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U.S. Department of Health and Human Services

Safety

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Enforcement Report for January 13, 2010

January 13, 2010 10-02

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
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PRODUCT
1) Fireside Chai tea, vanilla, fat free, net wt. 12 oz., UPC 6116760522; Net wt. 5 pound sampling bag, not for resale, no UPC code and net wt. 1.2 oz. (single serve package), UPC 61167-30522. 1 lb. sampling bag; no UPC code. Recall # F-0488-2010;

 

2) Fireside Chai tea, decaf vanilla, fat free, Net wt. 12 oz, UPC 6116761508 and net wt 1.2 oz. (single serve package), UPC 61167-31508. Recall # F-0489-2010;

3) Fireside Chai tea, chocolate, fat free, net wt. 12 oz., UPC 6116760523; Net wt. 5 pound sampling bag, not for resale, no UPC code; net wt. 1.5 oz. (single serve package), UPC 61167-30523 and 1 lb. sampling bag; no UPC code. Recall # F-0490-2010;

4) Fireside Chai tea, spiced, fat free, net wt. 12 oz., UPC 6116760524; Net wt. 5 pound sampling bag, not for resale, no UPC code; net wt. 1.5 oz. (single serve package), UPC 61167-30524; 1 lb. sampling bag; no UPC code; and 5 lb bag, no UPC code. Recall # F-0491-2010
CODE
1) 12 oz. lots A82432157, B827I32156/57, D80932156/57, E802213/58/32, J831VCHAI132155, L804VCHAI32154 and A916VCHAI32216. Single serve package lots 8311/31255, 8312/31255/35 and 8312/31255/3. 5 lb. bag lots C81432158, D81732157/58/33, J831VCHAI32155 and A929VCHAI32216. 1 LB. sampling bag lot D81732157/58/33;

2) 12 oz. lot A916DVCH32215. Single serve package lot 8311/32129/205;

3) 12 oz. lots A80432162, A81132141/62, A82432137/63, A831312163/37/38, D80932138/63, D82432162/63/38/41, J830CHOCOCHAI32209/139, K812CHOCOCHAI32209/161, L804CHOCOCHAI32160 and B917CHOCOCHAI32160/59. Single serve package lot 8215/32209/08. 5 lb. bag lots A82432137/63, J814CHOCOCHAI32159, K812CHOCOCHAI32209/161 and A929CHOCOCHAI32160. 1 lb. sampling bag lots A83132163/37/38, B801I32137/63/38, D83032141/40 and A930CHOCOCHAI32160;

4) 12 oz. lots A80332147, A81132148, A82432148/47, B80632148/52/53, B80832152/51, B81332151, D81032151/50, J824SPICEDCHAI32207, J830SPICEDCHAI32207/06, J831SPICEDCHAI32206, K810SPICEDCHAI32146/207, K811SPICEDCHAI32146/47/207, K819SPICEDCHAI32147 and A908SPICEDCHAI32220. Single serve package lot 8312/32206. 1 lb bag lots L70432148/49, B80632148/52/53, D81132150, D83032145 and A930SPICEDCHAI32219. 5 lb bag lots K72732149, A80732149, A82432148/47, B80632148/52/53, F81932147, K811SPICEDCHAI32146/47/207 and A908SPICEDCHAI32220
RECALLING FIRM/MANUFACTURER
Fireside Coffee Co., Inc., Swartz Creek, MI, by press release on July 27, 2009 and by letter dated July 29, 2009.
Manufacturer: Plainview Milk Products Cooperative, Plainview. MN. Firm initiated recall is complete.
REASON
The tea was manufactured using non-fat dry milk which was recalled by Plainview because of potential contamination with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
10,254
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) High Protein Chocolate Drink/Aspartame, Net Wt. 196g (6.91 oz.); seven 28g (.99 oz.) packets per box; stock number 00109; The Chocolate Drink was also sold as 26g (.91 oz.) powder in single serving 8 fl. oz. plastic bottles (add water and shake to mix) labeled as Pro-to-Go Chocolate Drink, item 11209. Recall # F-0492-2010;

2) High Protein Cocoa Drink/Sucralose, Net Wt. 210g (7.41 oz.); seven 30g (1.06 oz.) packets per box; stock number 00120. Recall # F-0493-2010;

3) High Protein Cocoa Drink/Aspartame, Net Wt. 210g (7.41 oz.); seven 30g (1.06 oz.) packets per box; stock number 00222. Recall # F-0494-2010;

4) Pro-to-Go High Protein Chocolate Drink/Sucralose; 26g (.91 oz.) powder in single serving 8 fl. oz. plastic bottles (add water and shake to mix); stock number 00209. Recall # F-0495-2010
CODE
All products sold between 12/3/07 and 6/26/2009
RECALLING FIRM/MANUFACTURER
New Century Packaging/Health Products, Inc., Tinley Park, IL, by letters on June 29, 2009. Firm initiated recall is ongoing.
REASON
The products were manufactured using an ingredient recalled by Plainview Milk Products Cooperative because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
61,176 boxes, 4,293 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Choripdong "Apricot", 15 oz. The product is packaged in a clear plastic container.
UPC 0761898650622, Item number GP1004A. Recall # F-0496-2010
CODE
No code
RECALLING FIRM/MANUFACTURER
Recalling Firm: Seoul Shik Poom Inc., Englewood NJ, by letter on September 15, 2009.
Manufacturer: Palmas Palmiye Gida Sanayi Ve Ticaret A.S., Izmir, Turkey. Firm initiated recall is ongoing.
REASON
Dried apricots contain undeclared sulfites based on FDA sampling.
VOLUME OF PRODUCT IN COMMERCE
28 cases (12 x 15 oz. containers
DISTRIBUTION
CO, WA
___________________________________
PRODUCT
PRICE RITE brand BEEF FLAVORED Bouillon Cubes, Net Wt. 3.25 oz. (92 g), 25 Cubes, UPC 41190 75581. The product is packaged in retail plastic bottles with 25 individually wrapped bouillon cubes per bottle. Recall # F-0497-2010
CODE
Lot code 22 JUL 11 (printed on top of the bottle)
RECALLING FIRM/MANUFACTURER
Associated Brands, Inc., Medina, NY, by press release on September 24, 2009. Firm initiated recall is ongoing.
REASON
The product contains undeclared milk from the sub-ingredients. The problem was discovered by the company during a routine quality audit.
VOLUME OF PRODUCT IN COMMERCE
320 cases (3,840 selling units)
DISTRIBUTION
PA
___________________________________
PRODUCT
Deerfield Farms Mediterranean Fruit & Nut Blend with Raisins, Walnuts, Figs, Apricots, Almonds, Pistachios, Cherries, Blueberries & Hazelnuts; trail mix; Net Wt 10 oz. (283g) ziplock plastic bags, 12 bags per case; item #WIC 255211, UPC 49022 45444. Recall # F-0498-2010
CODE
Best by 3/5/10 9064A3, 3/5/10 9064B3, 3/30/10 9089A4, 3/31/10 9090A4, 4/13/10 9103A3
RECALLING FIRM/MANUFACTURER
Recalling Firm: Walgreen Co., Deerfield, IL, by press release on April 21, 2009.
Manufacturer: Schutzman, A. L. Co., Waukesha, WI. Firm initiated recall is ongoing.
REASON
The product was manufactured using pistachios recalled by Setton Pistachio of Terra Bella, Inc. because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
2,753 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Taylors Roasted & Salted Natural Pistachios; dry roasted in-shell pistachios packaged in pre-priced plastic bags, 12 bags per case; a) $1.99 bag - UPC 7 43779 20983 9; b) $0.99 bag - UPC 7 43779 20291 5. Recall # F-0499-2010;

2) Taylors Roasted & Salted Red Pistachios; dry roasted in-shell pistachios packaged in pre-priced plastic bags, 12 bags per case; UPC 7 43779 20290 8. $0.99 pre-priced label, UPC 743779-20290. Recall # F-0500-2010
CODE
1) a) Code date 0689 and 3368; b) Code date 0689 and 3228;
2) Code date 2808
RECALLING FIRM/MANUFACTURER
Taylor’s Candy, Inc., Alsip, IL, by telephone, letters and fax on March 31, 2009. Firm initiated recall is ongoing.
REASON
The pistachio nuts were manufactured using pistachios recalled by Setton Pistachio of Terra Bella because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
225 cases - $1.99; 1,108 cases - $0.99
DISTRIBUTION
IL, IN
___________________________________
PRODUCT
1) in-shell natural pistachios packaged under the following labels: a) Superior Snacks Natural Pistachios, Net Wt. 1.25 oz (35.4g) and 2.75 oz (78g) plastic film bags, 12 bags per case, 1.25 oz. - item 98012, UPC 7 22648 98012 3, 2.75 oz - item 98708, UPC 7 22648 98708 5; b) Natural Pistachios Dry Roasted, Net Wt. 16 oz (454g) ziplock plastic bags, 18 bags per case, item 65002, UPC 7 22648 65002 6; c) Natural Pistachios Dry Roasted, Net Wt. 5 oz (142g) multi-color confetti on black background plastic film bags, 24 bags per case, item 94968, UPC 7 22648 94968 7; d) Streit's Natural Pistachios Kosher for Passover, Net Wt. 8 oz (227g) clear plastic tubs, 12 tubs per case, item 70233, UPC 0 70227 64005 1. Recall # F-0501-2010;

2) Superior Nut & Candy Raw Pistachio Kernels, Net Wt. 35 oz (992g) ziplock plastic bags, 6 bags per case, item 64960, UPC 7 22648 64960 0. Recall # F-0502-2010
CODE
1) item 98012, lots 057 9, 063 9, 065 9, 072 9 and 073 9 ; item 98708, lots 063 9, 064 9 and 078 9; item 65002, lot 064 9; item 94968, lots 054 9, 055 9 and 083 9; item 70233, lot 056 9;

2) Lots 336 8, 352 8, 062 9, 077 9 and 086 9
RECALLING FIRM/MANUFACTURER
Superior Nut & Candy Dist., Co., Chicago, IL, by press release on April 14, 2009. Firm initiated recall is complete.
REASON
The products were manufactured using pistachios that have been recalled by Setton because they may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
2,491 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Osage Pecan Company Pistachios, packaged in 16-oz. plastic bags. Recall # F-0530-2010.
CODE
None
RECALLING FIRM/MANUFACTURER
Osage Pecan Co., Butler, MO, by press release on April 16, 2009 and by letters dated April 21, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using pistachios recalled by Setton Pistachio of Terra Bella because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,629/1-lb bags
DISTRIBUTION
KS, MO, IA, NE, OR, IL, WV, IN, CO, WY, ID, MN
___________________________________
PRODUCT
Pistachio ice cream. LaSalle brand pistachio ice cream, 1 pint; a) UPC code 8568313144 and b) UPC code 7761950679. 9629 Sedutto pistachio 555 ice cream, net 2.5 GAL, c) UPC 7258692520. Recall # F-0531-2010
CODE
a) code dates of 08340 and 09034; b) code dates of 08285, 08295, 08304 and 09003; c) code date of 08329
RECALLING FIRM/MANUFACTURER
House Of Flavors, Inc., Ludington, MI, by press release, e-mail and telephone on April 10, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using pistachios recalled by Setton Pistachio of Terra Bella because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
43.088 pints and 127 – 2.5 gallon containers
DISTRIBUTION
CT, NJ, NY, PA
___________________________________
PRODUCT
1) Mixed nuts, fruit and spices. Sahale Snacks - KSAR. Label includes: "Sahale Snacks Nut Blend KSAR Pistachios with Sesame Seeds, Pepitas, Fig + Moroccan Harissa". First three ingredients include Pistachio Nuts, Pumpkin Seeds, and Dried Figs. Product is packaged in 2 oz and 5 oz laminated gusseted pouches. UPC codes 2 oz package sold in US: UPC 8-93869-00001-0, Case UPC 8-93869-00011-9. UPC codes 5 oz package sold in US: UPC 8-93869-00501-5, Case UPC 8-93869-00511-4. UPC codes 5 oz package sold in CANADA: UPC 8-93869-00541-1, Case UPC 8-93869-00551-0. Firm also manufactured 0.75 oz plastic pillow pouch samples distributed in-house with no labeling except a Best By code. Recall # F-0532-2010;

2) Mixed nuts, fruit and spices. Sahale Snacks - MARRAKESH. Product is manufactured to be sold in Harry & David Retail stores nationwide. Label includes: "Sahale Snacks HARRY & DAVID Exclusive Nut Blend MARRAKESH Pistachios with Pomegranate, Sea Salt + Marash Pepper Net Wt. 4.0 oz (113g). Product of USA". First three ingredients include Pistachios, Dried Apples, and Sugar. Product is packaged in 4 oz laminated gusseted pouches. UPC code 8-93869-00587-9. Harry and David SKU 154628. Recall # F-0533-2010
CODE
1) USA 2 oz packages Best by dates 10/16/2009, 10/30/2009, 11/20/2009, 11/27/2009, and 12/25/2009. USA 5 oz package: Best by dates 10/16/2009, 10/30/2009, 11/20/2009, 11/27/2009, and 12/25/2009. CANADA 5 oz packages Best by/Meilleur Avant dates 09 OC 16 (time of pack) 3, 09 OC 30 (time of pack) 2, 09 NO 20 (time of pack) 2, 09 NO 27 (time of pack) 5, 09 DE 25 (time of pack) 1. 0.75 oz samples Best By code 12/25/2009.

