ingredients: Instant Coffee, Barbary Wolfberry Fruit (Goji Berry), Epimedium herb (Horny Goat Weed), American Ginseng, Xylitol (Natural Sweetener), Vitamins. The product is also sold in a 12-serving carton containing six 2-serving boxes. Recall # D-886-2010

CODE

All "Production dates" up until 05/08/2010 are being recalled. The product is not lot coded. The product has a "Production date" (for example 03/08/2010) and a "Best before" date (for example 03/07/2012) on the packets and unit carton.

RECALLING FIRM/MANUFACTURER

Recalling Firm: Inz Distributors Inc. / Magic Power Coffee Inc., Brooklyn, NY, by press release on June 19, 2010, and by letter on June 29, 2010.

Manufacturer: JIANGXI JIANYUAN BIOLOGICAL TECHNOLOGY CO LTD, JIANHXI, China. FDA initiated recall is ongoing.

REASON

Marketed Without an Approved NDA/ANDA: analysis of Magic Power Coffee, marketed as a dietary supplement, revealed that the product contains hydroxythiohomosildenafil. This is a chemical similar to sildenafil, the active ingredient in an FDA-approved drug for Erectile Dysfunction (ED).

VOLUME OF PRODUCT IN COMMERCE

UNKNOW

DISTRIBUTION

Nationwide and US Virgin Islands

 

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________

PRODUCT   

Carbidopa and Levodopa Extended-Release Tablets, 25/100 mg, a) 100-count bottle (NDC 60505-0131-1), b) 1000-count bottle (NDC 60505-0131-0), Rx only. Recall # D-842-2010;

 

2) Carbidopa and Levodopa Extended-Release Tablets, 50/200 mg, a) 100-count bottle (NDC 60505-0132-1), b) 1000-count bottle (NDC 60505-132-0), Rx only. Recall # D-843-2010;

 

3) Clonazepam Tablets USP, 0.5 mg, a) 100-count bottle (NDC 60505-0066-1), b) 500-count bottle (NDC 60505-0066-3), Rx only. Recall # D-844-2010;

 

3) Clonazepam Tablets USP, 2 mg, a) 100-count bottle (NDC 60505-0068-1), b) 500-count bottle (NDC 60505-0068-3), Rx only. Recall # D-845-2010;

 

5) CycloSPORINE Capsules USP, 100 mg, 30-count bottle, Rx only, NDC 60505-0134-0. Recall # D-846-2010;

 

6) CycloSPORINE Capsules USP, 25 mg, 30-count bottle, Rx only, NDC 60505-0133-0. Recall # D-847-2010;

 

7) Diclofenac Potassium Tablets, 50 mg, 100-count bottle, Rx only; NDC 60505-0135-0. Recall # D-848-2010;

 

8) DILT-CD (Diltiazem Hydrochloride) Extended-Release Capsules, USP, (Once-a-day dosage), 120 mg, a) 90-count bottle (NDC 60505-0007-4), b) 500-count bottle (NDC 60605-0007-8), Rx only. Recall # D-849-2010;

 

9) DILT-CD (Diltiazem Hydrochloride) Extended-Release Capsules, USP, (Once-a-day dosage), 180 mg, a) 90-count bottle (NDC 60505-0008-4), b)) 500-count bottle (NDC 60605-0008-8), Rx only. Recall # D-850-2010;

 

10) DILT-CD (Diltiazem Hydrochloride) Extended-Release Capsules, USP, (Once-a-day dosage), 240 mg, a) 90-count bottle (NDC 60505-0009-4), b) 500-count bottle (NDC 60605-0009-8), Rx only. Recall # Recall # D-851-2010; 

 

11) DILT-CD (Diltiazem Hydrochloride) Extended-Release Capsules, USP, (Once-a-day dosage), 300 mg, a) 90-count bottle (NDC 60505-0010-4), b) 500-count bottle (NDC 60605-0010-8), Rx only. Recall # D-852-2010;

 

12) DILTZAC (Diltiazem Hydrochloride) Extended-Release capsules USP, (Once-a-day dosage), 120 mg, a) 30-count bottle (NDC 60605-0210-3), b) 90-count bottle (NDC 60505-0210-9), Rx only. Recall # D-853-2010;

 

13) DILTZAC (Diltiazem Hydrochloride) Extended-Release Capsules USP, (Once-a-day dosage), 180 mg, a) 30-count bottle (NDC 60605-0211-3), b) 90-count bottle (NDC 60505-0211-9), Rx only. Recall # D-854-2010;

 

14) DILTZAC (Diltiazem Hydrochloride) Extended-Release Capsules USP, (Once-a-day dosage), 240 mg, a) 30-count bottle (NDC 60605-0212-3), b) 90-count bottle (NDC 60505-0212-9), Rx only. Recall # D-855-2010;

 

15) DILTZAC (Diltiazem Hydrochloride) Extended-Release Capsules USP, (Once-a-day dosage), 300 mg, a) 30-count bottle (NDC 60605-0213-3), b) 90-count bottle (NDC 60505-0213-9), Rx only. Recall # D-856-2010;

 

16) DILTZAC (Diltiazem Hydrochloride) Extended-Release Capsules USP, (Once-a-day dosage), 360 mg, a) 30-count bottle (NDC 60605-0214-3), b) 90-count bottle (NDC 60505-0214-9), Rx only. Recall # D-857-2010;

 

17) Divalproex Sodium Delayed-Release Tablets USP, 125 mg (Valproic Acid Activity), 100-count bottle, Rx only, NDC 60605-3065-1. Recall # D-858-2010;

 

18) Divalproex Sodium Delayed-Release Tablets USP, 250 mg (Valproic Acid Activity), a) 100-count bottle (NDC 60605-3066-1), b) 500-count bottle (NDC 60605-3066-5), Rx only. Recall # D-859-2010;

 

19) Eplerenone Tablets, 25 mg, a) 30-count bottle (NDC 60605-2651-3), b) 90-count bottle (NDC 60606-2651-9), c) 500-count bottle (NDC 60605-2651-5), Rx only. Recall # D-860-2010;

 

20) Eplerenone Tablets, 50 mg, a) 30-count bottle (NDC 60605-2652-3), b) 90-count bottle (NDC 60606-2652-9), Rx only. Recall # B-861-2010;

 

21) Moexipril Hydrochloride Tablets, 15 mg, 100-count bottle, Rx only; NDC 60605-0272-1. Recall # D-862-2010;

 

22) Moexipril Hydrochloride Tablets, 7.5 mg, 100-count bottle, Rx only, NDC 60605-0271-1. Recall # D-863-2010;

 

23) Omeprazole Delayed-Release Capsules USP, 20 mg, a) 30-count bottle (NDC 60505-0065-0), b) 100-count bottle (NDC 60505-0065-2), c) 1000-count bottle (NDC 60505-0065-1), d) 5000-count bottle (NDC 60605-0065-8), e) 100-count carton (10 x 10 unit dose) (NDC 60505-0065-7), Capsules (10 X 10 unit dose), Rx only. Recall # D-864-2010;

 

24) Omeprazole Delayed-Release Capsules USP, 10 mg, a) 30-count bottle (NDC 60605-0145-0), b) 100-count bottle (NDC 60605-0145-2), c) 1000-count bottle (NDC 60605-0145-1), Rx only. Recall # D-865-2010;

 

25) Omeprazole Delayed-Release Capsules USP, 40 mg, a) 30-count bottle (NDC 60605-0146-0), b) 90-count bottle (NDC 60605-0146-9), c) 100-count bottle (NDC 60605-0146-2), d) 500-count bottle (NDC 60605-0146-1), Rx only. Recall # D-866-2010;

 

26) Ondansetron Hydrochloride Tablets, 4 mg, 30-count bottle, Rx only; NDC 60605-1311-3. Recall # D-867-2010;

 

27) Ondansetron Hydrochloride Tablets, 8 mg, 30-count bottle, Rx only; NDC 60605-1312-3. Recall # D-868-2010

CODE

1) Lot #: a) HW8674, Exp 07/10; HX8240, HX8243, Exp 09/10; HZ5776, Exp 10/10; JD0810, Exp 02/11; b) HX8239, HX8241, Exp 09/10; JF4544, Exp 06/11;

 

2) Lot #: a) HW8679, HW8680, Exp 07/10; HW8681, HW8682, Exp 09/30/10; HZ5767, HZ5768, HZ5769, HZ5770, HZ5771, Exp 11/10; HZ5766, Exp 01/11; JD0814, JD0815, Exp 02/11; JE1115, JE1116, JE1117, Exp 06/11; b) HW8683, Exp 07/10; HW8684, Exp 09/10; HZ5773, HZ5774, HZ5775, Exp 01/11; JE1118, Exp 06/11;

 

3) Lot #: a) HX8305, Exp 08/10; JE7102, Exp 04/11; b) HX8306, Exp 08/10; JE7105, JE7406, Exp 04/11;

 

4)  Lot #: a) HY6874, Exp 08/10; b) HY6870, HY6871, Exp 08/10; JE7525, Exp 04/11;

 

5) Lot #: HP9576, HW5445, Exp 05/10; HY6968, HY6969, Exp 08/10; JD6291, Exp 03/11; JE8040, Exp 04/11;

 

6) Lot #: HW5450, Exp 05/10; HY6964, JC0283, Exp 08/10; JD6290, Exp 03/11;

 

7) Lot #: HX3581, HZ4734, Exp 09/10; HZ4735, JD1676, Exp 01/11;

 

8) Lot #: a) HZ8661, Exp 06/10; JA4977, Exp 09/10; JE9298, Exp 02/11; JF3577, Exp 05/11; b) HZ8662, Exp 06/10; JA4978, Exp 09/10; JF3578, Exp 05/11;

 

9) Lot #: a) HY9659, Exp 05/10; JA0229, Exp 06/10; HZ2919, JA4982, 07/10; JD1453, JE3048, Exp 02/11; JE9296, Exp 04/11; JE9297, JF3588, Exp 05/11; b) JA0227, Exp 06/10; HZ2918, Exp 07/10; JA4985, Exp 09/10; JD1889, Exp 02/11; JE9293, JF3580, Exp 05/11;

 

10) Lot #: a) JA0332, JA2105, JA4988, Exp 05/10; JA4987, Exp 07/10; JD1489, Exp 10/10; JD5695, JE3034, JF1473, Exp 01/11; JE3035, Exp 02/11; JE9288, JE9289, Exp 04/11; JF3591, Exp 05/11; b) JA0330, JA2104, JA4991, Exp 05/10; JA4989, Exp 07/10; JD5696, Exp 01/11; JF3590, Exp 05/11;

 

11) Lot #: a) HZ8690, Exp 06/10; JC1281, Exp 07/10; JE9279, JE9280, Exp 05/11; b) HZ8691, Exp 06/10; JA4980, Exp 09/10;

 

12) Lot #: a) JD3976, Exp 02/11; JF3643, Exp 03/11; b) JA4854, Exp 09/10; JD3977, Exp 02/11; JE3609, JF0150, Exp 03/11;

 

13) Lot #: a) JD3978, Exp 02/11; JE3604, Exp 03/11; b) JA4862, Exp 09/10; JD3979, Exp 02/11; JE3589, Exp 03/11;

 

14) Lot #: a) JA8448, Exp 09/10; JD3980, Exp 02/11; JF0143, Exp 04/11; b) JA4865, Exp 09/10; JD3981, JD3982, Exp 02/11; JE3573, Exp 03/11;

 

15) Lot #: a) JD3984, Exp 02/11; JE3579, Exp 03/11; b) JC2005, Exp 09/10; JD3985, Exp 02/11; JE3583, Exp 03/11;

 

16) Lot #: a) JA8450, Exp 09/10; JD3986, Exp 01/11; JE3586, JF0157, Exp 03/11; b) JA4867, Exp 09/10; JD3987, JD3988, JE4351, Exp 01/11; JE3584, Exp 02/11; JE3585, JF0158, JF0161, JF3678, Exp 03/11;

 

17) Lot #: HZ4212, Exp 10/10;

 

18) Lot #: a) HW0441, HW7458, HW7466, HW7467, Exp 06/10; HW0431, HW0433, HW0434, HW0435, HW0436, HW0438, HW0439, HW7460, HZ1063, Exp 08/10; HZ4447, HZ4448, HZ4449, HZ4450, HZ4451, Exp 10/10; JC9956, JC9957, JC9958, JC9959, JD6587, Exp 03/11; JD6584, JD6585, JD6586, JE1856, JE1857, Exp 04/11; b) HW0445, HW7509, HW7510, Exp 06/10; HW7513. HY9238, Exp 08/10; HZ4442, Exp 10/10; JC9955, JD6588, JD6589, Exp 03/11; JE1860, JE9516, Exp 04/11;

 

19) Lot #: a) HW0774, Exp 10/10; JC6593, JC9429, Exp 03/11; JH2193, Exp 06/11; b) HY7640, Exp 03/11; JH2190, Exp 06/11; c) JC9428, Exp 03/11; JF4992, Exp 06/11;

 

20) Lot #: a) JC6601, JC9477, Exp 03/11; b) JC6604, Exp 03/11;

 

21) Lot #: JD7716, Exp 03/11;

 

22) Lot #: JD7717, Exp 03/11;

 

23) Lot #: a) HL4244, HL7315, HW4355, Exp 06/10; HX8525, Exp 07/10; HX2483, HY3752, Exp 08/10; HN6311, Exp 09/10; HP3824, HZ2554, Exp 10/10; JA1868, JC3938, Exp 11/10; HP3827, JC3915, Exp 12/10; HR5045, HT2183, JE8165, Exp 01/11; JD5405, JE8700, Exp 02/11; HV0102, JE8757, JF7544, Exp 04/11; HL2492, HV0103, Exp 05/11; b) KH2931, HL2477, HL3181, HL3182, Exp 05/10; HL7314, HM3346, HM3347, HW4362, HX2479, HX2481, Exp 06/10; HM9677, HX2480, HX2482, JC4897, Exp 07/10; HM3348, HM9678, HN4405, HN4408, HN6313, HX8523, HX8524, HY3750, HY3751, HZ2540, HZ5287, Exp 08/10; HN5465, HN5826, HN6243, HR2532, HZ2542, Exp 09/10; HN6310, HN6312, HN6314, HP9353, HP9354, JA1870, JA1871, Exp 10/10; HR2537, JA1873, JA6887, JA6888, JA6889, JC5709, Exp 11/10; HR2533, JC9698, JD3992, Exp 12/10; JD0113, JD0117, JD5388, JD5389, JD7326, Exp 01/11; JD5387, JD5390, JE4646, Exp 02/11; HV0107, HV0108, HV8054, HV8055, HW3108, JE8752, JE8753, JE8756, JF1851, Exp 03/11; HV8056, HW4363, Exp 04/11; HW4358, HW4360, HW4361, Exp 05/11; c) HJ2268, HL2500, HL2501, HL2502, HL2503, HL3171, HL3174, HL3177, HL7316, HX7612, HX7615, HX7616, HX7617, Exp 05/10; HL2499, HL3176, HL3178, HL3179, HL7317, HL7318, HM3350, HM3351, HM3352, HM7180, HM8609, HM9679, HM9680, HX2485, HX2486, HX2487, HX7608, HX7609, HX7610, HX7613, HX7614, HX8551, Exp 06/10; HX7618, HX8544, HX8552, HX8553, HX8554, JC3483, Exp 07/10; HX8545, HX8546, HX8547, HX8548, HX8549, HX8550, HX8556, HX8558, HX8559, HY3753, HY3754, HY3755, HY3756, HY3758, HY3760, HY3763, HY3771, HY3775, HZ0065, HZ0066, HZ7139, JA2151, HM9681Exp 08/10; HN4453, HN5481, HY3766, HY3768, HY3773, HZ2534, HZ2535, HZ2536, HZ7137, HZ7138, Exp 09/10; HN6330, HP2381, HP3832, HP3836, HR4986, HT2232, HZ2538, HZ2544, JA2142, JA2144, JA2145, JA2148, JD5392, Exp 10/10; HP3833, HR4982, JA2143, JA2147, JA2149, JA6891, JA6892, JA6893, JA6894, JA6895, JC3481, JC3482, JC3484, JC3485, JC3486, JC3487, JC3488, JC3489, JC3490, JC8807, Exp 11/10; HP9359, HP9360, HR5075, HR5683, JC3491, JC9695, JC9696, JC9701, JC9702, JC9703, JC9705, JD0109, JD0110, JD0118, JD5393, JE0294, Exp 12/10; HR5073, HR5084, HT2230, HT2235, HT6557, HT6559, HT6560, HT8020, HT8021, HT8152, JD0108, JD0111, JD0112, JD0114, JD0115, JD8787, JD9105, JD9110, JE0783, JE4472, JE4783, Exp 01/11; HT2233, HT2234, HT2236, HT2238, HT6561, JD5391, JD5394, JD5395, JE0779, JE0780, JE0781, JE0782, JE0784, JE2956, JE5323, JE5324, JE5341, Exp 02/11; HT2237, HT2239, HV0109, HV0110, HV0111, HV0118, HV0121, HV8076, HV8078, HW5311, JE2958, JF1119, JF1120, JF1121, JF1122, JF1857, JF1860, JF2220, Exp 03/11; HV0112, HV8079, HV8082, HW4373, HW4408, JE8758, JE8759, JE8760, JE8762, JE8767, JE8768, JE8769, JF1147, JF1859, JF1861, JF1981, JF5842, JF7160, JF8021, JF8022, JF8023, JF8024, JF8025, Exp 04/11; HW4374, HW4378, HW4387, HW4397, HW4398, HW4399, HW4400, HW4401, HW4402, HX2484, JE8771, JF5843, JF5845, JF5846, JF5847, JF9662, JF9663, JG1912, JG1913, JG1914, Exp 05/11; d) HZ8676, HZ8681, HZ8685, Exp 05/10; HZ8680, JA2120, JA2121, JA2127, JA2136, JA6930, JA6937, Exp 06/10; JA6931, JA6932, JA6933, JA6934, JA6935, JA6936, JC3495, JD0130, Exp 07/10; JC3492, JC3493, JC3494, JC3496, JC3497, JC3498, Exp 08/10; JC9699, JC9700, JC9709, JD0123, JD0125, JD0127, JD0128, JD5398, JD5399, JD5400, JD5401, Exp 09/10; JD5402, JD7334, Exp 10/10; JE0795, JE0798, JE5630, JE5631, Exp 11/10; JF2231, JF2232, JF2234, Exp 12/10; JF5849, Exp 01/11; JG1909, JG1910, Exp 02/11; e) HY9656, Exp 08/10; JD5404, Exp 10/10; JC3942, Exp 11/10; JE4100, Exp 02/11;

 

24) Lot #: a) HZ1742, Exp 07/10; HX9342, Exp 08/10; HN5167, Exp 09/10; JD5422, Exp 02/11; HW1580, Exp 04/11; b) HN3625, Exp 09/10; HR8424, Exp 01/11; c) HZ1743, Exp 07/10; HN5142, Exp 09/10; HR9367, Exp 01/11; JD5421, Exp 02/11; HW1583, Exp 04/11;

 

25) Lot #: a) JC4538, JC4539, Exp 10/10; JC2939, JD8861, Exp 12/10; JD8873, Exp 01/11; JF2262, JF2984, Exp 04/11; JF8082, JF8634, Exp 05/11; JF8637, Exp 06/11; b) JG9727, Exp 06/11; c) JC2826, JC4536, Exp 10/10; JD1258, Exp 12/10; JD8872, Exp 02/11; JE8813, JF2268, Exp 04/11; JF8087, Exp 05/11; JG1988, Exp 06/11; d) JC2827, JC7602, JD0672, JD2869, JD2870, JD8858, Exp 12/10; JD8859, JE1350, Exp 02/11; JD8860, Exp 03/11; JF2261, Exp 04/11; JF3153, JF3154, Exp 05/11; JG1987, Exp 06/11;

 

26) Lot #: HP9522, HX5296, JA3653, Exp 07/10;

 

27) Lot #: HP9549, HP9552, Exp 07/10;

RECALLING FIRM/MANUFACTURER

Recalling Firm: Apotex, Inc, Weston, FL, by letter on May 7, 2010.

Manufacturer: Apotex, Inc, Toronto Ontario, Canada. Firm initiated recall is ongoing.

REASON

CGMP Deviations: Apotex, Inc. Canada, is recalling multiple pharmaceutical products for cGMP violations that may have resulted in product cross contamination.

VOLUME OF PRODUCT IN COMMERCE

9,626,385 bottles and cartons

DISTRIBUTION

Nationwide

___________________________________

PRODUCT   

1) Arthrotec 50 (diclofenac sodium/misoprostol), 50 mg/200 mcg tablets, 90 count bottle, Rx only, NDC 0025-1411-90. Recall # D-869-2010;

 

2) Arthrotec 75 (diclofenac sodium/misoprostol), 75 mg/200 mcg tablets, 60 count bottles, Rx only, NDC 0025-1421-60. Recall # D-870-2010

CODE

1) Lot #: CO80071, Exp. July 2011;

2) Lot #’s: C090972, Exp. Feb 2013; C090149, Exp. Sep 2012

RECALLING FIRM/MANUFACTURER

Pfizer US Pharmaceutical Group, New York, NY, by letter on July 8, 2010. Firm initiated recall is ongoing.

REASON

Tablet Separation: The product may contain broken tablets.  

VOLUME OF PRODUCT IN COMMERCE

160,300 bottles

DISTRIBUTION

Nationwide (including Hawaii)

___________________________________

PRODUCT   

Citalopram Tablets, USP, 40 mg, 1000 Tablets, Rx only, NDC 24658-142-10. Recall # D-873-2010

CODE

Lot #: 11004340, Exp. 03/2012

RECALLING FIRM/MANUFACTURER

InvaGen Pharmaceuticals, Inc., Hauppauge, NY, by letter dated August 17, 2010. Firm initiated recall is ongoing.

REASON

Superpotent (Single Ingredient Drug); oversized tablets found.

VOLUME OF PRODUCT IN COMMERCE

1,462 bottles

DISTRIBUTION

KY

___________________________________

PRODUCT   

Butorphanol Tartrate Injection, USP, 1 mg/mL, 10 x 1 mL Single Dose Vials per carton, Novaplus, Rx only, Novation, the supply company of VHA and UHC, and NOVAPLUS are trademarks of Novation, LLC.; NDC 55390-341-10. Recall # D-874-2010

CODE

Lot # 0808-40-1865018, Exp 07/12

RECALLING FIRM/MANUFACTURER

Ben Venue Laboratories, Inc., Bedford, OH, by letter on August 6, 2010. Firm initiated recall is ongoing.

REASON

Labeling: Label w/ wrong or Incorrect Exp Date: The expiration date on the labeling is incorrect; the product is labeled with an expiration date of JUL 2012 instead of JUL 2011.

VOLUME OF PRODUCT IN COMMERCE

1,306 cartons

DISTRIBUTION

Nationwide

___________________________________

PRODUCT   

Isosorbide Dinitrate Extended Release Tablets, USP, 40mg, 100 Count Bottle, Rx only; NDC 64980-144-01. Recall # D-875-2010

CODE

Lot Number: 101937, Exp 8/2011

RECALLING FIRM/MANUFACTURER

Corepharma LLC, Middlesex, NJ, by letter on August 16, 2010. Firm initiated recall is ongoing.

REASON

Failed USP Dissolution Test Requirements: Out of Specification results for dissolution at the 9 month time test interval.

VOLUME OF PRODUCT IN COMMERCE

9,804 bottles

DISTRIBUTION

NJ

___________________________________

PRODUCT   

Propofol Injectable Emulsion 1%, (10mg/mL) 500 mg/50 mL, a) 5 Units x 20 mL vials per carton (NDC 0409-4699-30), 200 mg/20 mL; b) 5 Units x 20 mL vials per carton (NDC 0409-4699-61), 200 mg/20 mL, Amerinet Choice; c) 20 Units x 50 mL vials per carton (NDC 0409-4699-33), 500 mg/50 mL; d) 20 Units x 50 mL vials per carton (NDC 0409-4699-62), 500 mg/50 mL, Amerinet Choice; e) 10 Units x 100 mL vials per carton (NDC 0409-4699-24), 1 g/100 mL; f) 10 Units x 100 mL vials per carton (NDC 0409-4699-63), 1 g/100 mL, Amerinet Choice; Rx only. Recall # D-879-2010