2) Best by dates 11/13/09 (time of pack) 3 Lot Code 042 9, 11/27/09 (time of pack) 1 Lot Code 054 9, and 12/25/09 (time of pack) 2 Lot Code 083 9
RECALLING FIRM/MANUFACTURER
Sahale Snacks, Inc., Seattle, WA, by e-mail and telephone and press release on April 9, 2009. Firm initiated recall is complete.
REASON
Products were manufactured using pistachios recalled by Setton Pistachio of Terra Bella because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
46,235 pouches
DISTRIBUTINON
Nationwide, Canada, Panama, the Philippines, and Dominican Republic
___________________________________
PRODUCT
Raw shelled pistachio kernels, Marca Croce brand, in 5 lb. plastic bags. No weight information on label. "Raw Pistachio" is hand written on the label. Recall # F-0534-2010
CODE
No codes are utilized
RECALLING FIRM/MANUFACTURER
Pacific Food Importers, Seattle, WA, by telephone on April 8, 2009, press release on April 10, 2009 and by letter on April 13, 2009. Firm initiated recall is complete.
REASON
Product repacked using pistachios that were recalled by Setton Pistachio of Terra Bella because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
55/5 lb bags
DISTRIBUTION
WA
___________________________________
PRODUCT
Raw Pistachios. Raw pistachio meats and kernals distributed through the firm's retail store in 12oz heat sealed clear plastic bags, self-service bulk bins, and plastic bags filled to specified Food Service orders. UPC code 0 00000 55700 9, No other codes. Bulk bins are labeled "Raw Pistachio Kernals - Product of California Bin #945". No other codes. Food Service orders have no labeling and vary in size according to specific orders. Recall # F-0535-2010
CODE
None
RECALLING FIRM/MANUFACTURER
Sheridan Fruit Co., Inc., Portland, OR, by press release and telephone on May 3, 2009. Firm initiated recall is complete.
REASON
Products were manufactured using pistachios recalled by Setton Pistachio of Terra Bella because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
75 lb bulk and 9-12 oz packaged product
DISTRIBUTION
OR
___________________________________
PRODUCT
1) Bifeng Nong fu Shanzhuang Plum Candy, 122 grams, UPC 6 920404 375624, Product of China. The product is packaged in an uncoded, plastic foil bag. Nutrition Facts: Serving Size 50 g Servings Per Container 2. Recall # F-0634-2010

2) CHI LING Gourmet Foods brand Hot Olive, Net Wt. 200g, UPC 4 712290 700077, Product of Taiwan --- The product is packaged in an uncoded clear plastic bag --- NOTE: The Nutrition Facts panel does not list the servings per container and serving size. Recall # F-0635-2010
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tiffany Food Co., Brooklyn, NY, by letters on July 30, 2009. Firm initiated recall is complete.
REASON
The imported product contained undeclared sulfites (112 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
1) 27 cases (30 bags per case); 2) 30 cases (60 bags per case)
DISTRIBUTION
NY, NJ, PA, VA, IN, TN, FL, TX, MA, MD, NC, GA, MI, IL
___________________________________
PRODUCT
Sundae Cone Vanilla, Vanilla Nutty Cone, Round Top Vanilla Cone: Cub brand - item #61025, size 6PK, UPC 41130-47379; Richfood brand - item #62774, size 6PK, UPC 11166-62759; Flavorite brand - item #62731, size 6PK, UPC 41130-03778; Shop & Save brand - item #62759, size 6PK, UPC 41130-34362; Roundys brand - Round Top, item #62307, size 8PK, UPC 11150-58946; Hood brand - item #3160, size 6PK, UPC 44100-23160 & item #3436, size 24PK, UPC 44100-23436; Greens brand - item #52343, size 6PK, UPC 71441-03239 & item #55198, size 24PK, UPC 71441-74842; Hagan brand - item# 53790, size 6PK, UPC 37498-00702.. Recall # F-0644-2010;

2) Tin Roof Sundae : Kemps brand - size Half Gallon (1.89L), UPC 41483-00528, item #50190 & size 140-oz, UPC 41483-00377, item #45121 & size 5-Qt Pail, UPC 41483-00377, item #45065 & size 3-Gal, UPC 41483-01147, item #54193; IGA brand - size Half Gallon (1.89L), UPC 41270-46102, item #51276; Flavorite brand - size Half Gallon (1.89L), UPC 41130-00042, item #51285; Shop & Save brand - size Half Gallon (1.89L), UPC 41130-34234, item #51298; Cub Foods brand - size Half Gallon (1.89L), 41130-97713; Richfood brand - size Half Gallon (1.89L), UPC 11166-01322, item #51328; Highs brand - size 56-oz, UPC 71441-07384, item #55438. Recall # F-0645-2010;

3) Snicker Doodle Ice Cream: Kemps brand - size 56-oz, UPC 41483-02829, item #47149. Recall # F-0646-2010;

4) Chocolate Monster Ice Cream: Kemps brand - size Half Gallon (1.89L), UPC 41483-03087, item #50143 & size 3-GAL, UPC 41483-02998. Recall # F-0647-2010;

5) Dice Kream: Brighams brand - size Quarts, UPC 24011-60346, item #50143 & size 3-GAL, UPC 24011-60915, item #54024. Recall # F-0648-2010;

6) Hood Premium Candy Bar Whirl: Hood brand - size 3-GAL, UPC 44100-24439, item #4439. Recall # F-0649-2010
CODE
1) 001-7A or 7B to 009-9A or 9B;
2) thru 6) Lot: 0017 to 0309
RECALLING FIRM/MANUFACTURER
Kemps, LLC, Falcon Heights, MN, by e-mail on January 29, 2009 and press release on February 2, 2009. Firm initiated recall is ongoing.
REASON
The products were manufactured using peanut products recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
Milk of Magnesia (magnesium hydroxide), 1200 mg Saline Laxative, Cherry Liquid 12 Fl oz, NDC # 59779-949-40, UPC 5042807094. Recall # D-138-2010
CODE
9DK0168, 9DK0376, 9EK0118, 9EK0173, 9EK0367, 9EK0525, 9FK0044, 9FK0256, 9FK0425, 9FK0521, 9GK0049, 9GK0308, 9GK0436, 9GK0668, 9HK0106, 9HK0285, 9HK0372 and 9JK0126
RECALLING FIRM/MANUFACTURER
L. Perrigo Co., Allegan, MI, by letter on November 24, 2009. Firm initiated recall is ongoing.
REASON
Labeling: Label mix-up: Product is labeled as sugar-free but it actually contains sugar.
VOLUME OF PRODUCT IN COMMERCE
72,840 bottles
DISTRIBUTION
Nationwide. Sold only at CVS stores

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
Multitrace-5 Concentrate (Trace Elements Injection 5, USP), 1 mL Single Dose Vial, for IV use after dilution, Rx Only, NDC 0517-8201-25. Recall # D-140-2010
CODE
Lot 8033, 8520, 9317
RECALLING FIRM/MANUFACTURER
Luitpold Pharmaceuticals, Inc., Shirley NY, letters dated August 26, 2009 via fax and UPS mail. Firm initiated recall is ongoing.
REASON
Out-of-specification product for aluminum levels.
VOLUME OF PRODUCT IN COMMERCE
187,825
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) ALCAINE (proparacaine hydrochloride USP) ophthalmic solution, 0.5%, 15ML, Sterile, Rx Only, NDC 0998-0016-15. Cardinal Item #1258490. Recall # D-141-201;

2) ALPROSTADIL (prostaglandin E1), 500MCG/ML 5 X 1ML, Rx Only, NDC 0703-1501-02. Cardinal Item #2887784. Recall # D-142-2010;

3) AMBISOME INJECTION (amphotericin B) liposome for injection, 50mg, 1 vial, Rx Only, NDC #0469-3051-30. Cardinal Item #2613164. Recall # D-143-2010;

4) AMPHADASE INJECTION (Hyaluronidase Injection, USP), Not for IV use. 150 U/mL, 10x1 mL PFL, Rx only, NDC 0548-9090-10. Cardinal Item #3662335. Recall # D-144-2010;

5) AMPHADASE INJECTION, (Hyaluronidase Injection, USP), Not for IV use. 150 U/mL 25 x 1 mL PFL, Rx only, NDC #0548-9090-00. Cardinal Item #3621331. Recall # D-145-2010;

6) AMPHOTERICIN B FOR INJECTION. 50MG 1Vial, Rx Only, NDC #39822-1055-7. Cardinal Item #3722618, Recall # D-146-2010;

7) AMPHOTERICIN B FOR INJECTION 50MG 1Vial, Rx Only, NDC #39822-1055-5. Cardinal Item #1199140. Recall # D-147-2010;

8) AMYL NITRITE INHALANT, USP, 12 0.3ML ampule, Rx only, NDC #39822-9950-2. Cardinal Item #1379494. Recall # D-148-2010;

9) APIDRA INJECTABLE [insulin glulisine (rDNA origin) injection], 100U/ML 10ML, Rx Only, NDC #0088-2500-33. Cardinal Item #3707817. Recall # D-149-2010;

10) APIDRA INJECTABLE [insulin glulisine (rDNA origin) injection], 100U/ML 5X3ML, For use only in OPTICLIK Insulin Delivery Device, Rx Only, NDC #0088-2500-52. Cardinal Item #3707775. Recall # D-150-2010;

11) APTIVUS (tipranovir) 250MG 120 SOFTGEL Capsules, Rx only, NDC #0597-0003-02. Cardinal Item #3674249. Recall # D-151-2010;

12) AQUASOL A Parenteral Water-Miscible, Vitamin A Palmitate, Solution 50MU/ML 10X2ML, Rx Only, NDC #61703-418-07. Cardinal Item #3722931. Recall # D-152-2010;

13) AVONEX, 30MCG 4 Prefilled Syringe, Rx Only, NDC #59627-002-05. Cardinal Item #3509718. Recall # D-153-2010;

14) BACIIM" (Bacitracin for Injection USP), Powder for Inj. Solution 50MU 10 VIALS, For Intramuscular Use, Rx Only, NDC #39822-0277-7. Cardinal Item #3689494. Recall # D-154-2010;

15) BACIIM" (Bacitracin for Injection USP) Powder for Inj. Solution 50MU 10VIAL, Rx Only, NDC #39822-0277-2. Cardinal Item #2898930. Recall # D-155-2010;

16) BACITRACIN FOR INJECTION 50MU 1VIAL, Rx Only, NDC #0009-0233-01. Cardinal Item #1323898. Recall # D-156-2010;

17) BACITRACIN FOR INJ. 50MU 1Vial, Rx Only, NDC #63323-329-30. Cardinal Item #3573425. Recall # D-157-2010;

18) BLEOMYCIN FOR INJECTION, UPS, equivalent to 15 Units Bleomycin, Single use 1Vial, For IV, IM, SC or Intrapleural Use, Rx Only, NDC #0703-3154-91. Cardinal Item #3339819. Recall # D-158-2010;

19) BLEOMYCIN FOR INJECTION 15U 1Vial, Rx Only, NDC #0703-3154-01. Cardinal Item #3216934. Recall D-159-2010;

20) BLEOMYCIN FOR INJECTION 30U 1Vial, Rx Only, NDC #0703-3155-01. Cardinal Item #3339751. Recall # D-160-2010;

21) CANCIDAS (caspofungin acetate) FOR INJECTION 50MG 1Vial, Rx only, NDC #0006-3822-10. Cardinal Item #3006848. Recall # D-161-2010;

22) CANCIDAS (caspofungin acetate) POWDER FOR INJECTION, 70MG 1VIAL, Rx Only, NDC #0006-3823-10. Cardinal Item #3006830. Recall # D-162-2010;

23) CAVERJECT, 40MCG 6 VIAL, Rx Only, NDC #0009-7686-04. Cardinal Item #2691582. Recall #D-163-2010;

24) CENOLATE INJ. 500MG/ML (Ascorbic Acid Injection, USP), Single Dose, 50X1ML, Rx only, NDC #0409-3118-31. Cardinal Item #2471647. Recall # D-164-2010;

25) CENOLATE INJ. 500MG/ML 50X2ML, (Ascorbic Acid Injection, USP), Single Dose, Rx only, NDC #0409-3397-32. Cardinal Item #2578441. Recall # D-165-2010;

26) CEREBYX INJ. (Fosphenytoin Sodium Injection), 50MG/ML 10X10ML, (PE=phenytoin sodium equivalent), Rx only, NDC #0071-4008-10. Cardinal Item #2503449. Recall # D-166-2010;

27) CEREBYX INJ. (Fosphenytoin Sodium Injection), 50MG/ML 25X2ML, (PE=phenytoin sodium equivalent), Rx only, NDC #0071-4007-05. Cardinal Item #2503456. Recall # D-167-2010;

28) CLADRIBINE INJECTION, 1MG/ML 10ML, Single Dose Vial, For Intravenous Infusion, Rx only, NDC #63323-140-10. Cardinal Item #36000665. Recall # D-168-2010;

29) CLEVIPREX" (clevidipine butyurate injectable emulsion), 0.5MG/ML, 10X100ML, Rx Only, NDC #65293-002-11. Cardinal Item #4105300. Recall # D-169-2010;