CODE

Lot numbers: a) 66143DJ; 66144DJ; 66145DJ; 66146DJ; 66147DJ; 66149DJ; 66150DJ; 66950DJ; 66952DJ; 66953DJ; 66954DJ; 66955DJ; 66956DJ; 66966DJ; 66967DJ; 66968DJ; 66969DJ, Exp 06/01/10; 66151DJ; 66152DJ; 67153DJ; 67154DJ; 67155DJ; 67156DJ; 67157DJ; 67159DJ; 67160DJ; 67161DJ; 67162DJ; 67163DJ; 67165DJ; 67166DJ; 67167DJ; 67340DJ; 67341DJ; 67342DJ; 67343DJ; 67344DJ; 67361DJ; 67362DJ; 67364DJ; 67365DJ; 67368DJ; 67369DJ; 67370DJ; 67373DJ; 67374DJ; 67377DJ; 67378DJ; 67379DJ; 67382DJ, Exp 07/01/10; 68476DJ; 68553DJ; 68554DJ; 68555DJ; 68556DJ; 68557DJ; 68559DJ; 68560DJ; 68561DJ, Exp 08/01/10; 69668DJ; 69669DJ; 69672DJ; 69673DJ; 69674DJ; 69677DJ; 69678DJ; 69682DJ; 69688DJ; 69835DJ; 69837DJ; 69838DJ; 69840DJ; 69841DJ; 69842DJ; 69843DJ; 69844DJ; 69845DJ; 69846DJ; 69850DJ; 69851DJ; 69852DJ; 69856DJ; 69857DJ; 69861DJ; 70862DJ, Exp 09/01/10; 70016DJ; 70017DJ; 70019DJ; 70020DJ; 70022DJ; 70023DJ; 70024DJ; 70025DJ; 70863DJ; 70867DJ; 70868DJ; 70872DJ; 70873DJ; 70874DJ; 70876DJ; 70877DJ; 70879DJ; 70883DJ; 70884DJ; 70885DJ; 70886DJ; 70887DJ; 70888DJ; 70890DJ; 70891DJ; 70895DJ; 70896DJ; 70897DJ; 70901DJ, Exp 10/01/10; 71207DJ; 71208DJ; 71233DJ; 71234DJ; 71235DJ; 71239DJ; 71240DJ; 71241DJ; 71244DJ; 71245DJ; 71246DJ; 71248DJ; 71249DJ; 71250DJ; 71253DJ; 71254DJ, Exp 11/01/10; 72331DJ; 72332DJ; 72334DJ; 72335DJ; 72336DJ; 72338DJ; 72339DJ; 72340DJ; 72341DJ; 72342DJ; 72343DJ; 72344DJ; 72345DJ; 72392DJ, Exp 12/01/10; 73518DJ; 73519DJ; 73520DJ; 73521DJ; 73522DJ; 73523DJ; 73568DJ; 73569DJ; 73571DJ; 73572DJ; 73598DJ; 73599DJ; 73600DJ; 73602DJ; 73606DJ, Exp 01/01/11; 74718DJ; 74719DJ; 74720DJ; 74721DJ; 74722DJ; 74723DJ; 74724DJ; 74725DJ; 74728DJ; 74729DJ; 74756DJ; 74757DJ; 74758DJ; 74759DJ; 74760DJ; 74761DJ; 74762DJ; 74763DJ; 74764DJ; 74765DJ; 74928DJ; 74929DJ; 74934DJ; 74935DJ; 74936DJ; 74937DJ, Exp 02/01/11; 75090DJ; 75091DJ; 75094DJ; 75095DJ; 75098DJ; 75099DJ; 75100DJ; 75103DJ; 75104DJ; 75120DJ; 75121DJ; 75137DJ; 75138DJ; 75140DJ; 75141DJ; 75142DJ; 75144DJ; 75145DJ; 75942DJ; 75943DJ; 75944DJ; 75946DJ; 75947DJ; 75948DJ; 75951DJ; 75952DJ, Exp 03/01/11; 76232DJ; 76234DJ; 76244DJ; 76245DJ; 76251DJ; 76252DJ; 76254DJ; 76255DJ; 76256DJ; 76258DJ; 76259DJ; 76261DJ; 76263DJ; 76265DJ; 76266DJ; 76271DJ; 76272DJ, Exp 04/01/11; 77445DJ; 77447DJ; 77448DJ; 77449DJ; 77451DJ; 77452DJ; 77465DJ, Exp 05/01/11; 78612DJ; 78613DJ; 78621DJ; 78622DJ; 78624DJ; 78625DJ; 78636DJ; 78637DJ; 78638DJ; 78641DJ; 78642DJ; 78645DJ; 78646DJ; 78647DJ; 78649DJ; 78650DJ; 78652DJ, Exp 06/01/11; 82305DJ; 82306DJ; 82307DJ; 82378DJ; 82379DJ; 82463DJ; 82464DJ; 82465DJ; 82466DJ; 82467DJ, Exp 10/01/11; 83469DJ; 83471DJ; 83472DJ; 83473DJ; 83474DJ; 83475DJ; 83477DJ; 83478DJ; 83515DJ; 83516DJ; 83517DJ; 83519DJ; 83520DJ; 83521DJ; 83523DJ; 83524DJ; 83528DJ; 83529DJ; 83530DJ; 83531DJ; 83535DJ; 83553DJ, Exp 11/01/11; 84807DJ; 84808DJ; 84809DJ; 84811DJ; 84812DJ; 84813DJ; 84814DJ; 84815DJ; 84817DJ; 84818DJ; 84819DJ; 84820DJ; 84821DJ; 84822DJ; 84823DJ; 84824DJ; 84827DJ; 84828DJ; 84831DJ; 84833DJ; 84836DJ; 84837DJ, Exp 12/01/11; 85002DJ; 85003DJ; 85006DJ; 85007DJ; 85008DJ; 85010DJ; 85011DJ; 85013DJ; 85014DJ; 85015DJ; 85018DJ; 85019DJ; 85106DJ; 85107DJ; 85108DJ; 85110DJ; 85111DJ; 85114DJ; 85115DJ; 85116DJ; 85117DJ; 85118DJ; 85119DJ; 85120DJ; 85121DJ; 85122DJ; 85123DJ; 85125DJ; 85167DJ; 85168DJ; 85169DJ; 85171DJ; 85172DJ; 85173DJ; 85175DJ; 85176DJ; 85177DJ; 85178DJ, Exp 01/01/11; b) 66972DJ, Exp 06/01/10; 67397DJ, Exp 07/01/10; 68399DJ; 68400DJ; 68401DJ; 68402DJ; 68647DJ; 68648DJ, Exp 08/01/10; 70015DJ; 70881DJ; 70882DJ, Exp 10/01/10; 71330DJ, Exp 11/01/10; 73516DJ; 73517DJ; 73614DJ; 73615DJ, Exp 01/01/11; 75978DJ; 75979DJ, Exp 03/01/11; 76147DJ; 76148DJ; 76149DJ; 76267DJ; 76268DJ; 76269DJ, 04/01/11; 78617DJ; 78618DJ; 78619DJ; 78632DJ; 78633DJ, Exp 06/01/11; 82302DJ; 82303DJ, Exp 10/01/11; c) 66113DJ; 66114DJ; 66115DJ; 66116DJ; 66117DJ; 66118DJ; 66119DJ; 66979DJ; 66980DJ; 66981DJ, Exp 06/01/10; 67345DJ; 67346DJ; 67347DJ; 67348DJ, Exp 07/01/10; 68546DJ; 68547DJ; 68549DJ; 68550DJ; 68551DJ; 68552DJ, Exp 08/01/10; 69692DJ; 69693DJ; 69694DJ; 69695DJ; 69696DJ; 69697DJ, Exp 09/01/10; 71115DJ; 71116DJ; 71117DJ; 71118DJ; 71120DJ; 71121DJ; 71122DJ; 71123DJ; 71314DJ; 71315DJ; 71316DJ; 71317DJ; 71319DJ; 71320DJ; 71321DJ; 71322DJ; 71327DJ; 71328DJ, Exp 11/01/10; 73532DJ; 73533DJ; 73534DJ; 73536DJ; 73537DJ, Exp 01/01/11; 74769DJ; 74770DJ; 74771DJ; 74772DJ; 74776DJ; 74777DJ; 74778DJ; 74781DJ; 74782DJ; 74783DJ; 74784DJ; 74787DJ; 74788DJ; 74789DJ; 74790DJ; 74919DJ; 74920DJ, Exp 02/01/11; 77474DJ; 77475DJ; 77476DJ; 77477DJ; 77479DJ; 77480DJ; 77481DJ; 77482DJ; 77485DJ; 77486DJ; 77487DJ; 77488DJ; 77490DJ; 77491DJ; 77492DJ, Exp 05/01/11; 83542DJ; 83543DJ; 83544DJ; 83545DJ; 83688DJ, Exp 11/01/11; 84690DJ; 84693DJ; 84694DJ; 84695DJ; 84696DJ; 84699DJ; 84700DJ; 84701DJ; 84702DJ; 84705DJ; 84707DJ; 84708DJ, Exp 12/01/11; 85152DJ; 85153DJ; 85154DJ; 85155DJ, Exp 01/01/12; d) 68544DJ; 68545DJ, Exp 08/01/2010; 69690DJ, Exp 09/01/2010; 74822DJ; 74823DJ; 74824DJ, Exp 02/01/2011; e) 66004DJ; 66005DJ; 66006DJ; 66007DJ; 66008DJ; 66009DJ; 66010DJ; 66011DJ; 66012DJ; 66013DJ; 66014DJ; 66015DJ; 66016DJ; 66017DJ; 66018DJ; 66019DJ; 66020DJ; 66021DJ; 66022DJ; 66023DJ; 66024DJ; 66094DJ; 66095DJ; 66096DJ; 66097DJ; 66129DJ; 66131DJ; 66994DJ; 66995DJ; 66996DJ; 66997DJ; 66998DJ; 66999DJ, Exp 06/01/10; 68507DJ; 68508DJ; 68509DJ; 68510DJ; 68511DJ; 68512DJ; 68515DJ; 68516DJ; 68517DJ; 68518DJ; 68519DJ; 68520DJ; 68523DJ; 68524DJ; 68525DJ, Exp 08/01/10; 69709DJ; 69710DJ; 69711DJ; 69715DJ; 69716DJ; 69717DJ; 69718DJ; 69719DJ, Exp 09/01/10; 70003DJ; 70004DJ; 70005DJ; 70006DJ; 70007DJ; 70008DJ; 70009DJ; 70010DJ; 70032DJ; 70033DJ; 70034DJ; 70036DJ; 70037DJ; 70038DJ; 70039DJ; 70040DJ; 70049DJ; 70050DJ; 70051DJ; 70052DJ; 70053DJ; 70058DJ; 70059DJ; 70060DJ; 70061DJ; 70062DJ; 70066DJ; 70067DJ; 70068DJ; 70069DJ; 70070DJ; 70071DJ; 70993DJ; 70994DJ; 70995DJ; 70996DJ, Exp 10/01/10; 71083DJ; 71084DJ; 71085DJ; 71086DJ; 71087DJ; 71089DJ; 71090DJ; 71091DJ, Exp 11/01/10; 72350DJ; 72351DJ; 72352DJ; 72353DJ; 72354DJ; 72355DJ; 72356DJ; 72357DJ; 72358DJ; 72359DJ; 72362DJ; 72363DJ; 72364DJ; 72365DJ; 72366DJ; 72369DJ; 72370DJ; 72371DJ; 72372DJ; 72373DJ; 72377DJ; 72378DJ; 72379DJ; 72380DJ; 72381DJ; 72385DJ; 72386DJ; 72387DJ; 72388DJ; 72389DJ; 72391DJ; 72393DJ; 72394DJ; 72395DJ; 72478DJ; 72479DJ; 72480DJ; 72481DJ, Exp 12/01/10; 73487DJ; 73488DJ; 73489DJ; 73490DJ; 73491DJ; 73492DJ; 73493DJ; 73494DJ; 73495DJ; 73496DJ; 73497DJ; 73498DJ; 73499DJ; 73500DJ; 73501DJ; 73502DJ; 73503DJ; 73504DJ; 73505DJ; 73506DJ; 73507DJ; 73508DJ; 73509DJ; 73576DJ; 73577DJ; 73578DJ; 73579DJ; 73580DJ; 73581DJ; 73582DJ; 73583DJ; 73584DJ; 73585DJ; 73586DJ; 73587DJ; 73588DJ; 73589DJ; 73590DJ; 73591DJ; 73592DJ, Exp 01/01/11; 75003DJ; 75004DJ; 75005DJ; 75006DJ; 75081DJ; 75986DJ; 75987DJ; 75988DJ; 75989DJ; 75990DJ; 75993DJ; 75994DJ; 75995DJ; 75996DJ; 75997DJ, Exp 03/01/11; 76197DJ; 76198DJ; 76199DJ; 76201DJ; 76202DJ; 76203DJ; 76204DJ; 76205DJ; 76208DJ; 76277DJ; 76279DJ; 76280DJ; 76281DJ; 76285DJ; 76286DJ; 76287DJ; 76288DJ; 6289DJ; 76291DJ; 76292DJ; 76293DJ; 76294DJ; 76295DJ; 76339DJ; 76340DJ; 76341DJ; 76342DJ, Exp 04/01/11; 77361DJ; 77364DJ; 77365DJ; 77366DJ; 77367DJ; 77368DJ; 77372DJ; 77373DJ; 77547DJ; 77555DJ; 77556DJ, Exp 05/01/11; 78562DJ; 78563DJ; 78564DJ; 78565DJ; 78566DJ; 78569DJ; 78570DJ; 78571DJ; 78572DJ; 78573DJ; 78576DJ; 78577DJ; 78578DJ; 78579DJ; 78583DJ; 78584DJ; 78585DJ; 78586DJ; 78587DJ; 78589DJ; 78590DJ, Exp 06/01/11; 82326DJ; 82327DJ; 82328DJ; 82329DJ; 82330DJ; 82332DJ; 82333DJ; 82334DJ; 82335DJ; 82336DJ; 82337DJ; 82338DJ; 82339DJ; 82340DJ; 82341DJ; 82342DJ; 82343DJ; 82344DJ; 82345DJ; 82346DJ; 82372DJ, Exp 10/01/11; 83650DJ; 83651DJ; 83652DJ; 83653DJ; 83658DJ; 83659DJ; 83660DJ; 83661DJ; 83662DJ; 83664DJ; 83665DJ; 83666DJ; 83667DJ; 83668DJ; 83669DJ; 83670DJ; 83671DJ; 83672DJ; 83673DJ; 83675DJ; 83676DJ; 83677DJ; 83678DJ; 83679DJ; 83680DJ; 83681DJ; 83685DJ; 83686DJ; 83687DJ; 83717DJ; 83718DJ; 83719DJ; 83720DJ, Exp 11/01/11; f) 68499DJ; 68500DJ; 68501DJ; 68502DJ; 68503DJ, Exp 08/01/10; 69706DJ; 69707DJ; 69708DJ, Exp 09/01/10; 75980DJ; 75981DJ; 75982DJ; 75983DJ, 03/01/11; 77554DJ, Exp 05/01/11

RECALLING FIRM/MANUFACTURER

Recalling Firm: Hospira, Inc., Lake Forest, IL, by letters dated March 31, 2010 and June 3, 2010, and by press release on May 27, 2010. 

Manufacturer: Hospira, Inc., Clayton, NC. Firm initiated recall is ongoing.

REASON

Presence of Particulate Matter: The product may contain stainless steel particulate matter.

VOLUME OF PRODUCT IN COMMERCE

18,771,402 vials

DISTRIBUTION

Nationwide

___________________________________

PRODUCT   

1) METROnidazole Injection, USP, 500 mg/100 mL (5 mg/mL), 100 mL bag, 24 bags per case, Rx only, NDC 0143-9772-26. Recall # D-884-2010;

 

2) ONDANsetron in 5% Dextrose Injection, 32 mg/50 mL (0.64 mg/mL), 50 mL Sterile Single Use Plastic Container bag, 6 bags per case, Rx only, NDC 0143-9771-06. Recall # D-885-2010

CODE

1) Lots: A080819, A080820, A080822, A080823, A080824, A080826, A080828, A080829, A080836, A080837, A080844, A080851, A080857, A080858, A080860, A080863, A080864, A080867, A080868, Exp 11/30/10; A090000, A090006, A090007, A090026, A090027, A090028, A090029, Exp 12/31/10;

 

2) Lots: A080782, A090004, A090005, A090013, Exp 12/31/10

RECALLING FIRM/MANUFACTURER

Recalling Firm: West-ward Pharmaceutical Corp., Eatontown, NJ, by press release and letters on June 3, 2010.  

Manufacturer: Claris Lifesciences Limited, Ahmedabad, India. Firm initiated recall is ongoing.

REASON

Lack of Assurance of Sterility: The intravenous medications metronidazole and ondansetron were manufactured for West-Ward by the same firm which manufactured the same products for another distributor which was found to be contaminated with mold, fungus, or bacteria.

VOLUME OF PRODUCT IN COMMERCE

1) 13,911 cases; 2) 1,938 cases

DISTRIBUTION

Nationwide

___________________________________

PRODUCT   

Sensorcaine Injection Solution 0.5%, Bupivacaine Hydrochloride and Epinephrine Injection, USP; Bupivacaine HCl 5 mg/mL with Epinephrine 1:200,000 (as bitartrate); an Rx local anesthetic; 50 mL multidose vial; NDC #63323-463-50. Recall # D-887-2010

CODE

Lot WC2176, expiration date 03/31/2012

RECALLING FIRM/MANUFACTURER

Recalling Firm: App Pharmaceuticals LLC, Schaumburg, IL, by letters dated August 16, 2010. 

Manufacturer: AstraZeneca LP, Westborough, MA. Firm initiated recall is ongoing.

REASON

Some of the vial labels are missing red text that should state "with Epinephrine 1:200,000 (as bitartrate" and "Warning: Contains Sulfites".

VOLUME OF PRODUCT IN COMMERCE

88,300 vials

DISTRIBUTION

Nationwide

 

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III

___________________________________

PRODUCT   

Zoderm (6.5% Benzoyl Peroxide) Cleanser, Benzoyl Peroxide in a Urea vehicle, Topical Acne Therapy, 400 mL, NDC 10337-751-51, Rx Only. Recall # D-871-2010

CODE

Lot 9G15 exp. 8/2011

RECALLING FIRM/MANUFACTURER

Recalling Firm: Nycomed US, Inc., Melville, NY, by letters dated July 16, 2010.

Manufacturer: Groupe Parima Inc., Montreal Quebec, Canada. Firm initiated recall is ongoing.

REASON

Labeling: Correct Labeled Product Miscart/Mispack: the firm received a customer complaint that two of twelve cartons received were labeled as Zoderm Cleanser 4.5% but they actually contained bottles of Zoderm Cleanser 6.5%.

VOLUME OF PRODUCT IN COMMERCE

853 units

DISTRIBUTION

Nationwide

___________________________________

PRODUCT   

Derma-Smoothe/FS (Fluocinotone Acetonide) 0.01% Topical Oil (Scalp Oil) For Topical Use Only Not For Oral Ophtalmic or Intravaginal Use Shake Well Before Use. Net Contents 118.28mL (4 Fl. oz.) NDC 28105-149-04 Rx Only. Contains: Fluocinolone Acetonide (0.01%), Isopropyl Alcohol (1.6%), in a base containing Refined Peanut Oil NF, Mineral Oil, Isopropyl Myristate, Oleth-2, Cream Fragrance and Balsam Pine. Contents of Package 4 fl. oz. bottle/2 shower caps. Recall # D-872-2010

CODE

Lot # F080120, exp 06/2010

RECALLING FIRM/MANUFACTURER

Hill Dermaceuticals, Inc., Sanford, FL, by letter dated June 4, 2010. Firm initiated recall is ongoing.

REASON

Subpotent; 23 month stability.

VOLUME OF PRODUCT IN COMMERCE

8,928 units

DISTRIBUTION

Nationwide

 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

___________________________________

PRODUCT   

Red Blood Cells Leukocytes Reduced. Recall # B-1618-10

CODE

 Units: 18FG43624; 18FY78472; 18GR52024; 18KW00879

RECALLING FIRM/MANUFACTURER

American National Red Cross Great Lakes Region, Lansing, MI, by telephone on January 22, 2010, fax on January 23, 2010 and letters dated March 6, 2010 and April 10, 2010.  Firm initiated recall is complete.

REASON

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

VOLUME OF PRODUCT IN COMMERCE

4 units

DISTRIBUTION

MD, MI

___________________________________

PRODUCT   

Red Blood Cells Leukocytes Reduced. Recall # B-1619-10

CODE

Unit: 03KP39560

RECALLING FIRM/MANUFACTURER

The American National Red Cross – Southern Region, Douglasville, GA, by telephone on April 6, 2010 and follow up letter dated June 7, 2010. Firm initiated recall is complete.

REASON

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

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

GA

___________________________________

PRODUCT   

Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1620-10

CODE

Units: W043209059537; W043209059537

RECALLING FIRM/MANUFACTURER

Blood Assurance, Inc., Chattanooga, TN, by fax on May 21, 2010. 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

2 units

DISTRIBUTION

GA, TN

___________________________________

PRODUCT   

Red Blood Cells Leukocytes Reduced. Recall # B-2041-10

CODE

Unit: W040710234974

RECALLING FIRM/MANUFACTURER

Indiana Blood Center, Indianapolis, IN, by telephone on April 12, 2010 and by letter dated May 25, 2010. Firm initiated recall is complete.

REASON

Blood product, which tested reactive for the hepatitis C virus, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

IN

___________________________________

PRODUCT   

1) Red Blood Cells Leukocytes Reduced. Recall # B-2153-10;

2) Fresh Frozen Plasma. Recall # B-2154-10

CODE

 1) and 2) Unit: W035209149584L

RECALLING FIRM/MANUFACTURER

Carter BloodCare, Bedford, TX, by telephone on April 30, 2010 and letter dated May, 25, 2010. 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

2 units

DISTRIBUTION

TX

___________________________________

PRODUCT   

1) Cryoprecipitated AHF, Pooled. Recall # B-2155-10;

2) Recovered Plasma. Recall # B-2156-10

CODE

1) Unit: W036309907231;

2) Unit: W036309616077

RECALLING FIRM/MANUFACTURER

BloodCenter of Wisconsin, Inc., Milwaukee, WI, by fax and internet on May 5, 2010 and May 13, 2010. Firm initiated recall is complete.

REASON

Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

TX, Switzerland

___________________________________

PRODUCT   

Red Blood Cells Leukocytes Reduced. Recall # B-2157-10

CODE

Unit: 6371718

RECALLING FIRM/MANUFACTURER

South Texas Blood & Tissue Center, San Antonio, TX, by telephone on January 23, 2010 and by fax on January 25, 2010. Firm initiated recall is complete.

REASON

Blood product, collected from a donor who failed to answer questions regarding risk for vCJD, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

TX

___________________________________

PRODUCT   

Red Blood Cells Leukocytes Reduced. Recall # B-2158-10

CODE

Units: W036709116757; W036709120693

RECALLING FIRM/MANUFACTURER

Central Illinois Community Blood Center, Springfield, IL, by fax and letter on April 22, 2010. Firm initiated recall is complete.

REASON

Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

IL

___________________________________

PRODUCT   

Platelets Pheresis Leukocytes Reduced. Recall # B-2159-10

CODE

Unit: 72N582471

RECALLING FIRM/MANUFACTURER

LifeSouth Community Blood Centers - Wiregrass Region, Dothan, AL, by fax on May 27, 2010. Firm initiated recall is complete.

REASON

Blood product, with platelet yield below the specified minimum requirement, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

AL

___________________________________

PRODUCT   

Platelets Pheresis Leukocytes Reduced. Recall # B-2160-10

CODE

Unit: 72N910735

RECALLING FIRM/MANUFACTURER

LifeSouth Community Blood Centers - Montgomery Region, Montgomery, AL, by fax on May 27, 2010. Firm initiated recall is complete.

REASON

Blood product, with platelet yield below the specified minimum requirement, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

AL

___________________________________

PRODUCT   

Platelets Pheresis Leukocytes Reduced. Recall # B-2161-10

CODE

Unit: 72N710424

RECALLING FIRM/MANUFACTURER

LifeSouth Community Blood Centers, Mobile, AL, by fax on June 1, 2010. Firm initiated recall is complete.

REASON

Blood product, with platelet yield below the specified minimum requirement, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

AL

___________________________________

PRODUCT   

Platelets Pheresis Leukocytes Reduced. Recall # B-2162-10

CODE

Unit: 72N300889

RECALLING FIRM/MANUFACTURER

LifeSouth Community Blood Centers, Inc, Huntsville, AL, by fax on May 12, 2010. Firm initiated recall is complete.

REASON

Blood product, with platelet yield below the specified minimum requirement, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

AL

___________________________________

PRODUCT   

Platelets Pheresis Leukocytes Reduced. Recall # B-2163-10

CODE

Unit: 72N836487

RECALLING FIRM/MANUFACTURER

LifeSouth Community Blood Centers, Inc, Birmingham Region, Birmingham, AL, by fax on May 7, 2010. Firm initiated recall is complete.

REASON

Blood product, with platelet yield below the specified minimum requirement, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

AL

___________________________________

PRODUCT   

1) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-2166-10

2) Fresh Frozen Plasma (Apheresis). Recall # B-2167-10

CODE

1) W041609047868J;

2) W041609047868J (3 units)

RECALLING FIRM/MANUFACTURER

Blood Systems Inc/dba United Blood Services, Meridian, MS, by telephone and facsimile on May 4, 2010 and May 5, 2010. Firm initiated recall is complete.

REASON

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

VOLUME OF PRODUCT IN COMMERCE

4 units

DISTRIBUTION

UK, MS

___________________________________

PRODUCT   

Source Plasma. Recall # B-2169-10

CODE

Unit: 3820093715

RECALLING FIRM/MANUFACTURER

Talecris Plasma Resources Inc., Tuscaloosa, AL, by facsimile on June 15, 2010. Firm initiated recall is complete.

REASON

Blood product, collected from a donor who did not have an annual physical examination, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

NC

___________________________________

PRODUCT   

Red Blood Cells Leukocytes Reduced. Recall # B-2170-10

CODE

Unit: 02GG44179

RECALLING FIRM/MANUFACTURER

American Red Cross Blood Services, Wichita, KS, by facsimile and electronic notification on May 18, 2010. 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

KS, CA

___________________________________

PRODUCT   

Source Plasma. Recall # B-2172-10

CODE

Unit: 2070313263

RECALLING FIRM/MANUFACTURER

PlasmaCare, Inc., Indianapolis, IN, by facsimile on April 19, 2010. Firm initiated recall is complete.

REASON

Blood product, collected from a donor who did not have an annual physical examination, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

CA

___________________________________

PRODUCT   

Red Blood Cells Leukocytes Reduced. Recall # B-2173-10

CODE

Units: 03LK30215, 03LK30222, 03LK30236

RECALLING FIRM/MANUFACTURER

The American National Red Cross - Southern Region, Douglasville, GA, by telephone on March 31, 2010. Firm initiated recall is complete.

REASON

Blood products, manufactured from units of Whole Blood that were overweight, were distributed.

VOLUME OF PRODUCT IN COMMERCE

3 units

DISTRIBUTION

GA

___________________________________

PRODUCT   

1) Red Blood Cells Leukocytes Reduced. Recall # B-2183-10;

2) Cryoprecipitated AHF. Recall # B-2184-10

CODE

1) and 2) Unit: 03FJ00147

RECALLING FIRM/MANUFACTURER

The American National Red Cross - Southern Region, Douglasville, GA, by letters dated April 20, 2010 and May 26, 2010. Firm initiated recall is complete.

REASON

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

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

GA

___________________________________

PRODUCT   

Platelets Pheresis Leukocytes Reduced. Recall # B-2186-10

CODE

Units: 03FZ27440 (2 units)

RECALLING FIRM/MANUFACTURER

The American National Red Cross - Southern Region, Douglasville, GA, by facsimile on March 5, 2010 and by letter dated May 27, 2010. Firm initiated recall is complete.

REASON

Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

GA

___________________________________

PRODUCT   

1) Red Blood Cells Leukocytes Reduced. Recall # B-2190-10;

2) Platelets Pooled Leukocytes Reduce. Recall # B-2191-10

CODE

1) Unit: W051710104356;

2) Unit: W05171010802902

RECALLING FIRM/MANUFACTURER

Rhode Island Blood Center, Providence, RI, by letter dated June 11, 2010. Firm initiated recall is complete.