30) CLORPACTIN WCS-90, 5X2GM, (Brand of Oxychlorosene, Sodium), OTC, NDC #0327-0011-00. Cardinal Item #1176452. Recall # D-170-2010;

31) CUROSURF (poractant alfa) Intratracheal Suspension, 80MG/ML 1.5ML single use vial, Rx Only, NDC #49502-180-01. Cardinal Item #2942829. Recall # D-171-2010;

32) CUROSURF (poractant alfa) Intratracheal Suspension, 80MG/ML 3ML single use vial, Rx Only, NDC #49502-180-03. Cardinal Item #2942837, Recall # D-172-2010;

33) DESMOPRESSIN ACETATE NASAL SOLUTION 0.1MG/ML 5ML, Rx Only, NDC #24208-342-05. Cardinal Item #2700888. Recall # D-173-2010;

34) DESMOPRESSIN ACETATE INJ. 4MCG/ML 10X1ML, Rx Only, NDC #0409-2265-01.
Cardinal Item #3342771. Recall # D-174-2010;

35) DESMOPRESSIN ACETATE 4MCG/ML 10ML, Rx Only, NDC #0703-5054-01. Cardinal Item #2707123. Recall # D-175-2010;

36) DESMOPRESSIN ACETATE 4MCG/ML 10 X 1ML, Rx Only, NDC #0703-5051-01. Cardinal Item #2579308. Recall # D-176-2010;

37) DILTIAZEM Hydrochloride Injection, 5MG/ML 10X10ML, Single-dose Fliptop Vial, For Direct I.V. Bolus Injection and Continuous I.V. Infusion, Rx only, NDC #0409-1171-02. Cardinal Item #2812360. Recall # D-177-2010;

38) DILTIAZEM Hydrochloride Injection, 5MG/ML 10X5ML, Single-dose Fliptop Vial, For Direct I.V. Bolus Injection and Continuous I.V. Infusion, Rx only, NDC #0409-1171-01. Cardinal Item #2812378. Recall # D-178-2010;

39) DOXIL (doxorubicin HCl Liposome injection), INJ. 2MG/ML 10ML,sterile, single use vial, For Intravenous Infusion Only, Rx Only, NDC #17314-9600-1. Cardinal Item #2408839. Recall # D-179-2010;

40) DOXIL (doxorubicin HCl Liposome injection), INJ. 2MG/ML 25ML, sterile, single use vial, For Intravenous Infusion Only, Rx Only, NDC #17314-9600-2. Cardinal Item #2990497. Recall # D-180-2010;

41) ELIGARD (leuprolide acetate for injectable suspension), 22.5MG FOR INJ. SUSPENSION, Sterile, for subcutaneous injection, Rx Only, NDC #0024-0222-05. Cardinal Item #3531712. Recall # D-181-2010;

42) ELIGARD (leuprolide acetate for injectable suspension), 45MG, Rx Only, US, NDC #0024-0605-45. Cardinal Item #3647286, Recall # D-182-2010;

43) ELIGARD (leuprolide acetate for injectable suspension), 7.5MG, Rx Only, NDC # 0024-0793-75. Cardinal Item #3509866. Recall # D-183-2010;

44) ELIGARD (leuprolide acetate for injectable suspension), 30MG, Sterile, Rx only, NDC #0024-0610-30. Cardinal Item #3481678, Recall # D-184-2010;

45) EMCYT CAPSULES, (estramustine phosphate), 140MG 100, Rx Only, NDC #0013-0132-02. Cardinal Item #1058023. Recall # D-185-201;

46) EMEND (fosaprepitant dimeglumine) for Injection, 115MG 1VIAL, Rx only, NDC #0006-3884-32. Cardinal Item #4049516. Recall # D-186-2010;

47) EPIRUBICIN HCL INJ., 2MG/ML 100ML, For IV Use Only, Cytotoxic Agent, Rx only, NDC #55390-208-01. Cardinal Item #4001350. Recall # D-187-2010;

48) FLUDARABINE PHOSPHATE FOR INJECTION, 25MG/ML 2ML, Single Dose Vial For IV Use Only, Rx only, NDC #0703-4852-11. Cardinal Item #3580826. Recall # D-188-2010;

49) FLUDARABINE PHOSPHATE FOR INJECTION 50MG 1VIAL, Single Dose Vial For IV Use Only, Rx only, NDC #0703-5854-01. Cardinal Item #3515947. Recall # D-188-2010;D-189-2010;

50) FORADIL Aerolizer (formoterol fumarate inhalation powder), 12MCG 12 Capsules with Device, Rx only, NDC #0085-1402-01. Cardinal Item #3459971. Recall # D-190-2010;

51) FORADIL Aerolizer (formoterol fumarate inhalation powder), 12MCG 60 Capsules with Device, Rx only, NDC #0085-1401-01. Cardinal Item #3459955. Recall # D-191-2010;

52) FORTEO (teriparatide [rDNA origin]) Injection, 250MCG/ML 3ML, For subcutaneous use. Rx only, NDC #0002-8971-01. Cardinal Item #3442860. Recall # D-192-2010;

53) FOSPHENYTOIN SODIUM INJECTION USP, 50MG/ML 10X10ML Single Dose Vials, (PE=phenytoin sodium equivalents), For IM or IV Use, Rx only, NDC #64679-730-01. Cardinal Item #4001590. Recall # D-193-2010;

54) FOSPHENYTOIN SODIUM INJECTION USP, 50MG/ML 10X10ML Single Dose Vials, (PE=phenytoin sodium equivalents), For IM or IV Use, Rx only, NDC #10139-025-22. Cardinal Item #4001145. Recall # D-194-2010;

55) FOSPHENYTOIN SODIUM INJECTION USP, For IM or IV use, Rx only, 50MG/ML 10X2ML Single Dose Vials, NDC #55390-175-10. Cardinal Item #4001368. Recall # D-195-2010;

56) FOSPHENYTOIN SODIUM INJECTION, For IM or IV use, Rx only, 50MG/ML 10X10ML Single Dose Vials, Rx only, NDC #55390-176-10. Cardinal Item #4001376. Recall # D-196-2010;

57) FOSPHENYTOIN SODIUM INJECTION, USP, 50MG/ML 10X10ML Single Dose Vials, (PE=phenytoin sodium equivalents), Rx only, NDC #0409-4857-10. Cardinal Item #4001343. Recall # D-197-2010;

58) FOSPHENYTOIN SODIUM INJECTION, USP, 50MG/ML 25X2ML Single Dose Vials, (PE=phenytoin sodium equivalents), For IM or IV Use, Rx only, NDC #0409-4857-02. Cardinal Item #4001319. Recall # D-198-2010;

59) FOSPHENYTOIN SODIUM 50MG/ML 10 X 10ML, Rx Only, NDC #0703-7105-03. Cardinal Item #4018909. Recall # D-199-2010;

60) FOSPHENYTOIN SODIUM 50MG/ML 25 X 2ML, Rx Only, NDC #0703-7101-04. Cardinal Item #4018891. Recall # D-200-2010;

61) FOSPHENYTOIN SODIUM, 50MG/ML 10 X 10ML, Rx Only, NDC #63323-403-10. Cardinal Item #4011276. Recall # D-201-2010;

62) HUMATROPE CARTRIDGE KIT, (somatropin [rDNA origin]) for injection, 12MG for use with the Humatrope pen injection device, Rx only, NDC #0002-8148-01. Cardinal Item #3740198. Recall # D-202-2010;

63) HUMATROPE FOR INJ. (somatropin [rDNA origin]) for injection, 5MG for use with the Humatrope pen injection device, Rx only, NDC #0002-7335-16. Cardinal Item #3740214. Recall # D-203-2010;

64) HUMATROPE CARTRIDGE KIT (somatropin [rDNA origin]) for injection, 6MG for use with the Humatrope pen injection device, Rx only, NDC #0002-8147-01. Cardinal Item #3740222. Recall # D-204-2010;

65) IDARUBICIN HCL INJECTION, 1MG/ML 5ML, Single Dose Vial, For Intravenous Use Only, Rx only, NDC #0703-4154-11. Cardinal Item #3421864. Recall # D-205-2010;

66) IDARUBICIN HCL INJ. 1MGML 20ML, Single Dose Vial, For Intravenous Use Only, Rx only, NDC #0703-4156-11. Cardinal Item #3421880. Recall # D-206-2010;

67) LEUKERAN (chlorambucil) Tablets 2MG 50 Tablets, Rx only, NDC #0173-0635-35. Cardinal Item #3298189. Recall # D-207-2010;

68) M.V.I. ADULT (Multi-Vitamin Infusion), For Dilution in Intravenous Infusions only, 10ML/2VIALX10 Units to be used as a single dose only, Rx only, NDC #61703-422-82. Cardinal Item #3743655. Recall # D-208-2010;

69) M.V.I. ADULT (Multi-Vitamin Infusion), For Dilution in Intravenous Infusions 10X10ML Units to be used as a single dose only, Rx only, NDC #61703-422-81. Cardinal Item #3732211. Recall # D-209-2010;

70) M.V.I. PEDIATRIC (Multi-Vitamin Infusion), For Reconstitution and Dilution in Intravenous Infusions Only, Ten 5ML Single Dose Vials, Sterile, Rx only, NDC #61703-421-53. Cardinal Item #3771425. Recall # D-210-2010;

71) M.V.I.-12 (Multi-Vitamin Infusion Without Vitamin K) Unit Vial, For Dilution in Intravenous Infusions Only, 10 Unit Vials of 10ML each to be used as a single dose, Rx only, NDC #61703-423-81. Cardinal Item #3611134. Recall # D-211-2010;

72) M.V.I.-12 (Multi-Vitamin Infusion without Vitamin K) 50ML/2VIALX10, Rx only, NDC #61703-423-83. Cardinal Item #3611126. Recall # D-212-2010;

73) NEOMYCIN AND POLYMYXIN B SULFATES SOLUTION FOR IRRIGATION, 10X1ML, A Concentrated Sterile Antibiotic Solution to be Diluted for Urinary Bladder Irrigation. Rx Only, NDC #39822-1201-2. Cardinal Item #3722584. Recall # D-213-2010;

74) NEOMYCIN AND POLYMYXIN B SULFATES SOLUTION FOR IRRIGATION, USP (Sterile), A Concentrated Sterile Antibiotic Solution to be Diluted for Urinary Bladder Irrigation, 10ML, Rx only, NDC #39822-1220-1. Cardinal Item #3722600. Recall # D-214-2010;

75) NEOMYCIN AND POLYMYXIN B SULFATE SOLUTION FOR IRRIGATION, 10X1ML Ampules, Rx only, NDC #0591-2190-45. Cardinal Item #3744695. Recall # D-215-2010;

76) NEOMYCIN/POLYMYXIN B 50X1ML IRRIGATION, Rx Only, NDC #39822-1201-5. Cardinal Item #3722592. Recall # D-216-2010;

77) NORDITROPIN CARTRIDGE Somatropin (rDNA origin) Injection, 15MG/1.5ML, for use only with a green color-coded NoridPen, Rx only, NDC #0169-7770-11. Cardinal Item #2989846. Recall # D-217-2010;

78) NORDITROPIN CARTRIDGE Somatropin (rDNA origin) Injection, 5MG/1.5ML, Rx only, NDC #0169-7768-11. Cardinal Item #3307311. Recall # D-218-2010;

79) NORDITROPIN NORDIFLEX (Somatropin [rDNA origin]) Injection 10MG/1.5ML, Rx only, NDC #0169-7705-11. Cardinal Item #3705431. Recall # D-219-2010;

80) NORDITROPIN NORDIFLEX (Somatropin [rDNA origin]) Injection 5MG/1.5ML Prefilled Pen, Rx only, NDC #0169-7704-11. Cardinal Item #3644747. Recall # D-220-2010;

81) NYSTAT-Rx, NYSTATIN USP, 150Million Units, 1GM Bulk, For use in extemporaneous preparation of the oral suspension & prescription compounding, Not Sterile, Rx Only, NDC #39822-0900-3. Cardinal Item #1932045. Recall # D-221-2010;

82) OCTREOTIDE ACETATE INJECTION, 0.5MG/ML 10X1ML, Single Dose Vials, For Subcutaneous Injection, Rx only, NDC #55390-162-10. Cardinal Item #3657335. Recall # D-222-2010;

83) OCTREOTIDE ACETATE INJECTION, 0.2MG/ML 5ML, Single Dose Vials, Multiple dose vial, Rx only, NDC #55390-163-01. Cardinal Item #3657343. Recall # D-223-2010;

84) OCTREOTIDE ACETATE INJECTION, 0.1MG/ML 10X1ML Single Dose Vials, For Subcutaneous Injection, Rx only, NDC #55390-161-10. Cardinal Item #3657327. Recall # D-224-2010;

85) OCTREOTIDE ACETATE INJECTION, 1MG/ML, 5ML Multiple Dose Vial, For Subcutaneous Injection, Rx only, NDC #0703-3343-01. Cardinal Item #3702255. Recall # D-225-2010;

86) NORVIR (Ritonavir Capsules) 100MG, 30 Soft Gelatin Capsules, Rx Only, NDC #0074-6633-30. Cardinal Item #3641016. Recall # D-226-2010;