REASON

Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

CT, MA

___________________________________

PRODUCT   

1) Red Blood Cells Leukocytes Reduced. Recall # B-2192-10;

2) Recovered Plasma. Recall # B-2193-10;

3) Platelets Pooled Leukocytes Reduced. Recall # B-2194-10

CODE

1) and 2) W038110103713;

3) Unit: W038110984458

RECALLING FIRM/MANUFACTURER

Florida’s Blood Centers, Inc., Orlando, FL, by telephone on April 26, 2010, by e-mail on April 27, 2010, and by letter dated April 28, 2010. Firm initiated recall is complete.

REASON

Blood products, collected from a donor who was deferred for high-risk behavior, were distributed.

VOLUME OF PRODUCT IN COMMERCE

3 units

DISTRIBUTION

Austria, FL

___________________________________

PRODUCT   

Platelets Pheresis Leukocytes Reduced. Recall # B-2195-10

CODE

Unit: W038110111799

RECALLING FIRM/MANUFACTURER

Recalling Firm: Florida's Blood Centers - Lake Park, Lake Park, FL, by telephone on May 5, 2010 and by letter dated May 5, 2010. 

Manufacturer: Florida's Blood Centers - Lake Worth, Lake Worth, FL. Firm initiated recall is complete.

REASON

Blood product, which was not quarantined after receipt of information concerning a post donation illness, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

FL

___________________________________

PRODUCT   

Fresh Frozen Plasma Apheresis. Recall # B-2196-10

CODE

Units: 306052008, 30604900Z, 351141000, 33773900J

RECALLING FIRM/MANUFACTURER

Florida Blood Services, Inc., St Petersburg, FL, by letter dated May 19, 2010. Firm initiated recall is complete.

REASON

Blood products, labeled with an extended expiration date, were distributed.

VOLUME OF PRODUCT IN COMMERCE

4 units

DISTRIBUTION

FL

___________________________________

PRODUCT   

Source Plasma. Recall # B-2200-10

CODE

Units: TA2090278, TA2090416

RECALLING FIRM/MANUFACTURER

DCI Biologicals Texarkana, LLC, Texarkana, AR, by facsimile on May 17, 2010 and by e-mail on June 17, 2010. Firm initiated recall is complete.

REASON

Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

UK

___________________________________

PRODUCT   

Red Blood Cells Leukocytes Reduced. Recall # B-2202-10

CODE

Unit: 012GS98578

RECALLING FIRM/MANUFACTURER

Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC, by facsimile on May 23, 2010 and by letter dated May 23, 2010.

Manufacturer: American Red Cross Blood Services, Durham, NC. 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

NC, CA

___________________________________

PRODUCT   

1) Red Blood Cells Leukocytes Reduced. Recall # B-2203-10;

2) Plasma Frozen within 24 hours (FP24). Recall # B-2204-10

CODE

1) and 2) Unit: 012C87510

RECALLING FIRM/MANUFACTURER

The American National Red Cross, Carolinas Region, Charlotte, NC, by facsimile on May 14, 2010 and by letters dated May 17, 2010 and June 18, 2010. Firm initiated recall is complete.

REASON

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

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

NC, TN

___________________________________

PRODUCT   

Red Blood Cells (Aphresis) Leukocytes Reduced. Recall # B-2205-10

CODE

Units: W117008128247 Part 1; W117008128247 Part 2

RECALLING FIRM/MANUFACTURER

Blood Centers of the Pacific, San Francisco, CA, by telephone on December 23, 2008 and letter on December 26, 2008. Firm initiated recall is complete.

REASON

Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

CA

___________________________________

PRODUCT   

Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-2207-10

CODE

Unit: W127810101844

RECALLING FIRM/MANUFACTURER

Tacoma Pierce County Blood Bank, Tacoma, WA, by telephone on May 5, 2010 and electronic mail on May 8, 2010. 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

Switzerland, WA

___________________________________

PRODUCT   

Source Plasma. Recall # B-2209-10

CODE

Units: 10EWIC2836; 10EWIC1737; 10EWIC0870; 10EWIB9841; 10EWIB9059; 10EWIB7611; 10EWIB6670

RECALLING FIRM/MANUFACTURER

BioLife Plasma Services, L.P., Eau Claire, WI, by facsimile on June 1, 2010. Firm initiated recall is complete.

REASON

Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed.

VOLUME OF PRODUCT IN COMMERCE

7 units

DISTRIBUTION

Austria

___________________________________

PRODUCT   

Red Blood Cells Leukocytes Reduced. Recall # B-2210-10

CODE

Unit: W221609613127

RECALLING FIRM/MANUFACTURER

Central Texas Regional Blood & Tissue Center, Austin, TX, by fax on May 6, 2010. Firm initiated recall is complete.

REASON

Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

TX

___________________________________

PRODUCT   

Red Blood Cells Leukocytes Reduced. Recall # B-2211-10

CODE

Unit: 6315057

RECALLING FIRM/MANUFACTURER

South Texas Blood and Tissue Center, San Antonio, TX, by fax on March 3, 2010. Firm initiated recall is complete.

REASON

Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

TX

___________________________________

PRODUCT   

Source Plasma. Recall # B-2212-10

CODE

Units: 09FMOG6851; 09FMOG3410; 09FMOG2756; 09FMOG1418; 09FMOF6640; 09FMOF2642; 09FMOF1554; 09FMOD7746; 09FMOF0063; 09FMOF7599

RECALLING FIRM/MANUFACTURER

BioLife Plasma Service LP, Springfield, MO, by fax on April 1, 2010. Firm initiated recall is complete.

REASON

Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

VOLUME OF PRODUCT IN COMMERCE

10 units

DISTRIBUTION

CA

___________________________________

PRODUCT   

1) Red Blood Cells Leukocytes Reduced. Recall # B-2213-10;

2) Recovered Plasma. Recall # B-2214

CODE

1) and 2) Unit: 6325245

RECALLING FIRM/MANUFACTURER

South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on February 8, 2010. Firm initiated recall is complete.

REASON

Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

FL, TX

___________________________________

PRODUCT   

Red Blood Cells. Recall # B-2281-10

CODE

Unit: W039709212329E

RECALLING FIRM/MANUFACTURER

Aurora Area Blood Bank dba Heartland Blood Centers, Aurora, IL, by letter dated May 14, 2010. Firm initiated recall is complete.

REASON

Blood product, collected from a donor who reported traveled to a malarial endemic area, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

MO

___________________________________

PRODUCT   

Source Plasma. Recall # B-2282-10

CODE

Unit: 09LTXG8001

RECALLING FIRM/MANUFACTURER

BioLife Plasma Services, LP, Laredo, TX, by fax on May 26, 2010. Firm initiated recall is complete.

REASON

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

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

CA

 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

___________________________________

PRODUCT   

Platelets Pheresis Leukocytes Reduced. Recall # B-2040-10

CODE

Unit: W0352101360825

RECALLING FIRM/MANUFACTURER

Carter BloodCare, Bedford, TX, by telephone on April 27, 2010 and by letter dated May 25, 2010. Firm initiated recall is complete.

REASON

Blood product, which was not stored under continuous agitation and controlled temperature, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

TX

___________________________________

PRODUCT   

Platelet Rich Plasma. Recall # B-2168-10

CODE

Unit: W044210718351

RECALLING FIRM/MANUFACTURER

San Diego Blood Bank, San Diego, CA, by telephone on March 25, 2010. Firm initiated recall is complete.

REASON

Blood product, manufactured using Lactated Ringers solution instead of saline, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

CA

___________________________________

PRODUCT   

Recovered Plasma. Recall # B-2171-10

CODE

Unit: 02GG44179

RECALLING FIRM/MANUFACTURER

American Red Cross Blood Services, Wichita, KS, by facsimile and electronic notification on May 18, 2010. 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

KS, CA

___________________________________

PRODUCT   

Plasma Cryoprecipitated Reduced. Recall # B-2185-10

CODE

Unit: 03FJ00147

RECALLING FIRM/MANUFACTURER

The American National Red Cross - Southern Region, Douglasville, GA, by letters dated April 20, 2010 and May 26, 2010. 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

GA

___________________________________

PRODUCT   

Fresh Frozen Plasma Apheresis (Thawed). Recall # B-2197-10

CODE

Units: 30441000S, 32297700T, 32287099X, 30237400, 34163300T, 322817000, 353151001, 30208200N, 37739400K, 306055002, 38258100P, 38259300H, 32079500

RECALLING FIRM/MANUFACTURER

Florida Blood Services, Inc., St Petersburg, FL, by letter dated May 19, 2010. Firm initiated recall is complete.

REASON

Blood products, labeled with an extended expiration date, were distributed.

VOLUME OF PRODUCT IN COMMERCE

13 units

DISTRIBUTION

FL

___________________________________

PRODUCT   

Recovered Plasma. Recall # B-2201-10

CODE

Unit: 012GS98578

RECALLING FIRM/MANUFACTURER

Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC, by facsimile on May 23, 2010 and by letter dated May 23, 2010.

Manufacturer: American Red Cross Blood Services, Durham, NC. 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

NC, CA

___________________________________

PRODUCT   

Red Blood Cells. Recall # B-2206-10

CODE

Units: 2518547 Part A; 2518547 Part B

RECALLING FIRM/MANUFACTURER

Central Kentucky Blood Center, Inc., Lexington, KY, by letter on November 19, 2008. Firm initiated recall is complete.

REASON

Blood products, which were labeled with an incorrect anticoagulant volume, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

KY

___________________________________

PRODUCT   

Recovered Plasma. Recall # B-2208-10

CODE

Unit: W127810101844

RECALLING FIRM/MANUFACTURER

Tacoma Pierce County Blood Bank, Tacoma, WA, by telephone on May 5, 2010 and electronic mail on May 8, 2010. 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

Switzerland, WA

 

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS I

___________________________________

PRODUCT   

Hospira Inc. Symbiq One- and Two- Channel Infuser. Recall # Z-2381-2010

CODE

List number configurations: 16026-04-01/03/04, 51/52, 53/54, 79/80, 81/82, 83/84, 87/88, 89/90; 16027-04-01/03/04, 51/52, 53/54, 79/80, 81/82, 83/84, 87/88, 89/90; 16026-27-89/90, 16026-13-25/26, 53/54; 16027-27-89/90; 16027-13-25/26, 53/54

RECALLING FIRM/MANUFACTURER

Recalling Firm: Hospira, Inc., Morgan Hill, CA, by letter on March 26, 2010.

Manufacturer: Hospira Holdings de, Costa Rica Ltd., La Aurora de Heredia, Costa Rica. Firm initiated recall is ongoing.

REASON

If the administrator set is removed prior to the cassette carriage fully opening without closing the slide/roller clamp, unrestricted flow and delivery may result.

VOLUME OF PRODUCT IN COMMERCE

28,485 units

DISTRIBUTION

Nationwide, Australia, Canada, Colombia, Costa Rica, Malaysia, Mexico, Puerto Rico, Singapore and the UAE

 

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II

___________________________________

PRODUCT

Microwave Ovens, Model Number DG-2. Recall # Z-2114-2010

CODE

Accession number: 0930317-000

RECALLING FIRM/MANUFACTURER

Duke Manufacturing Co., Saint Louis, MO, by letter on May 12, 2010. Firm initiated recall is ongoing.

REASON

The oven did not meet Federal Performance Standard for certain requirements.

VOLUME OF PRODUCT IN COMMERCE

62 units

DISTRIBUTION

Nationwide

___________________________________

PRODUCT

1) SpeedPass Disposable Suture Lariat with Nitinol Wire 45 Degree Up, Qty. 1. Sterile. Part number 904008. Used to pass suture through tissue. Recall # Z-2228-2010;

 

2) SpeedPass Disposable Suture Lariat with Nitinol Wire 25 Degree Left, Qty. 1. Sterile. Part number 904010. Used to pass suture through tissue. Recall # Z-2229-2010;

 

3) SpeedPass Disposable Suture Lariat with Nitinol Wire 25 Degree Right, Qty. 1. Sterile. Part number 904012. Used to pass suture through tissue. Recall # Z-2230-2010;

 

4) Suture Lariat 30 Degree Up, Qty. 1. Sterile. Part number 904022. Used to pass suture through tissue. Recall # Z-2231-2010;

 

5) Suture Lariat 45 Degree Dog Leg Up, Qty. 1. Sterile. Part number 904025. Used to pass suture through tissue. Recall # Z-2232-2010

CODE

1) Lot numbers: 863940 and 863950;

2) Lot numbers: 050260, 863960, and 863970;

3) Lot numbers: 863920 and 863930;

4) Lot numbers: 863990 and 864010;

5) Lot numbers: 864020 and 864030

RECALLING FIRM/MANUFACTURER

Biomet, Inc. Warsaw, IN, by letter on June 18, 2010. Firm initiated recall is ongoing.

REASON

The nitinol wire may be fractured or may have the potential to fracture making the suture lariat unusable and possibly delaying surgery.

VOLUME OF PRODUCT IN COMMERCE

301 units

DISTRIBUTION

Nationwide, Columbia and the Netherlands

___________________________________

PRODUCT

Hospira Accessory Power Pack; a 4 outlet power strip with a custom pole clamp bracket to attach to the IV pole with the infusion pump; part number 39003-04-01, Modo #HSP1700, Model Tripp-Lite PS-415-HG Accessory power pack used for use with medical devices. Recall # Z-2234-2010

CODE

Lot numbers: 102806, 57001G3, 59034G3, 62002G3, and 64009G3

RECALLING FIRM/MANUFACTURER

Recalling Firm: Hospira Inc., Lake Forest, IL, by letters dated July 1, 2010.