87) OMNITROPE (Somatropin [rDNA origin] for injection) and diluent with preservation (Bacteriostatic Water for Injection 1.14mL) 5.8MG, Rx Only, NDC #0781-4004-36. Cardinal Item #3918315. Recall # D-227-2010;

88) OMNITROPE" (Somatropin [rDNA origin] infection, 5MG/1.5ML CARTRIDGE, Rx Only, NDC #0781-3001-07. Recall # D-228-2010;

89) OVIDREL (choriogonadotropin alfa injection) Prefilled Syringe, 250MCG, 0.5ML, Rx Only, NDC #44087-1115-1. Cardinal Item #3532868. Recall # D-229-2010;

90) PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION, 5mg/5ml, 120 ml bottle, Rx only, NDC #50383-040-04. Cardinal Item #3484532. Recall # D-230-2010;

91) S-2 2.25% 30 X 0.5ML STERILE INHALATION, OTC, NDC #0487-5901-99. Cardinal Item #3235652. Recall # D-231-2010;

92) SOLUCLENZ RX GEL (Benzoyl Peroxide 5%), 27ML, Rx Only, NDC #62032-121-10. Cardinal Item #4100053. Recall # D-232-2010;

93) SURVANTA, (beractant) intratracheal suspension, Sterile Suspension For Intratracheal Administration Only, Not for Injection, 25MG/ML 4ML Single Use Vial, Rx only, NDC #0074-1040-04. Cardinal Item #2912814. Recall # D-233-2010;

94) SURVANTA (beractant) intratracheal suspension, 25MG/ML 8ML, Sterile Suspension For Intratracheal Administration Only, Not for injection, Rx Only, NDC #0074-1040-08. Cardinal Item #1006972. Recall # D-234-2010;

95) SYPRINE (Trientine Hydrochloride), 250MG Capsule X 100 Capsules, Rx only, NDC #25010-710-15. Cardinal Item #4028650. Recall # D-235-2010;

96) TETRACAINE HCL 1% (Tetracaine HCl Injection), USP, for Prolonged Spinal Anesthesia, 25 X 2ML, Rx only, NDC #11098-045-32. Cardinal Item #3605250. Recall # D-236-2010;

97) TEV-TROPIN" [Somatropin (rDNA origin) for Injection] 5MG 1Vial with Diluent, Reconstitute with Bacteriostatic 0.9% Sodium Chloride Injection, USP (Benzil Acolhol Preserved), Rx only, NDC #57844-713-19. Cardinal Item #4005211. Recall # D-237-2010;

98) TORISEL KIT, (temsirolimus), 25MG With Diluent, Rx Only, NDC #0008-1179-01. Cardinal Item #3994282. Recall # D-238-2010;

99) TRIFLURIDINE OPHTHALMIC SOLUTION, 1% 7.5ML Sterile, Rx only, NDC #61314-044-75. Cardinal Item #3258274. Recall # D-239-2010;

100) VFEND (voriconazole) For Oral Suspension, Orange Flavored, 40MG/ML 75ML, Rx only, NDC #0049-3160-44. Cardinal Item #3553385. Recall # D-240-2010;

101) VINCASAR PFS (vincristine sulfate injection, USP), 1MG/ML 1ML, Single Dose Vial, Rx only, NDC #0703-4402-11. Cardinal Item #2955359. Recall # D-241-2010;

102) VINCASAR PFS (vincristine sulfate injection, USP), 2MG/ 2ML, Single Dose Vial, Rx only, NDC #0703-4412-11. Cardinal Item #2955367. Recall # D-242-2010;

103) VINORELBINE TARTRATE INJECTION equivalent to vinorelbine, 10MG/ML 5ML Single-Use Vial, For Intravenous Use Only, Rx only, NDC #0703-4183-91. Cardinal Item #3493368. Recall # D-243-2010;

104) VINORELBINE TARTRATE INJECTION, equivalent to vinorelbine, For Intravenous use only, 10MG/ML 5ML Single-Use Vial, For Intravenous Use Only, Rx only, NDC #0703-4183-01. Cardinal Item #3450699. Recall # D-244-2010;

105) VIROPTIC OPHTHALMIC SOLUTION 1% (trifluuridine ophthalmic solution) Sterile, 7.5ML Drop Dose, Rx Only, NDC #61570-037-75. Cardinal Item #1341023. Recall # D-245-2010;

106) VITRASE (hyaluronidase injection) Ovine Kit, 200U/ML 6 Single Use Vials X 1.2ML, Rx only, NDC #67425-002-10. Cardinal Item #3638772. Recall # D-246-2010;

107) ZANOSAR (streptozocin sterile powder) 1GM 1 Single Dose Vial, For Intravenous Use Only, Rx only, NDC #0703-4636-01. Cardinal Item #3535937. Recall # D-247-2010;

108) INFASURF (calfactant), 35MG/ML 3ML Suspension, Single use vial, Rx only, NDC #0456-4600-03. Cardinal Health number: 3544327. Recall # D-248-2010;

109) INFASURF (calfactant), 35MG/ML 6ML Suspension, Single use vial, Rx only, NDC #0456-4600-06. Cardinal Health number: 2779338. Recall # D-249-2010;

110) PREMARIN Intravenous (conjugated estrogens, USP) for injection, 25MG 1Vial, Rx only, Wyeth, NDC #0046-0749-05. Cardinal Health number: 1124528. Recall # D-250-2010;

111) NORVIR (Ritonavir Capsules) Soft Gelatin, 100MG 30 capsules, Rx Only, NDC #0074-6633-30. Cardinal Health number: 3641016. Recall # D-251-2010;

112) NIMBEX Injection (cisatracurium besylate), 2MG/ML 10 X 5ML, Rx Only, NDC # 0074-4378-05. Cardinal Health number: 3011335. Recall # D-252-2010;

113) NIMBEX Injection (cisatracurium besylate), 200MG 10MG/ML 20ML, Rx Only, NDC #0074-4382-20. Cardinal Health number: 3000890. Recall # D-253-2010;

114) NIMBEX Injection (cisatracurium besylate), 20MG 2MG/ML 10 X 10ML, Rx Only, NDC #0074-4380-10. Cardinal Health number: 3000908. Recall # D-254-2010;

115) AMEVIVE IM KIT, 15 mg, 4 vials of lyophilized powder for injection, Rx Only, NDC #0469-0021-03. Cardinal Item #4061636. Recall # D-255-2010;

116) AMEVIVE IM KIT 15 mg, 1 vial lyophilized powder for injection, Rx Only, NDC #0469-0021-04. Cardinal Item #4038493. Recall # D-256-2010;

117) ARANESP (darpepoetin alfa) recombinant, 150MCG/0.75ML, 4 X 0.75ML Single Use Vials, Rx Only, NDC #55513-053-04. Cardinal Item #3772696. Recall # D-257-2010;

118) ARANESP (darpepoetin alfa) recombinant, SINGLEJECT 40MCG/0.4mL, 4 X 0.4 mL, Rx Only, NDC #55513-021-04. Cardinal Item #3746039. Recall # D-258-2010;

119) ARANESP (darpepoetin alfa) recombinant, SINGLEJECT 150MCG/0.3mL, 4 X 0.3mL, Rx Only, NDC #55513-027-04. Cardinal Item #3772712. Recall # D-259-2010;

120) ARANESP (darpepoetin alfa) recombinant, SINGLEJECT 60MCG/0.3mL, 4 X 0.3mL, Rx Only, NDC #55513-023-04. Cardinal Item #3745999. Recall # D-260-2010;

121) ARANESP (darpepoetin alfa) recombinant, SINGLEJECT 500MCG/1ML, Rx Only, NDC #55513-032-01. Cardinal Item #3735487. Recall # D-261-2010;

122) ARANESP (darpepoetin alfa) recombinant, SINGLEJECT 25MCG/0.4mL, 4 X 0.4mL, Rx Only, NDC #55513-057-04. Cardinal Item #3746070. Recall # D-262-2010;

123) ARANESP (darpepoetin alfa) recombinant, SINGLEJECT 200MCG/0.4mL, Rx Only, NDC #55513-028-01. Cardinal Item #3746062. Recall # D-263-2010;

124) ARANESP,(darpepoetin alfa) recombinant, SINGLEJECT 100MCG/0.5mL, 4 X 0.5mL, Rx Only, NDC #55513-025-04. Cardinal Item #3746047. Recall # D-264-2010;

125) ARANESP (darpepoetin alfa) recombinant, SURECLICK 40MCG/0.4mL, Rx Only, NDC #55513-091-01. Cardinal Item #3779394. Recall # D-265-2010;

126) ARANESP (darpepoetin alfa) recombinant, SURECLICK 200MCG/0.4mL, Rx Only, NDC #55513-095-01. Cardinal Item #3779360. Recall # D-266-2010;

127) ARANESP (darpepoetin alfa) recombinant, SINGLEJECT 300MCG/0.6mL, Rx Only, NDC #55513-111-01. Cardinal Item #3746005. Recall # D-267-2010;

128) ARANESP (darpepoetin alfa) recombinant, 200MCG/ML 1ML Single Use Vials, Rx only, NDC #55513-006-01. Cardinal Item #3772704. Recall # D-268-2010;

129) ARANESP (darpepoetin alfa) recombinant, 25MCG/ML, 4 X 1ML Single Use Vials, Rx only, NDC #55513-002-04. Cardinal Item #3772654. Recall # D-269-2010;

130) ARANESP (darpepoetin alfa) recombinant, 300MCG/ML, 1ML Single Use Vials, Rx only, NDC #55513-011-01. Cardinal Item #3746088. Recall # D-270-2010;

131) ARANESP (darpepoetin alfa) recombinant, 40MCG/ML, 4 X 1ML Single Use Vials, Rx only, NDC #55513-003-04. Cardinal Item #3772662. Recall # D-271-2010;

132) ARANESP (darpepoetin alfa) recombinant, 60MCG/ML, 4 X 1ML Single Use Vials, Rx only, NDC #55513-004-04. Cardinal Item #3772670. Recall # D-272-2010;

133) ARANESP (darpepoetin alfa) recombinant, 100MCG/ML, 4 X 1ML Single Use Vials, Rx only, NDC #55513-005-04. Cardinal Item #3772688. Recall # D-273-2010;

134) 134) AVASTIN INJ. (bevacizumab), 25MG/ML 16ML, List No. 16482, Single Use Vial, For Intravenous Use, Rx only, NDC #50242-061-01. Cardinal Item #3617701. Recall # D-274-2010;

135) AVASTIN INJ. (bevacizumab), 25MG/ML 4ML, List No. 15734, Single Use Vial, For Intravenous Use, Rx only, NDC #50242-060-01. Cardinal Item #3556156. Recall # D-275-2010;

136) AVONEX (Interferon beta-la), 30MCG, 4 VIAL, Rx only, NDC #59627-001-03.
Cardinal Item #2471043. Recall # D-276-2010;

137) CATHFLO ACTIVASE (ALTEPLASE), Powder for Inj. 2MG 1VIAL, For Use in Central Venous Access Devices, Rx only, NDC #50242-041-64. Cardinal Item #3289915. Recall # D-277-2010;

138) DDAVP Rhinal Tube, (desmopressin acetate), FOR Intranasal Use Only, 10MCG/0.1mL, 2.5ML, Rx Only, NDC #0075-2450-01. Recall # D-278-2010;

139) AMGEN ENBREL (etanercept), SURECLICK 50mg/mL, 4 Single-use Prefilled SureClick Autoinjectors, Rx only, NDC #58406-445-04. Cardinal Item #3742848. Recall # D-279-2010;

140) AMGEN ENBREL (etanercept), 25MG/4 Multiple-use Vial, Rx only, NDC #58406-425-34. Cardinal Item #2822518. Recall # D-280-2010;

141) AMGEN ENBREL (etanercept), 25MG/0.5ML, 4 Single-use Prefilled Syringes, Rx Only, NDC #58406-455-04. Cardinal Item #33965100. Recall # D-281-2010;

142) AMGEN ENBREL (etanercept), 4 x 50MG/ML Single-use Prefilled Syringes, Rx only, NDC #58406-435-04. Cardinal Item #3620416. Recall # D-282-2010;

143) AMGEN EPOGEN, (EPOETIN ALFA, recombinant), 10MU/ML 10X2ML Single Use Vials, Rx only, NDC #55513-283-10. Cardinal Item #2254944. Recall # D-283-2010;

144) AMGEN EPOGEN (EPOETIN ALFA, recombinant), 10MU/ML 10X1ML Single Use Vials, Rx only, NDC #55513-144-10. Cardinal Item #2716306. Recall # D-284-2010;

145) AMGEN EPOGEN (EPOETIN ALFA, recombinant), 20MU/ML 10 X 1ML Single Use Vials, Rx only, NDC #55513-478-10. Cardinal Item #2544286. Recall # D-285-2010;

146) AMGEN EPOGEN (EPOETIN ALFA, recombinant), 2MU/ML 10 X 1ML Single Use Vials, Rx only, NDC #55513-126-10. Cardinal Item #1718477. Recall # D-286-2010;

147) AMGEN EPOGEN (EPOETIN ALFA, recombinant), 3MU/ML 10 X 1ML Single Use Vials, Rx only, NDC #55513-267-10. Cardinal Item #1814060. Recall # D-287-2010;

148) AMGEN EPOGEN (EPOETIN ALFA, recombinant), 40MU/ML 10 X 1ML Single Use Vials, Rx only, NDC #55513-823-10. Cardinal Item #2849156. Recall # D-288-2010;

149) AMGEN EPOGEN (EPOETIN ALFA, recombinant), 4MU/ML 10 X 1ML Single Use Vials, Rx only, NDC #55513-148-10. Cardinal Item #1718469. Recall # D-289-2010;

150) HERCEPTIN KIT (Trastizibab), 440MG Multi-dose Vial, Rx only, NDC #50242-134-68. Cardinal Item #3515020. Recall # D-290-2010;

151) HUMIRA PEN (adalimumab) 40MG/0.8ML 27G Needle 2 Single-Use Prefilled Pens, For Subcutaneous Use Only, Rx only, NDC #0074-4339-02. Cardinal Item #3744547. Recall # D-291-2010;

152) HUMIRA PEN (adalimumab) 40MG/0.8ML 27G Needle 6 Single-Use Prefilled Pens, Crohn's Disease Starter Package, Rx Only, NDC #0074-4339-06. Cardinal Item #3946522. Recall # D-292-2010;

153) HUMIRA (adalimumab) Syringe, 40MG/0.8ML 2 Single-Use Prefilled Syringes (2), 40mg/0.8mL, For Subcutaeoous Use Only, Rx only, NDC #0074-3799-02. Cardinal Item #3450400. Recall # D-293-2010;

154) INFERGEN (Interferon alfacon-1), A recombinant consensus alpha interferon, For Subcutaneous Use Only, 15MCG/0.5ML 6X0.5ML, Single-Use Vials, Rx only, NDC #0187-2006-05. Cardinal Item #4072393. Recall # D-294-2010;

155) INFERGEN (Interferon alfacon-1), A recombinant consensus alpha interferon, For Subcutaneous Use Only, 9MCG/0.3ML 6X0.3ML, Single-Use Vials, Rx only, NDC #0187-2007-06. Cardinal Item #4072385. Recall # D-295-2010;

156) INTRON A (Interferon Alfa-2b, recombinant) Solution for Injection 10MMU/0.2ML 1.5ML, Multidose Pen, For Subcutaneous Use, Rx only, NDC #0085-1254-01. Cardinal Item #2778710. Recall # D-296-2010;

157) INTRON A (Interferon Alfa-2b, recombinant) Solution for Injection, 25 million IU multidose vial, 5 million IU/0.5 mL, For Intramuscular/Subcutaneous Use. Rx only, Schering, NDC #0085-1133-01. Cardinal Item #2539237. Recall # D-297-2010;

158) INTRON A (Interferon Alfa-2b, recombinant) Solution for Injection 6MMU/ML 3.8ML, Multidose vial, For Intramuscular/Subcutaneous Use. Rx only, NDC #0085-1168-01. Cardinal Item #2539229. Recall # D-298-2010;

159) Interferon Alfa-2b, recombinant 10MMU 1 Vial with Diluent, Rx only, NDC #0085-0571-02. Cardinal Item #1067156. Recall # D-299-2010;

160) KINERET (anakinra), 100MG/0.67ML 28X0.67ML, Single Use Prefilled Glass Syringes with 27 Gauge Needles, Rx Only, NDC #55513-177-28. Cardinal Item #3552437. Recall # D-300-2010;

161) LACTINEX" (Lactobacillus) (Granules/Dietary Supplement), 12X1GM, OTC, Becton Dickinson Microbiology System, NDC #8290-2367-12. Cardinal Item #1116938. Recall # D-301-2010;

162) LACTINEX" 50, (Lactobacillus), OTC, Becton Dickinson Microbiology System, NDC #8290-2368-50. Cardinal Item #1116946. Recall # D-302-2010;

163) AMGEN NEULASTA (PEGFILGRASTIM), Pegylated Recombinant Methionyl Human Granulocyte Colony Stimulating Factor (PEG-r-metHuG-CSF) derived from Ecoli, 6MG/0.6ML 0.6ML, Single Use Prefilled Syringe, For Subcutaneous Use Only, Sterile Solution, Rx Only, NDC #55513-190-01. Cardinal Item #3337318. Recall # D-303-2010;

164) PROCRIT (EPOETIN ALFA) Sterile Solution for Injection, For Intravenous or Subcutaneous Use Only, 10MU/ML 25X1ML Vials, Rx Only, NDC #59676-310-02. Cardinal Item #1910512. Recall # D-304-2010;

165) PROSTIN VR PEDIATRIC (alprostadil injection, USP). 5X1ML Ampoules, Rx only, NDC #0009-3169-06. Cardinal Item #1703644. Recall # D-305-2010;

166) PULMOZYME Inhalation Solution, (Dornase Alfa), 1MG/ML, as 30 X 2.5ML Ampules, Rx Only, NDC #50242-100-40. Cardinal Item #1368455. Recall # D-306-2010;

167) REOPRO Solution, (ABCIXIMAB), 2MG/ML 5ML Vial, Rx only, NDC #0002-7140-01. Recall # D-307-2010;

168) RITUXAN (Rituximab) Injection, 10MG/ML Vial, 10ML Vial, For Intravenous Use, Rx only, NDC #50242-051-21. Cardinal Item #2714749. Recall # D-308-2010;

169) VECTIBIX (panitumumab), SINGLE USE VIAL INJECTION 20MG/ML 10ML, Rx only, NDC #55513-955-01. Cardinal Item #3805181. Recall # D-309-2010;

170) VECTIBIX (panitumumab), Single Use Vial 20MG/ML 20ML, Rx only, NDC #55513-956-01. Cardinal Item #3805199. Recall # D-310-2010;

171) VECTIBIX (panitumumab), Single Use Vial Injection 20MG/ML 5ML, Rx only, NDC #55513-954-01. Cardinal Item #3805173. Recall # D-311-2010;

172) XIGRIS (Drotrecogin alfa, activated), 1 x 5MG Vial, For Intravenous Use, Rx only, NDC #0002-7559-01. Cardinal Item #3310158. Recall # D-312-2010;

173) XIGRIS (Drotrecogin alfa, activated), 1 x 20MG Vial, Rx only, Eli Lilly, NDC #0002-7561-01. Cardinal Item #3310174. Recall # D-313-2010
CODE
1) Lot #146044F;

2) Lot #7N211, 8A206, and 31301422B;

3) Lot #0427A1AA, 042792AA, 042793AA, 0427A7AA, 04791AA, 047291AA, 0427A1AA, 0427A6AA, 042801AA, 042793AA, 042802AA, 0427A7AA and 042795AA;

4) Lot #HD10158, HD012G8 and HD012G8;

5) Lot #HD011F8 and HD012G8;

6) Lot #7U7AB;

7) Lot # A28650;

8) Lot #22074A;

9) Lot #470U020, 40U020, 40U036, 40U041, 40U299, 40U047 and 40U064;

10) Lot #40U109 and 40U113;

11) Lot #501247G, 559403AB, 559405AM, 743080S, 769584N and 795052B;

12) Lot #PF2001 and PL2399;

13) Lot # P32058, P32059, P32060, P32061, P32062 and P32064;

14) Lot #ZE7BS, AM7BS, ZM7BS, ZM7B2 and 388BS;

15) Lot #057BS, 0A7BS, 0R7BS and 0M7BS;

16) Lot #0APPY, 0APYY and 0ARJW;

17) Lot #203489, 203594, 203610, 203617, 203531, 203552, 203599, 203639 and 203667;

18) Lot #7D622;

19) Lot #31301824A and 31301824B;

20) Lot #31301594B and 31301971B;

21) Lot #0563X, 1109X, 1236X, 0943X, 0944X and 0710X;

22) Lot #0986X, 1310X, 1077X, 1108X and 1239X;

23) Lot #OAPF2 and OAWFP;

24) Lot #68225EV, 64293EV and 61117EV;

25) Lot #62133EV and 68226EV;

26) Lot #42320A and 42309A;

27) Lot #41995A, 42085A, 42166A and 42196A;

28) Lot #202899;

29) Lot #63-386-DJ;

30) Lot # WC07120 and WC08007;

31) Lot #085832, 082856 and 084983;

32) Lot #084613, 083650, 084612, 085053 and 084970;

33) Lot #337651, 307331 and 317601;

34) Lot #59350DD and 59355DD;

35) Lot #8B104, 31302138B and 31302276B;

36) Lot #7P125 and 8B109;

37) Lot #68415DD and 63545DD;

38) Lot #63540DD;

39) Lot #080974B;

40) Lot #0812820, 0228412, 0806981 and 0728412;

41) Lot #2719, 2786, 2756, 2827, 2995, 2996 and 2907;

42) Lot #2771, 2775, 2814, 2844, 2685, 2788, 2829, 2846, 2882, 2953, 3185, 2955, 3026 and 3097;

43) Lot #2905;

44) Lot #2794;

45) Lot # F687A and H946A;

46) Lot # 0403X;

47) Lot #1199426;

48) Lot #7P621, 7E635 and 7C635;

49) Lot #7S618;

50) Lot #S0176B;

51) Lot #S0165A, S0166A, S0167 and S0167A;

52) Lot #A401759K, A404808A and A409327A;

53) Lot # DH10009;

54) Lot # 701100;

55) Lot #1254572;

56) Lot #1254576;

57) Lot # 63198EV;

58) Lot #64174EV, 65199EV;

59) Lot #7H114 and 31301344B;

60) Lot #7H112, 7H113 and 3130285B;

61) Lot #404281;

62) Lot # A491801C;

63) Lot # A431046D;

64) Lot # A402933A, A409591E, A402932C and A425646F;

65) Lot #31430860B and 31300860B;

66) Lot #7N619 and 31302398B;

67) Lot #800716 and 807012;

68) Lot # NN0014, NN0048, NP0103, NP0105, NP0106, NP0108, PB0011, PB0013, PB0014, PH0061, PH0062, PH0063, PN0089, 8134A and 8135A;

69) Lot #8017A, 8033A, 8018A, 8021A, 8032A, 8033A, 8132A and 8133A;

70) Lot # A33755C, A35570B, A35570C, A33374C and A33374B;

71) Lot #8029A and 8030A;

72) Lot # PF0136;

73) Lot #488GA, 3K8GA and AK8GA;

74) Lot #448GV and 8P7GV;

75) Lot #08D010B;

76) Lot #0L7GA;

77) Lot #VU60265, VU60665, TU60771, TU61145, TU60980, TU61145, TU61509, VU60382 and VU60464;

78) Lot # TU60705, TU61110, TU61501 and VU60407;

79) Lot # TC70791, TC70601, TC70826, TC70741, TC70716, TC70689, TC70770 and TC70734;

80) Lot # TC70842, TC70599, TC70631, TC70812, TC70687, TC70715, TC70740, TC70732, TC70735, TC70686;

81) Lot #5R8A;

82) Lot #1178517, 1242233 and 130560

83) Lot #1330801;

84) Lot #1316434;

85) Lot #31300725B, 31301329B and 8A210;

86) Lot #641782E21, 624762E22, 641752E21, 624802E24, 641872E21, 641882E21 and 656962E22;

87) Lot # S0002, S0007, S0072, 51556791, 51557445, 51557991, 51556103, 51556101, 51558539, 51559166, 51559362, 51559589, 51557943, 51558866, 51558806, 51560116 and 51561372;

88) Lot #51558457;

89) Lot #Y10B9754, Y10B7223 and Y10B3795;

90) Lot #814040, 813040, 812040, 811040 and 810040;

91) Lot # R8032A and R8042A;

92) Lot # H06108B, H06058B and H06098B;

93) Lot #63709Z7and 63819Z7;

94) Lot #63820Z7;

95) Lot #8A067, 8A066, 8B171, 8B170, 8A065 and 8A064;

96) Lot #91507 and 81227;

97) Lot #50810440;

98) Lot #P00005AB;

99) Lot #137683F;

100) Lot #8245902, 0135K08A, 8245902 and 0240K08A;

101) Lot #7L625;

102) Lot #31300738B;

103) Lot #7N623;

104) Lot #7N624P1;

105) Lot #46699;

106) Lot # W0004736, W0004709, W0004693, W0004610, W0004608, W0004577, W0004576, W0004574, W0004552, W0004545, W0004538, W0005437, W0004540,W0004519, W0004518, W0004517, W0004506, W0004504, W0004495, W0004493, W0004491, W0004477, W0004475 and W0004461;

107) Lot #7E610, 6N601, 8B604 and 31301012B;

108) Lot number: 71904298 and 71103258;

109) Lot number: 70503048, 71204018 and 72506248;

110) Lot number: 08P013A;

111) Lot numbers: 641782E21, 624762E22, 641752E21, 624802E24, 641872E21, 641882E21, 656962E22;

112) Lot numbers: 63490DD;

113) Lot numbers: 63305DD;

114) Lot numbers: 62025DD, 62420DD and 64340DD;

115) Lot #-27007;

116) Lot #P27005 and 27004;

117) Lot #P113561;

118) Lot #P115744 and 1006259;

119) Lot #P104612, P097880 and 1007217;

120) Lot #P115737;

121) Lot #P097881and P102341;

122) Lot # P115757;

123) Lot #P104613;

124) Lot #1007780 and P122921;

125) Lot #1001038;

126) Lot #1001001;

127) Lot #P104599;

128) Lot #P107119;

129) Lot #-113562 and 1005205;