Manufacturer: Modo Inc., Beaverton, OR. Firm initiated recall is ongoing.

REASON

The Power Pack Accessory is not certified to UL 60601 standard or Subject 1363A for relocatable power taps intended for use with medical equipment. Potential problems could include electrical shock, electrical short or electrical fire.

VOLUME OF PRODUCT IN COMMERCE

1,766 units

DISTRIBUTION

Nationwide and Canada

___________________________________

PRODUCT   

1) External Sterilizable Paddles for use with the LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12, and LIFEPAK 20/20e Defibrillator/Monitor. External Sterilizable Paddles used with LIFEPAK 12 and 20/20e Defibrillators have a Part Number 3009166-XX (XX symbolized any 2 numbers). External Sterilizable Paddles used with LIFEPAK 9 and 9P Defibrillators have a Part Number 804507-XX (XX symbolizes any 2 numbers). Recall # Z-2311-2010;

 

2) Pediatric Paddles attachments used with LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12 and LIFEPAK 20/20e Defibrillator/Monitors. The product has the Part Number 800418-XX (XX symbolize any 2 numbers). Recall # Z-2312-2010

CODE

The product does not have serial numbers or lot numbers.  

RECALLING FIRM/MANUFACTURER

Physio Control, Inc., Redmond, WA, letter on November 14, 2008. Firm initiated recall is complete.

REASON

Sterilization efficacy could not be confirmed for sterilization methods on External Sterilizable Paddles and Pediatric Paddle attachments.

VOLUME OF PRODUCT IN COMMERCE

39,910 units

DISTRIBUTION

Nationwide, Canada, Germany, India, Netherlands, Australia, Hong Kong, Japan, Brazil, Panama, Russia, Korea, Malaysia, Venezuela, United Arab Emirates(UAE)

___________________________________

PRODUCT   

Abbott Spine PathFinder, Cannulated Poly Screwdriver II - MOD, non-sterile; Ref. 1160-2. Usage: The screwdriver is intended to mate to the hexalobular feature of a PathFinder open polyaxial screw and threads onto the head to hold it in on-axis for implanting. Recall # Z-2335-2010

CODE

All units. Lots 36WC, 39BA, 43MN, 44WP, 47FE, 18TH, 20XF, 25WE, 29CQ, 29YJ, 31TJ, 33ZH, 47RM, 48PC, 49QW, 51PF and 58SD

RECALLING FIRM/MANUFACTURER

Recalling Firm: Zimmer Inc., Warsaw, IN, by letter on April 6, 2010.

Manufacturer: Zimmer Spine Austin, Inc., Austin, TX. Firm initiated recall is ongoing.

REASON

The screwdriver may fracture, resulting in surgical delays and/or fragments going into the surgical site.

VOLUME OF PRODUCT IN COMMERCE

691 units

DISTRIBUTION

Nationwide and Internationally

___________________________________

PRODUCT   

Mayfield Infinity XR2 Base Unit, model A-2079. The MAYFIELD Infinity XR2 Base Unit (A-2079) is an operating room table accessory intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where x-ray imaging modalities will be used. Recall # Z-2336-2010

CODE

Serial number(s) XB091031, XB091032, XB091033, XB091034, XB091035, XB091036, XB091037, XB091038, XB091039, XB091040, XB091041, XB091042, XB091043, XB091044, XB091045, XB091046, XB091047, XB091048, XB091049, XB091050

RECALLING FIRM/MANUFACTURER

Integra LifeSciences Corp., Cincinnati, OH, by telephone and letter on May 10, 2010. Firm initiated recall is ongoing.

REASON

Storage case incorrectly labeled. The labels were for the Infinity XR2 Skull Clamp storage containers but were inadvertently placed on the Infinity XR2 Base Unit storage cases.

VOLUME OF PRODUCT IN COMMERCE

13 units

DISTRIBUTION

IN, MO, NJ, TX, VA, Belgium, Canada, New Zealand

___________________________________

PRODUCT   

1) Eye surgery stretcher with crank fowler, model 1069. Intended use: A stretcher used for eye surgery. Recall # Z-2341-2010;

 

2) Eye surgery stretcher with crank fowler, model 1079. Intended Use: A stretcher used for eye surgery. Recall # Z-2342-2010;

 

3) Service parts for Crank Screw Assembly (PN1069-042-010S and 1069-042110S). Intended use: Service parts are replacement parts for the eye surgery stretcher. Recall # Z-2343-2010

CODE

1)  Lots: 405058504, 405058609, 405058610, 405058611, 405058736, 405058737, 405058835, 405058912, 406059340, 406065514, 406065515, 406065516, 406066560, 406066561, 406066562, 406066607, 406066638, 406066639, 406066640, 406066641, 406066642, 406066657, 406066658, 406066659, 406066660, 406066685, 406066686, 406066687, 406066688, 406066715, 406066716, 406066717, 406066718, 406066719, 406066720, 406066781, 406066799, 406066800, 406066801, 406066872, 406066873, 406066874, 406066875, 406066897, 406066932, 406066933, 407061553, 407061554, 407061555, 407061578, 407061613, 407061614, 407061615, 407061616, 407061617, 407061631, 407061632, 407061633, 407061634, 407061635, 407061661, 407061662, 407061685, 407061738, 407061781, 407061782, 407061783, 407061784, 407061861, 407061862, 407061867, 407061868, 407061997, 407062009, 408062048, 408062049, 408062051, 408062052, 408062053, 408062054, 408062055, 408062088, 408062098, 408062109, 408062110, 408062191, 408062192, 408062193, 408062336, 408062337, 409062130, 409062137, 409062138, 409062139, 409062186, 409062188, 409062204, 409062205, 409062206, 409062207, 409062299, 409062302, 409062303, 409062304, 409062305, 409062330, 409062374, 410058642, 410058643, 410058704, 410058745, 410058776, 410058777, 410058778, 410058779, 410058838, 410058839, 410065030, 410065040, 410065041, 411058892, 411058893, 411058894, 411058895, 411058896, 411060540, 411060675, 411060676, 411060709, 411060710, 411060743, 411060744, 412062620, 412062711, 412062712, 412062713, 412062714, 412062715, 412062716, 412062717, 412062718, 412062719, 412062720, 412062721, 412062722, 412062723, 412062724, 412062725, 412062726, 412062730, 412062740, 412062758, 412062849, 412062998, 412067518, 412067519, 412067641, 412067642, 412067643, 412067644, 412067645, 412067646, 412067647, 412067689, 412067690, 412067691, 412067700, 412067704, 412067802, 412067816, 412067817, 412067880, 501071090, 501071091, 501071092, 501071093, 501071094, 501071095, 501071096, 501071097, 501071098, 501071279, 501071280, 501071281, 501071282, 501071341, 501071358, 501071414, 501071415, 501071468, 501072743, 501072744, 501076034, 501076035, 501076036, 501076040, 501076175, 502070901, 502070902, 502070903, 502070904, 502070905, 502071571, 502071572, 502071573, 502071574, 502071580, 502071670, 502071711, 502071712, 502071713, 502071714, 502071799, 502071800, 502071801, 502071802, 502071809, 502071810, 502071972, 502072066, 502072068, 502072099, 502072100, 502072101, 502072103, 502072104, 502072161, 502072162, 502072163, 502072164, 502072165, 502072166, 502072167, 502072168, 502072169, 502072170, 502072171, 502072172, 502072288, 502072360, 502072482, 502072485, 502077062, 502077063, 503069563, 503069564, 503069593, 503069594, 503069649, 503069650, 503069651, 503069652, 503069730, 503069731, 503069778, 503069895, 503069896, 503069897, 503069898, 503070018, 503070176, 503070334, 503070336, 503070337, 503070338, 503070339, 503070340, 503071527, 503071528, 503071529, 503071531, 503071556, 503071574, 503071643, 503071644, 503071645, 503071683, 503071684, 503071685, 503071686, 503071687, 503071688, 504069564, 504069565, 504069777, 504070044, 504070105, 504070106, 504070107, 504070108, 504070109, 504070110, 504070208, 504070209, 504070210, 504070231, 504070232, 504070233, 504070271, 504070272, 504070273, 504070274, 504070275, 504070276, 505074051, 505074052, 505074059, 505074282, 505074283, 505074331, 505074332, 505074333, 505074334, 505074335, 505074336, 505074337, 505074338, 505074339, 505074340, 505074371, 505074372, 505074373, 505074374, 505074375, 505074376, 505074377, 505074378, 505074379, 505074380, 505074501, 505074502, 505074503, 505074504, 505074505, 505074506, 505074507, 505074508, 505074509, 505074510, 505074511, 505074512, 505074513, 505074514, 505074515, 505074516, 505074517, 505074518, 505074519, 505074584, 505074585, 505074586, 505074587, 505074758, 505074759, 505074946, 505074947, 505074948, 505074949, 505074950, 506069505, 506069507, 506069508, 506069749, 506069750, 506069827, 506069828, 506069829, 506069867, 506069868, 506069916, 506069917, 506069918, 506069919, 506069926, 506069927, 506069990, 506070061, 506070062, 506070063, 506070064, 506070093, 506070096, 506070101, 506070102, 506070103, 506070521, 506070522, 506070523, 506070524, 506070525, 506070561, 506070562, 506070563, 506070564, 506070565, 506070566, 506070567, 506070568, 506070593, 506070594, 506070717, 506070738, 506070739, 506070841, 506070842, 506070843, 506070844, 506070861, 506070862, 506070863, 506070996, 506070997, 507071086, 507071087, 507071239, 507071242, 507073557, 507073621, 507073622, 507073623, 507073624, 507073625, 507073626, 507073683, 508068764, 508068765, 508068766, 508068767, 508068768, 508069101, 508069245, 508069246, 508069421, 508069422, 508069423, 508069485, 508069486, 508078686, 508078698, 508078699, 508078700, 508079101, 508079102, 508079103, 508079104, 508079132, 508079133, 508079147, 508079148, 508079149, 509070526, 509070561, 509070579, 509070843, 509070844, 509070845, 509070846, 509070847, 509070848, 509070849, 509074670, 509074743, 509074744, 509074745, 509074746, 509075023, 509075246, 509075247, 509075248, 509075249, 509075407, 509075408, 509075409, 509075410, 510069741, 510069953, 510069954, 510072114, 510072115, 510072116, 510072117, 510072118, 510072119, 510072120, 510072283, 510072284, 510072314, 510072315, 510072498, 510072499, 510072529, 510072530, 510072531, 510072661, 510072662, 510072663, 510072664, 510072665, 510072666, 510072667, 510072668, 510072669, 510072670, 511069660, 511069661, 511069662, 511069727, 511069728, 511069729, 511069993, 511069994, 511069995, 511075514, 511075515, 511075565, 511075566, 511075809, 511075810, 511075811, 511075812, 512070103, 512070104, 512070121, 512070122, 512070123, 512070124, 512070205, 512070206, 512070207, 512070230, 512073096, 512073132, 512073133, 512073134, 512073135, 512073169, 512074088, 512074205, 512074206, 512074207, 601081577, 601081651, 601081652, 601083685, 601083687, 601083688, 601083738, 601083739, 601083801, 601083802, 601083803, 601083804, 602080761, 602082279, 602082280, 602082281, 602082282, 602082285, 602082286, 602082530, 603079060, 603079124, 603079136, 603079137, 603079138, 603079230, 603079231, 603079232, 603079281, 603079282, 603079283, 603079284, 603079322, 603079323, 603079324, 603079493, 603079510, 603080630, 603080674, 603080889, 603080890, 603080891, 603080892, 603080997, 603080998, 603081398, 604078919, 604078920, 604078921, 604078922, 604081109, 604081132, 604081133, 604081134, 604081135, 604081136, 604081159, 604081160, 604081217, 604081218, 604081221, 604081222, 604081223, 604081259, 604081260, 604081261, 604081262, 604081263, 604081274, 604081626, 604081627, 604081648, 604081649, 604081731, 604081778, 604081779, 604081894, 604081895, 604084019, 604084020, 604084021, 604084022, 604084023, 605078538, 605082603, 605082605, 605082639, 605082880, 605082894, 605082895, 605082896, 605082945, 605082946, 605082947, 605082948, 605082949, 605084531, 605084532, 605084537, 605084538, 605084566, 605084676, 605084677, 605084678, 605084712, 605084727, 605084728, 605084770, 605084875, 605084876, 605084877, 605084919, 605084920, 605085000, 606080934, 606083064, 606083065, 606083066, 606083067, 606083068, 606083069, 606083077, 606083085, 606083086, 606083087, 606083088, 606083089, 606086220, 606086286, 606086287, 606086288, 606086289, 606086442, 606087838, 606087839, 606087899, 607078934, 607078935, 607078936, 607078937, 607079006, 607079007, 607079008, 607079009, 607079028, 607079029, 607079156, 607079157, 607079213, 607079214, 607079215, 607079217, 607079218, 607079336, 607079337, 607079338, 607079339, 607079388, 607079389, 607079390, 607079391, 607079467, 607079474, 607079475, 607079476, 607079477, 607079478, 607081590, 607081641, 607081642, 607081643, 607081644, 607081645, 607081646, 607081647, 607081648, 607081649, 607081729, 607081757, 607081869, 607081880, 608078560, 608078611, 608078612, 608078613, 608078614, 608078615, 608078616, 608078654, 608078655, 608078656, 608078657, 608078740, 608078856, 608078857, 608078890, 608080148, 608080310, 608080845, 608081508, 608081538, 608081546, 608081669, 608081728, 608081740, 608081741, 608081742, 608081743, 609079566, 609079567, 609079636, 609079637, 609079639, 609079747, 609079748, 609079905, 609079926, 609079927, 609079928, 609079929, 609079930, 609079950, 609079977, 609079997, 609082009, 609082010, 610079032, 610079179, 610079180, 610079231, 610079232, 610079233, 610079234, 610079235, 610079236, 610079377, 610079378, 610079379, 610079406, 610079407, 610079408, 610079629, 610079630, 610079746, 610079747, 610080817, 610080818, 610080819, 610080820, 610080821, 610080822, 610080823, 610080824, 610080825, 611078526, 611078527, 611078543, 611078551, 611078552, 611078829, 611078999, 611079000, 611081030, 611081199, 611081200, 611081435, 611081436, 611081437, 611081438, 611081499, 611081500, 611081828, 611082518, 612078542, 612078543, 612078544, 612078598, 612078614, 612078750, 612078812, 612078813, 612078814, 612078815, 612078816, 612080524, 612080576, 612080580, 612080620, 612081060, 612081061, 612087539, 612087561, 612087562, 701088506, 701088507, 701088508, 701088516, 701088519, 701088520, 701088655, 701088656, 701088665, 701088666, 701088667, 701089519, 701089520, 701091099, 701091100, 701091169, 701091170, 701091220, 701091300, 701091426, 701091427, 701091428, 701091431, 701091432, 701091433, 701091434, 701091526, 701091527, 701091528, 701091532, 701093141, 701093142, 701093143, 701093144, 701093145, 701093146, 701093147, 701093148, 701093149, 701093150, 702089546, 702089547, 702089548, 702089549, 702089566, 702089567, 702089568, 702089569, 702089570, 702089571, 702089599, 702089605, 702089606, 702089632, 702089700, 702089716, 702089717, 702089797, 702089798, 702089799, 702089800, 702089820, 702089918, 702089919, 702089920, 702090702, 702090779, 702090780, 702090806, 702091559, 702091560, 702091576, 702091577, 4120602898, 4120602899, 4120630008 and 4120630009;