130) Lot #P102536 and 1006257;

131) Lot #P107113 and P122925;

132) Lot #P115733;

133) Lot #P122923, P122924 and 1005192;

134) Lot #716263, 717231, 717232, 728878, 728879, 728881and 739030;

135) Lot #706437, 708781, 706439, 735153, 737522 and 740494;

136) Lot #P011116, P01114 and P01117;

137) Lot #717230, 723332, 723340, 723411, 708807 and 723411;

138) Unknown

139) Lot # P115908, P118867, P11867, P118868, P118869, P118870, P11870, P118871, 1005248 and P118872;

140) Lot #D108961, D114429, D119037, D127514, and D127517;

141) Lot #1006138 and 106229;

142) Lot #P045101, P109306, P109307, P115705, P115706 and P115709;

143) Lot #P113702, P113701, P122570;

144) Lot #P113681, P113638, P113639, P113680and P113640;

145) Lot #P113705 and 122558;

146) Lot #P102165, P113147 and P122524;

147) Lot #P118859, P124804, 1005265;

148) Lot P069760 and P095191;

149) Lot #P122567, P122568, P122635, 1005232 and 1005233;

150) Lot #722385, 724365, 724370, 724370, N73218 and 725428;

151) Lot #61141SP40, 61141SP40, 611399A40, 60129LJ40, 61141SP40, 611429A41, 62149LJ40, 62146LJ40, 611389A40, 58106LX41, 60131LJ40, 611429A41, 68106LX41, 611389A40, 63168LJ40, 62146LJ40, 62149LJ40, 61141SP40, 611399A40, 68106LX41, 60131LJ40, 60131LJ, 59118LX40, 60132LJ40, 59118LX40, 60129LJ40, 60132LJ40, 61141SP40 and 60131LJ;

152) Lot #64188SP, 58105LX, 58105LX and 64188SP;

153) Lot #56078LX41, 56079LX41, 59120LX40, 62161LJ40, 641779A40, 64181SP40, 64184SP40, 591129A40, 64179SP40, 64170SP40, 641795P, 64179SP;

154) Lot # P094914 and P083996;

155) Lot # P115874;

156) Lot #8 CO 3001, 8 CO 3002, 8 CO 3003, 8 CO 3004 and 8 CO 2001;

157) Lot #7IOT404;

158) Lot #7IOQ403;

159) Lot #8CO201 and 8CO202;

160) Lot # P086263 and P084061;

161) Lot #8205508, 8140483, 8163945 and 8197372;

162) Lot #8217097, 8148202, 8168255 and 8182430;

163) Lot # P113628, P113629, P104493, P107037, P137107 and P107038;

164) Lot # D121439A, D091540A, D091536A and D091538A;

165) Lot #0AMRY;

166) Lot #707783, 704788, 704789, 705949, 705997 and 706758;

167) Lot #06L13AA and 07A04AA;

168) Lot #705394, 719292, 737039 and 737040;

169) Lot #1007223, D103289, D080740 and D080739;

170) Lot # D100364, D103342, D096222 and D096223;

171) Lot #1007223, 1008047, D081366, D094109, and D103289;

172) Lot # A36171, A34507;

173) Lot # A25690, A26979
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cardinal Health Care, McDonough, GA, by telephone beginning November 6, 2008 and letters on November 13, 2008.
Manufacturer: Gilead Sciences Inc., San Dimas, CA. Firm initiated recall is complete.
REASON
Temperature abuse; Product stability may have been compromised due to defective refrigeration storage unit.
VOLUME OF PRODUCT IN COMMERCE
Approximately 11,000 packages/units
DISTRIBUTION
AL, GA, MO, MS, SC, TN and WV

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Cornea. Recall # B-0104-10
CODE
CM112806OS and CM112806OD
RECALLING FIRM/MANUFACTURER
Lions Eye Bank of New Jersey, Springfield, NJ, by letter on January 30, 2009. Firm initiated recall is complete.
REASON
Human tissue, recovered from a donor history indicated increased risk factors for Creutzfeldt-Jacob disease. Tissues had been distributed for transplantation.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ, IL
___________________________________
PRODUCT
DBX Demineralized Bone Matrix, Mix 5 cc MTF Musculoskeletal Transplant Foundation Available through Synthes (USA) Pretreated with Gamma Irradiation. Tissue is recovered under aseptic conditions. Human Allograft Tissue, Passes USP <72> for Sterility. Item number 058050. Recall # B-0347-10
CODE
Exp 07Aug2011, Serial number: 02309028121056
RECALLING FIRM/MANUFACTURER
Musculoskeletal Transplant Foundation, Edison, NJ, by telephone beginning November 4, 2009 and letters on November 9, 2009. Firm initiated recall is ongoing.
REASON
Demineralized Bone Matrix with discoloration and the presence of Penicillium chrysogenum, was distributed.
VOLUME OF PRODUCT IN COMMERCE
43 units
DISTRIBUTION
MO, CT, PA, NY, AR, MS, LA, NH, NE, CA, VA, VT TN, KY, FL
___________________________________
PRODUCT
1) Fresh Frozen Plasma . Recall # B-0369-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0370-10
CODE
1) Unit: 06GL72717;
2) Unit: 06GL72717, 06LK95029
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by telephone and electronic notification on May 15, 2009 and by letter dated May 16, 2009. 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
3 units
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Cryoprecipitated AHF. Recall # B-0374-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0376-10
CODE
1) and 2) Unit: 06LR43238
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by telephone and electronic notification and letter dated July 22, 2009. 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
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-0381-10
CODE
Units: GA0937998, GA0939920
RECALLING FIRM/MANUFACTURER
DCI Biologicals LLC, Gallup, NM, by e-mail on June 16, 2009. 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
Austria
___________________________________
PRODUCT
Source Plasma. Recall # B-0382-10
CODE
Units: LC0561563, LC0561864, LC0562407, LC0562704, LC0563287, LC0563555, LC0564035, LC0564623, LC0565261, LC0565571, LC0566074, LC0566302, LC0566839, LC0578069, LC0583103, LC0586335, LC0587194, LC0587870, LC0588454, LC0588816, LC0589358, LC0589691, LC0590257, LC0590599, LC0591187, LC0592776, LC0593061, LC0593570, LC0593916, LC0595086, LC0595464, LC0596619, LC0598300, LC0598705, LC0599312, LC0600114, LC0600982, LC0601927, LC0602832, LC0603730, LC0608356, LC0608591, LC0609170, LC0609670, LC0609970, LC0610503, LC0610955, LC0611291, LC0611653, LC0611979, LC0612367, LC0612685, LC0613242, LC0613463, LC0614177, LC0614583, LC0614915, LC0615549, LC0615976, LC0616505, LC0617030, LC0617385, LC0617794, LC0618036
RECALLING FIRM/MANUFACTURER
Las Cruces Biologicals LLC, Las Cruces, NM, by e-mail on June 16, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
64 units
DISTRIBUTION
CA, UK
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0384-10
CODE
Unit: 20E58268
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Salt Lake City, UT, by facsimile and electronic notification on June 28, 2007. 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
ID
___________________________________
PRODUCT
Source Plasma. Recall # B-0386-10
CODE
Unit: 4240171017
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Davenport, IA, by letter dated July 7, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not receive a complete physical examination, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Germany

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Cryoprecipitated AHF, Pooled. Recall # B- 0084-10
CODE
Units: 3881, 3882 and 3901
RECALLING FIRM/MANUFACTURER
The American National Red Cross-Great Lakes Region, Lansing, MI, by telephone on December 18, 2006. Firm initiated recall is complete.
REASON
Blood products, which may have been exposed to unacceptable temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
MI
___________________________________
PRODUCT
Source Plasma. Recall # B-0277-10
CODE
Units: 380097217, 380096610, 380095940, 380094594, 380091794, 380078977, 380078586, 380077863, 380077457, 380075252, 380074383, 380073739, 380073336, 380071536, 380070840, 380070484, 380069812, 380069457, 380068834, 380068301, 380067818, 380067142, 380066347, 380065655, 380065311, 380064209, 380063431, 380061215, 380060309, 380059473, 380058887, 380058619, 380056989, 380056711, 380055552, 380055249, 380054761, 380050031, 380048410, 380047971, 380047263, 380046664, 380045368, 380043977, 380043601, 380043077, 380042670, 380042097, 380041736, 380041059, 380040669, 380039973, 380039599, 380038545, 380037934, 380036642, 380036209, 380035640, 380035104, 380032401, 380029947, 380029748, 380028755, 380028092, 380027784, 380026988, 380026425, 380026098, 380024175, 380023880, 380023227, 380022418, 380021626, 380021100, 380019762, 380019356, 380018662, 380018309, 380017539, 380017153, 380016327, 380015432, 380015824, 380014939, 380014177, 380013749, 380005146, 380004636, 380003476, 380002981, 380002275, 380001664, 380001079, I60096951, I60095370, I60094386, I60093822, I60093234, I60077333, I60079078
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources Inc., Monroe, LA, by facsimile on October 27, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who previously tested positive for the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
100 Units
DISTRIBUTION
NC
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0371-10
CODE
Unit: 06LK95029
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by telephone and electronic notification on May 15, 2009 and by letter dated May 16, 2009.
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
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0375-10
CODE
Unit: 06LR43238
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by telephone and electronic notification and letter dated July 22, 2009. 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
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0383-10
CODE
Units: 20T89092, 20E58268
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Salt Lake City, UT, by facsimile and electronic notification on June 28, 2007. 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
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0385-10
CODE
Unit: 22FV99313
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by facsimile on June 25, 2009 and by letter dated July 13, 2009. Firm initiated recall is complete.
REASON
Blood product, incorrectly labeled as to red cell antigen type, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
1) Decathalon 24CM DECATHLON STD KIT Models: DE19SH24 and DE19SH24-K 15.5 Fr Polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Recall # Z-0288-2010;

2) 28CM DECATHLON STD KIT Models: DE23SH28 and DE23SH28-K 15.5 Fr Polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Recall # Z-0289-2010;

3) 32CM DECATHLON STD KIT Model: DE27SH32 and DE27SH32-K 15.5 Fr Polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Recall # Z-0290-2010;

4) 36CM DECATHLON STD KIT Models: DE31SH36 and DE31SH36-K 15.5 Fr Polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Kit 28cm Decathlon Std Kit. Recall # Z-0291-2010;

5) 40CM DECATHLON STD KIT Models: DE35SH40 and DE35SH40-K 15.5 Fr Polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Recall # Z-0292-2010;

6) 55CM DECATHLON STD KIT Models: DE50SH55 and DE50SH55-K 15.5 Fr Polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Recall # Z-0293-2010;

7) 24CM DECATHLON FUNNEL TIP STD KIT Model: DF19SH24 DECATHLON FUNNEL TIP 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated funnel tips, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter with stylet, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr dilator, 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free. Recall # Z-0294-2010;

8) 28CM DECATHLON FUNNEL TIP STD KIT Model: DF23SH28 DECATHLON FUNNEL TIP 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated funnel tips, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter with stylet, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr dilator, 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free. Recall # Z-0295-2010;

9) 32CM DECATHLON FUNNEL TIP STD KIT Model: DF27SH32 DECATHLON FUNNEL TIP 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated funnel tips, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter with stylet, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr dilator, 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free. Recall # Z-0296-2010;

10) 36CM DECATHLON FUNNEL TIP STD KIT Model: DF31SH36 DECATHLON FUNNEL TIP 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated funnel tips, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter with stylet, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr dilator, 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free Recall # Z-0297-2010;

11) 40CM DECATHLON FUNNEL TIP STD KIT Model: DF35SH40 DECATHLON FUNNEL TIP 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated funnel tips, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter with stylet, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr dilator, 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free. Recall # Z-0298-2010;

12) 55CM DECATHLON FUNNEL TIP STD KIT Model: DF50SH55 DECATHLON FUNNEL TIP 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated funnel tips, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter with stylet, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr dilator, 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free. Recall # Z-0299-2010;

13) 24CM DECATHLON FUNNEL TIP CATHETER Model: DF19SH24-100 DECATHLON FUNNEL TIP - CATHETER ONLY 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Latex free. Recall # Z-0300-2010;

14) 28CM DECATHLON FUNNEL TIP CATHETER Model: DF23SH28-100 DECATHLON FUNNEL TIP - CATHETER ONLY 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Latex free. Recall # -0301-2010;

15) 32CM DECATHLON FUNNEL TIP CATHETER Model: DF27SH32-100 DECATHLON FUNNEL TIP - CATHETER ONLY 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Latex free. Recall # Z-0302-2010;

16) 24CM DECATHLON MINI KIT Model: DM19SH24 DECATHLON MINI KIT 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle, 16 Fr valved peel-away sheath dilator, tunneling stylet, (2) injection sealing caps, and warning label. Latex free. Recall # Z-0303-2010;

17) 28CM DECATHLON MINI KIT Model : DM23SH28 DECATHLON MINI KIT 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle, 16 Fr valved peel-away sheath dilator, tunneling stylet, (2) injection sealing caps, and warning label. Latex free. Recall # Z-0304-2010;

18) 32CM DECATHLON MINI KIT Model: DM27SH32 DECATHLON MINI KIT 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge intro. Recall # Z-0305-2010;

19) 24CM DECATHLON EXCHANGE KIT Model: DX19SH24-XP DECATHLON MINI KIT 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle, 16 Fr valved peel-away sheath dilator, tunneling stylet, (2) injection sealing caps, and warning label. Latex free. Recall # Z-0306-2010;

20) 28CM DECATHLON EXCHANGE KIT Model: DX23SH28-XP DECATHLON MINI KIT 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle, 16 Fr valved peel-away sheath dilator, tunneling stylet, (2) injection sealing caps, and warning label. Latex free. Recall # Z-0307-2010;

21) 32CM DECATHLON EXCHANGE KIT Model: DX27SH32-XP DECATHLON MINI KIT 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle, 16 Fr valved peel-away sheath dilator, tunneling stylet, (2) injection sealing caps, and warning label. Latex free. Recall # Z-0308-2010;

22) 24CM DECATHLON GOLD STD KIT Models: DEC19SH24 and DEC19SH24-K DECATHLON GOLD 15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr dilator, 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free. Recall # Z-0309-2010;

23). 28CM DECATHLON GOLD STD KIT Model: DEC23SH28 and DEC23SH28-K. Recall # Z-0310-2010;

24) 32CM DECATHLON GOLD STD KIT Models: DEC27SH32 and DEC27SH32-K DECATHLON GOLD 15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr dilator, 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free. Recall # Z-0311-2010;

25) 36CM DECATHLON GOLD STD KIT Model: DEC31SH36 and DEC31SH36-K DECATHLON GOLD 15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr dilator, 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free. Recall # Z-0312-2010;

26) 40CM DECATHLON GOLD STD KIT Model: DEC35SH40 and DEC35SH40-K DECATHLON GOLD 15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr dilator, 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free. Recall # Z-0313-2010;

27) 55CM DECATHLON GOLD STD KIT Models: DEC50SH55 and DEC50SH55-K DECATHLON GOLD 15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr dilator, 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free. Recall # Z-0314-2010;

28) 24CM DECATHLON GOLD FUNNEL TIP STD KIT Models: DFC19SH24 and DFC19SH24-K DECATHLON GOLD FUNNEL TIP 15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated funnel tips, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter with stylet, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr dilator, 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free. Recall # Z-0315-2010;

29) 28CM DECATHLON GOLD FUNNEL TIP STD KIT Models: DFC23SH28 and DFC23SH28-K DECATHLON GOLD FUNNEL TIP 15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated funnel tips, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter with stylet, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr dilator, 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free. Recall # Z-0316-2010;

30) 32CM DECATHLON GOLD FUNNEL TIP STD KIT Model: DFC27SH32 15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated funnel tips, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter with stylet, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr dilator, 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free. Recall # Z-0317-2010;

31) 24CM ALTA LR STANDARD KIT High Flow Recirculation Catheter Model: AL19SH24 ALTA CATHETER WITH SIDE HOLES 15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch x 100 cm marked guidewire, 12Fr dilator, 14Fr dilator, 16Fr valved peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free. Recall # Z-0318-2010;

32) 28CM ALTA LR STANDARD KIT High Flow Recirculation Model: AL23SH28 ALTA CATHETER WITH SIDE HOLES 15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch x 100 cm marked guidewire, 12Fr dilator, 14Fr dilator, 16Fr valved peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free. Recall # Z-0319-2010;

33) 32CM ALTA LR STANDARD KIT Model: AL27SH32 ALTA CATHETER WITH SIDE HOLES 15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch x 100 cm marked guidewire, 12Fr dilator, 14Fr dilator, 16Fr valved peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free. Recall # Z-0320-2010;

34) 36CM ALTA LR STANDARD KIT Model: AL31SH36 ALTA CATHETER WITH SIDE HOLES 15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch x 100 cm marked guidewire, 12Fr dilator, 14Fr dilator, 16Fr valved peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free. Recall # Z-0321-2010;

35) 40CM ALTA LR STANDARD KIT Model: AL35SH40 ALTA CATHETER WITH SIDE HOLES 15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch x 100 cm marked guidewire, 12Fr dilator, 14Fr dilator, 16Fr valved peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free. Recall # Z-0322-2010;

36) 24CM ALTA LR STANDARD KIT Model: AL19NH24 ALTA CATHETER WITH NO SIDE HOLES 15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff, and no side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle,12cc syringe, J/straight 0.038 inch x 100 cm marked guidewire, 12Fr dilator, 14Fr dilator, 16Fr valved peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free. Recall # Z-0323-2010;

37) 28CM ALTA LR STANDARD KIT Model: AL23NH28 ALTA CATHETER WITH NO SIDE HOLES 15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff, and no side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle,12cc syringe, J/straight 0.038 inch x 100 cm marked guidewire, 12Fr dilator, 14Fr dilator, 16Fr valved peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free. Recall # Z-0324-2010;

38) 32CM ALTA LR STANDARD KIT Model: AL27NH32 ALTA CATHETER WITH NO SIDE HOLES 15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff, and no side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle,12cc syringe, J/straight 0.038 inch x 100 cm marked guidewire, 12Fr dilator, 14Fr dilator, 16Fr valved peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free. Recall # Z-0325-2010;

39) 36CM ALTA LR STANDARD KIT Model: AL31NH36 ALTA CATHETER WITH NO SIDE HOLES 15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff, and no side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle,12cc syringe, J/straight 0.038 inch x 100 cm marked guidewire, 12Fr dilator, 14Fr dilator, 16Fr valved peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free. Recall # Z-0326-2010;

40) 24CM ALTA EXCHANGE KIT Model: AL19SH24-XP ALTA EXCHANGE KIT 15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Latex free. Recall # Z-0327-2010;

41) 28CM ALTA EXCHANGE KIT Model: AL23SH28XP ALTA EXCHANGE KIT 15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Latex free. Recall # Z-0328-2010;

42) 32CM ALTA EXCHANGE Model: AL27SH32XP ALTA EXCHANGE KIT 15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Latex free. Recall # Z-0329-2010;

43) 24CM ALTA LR GOLD STD KIT Model: ALC19SH24 ALTA GOLD 15.5 Fr polyurethane twin lumen fixed tip heparin coated hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch x 100 cm marked guidewire, 12Fr dilator, 14Fr dilator, 16Fr valved peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free. Recall # Z-0330-2010;

44) 28CM ALTA LR GOLD STD KIT Model: ALC23SH28 ALTA GOLD 15.5 Fr polyurethane twin lumen fixed tip heparin coated hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch x 100 cm marked guidewire, 12Fr dilator, 14Fr dilator, 16Fr valved peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free. Recall # Z-0331-2010;

45) 32CM ALTA LR GOLD STD KIT Model: ALC27SH32 ALTA GOLD 15.5 Fr polyurethane twin lumen fixed tip heparin coated hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch x 100 cm marked guidewire, 12Fr dilator, 14Fr dilator, 16Fr valved peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free. Recall # Z-0332-2010;

46) 36CM ALTA LR GOLD STD KIT Model: ALC31SH36 ALTA GOLD 15.5 Fr polyurethane twin lumen fixed tip heparin coated hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch x 100 cm marked guidewire, 12Fr dilator, 14Fr dilator, 16Fr valved peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free. Recall # Z-0333-2010;

47) 40CM ALTA LR GOLD STD KIT Model: ALC35SH40 ALTA GOLD 15.5 Fr polyurethane twin lumen fixed tip heparin coated hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch x 100 cm marked guidewire, 12Fr dilator, 14Fr dilator, 16Fr valved peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free. Recall # Z-0334-2010;

48) 55CM ALTA LR GOLD STD KIT Model: ALC50SH55 ALTA GOLD 15.5 Fr polyurethane twin lumen fixed tip heparin coated hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch x 100 cm marked guidewire, 12Fr dilator, 14Fr dilator, 16Fr valved peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free. Recall # Z-0335-2010
CODE
All lot codes
RECALLING FIRM/MANUFACTURER
Spire Biomedical, Inc., Bedford, MA, by letter dated October 22, 2009. Firm initiated recall is ongoing.
REASON
There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respiration.
VOLUME OF PRODUCT IN COMMERCE
55,218 units
DISTRIBUTION
Nationwide, Canada, France
___________________________________
PRODUCT
1) System Storage Cart, product code CART; SurgASSIST Service Manual, product code SRVM; SurgASSIST System Starter Kit, product code Surg200; SurgASSIST System with Integrated Controls, product code Surg300; Operator Manual, product code OPMA. Recall # Z-0392-2010;

2) Circular Stapler 21 mm Digital Loading Unit, product code CS21; Circular Stapler 25 mm Digital Loading Unit, product code CS25; Circular Stapler 29 mm Digital Loading Unit, product code CS29; Circular Stapler 33 mm Digital Loading Unit, product code CS33. Recall # Z-0393-2010;

3) Right Angle Linear Cutter, 30 mm Digital Loading Unit, product code RALC30; Right Angle Linear Cutter, 30 mm Vascular Digital Loading Unit, product code RALC30V; Right Angle Linear Cutter, 45 mm Digital Loading Unit, product code RALC45. Recall # Z-0394-2010;

4) Remote Control Unit with Wire, product code RCW100. Recall # Z-0395-2010;

5) Straight Linear Cutter 55 mm Blue Digital Loading Unit, product code SLC55B; Straight Linear Cutter 55 mm Green Digital Loading Unit, product code SLC55G; Straight Linear Cutter 55 mm Blue Reload, product code SLCR55B; Straight Linear Cutter 55 mm Green Reload, product code SLCR55G; Straight Linear 4 Row No Knife Digital Loading Unit, product code SLS55B4. Recall # Z-0396-2010;

6) FlexShaft, product code FS14; FlexShaft II, product code FS214; FlexShaft III, product code FS312; FlexShaft III Sterilization Connector Guard, product code FS3SCG; FlexShaft II Reconditioned, product code FS214RC; Manual Release for FlexShaft II & III, product code MR14. Recall # Z-0397-2010;

7) Power Linear Cutter 75 mm, Reusable Digital Loading Unit, product code PLC75; Power Linear Cutter Reload, 75 mm Blue, product code PLCR75B; Power Linear Cutter Reload, 75 mm Green, product code PLCR75G. Recall # Z-0398-2010;

8) Power Extender Straight, product code PES100; Power Extender Straight Reconditioned, product code PES100RC; Power Extender Curved with Integrated Controls Reconditioned, product code PEC200RC; Power Extender Straight with Integrated Controls Reconditioned, product code PES200RC. Recall # Z-0399-2010;

9) Endoscopic Linear Cutter Reload, 45 mm Blue, product code PLCR45B; Endoscopic Linear Cutter Reload, 45 mm Green, product code PLCR45G; Reusable Endoscopic Linear Cutter, 60 mm, product code PLC60; Endoscopic Linear Cutter Reload, 60 mm Blue, product code PLCR60B; Endoscopic Linear Cutter Reload, 60 mm Green, product code PLCR60G; Endoscopic Linear Cutter Reload, 60 mm Green Thoracic, product code PLCR60GT; Reusable Endoscopic Linear Cutter, 60 mm Reconditioned, product code PLC60RC. Recall # Z-0400-2010;

10) Power Circular Stapler 21 mm Digital Loading Unit, product code PCS21; Power Circular Stapler 29 mm Digital Loading Unit, product code PCS29. Recall # Z-0401-2010;

11) Power Console, product code PC100; Power Console System, product code PC100S; Power Console Reconditioned, product code PC100RC. Recall # Z-0402-2010;

12) Sterile Sheath, product code SS01. Recall # Z-0403-2010;

13) Program Memory Card, product code MCV1A. Recall # Z-0404-2010;

14) Intelligent Reload, 45 mm Blue, product code iR45B; Intelligent Reload, 45 mm Green, product code iR45G; Intelligent Reload Mid Cut 45mm Blue, product code iR45MB; Intelligent Reload Mid Cut 45mm Green, product code iR45MG; Intelligent Reload, 45 mm, Vascular, product code iR45V; Intelligent Reload, 60 mm Blue, product code iR60B; Intelligent Reload, 60 mm Green, product code iR60G; Intelligent Reload Mid Cut 60mm Blue, product code iR60MB; Intelligent Reload Mid Cut 60mm Green, product code iR60MG; Intelligent Reload, 60 mm Blue No Knife, product code iR60B4. Recall # Z-0405-2010;

15) Intelligent Delivery System, Straight, product code iDriveS; Intelligent Delivery System, Curved, product code iDriveC; Intelligent Delivery System, Flexible, product code iDriveF. Recall # Z-0406-2010;

16) Intelligent 60mm Straight Endoscopic Linear Cutter, product code i60S; Intelligent 60mm Straight Endoscopic Linear Cutter Reconditioned, product code i60SRC. Recall # Z-0407-2010;

17) Intelligent 60mm Articulating Endoscopic Linear Cutter, product code i60; Intelligent 60mm Articulating Endoscopic Linear Cutter Extra Long, product code i60XXL; Intelligent 45mm Articulating Endoscopic Linear Cutter, product code i45; Intelligent 45mm Articulating Endoscopic Linear Cutter, Vascular, product code i45V. Recall # Z-0408-2010;

18) Intelligent Battery Pack, product code iB100; Intelligent Battery Charger and Power Supply, product code iB1C1; Intelligent Battery Insertion Guide, product code iBIG-1; Intelligent Battery Insertion Tool, product code iBIT-1. Recall # Z-0409-2010;