 

2) Lots: 0703090620, 0703090648, 0703090779, 0703090856, 0703090995, 0703090996, 0703091081, 0703091082, 0703091083, 0703091084, 0703091086, 0703091203, 0703091204, 0703091278, 0703091279, 0703091280, 0703091281, 0703091393, 0703091394, 0703091493, 0703092116, 0703092117, 0703092118, 0703092119, 0703092208, 0703092209, 0704089798, 0704089799, 0704089800, 0704089801, 0704089802, 0704089803, 0704089804, 0704089805, 0704089806, 0704089807, 0704090505, 0704090671, 0704090672, 0704090673, 0704090674, 0704090675, 0704090676, 0704090677, 0704090678, 0704090809, 0704090810, 0704090811, 0704090813, 0704090941, 0704090942, 0704090943, 0704090944, 0704090945, 0704091504, 0704091541, 0704091542, 0704091650, 0704091651, 0704091739, 0705088537, 0705088550, 0705088763, 0705088764, 0705088765, 0705088766, 0705088767, 0705088768, 0705088769, 0705088771, 0705088772, 0705088773, 0705088774, 0705088775, 0705088776, 0705088907, 0705088929, 0705088930, 0705089850, 0705090751, 0705090752, 0705090753, 0705090754, 0705090762, 0705090763, 0705090764, 0705090765, 0705091007, 0705091008, 0705091009, 0705091010, 0705091100, 0705091101, 0705091200, 0705091201, 0705091202, 0705091258, 0705091259, 0705091260, 0706089263, 0706089265, 0706089398, 0706089399, 0706089446, 0706089469, 0706089470, 0706089721, 0706089722, 0706089723, 0706089724, 0706089926, 0706089927, 0706089928, 0706089929, 0706089962, 0706089965, 0706092584, 0706092585, 0706092685, 0706092686, 0706092765, 0706092839, 0706094503, 0707088510, 0707088529, 0707088530, 0707088564, 0707088565, 0707088566, 0707088869, 0707090027, 0707090217, 0707090259, 0707090260, 0707090308, 0707090364, 0707090365, 0707090366, 0707092293, 0707092294, 0707092391, 0707092392, 0707092393, 0707092394, 0707092395, 0707092396, 0707093170, 0707093171, 0707093172, 0707093173, 0708088545, 0708089051, 0708089129, 0708089300, 0708089301, 0708089302, 0708089309, 0708089472, 0708089481, 0708089482, 0708089483, 0708089484, 0708089485, 0708089486, 0708090536, 0708090745, 0708090750, 0708090838, 0708090846, 0708090847, 0708090848, 0708090851, 0708090852, 0708090853, 0708090857, 0708090858, 0708090859, 0708090860, 0708090861, 0708091021, 0708091022, 0708091023, 0708091097, 0708091098, 0708091099, 0708091100, 0708091259, 0708091260, 0708091261, 0708091262, 0708091479, 0708091489, 0708092590, 0708092621, 0708092622, 0708092623, 0708092624, 0708092625, 0708092626, 0709088503, 0709088560, 0709088905, 0709088906, 0709088907, 0709088991, 0709088992, 0709088993, 0709088994, 0709088995, 0709088996, 0709091571, 0709095182, 0709095183, 0709095184, 0709095185, 0709097389, 0709097390, 0710088599, 0710088600, 0710089023, 0710089024, 0710089108, 0710089109, 0710089280, 0710089397, 0710089401, 0710089402, 0710089403, 0710089459, 0710089460, 0710091551, 0710091552, 0710091553, 0710091554, 0710091555, 0710091759, 0710091760, 0710091778, 0710091779, 0710091830, 0710091876, 0710091877, 0710091878, 0710091879, 0710091887, 0710091890, 0711088518, 0711088519, 0711088538 0711088539, 0711088540, 0711088541, 0711088719, 0711088720, 0711088721, 0711088722, 0711088839, 0711088840, 0711088995, 0711088996, 0711088997, 0711089589, 0711089590, 0711089618, 0711089619, 0711089857, 0711089858, 0711090140, 0712089555, 0712089556, 0712089557, 0712089717, 0712089718, 0712089821, 0712089827, 0712089828, 0712089829, 0712089830, 0712089927, 0712089928, 0712089929, 0712089930, 0712089990, 0712090100, 0712090128, 0712090129, 0712090130, 0712090329, 0712090330, 0712090331, 0712090333, 0712090409, 0712090410, 0712090411, 0712090437, 0712090438, 0712090439, 0712090447, 0712090448, 0712090449, 0712090495, 0712090496, 0712090497, 0712094631, 0712094632, 0712094633, 0712094634, 0712094688, 0712094689, 0712094759, 0712094760, 0712094769, 0712094770, 0801099212, 0801099213, 0801099216, 0801099217, 0801099369, 0801099370, 0801100191, 0801100249, 0801100259, 0801100327, 0801100328, 0801100329, 0801104831, 0801104832, 0801104833, 0801104834, 0801104838, 0801104936, 0802098511, 0802098512, 0802098513, 0802098514, 0802098611, 0802098616, 0802098617, 0802098618, 0802098619, 0802098638, 0802098639, 0802098933, 0802098936, 0802098956, 0802098957, 0802102637, 0802102696, 0802102697, 0802102928, 0802102929, 0802102930, 0803099001, 0803103077, 0803103106, 0803103107, 0803103108, 0803103109, 0803103110, 0803103140, 0803103266, 0803103267, 0803104520, 0803104573, 0803104756, 0803104757, 0803104779, 0803104868, 0803106356, 0803106400, 0804098940, 0804099037, 0804099120, 0804099149, 0804099150, 0804099151, 0804099218, 0804099219, 0804099498, 0804099499, 0804099500, 0805099937, 0805099938, 0805101013, 0805101014, 0805101015, 0805101789, 0805101790, 0805101850, 0805101851, 0805101852, 0805101853, 0805101854, 0805101855, 0805101856, 0805101857, 0805101858, 0805102617, 0805102618, 0805102619, 0805102620, 0805102676, 0805102677, 0805102678, 0805102679, 0805102680, 0805102887, 0805102888, 0805102899, 0805104062, 0805104063, 0805104064, 0805104065, 0805104216, 0805104217, 0805104259, 0805104359, 0806099618, 0806099619, 0806099692, 0806099693, 0806099694, 0806099695, 0806101539, 0806101540, 0806101724, 0806101725, 0806101727, 0806101728, 0806101729, 0806101730, 0806104548, 0806104549, 0806104566, 0806104567, 0806104768, 0806104769, 0806104770, 0807100044, 0807100045, 0807100046, 0807100047, 0807100048, 0807100069, 0807100070, 0807100071, 0807100130, 0807100131, 0807100132, 0807100135, 0807100207, 0807100208, 0807100209, 0807100210, 0807100211, 0807100212, 0807100309, 0807100310, 0807100320, 0807100321, 0807100322, 0807102502, 0807103577, 0807103578, 0807103579, 0807103580, 0807103581, 0807103667, 0807103668, 0807103669, 0807103670, 0807103671, 0807103759, 0807103760, 0807103768, 0807107129, 0808100835, 0808100836, 0808100837, 0808100838, 0808100839, 0808100919, 0808100920, 0808100966, 0808100967, 0808100968, 0808100969, 0808100970, 0808100971, 0808100972, 0808100973, 0808103517, 0808103518, 0808103576, 0808103578, 0808103579, 0808103598, 0808103599, 0808103600 0808103633, 0808104051, 0808104052, 0808104053, 0808104148, 0808106636, 0808106637, 0808106638, 0808106639, 0808106969, 0809102480, 0809102494, 0809102495, 0809102496, 0809102497, 0809104124, 0809104125, 0809104231, 0809104380, 0809104381, 0809106565, 0809106636, 0809106637, 0809106638, 0809106639, 0809106640, 0809106722, 0809106759, 0809106760, 0809106920, 0809106946, 0809106982, 0809106983, 0809106984, 0809106985, 0809106986, 0810092532, 0810092533, 0810098609, 0810098619, 0810098684, 0810098685, 0810098688, 0810098689, 0810098864, 0810098865, 0810101228, 0810101229, 0810105148, 0810105232, 0810105379, 0811100540, 0811100563, 0811100564, 0811100565, 0811100566, 0811100567, 0811100651, 0811100652, 0811100653, 0811100654, 0811100655, 0811100995, 0811100996, 0811100997, 0811100998, 0811101161, 0811101162, 0811101163, 0811101164, 0811101247, 0811101248, 0811101376, 0811102037, 0811102376, 0811102377, 0811103843, 0812101566, 0812101567, 0812101568, 0812101569, 0812102279, 0812102280, 0812102357, 0812102358, 0812102359, 0812102360, 0812102507, 0812102508, 0812102509, 0812102510, 0812102798, 0812102928, 0812102929, 0812102939, 0812102940, 0812103103, 0812103160, 0812103415, 0812103416, 0812103417, 0812103500, 0901032626, 0901033831, 0901033832, 0901033833, 0901033929, 0901033931, 0901033932, 0901033933, 0901033934, 0901033935, 0901034198, 0901034199, 0901034284, 0901034285, 0902030075, 0902030076, 0902030297, 0902032604, 0902032605, 0902032606, 0902032607, 0902032860, 0902032910, 0902032939, 0902032940, 0902034591, 0902034592, 0902034593, 0902034594, 0903033658, 0903033659, 0903033691, 0903033692, 0903033693, 0903033694, 0903033695, 0903033696, 0903033732, 0903033733, 0903033784, 0903033785, 0903033787, 0903033788, 0903033832, 0903033892, 0903033893, 0903033894, 0903033940, 0903033941, 0903033942, 0903033943, 0903033944, 0903033945, 0903033960, 0903033982, 0903033983, 0903033984, 0903033985, 0903033986, 0903033987, 0903034371, 0903034645, 0903034646, 0903034647, 0903034648, 0903034649, 0903034699, 0903035069, 0904032014, 0904032117, 0904032167, 0904032168, 0904033801, 0904033933, 0904033936, 0904033937, 0904033938, 0904033949, 0904033966, 0904033967, 0905034051, 0905034052, 0905034053, 0905034054, 0905034055, 0905034056, 0905034057, 0905034058, 0905034059, 0905034080, 0905034220, 0905034221, 0905034281, 0905034282, 0905034283, 0905034284, 0905034285, 0905034340, 0905034456, 0905034457, 0905034489, 0905034499, 0905034500, 0905034761, 0905034762, 0905035073, 0905035074, 0905035075, 0905035076, 0905035121, 0905035122, 0905035123, 0905035124, 0905035125, 0905035179, 0905035180, 0905035184, 0905035221, 0906033091, 0906033092, 0906033093, 0906033094, 0906033095, 0906033259, 0906033260, 0906033262, 0906033263 and 0906033265;

 

3) There is no code.

RECALLING FIRM/MANUFACTURER

Stryker Medical Division of Stryker Corp., Portage, MI, by letter dated February 26, 2010. Firm initiated recall is ongoing.

REASON

The fowler of the bed is raised by a crank. The crank consists of a steel screw that moves through a brass nut. Over time the screw can wear the threads on the brass nut. The screw and the nut can become misaligned, causing a loud squealing noise when the screw comes in contact with the drive tube. In addition the fowler can become inoperable over time with excessive wear of the brass nut. This may delay care for a patient who requires the fowler to be raised.

VOLUME OF PRODUCT IN COMMERCE

1,640 units (1,128 Nationwide; 512 International)

DISTRIBUTION

Nationwide, Australia, Canada, Chile, China, France, Germany, Greece, Spain, Italy, Japan, South Africa, Taiwan, Korea, Singapore, and UK

___________________________________

PRODUCT   

1) TI N-Hance Rod 150mm Sterile The Synthes N-Hance and NFix II rods are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the spine. Catalog number 04.600.715.02S. Recall # Z-2344-2010;

 

2)  2) N-Hance System 150mm The Synthes N-Hance and NFix II rods are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the spine. Catalog number NH60150-1. Recall # Z-2345-2010;

 

3) 3) NFix II System 150mm The Synthes N-Hance and NFix II rods are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the spine. Catalog number NX60150-1. Recall # Z-2346-2010;

 

4) NFlex Straight monosegmental L 150mm The Synthes N-Hance and NFix II rods are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the spine. Catalog number 04.600.716.02S. Recall # Z-2347-2010;

 

5) NFlex Stabilization System 150mm The Synthes N-Hance and NFix II rods are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the spine. Catalog number NF60150-1. Recall # Z-2348-2010

CODE

1) Lot numbers: 5764185 and 5764346;

 

2) Lot number: P07M01;

 

3) Lot numbers P06J01, P06J02, P06M01, P06M02, P07D02, P07H01, P07J01, and P07G01;

 

4) Lot numbers: 5794446 and 5842468;

 

5) Lot numbers: P06H01, P06J01, P06M01, P07H02, P07J02, and P07M03

RECALLING FIRM/MANUFACTURER

Recalling Firm: Synthes USA (HQ), Inc., West Chester, PA, by letters dated February 9, 2009, February 12, 2009, March 11, 2009 and April 9, 2009.

Manufacturer: Synthes (USA), Monument, CO. Firm initiated recall is complete.

REASON

Package integrity compromised.

VOLUME OF PRODUCT IN COMMERCE

2,169 units

DISTRIBUTION

Nationwide, Denmark, Germany, Korea and Switzerland

___________________________________

PRODUCT   

Picasso/Picasso Lite lasers Intended use: Dentistry. Recall # Z-2349-2010

CODE

All associated serial numbers.

RECALLING FIRM/MANUFACTURER

AMD Lasers, LLC, Indianapolis, IN, by letters, dated April 30, 2010. Firm initiated recall is ongoing.

REASON

Product is noncompliant with the Federal laser product performance standard in certain requirements. The ON/OFF key on some of the Picasso/Picasso Lite lasers could be removed with force while the key was in the ON position.

VOLUME OF PRODUCT IN COMMERCE

3,000 units

DISTRIBUTION

Nationwide and Internationally

___________________________________

PRODUCT   

Impella 5.0 Circulatory Support System Catalog number: 004840 The Impella 5.0 System is intended for circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours. Recall # Z-2382-2010

CODE

Serial numbers: 45921, 45922, 45923, 45924

RECALLING FIRM/MANUFACTURER

Recalling Firm: Abiomed, Inc, Danvers, MA, by letter on July 5, 2010.

Manufacturer: Abiomed Europe Gmbh, Aachen, Germany. Firm initiated recall is complete.

REASON

Pump may separate at the motor housing while device is expanded.

VOLUME OF PRODUCT IN COMMERCE

6 units

DISTRIBUTION

Canada and France

___________________________________

PRODUCT   

SYNCHRON Systems Modular Creatinine (CREm) Reagent Kit, Part Number: 472525 Systems AQUA CAL 1 and 2 is intended for the quantitative determination of creatinine concentration in human serum, plasma or urine. CREm reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 800 System and SYNCHRON Systems AQUA CAL 1 and 2, is intended for the quantitative determination of creatinine concentration in human serum, plasma or urine. Recall # Z-2389-2010

CODE

Lot Number(s): M911428 & M911519

RECALLING FIRM/MANUFACTURER

Recalling Firm: Beckman Coulter, Inc, Brea, CA, by letter dated August 3, 2010.

Manufacturer: Beckman Coulter, Inc, Carlsbad, CA. Firm initiated recall is ongoing.

REASON

The recall was initiated after Beckman Coulter confirmed reports that black / brown particulates were observed in some bottles of the Creatinine Alkaline Buffer (Buffer lot M911427 and M911518) in modular Creatinine (CREm) reagent kit lots M911428 and M911519. Beckman Coulter has had reports of erroneous results when using the lots of Creatinine Alkaline Buffer listed above. Single creatinine determinations are used to predict end-stage renal failure (estimate glomerular filtration rate, or eGFR), to monitor renal transplant patients, and to dose medications and intravenous radiopaque dyes. Erroneous creatinine results corresponding to eGFR >60 mL/min/1.73 m2, when the true value is below these clinical thresholds, may result in serious harm. Creatinine values in the 0.5 to 2.5 mg/dL (45 to 220 micromol/L) range are important for drug dose adjustments. Low or high erroneous results in this range may result in inappropriate dosing of medication or chemotherapy.

VOLUME OF PRODUCT IN COMMERCE

3,106 units (2,941 Nationwide & 165 in Canada)

DISTRIBUTION

Nationwide and Canada

___________________________________

PRODUCT   

Invacare AC-Powered Adjustable Hospital Bed. Model 5890 IVC and 5490 IVC. Recall # Z-2393-2010

CODE

Model # only

RECALLING FIRM/MANUFACTURER

Invacare Corp., Sanford, FL, by letter on October 18, 2006. Firm initiated recall is ongoing.

REASON

Invacare Corporation issued a device correction in October 2006 for the IVC Bed Foot Actuator used on the IVC Bed Series, Models 5890 IVC and 5490 IVC. The actuators were not in the fully extended position and could not be mounted onto the beds. All affected consignees were notified of this correction in October 2006.

VOLUME OF PRODUCT IN COMMERCE

731 units

DISTRIBUTION

Nationwide

___________________________________

PRODUCT   

Stratus CS Acute Care Troponin 1 TestPak (Troponin I assay). Recall # Z-2400-2010

CODE

Lot# 239229002, EXP# 2/13/2010; lot# 239236002, EXP# 2/20/2010; lot# 239243002, EXP# 2/7/2010; lot# 239257002, EXP# 3/10/2010; lot# 239264002, EXP# 3/20/2010; lot# 239271002, EXP# 3/27/2010; lot# 239278002, EXP# 4/3/2010; lot# 239285002, EXP# 4/10/2010; lot# 239292002, EXP# 4/17/2010; lot# 239299002, EXP# 4/24/2010; lot# 239313002, EXP 5/8/2010; lot# 239334002, EXP 5/29/2010; lot# 239341002, EXP#6/5/2010; lot# 239362002, EXP# 6/26/2010  

RECALLING FIRM/MANUFACTURER

Siemens Healthcare Diagnostics, Inc., Newark, DE, by letter dated April 2010. Firm initiated recall is ongoing.

REASON

False elevated Stratus CS CTNI results

VOLUME OF PRODUCT IN COMMERCE

7,500 units

DISTRIBUTION

Nationwide

___________________________________

PRODUCT   

Maquet HLM Tubing Pack; Bioline Coating. Product number BEQ-TOP 14801. Recall # Z-2401-2010

CODE

Lot numbers: 70040244, 70046759

RECALLING FIRM/MANUFACTURER

Recalling Firm: Maquet Inc., Wayne, NJ, by letters and e-mail on July 13, 2010.
Manufacturer: Maquet Cardiopulmonary Ag, Hirrlingen, Germany. Firm initiated recall is ongoing.

REASON

The color of the tape on the arterial and the venous line were placed incorrectly, causing the connection of the arterial and the venous lines to be interchanged.

VOLUME OF PRODUCT IN COMMERCE

5 packs

DISTRIBUTION

PA

___________________________________

PRODUCT   

CareGuard Mattress Models CG10180 and CG10180A used with IVC and ValueCare Series of manual, semi-electric and electric beds. Mattresses can be identified by looking on the law label tag for the following information: Model # CG10180 or CG10180CA and a BLACK date code with the corresponding month and year of manufacture (i.e. September 2006. October 2006...August 2007). Affected bed packages are model numbers: BED24IVC, BED25IVC, BED24CA or BED25CA. Recall # Z-2402-2010

CODE

September 2006 through July 2007

RECALLING FIRM/MANUFACTURER

Invacare Corp., Sanford, FL, by letter dated October 15, 2007. Firm initiated recall is ongoing.

REASON

The mattresses when used in combination with the IVC and ValueCare Series of manual, semi-electric and electric beds and associated bed rails do not meet some of the requirements of the voluntary FDA Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment, as intended. Use of these particular mattresses in combination with Invacare beds and bed rails may put users at increased risk of entrapment.

VOLUME OF PRODUCT IN COMMERCE

19,143 units

DISTRIBUTION

Nationwide

___________________________________

PRODUCT   

Mattress Model 5185 and 5185XL. Mattress Model 5185 and 5185XL were packaged in the IVC Bed Models BED2-1633, BED4-1633, BED8-1633, BED9-1633, BED10-1633, BED12-1633, BED38LOW-1633, VCPKGIVC-1633 OR VCPKGIVC2-1633. In September 2007 Invacare Corporation recalled the innerspring mattresses associated with Invacare's IVC Bed Series Full Electric Beds, Semi-Electric Beds and Manual Beds and the ValueCare Bed Series Semi Electric Bed. These mattresses were manufactured between June 28, 2007 and July 12, 2007. Recall # Z-2403-2010

CODE

None

RECALLING FIRM/MANUFACTURER

Invacare Corp., Sanford, FL, by letter dated September 5, 2007. Firm initiated recall is ongoing.

REASON

These mattresses when used in combination with the IVC and ValueCare Series of manual, semi-electric and electric beds and associated bed rails, do not meet some of the requirements of the voluntary FDA Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment. Use of these particular mattresses in combination with Invacare beds and bed rails may put users at increased risk of entrapment.

VOLUME OF PRODUCT IN COMMERCE

4,896 units

DISTRIBUTION

Nationwide

___________________________________

PRODUCT   

Stryker Bur Guard REF 2296-301. The Impaction Bur Guard is intended to be used with the Impaction Drill. The drill is used for surgical procedures involving precision drilling and cutting of bone and hard tissue. The bur guard covers the nose of the handpiece and the shaft of the cutting accessory to prevent exposure to heat and moving parts, as well as minimize bur whip and handpiece vibration. Recall # Z-2420-2010

CODE

Replace by dates of May 2009 through August 2010

RECALLING FIRM/MANUFACTURER

Stryker Instruments Div. of Stryker Corp., Kalamazoo, MI, by letter dated June 10, 2010. Firm initiated recall is ongoing.

REASON

The reason for the field action is that the inner diameter of the Bur Guards may be out of specification. If there is excess material on the inside of the Bur Guard at the location where the guard tapers, it may come into contact with the Nose Cone of the drill. This could result in an injury or burn to the patient and/or user.

VOLUME OF PRODUCT IN COMMERCE

10,982 units

DISTRIBUTION

Nationwide and Internationally

 

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS III

___________________________________

PRODUCT   

Dimension Vista Chemistry 2 Calibrator, Catalog number KC120. Used to calibrate Phosphate, Salicylate, and Triglycerides methods on the Dimension Vista system. Recall # Z-2387-2010

CODE

Lot number: 9GM001, exp 7/2010

RECALLING FIRM/MANUFACTURER

Siemens Healthcare Diagnostics, Inc., Newark, DE, by letter dated February 2010. Firm initiated recall is ongoing.

REASON

There is incorrect barcode information, which can potentially cause the Alert Message "Calibrator Insert Missing" to be displayed.

VOLUME OF PRODUCT IN COMMERCE

1,310 cartons

DISTRIBUTION

Nationwide, Austria, Germany, Netherlands, Italy, France, Denmark, Portugal, Canada, South Korea, Malaysia, Australia, and New Zealand

 

RECALLS AND FIELD CORRECTIONS:  VETERINARY - CLASS II

___________________________________

PRODUCT   

1) Chap-Free Teat Dip with Chlorhexidine and Glycerine, One Gallon. Recall # V-217-2010;

 

2) Pre-Milking Udder Wash with Cocoa Butter & Chlorhexidine and Glycerine, One Gallon. Recall # V-218-2010

CODE

1) Lot #34089 (exp 8-12-10), Lot #35089 (exp 8-12-10), Lot #27099 (exp 9-8-10);

2) Lot #26089

RECALLING FIRM/MANUFACTURER

Recalling Firm: Aviva Products, Reading, PA, by telephone on July 27, 2010.

Manufacturer: Pagoda Products, Inc., Sinking Spring, PA. Firm initiated recall is ongoing.

REASON

Inadequate release testing for active ingredients.

VOLUME OF PRODUCT IN COMMERCE

776 gallons

DISTRIBUTION

PA, MD

 

END OF ENFORCEMENT REPORT FOR SEPTEMBER 15, 2010

 

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