19) Rigid Curved Positioner, product code RCP; Rigid Curved Positioner O-Ring, product code RCPOR. Recall # Z-0410-2010;

20) Device Sterilization Tray, product code T300. Recall # Z-0411-2010;

21) Power Supply -not sold separately, product code PWSP; Power Cord - Not sold separately, product code PWCD. Recall # Z-0412-2010
CODE
All codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Surgical Devices/Covidien, North Haven, CT, by letter dated September 23, 2009.
Manufacturer: Power Medical Interventions, Inc., Langhorne, PA. Firm initiated recall is ongoing.
REASON
Lack of assurance that products were manufactured under GMPs. This action is being undertaken due to certain products potentially exhibiting compromised staple formation or cutting which in some instances may result in extended surgical time for the patient.
VOLUME OF PRODUCT IN COMMERCE
240,432 units
DISTRIBUTION
Nationwide, Canada, Japan, Germany, Ireland, Italy, Spain, Taiwan, Belgium, Sweden, Netherlands, Israel, Portugal, India, Austria, Turkey, and Greece
___________________________________
PRODUCT
Medtronic Accessory Kit, Titan Anchor Accessory Kit, 3550-39, Single Use, RX Only, Contents of the inner packages are Sterile. Recall # Z-500-2010
CODE
Lot Numbers: B0373277K B0373278K B0373279K B0373280K B0373281K B0373282K B0373283K B0373284K B0373285K B0373286K B0373287K B0373288K B0373289K B0373290K B0373291K B0373292K B0373293K B0373294K B0373295K B0373296K B0373297K B0373298K B0373299K B0373300K B0373301K B0373302K B0373303K B0373304K B0373305K B0373306K B0373307K B0373308K B0373309K B0373310K B0373311K B0373312K B0373313K B0373314K B0373315K B0373316K B0373317K B0373318K B0373319K B0373320K B0373321K B0373322K B0373323K B0373324K B0373325K B0373326K B0375290K B0375291K B0375292K B0375293K B0375294K B0375295K B0375296K B0375297K B0375298K B0375299K B0375300K B0375301K B0375302K B0375303K B0375304K B0375305K B0375306K B0375307K B0375308K B0375309K B0375310K B0375311K B0375312K B0375313K B0375314K B0375315K B0375316K B0375317K B0375318K B0375319K B0375320K B0375321K B0375322K B0375323K B0375324K B0375325K B0375326K B0375327K B0375328K B0375329K B0375330K B0375331K B0375332K B0375333K B0375334K B0375335K B0375336K B0375337K 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N194344 N194400 N194829 N194830 N194831 N195145 N195652 N196618 N196619 N196792 N196795 N196799 N197005 N197006 N197168 N197582 N197585 N197588 N197590 N197776 N197780 N197784 N197974 N197976 N198299 N198415 N198596 N198598 N198824 N199227 N199228 N199426 N199430 N199839 N199841 N199842 N199843 N200010 N200012 N200277 N200280 N200282 N200284 N200361 N200362 N200620 N200621 N200818 N200821 N201019 N201020 N201021 N201201 N201203 N201204 N201726 N201739 N201743 N201746 N201853 N201856 N201857 N201858 N202061 N202063 N202067 N202069 N202073 N202075 N202076 N202079 N202814 N202817 N202820 N202824 N202825 N202828 N202830 N202832 N202835 N202997 N203632 N203684 N203689 N204447 N204786 N204848 N204853 N205107 N205108 N205111 N205112 N205282 N205283 N206798 N206965 N206969 N207298 N207299 N207460 N207462 N207463 N208124 N208126 N208130 N208131 N208517 N208520 N208525 N208526 N208534 N208535 N208537 N208538 N208541 N208542 N208544 N210951 N210956 N210957 N210962 N210963 N211236 N211245 N211248 N211671 N211675 N212442 N212443 N212449 N213194 N213336 N213338 N213340 N213345 N213350 N213352 N213353 N213355 N213356 N213462 N213464 N213467 N213843 N213844 N214166 N214169 N214171 N214175 N214176 N214177 N214180 N215648 N215649 N215650 N215652 N215674 N215675 N215676 N215678 N215939 N215944 N215946 N215947 N215949 N216015 N216799 N216802 N217692 N218090 N218869 N218870 N218881 N218883 N218887 N218888 N218900 N218903 N218905 N218907 N218910 N218911 N218912 N218913 N220012 N220017 N225948 N226039 N226042 N226043 N226047 N226050 N226051
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Neuromodulation, Minneapolis, MN, by letter on October 27, 2009.
Manufacturer: Medtronic Neuromodlation, Columbia Heights, MN. Firm initiated recall is ongoing.
REASON
Medtronic is issuing a medical device correction for the Model 3550-39 Titan anchor due to the potential for lead migration as a result of insert separation within the anchor. The Medtronic Model 3550-39 Titan anchor accessory kit is designed for use with Medtronic percutaneous in-line connector spinal cord stimulation leads. Medtronic has received reports of separation of the titanium insert from the silicone body of the anchor.
VOLUME OF PRODUCT IN COMMERCE
55,600 units
DISTRIBUTION
Nationwide, Australia, New Zealand, Canada, Andorra, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Netherlands, Ireland, Israel, Italy, Kuwait, Lebanon, Luxembourg, Norway, Portugal, South Africa, Spain Sweden, Switzerland, Turkey, United Kingdom
___________________________________
PRODUCT
IMPACT Catheters, Balloon Dilatation and Esophageal Dilatation Catheter, Model Number 307, STERILE, Rx only --- Common/Usual Name: PTA and Esophageal Catheter. The Impact catheter is packaged in a straight sheath and then heat sealed in two Tyvek pouches. The inner pouch is the one that is deteriorating when exposed to the sunlight. The outer pouch retains its seal so the sterility is not compromised. --- 510 K931009 - Device Listing #D003206 and 510 K983373 - Device Listing # D003212. Recall # Z-0509-2010
CODE
All Impact catheters distributed between 10/01/2004 and 9/23/2009 are affected: Lot numbers IM-0843, IM-0893, IM-0894, IM-0895, IM-0896, IM-0897, IM-0898, IM-0899, IM-0900, IM-0901, IM-0902, IM-0903, IM-0904, IM-0905, IM-0906, IM-0907, IM-0908, IM-0909, IM-0910, IM-0914, IM-0775, IM-0788, IM-0807, IM-0817, IM-0823, IM-0827, IM-0843, IM-0845, IM-0846, IM-0852, IM-0857, IM-0868, IM-0869, IM-0890, IM-0891, IM-0912, IM-0915, IM-0916, IM-0917, IM-0918, IM-0919, IM-0920, IM-0921, IM-0922, IM-0923, IM-0924, IM-0925, IM-0926, IM-0927, IM-0943, IM-0944, IM-0945, IM-0946, IM-0644, IM-0793, IM-0814, IM-0849, IM-0884, IM-0928, IM-0929, IM-0930, IM-0931, IM-0932, IM-0933, IM-0934, IM-0935, IM-0936, IM-0937, IM-0938, IM-0939, IM-0940, IM-0941, IM-0942, IM-0644, IM-0854, IM-0855, IM-0866, IM-0878, IM-0889, IM-0905, IM-0924, IM-0947, IM-0948, IM-0949, IM-0950, IM-0951, IM-0952, IM-0953, IM-0954, IM-0955, IM-0956, IM-0957, IM-0958, IM-0959, IM-0960, IM-0961, IM-0962, IM-0963, IM-0964, IM-0644, IM-0831, IM-0851, IM-0864, IM-0876, IM-0887, IM-0902, IM-0933, IM-0935, IM-0937, IM-0965, IM-0966, IM-0967, IM-0968, IM-0969, IM-0970, IM-0971, IM-0829, IM-0895, IM-0897, IM-0898, IM-0917, IM-0918, IM-0931, IM-0949, IM-0972, IM-0973, IM-0974, IM-0975, IM-0976, IM-0977, IM-0978, IM-0986, IM-0979, IM-0980, IM-0981, IM-0982, IM-0983, IM-0984, IM-0985, IM-0882, IM-0915, IM-0928, IM-0945, IM-0951, IM-0954, IM-0967, IM-1002, IM-1003, IM-0987, IM-0988, IM-0989, IM-0990, IM-0991, IM-0992, IM-0993, IM-0994, IM-0995, IM-0996, IM-0997, IM-0998, IM-0999, IM-1000, IM-1001, IM-0913, IM-0941, IM-1004, IM-1005, IM-1006, IM-1007, IM-1008, IM-1009, IM-1010, IM-1011, IM-1012, IM-1013, IM-1014, IM-1015, IM-1016, IM-0926, IM-0972, IM-1017, IM-1018, IM-0963, IM-0965, IM-1019, IM-0861, IM-0896, IM-0987, IM-1004, IM-1020, IM-1021, IM-1022, IM-1023, IM-1024, IM-1025, IM-1026, IM-1029, IM-1027, IM-1028, IM-1030, IM-1031, IM-1032, IM-1033, IM-1034, IM-1035, IM-0850, IM-0877, IM-0883, IM-0896, IM-0929, IM-0952, IM-0959, IM-0969, IM-0976, IM-0980, IM-1037, IM-1038, IM-1039, IM-1040, IM-1041, IM-1042, IM-1043, IM-1044, IM-0777, IM-0790, IM-0892, IM-0909, IM-0942, IM-0988, IM-1019, IM-1021, IM-0885, IM-0907, IM-0940, IM-0957, IM-0971, IM-0977, IM-0993, IM-1028, IM-1033, IM-1054, IM-1055, IM-1056, IM-1057, IM-1058, IM-0772, IM-0826, IM-0832, IM-0865, IM-0867, IM-0871, IM-0894, IM-0911, IM-0923, IM-0939, IM-0948, IM-0970, IM-0975, IM-0991, IM-1024, IM-1059, IM-1060, IM-1061, IM-1062, IM-1063, IM-1064, IM-1065, IM-1066, IM-0899, IM-0943, IM-1045, IM-0824, IM-0955, IM-0989, IM-1026, IM-1048, IM-1050, IM-1052, IM-1049, IM-1046, IM-1047, IM-1051, IM-1053, IM-0862, IM-0875, IM-0908, IM-0914, IM-0927, IM-0944, IM-0946, IM-0973, IM-1000, IM-1013, IM-1017, IM-1020, IM-1023, IM-1031, IM-1037, IM-1045, IM-1064, IM-1065, IM-1067, IM-1068, IM-1069, IM-1070, IM-1071, IM-1072, IM-1073, IM-1074, IM-1075, IM-0982, IM-1020, IM-1043, IM-1060, IM-1066, IM-1076, IM-1077, IM-1078, IM-1079, IM-1080, IM-1081, IM-1082, IM-1083, IM-1084, IM-1085, IM-0919, IM-0994, IM-1029, IM-1040, IM-1042, IM-1051, IM-1074, IM-1086, IM-1087, IM-1088, IM-1089, IM-1090, IM-1091, IM-1092, IM-1093, IM-1094, IM-1095, IM-1096, IM-1097, IM-1032, IM-1038, IM-1039, IM-1048, IM-1056, IM-1098, IM-1099, IM-1100, IM-1101, IM-1102, IM-1103, IM-1104, IM-1105, IM-1106, IM-1107, IM-1108, IM-0784, IM-1049, IM-1062, IM-1071, IM-1081, IM-1109, IM-1110, IM-1111, IM-1113, IM-1114, IM-1115, IM-1116, IM-1117, IM-1112, IM-1050, IM-1069, IM-1079, IM-1094, IM-1118, IM-1119, IM-1120, IM-1121, IM-1122, IM-1123, IM-1124, IM-1125, IM-1126, IM-1002, IM-1006, IM-1022, IM-1054, IM-1067, IM-1082, IM-1087, IM-1089, IM-1099, IM-1100, IM-1109, IM-1137, IM-1127, IM-1128, IM-1129, IM-1131, IM-1132, IM-1133, IM-1134, IM-1135, IM-1136, IM-0932, IM-1046, IM-1092, IM-1100, IM-1110, IM-1138, IM-1139, IM-1140, IM-1141, IM-1142, IM-1143, IM-1144, IM-1145, IM-1146, IM-0932, IM-1096, IM-1101, IM-1105, IM-1107, IM-1113, IM-1120, IM-1124, IM-1127, IM-1147, IM-1148, IM-1149, IM-1150, IM-1151, IM-1152, IM-1153, IM-1154, IM-1155, IM-1156, IM-1157, IM-0886, IM-0903, IM-0936, IM-0985, IM-1044, IM-1112, IM-1116, IM-1126, IM-1159, IM-1158, IM-1160, IM-1161, IM-1162, IM-1163, IM-1164, IM-1068, IM-1090, IM-1025, IM-1149, IM-1161, IM-1165, IM-1166, IM-1167, IM-1168, IM-1169, IM-1170, IM-1171, IM-1172, IM-0968, IM-1009, IM-1080, IM-1159, IM-1174, IM-0981, IM-1102, IM-1132, IM-1142, IM-1155, IM-1173, IM-1175, IM-1176, IM-1177, IM-1178, IM-1179, IM-1180, IM-1186, IM-0958, IM-0960, IM-0983, IM-0999, IM-1063, IM-1111, IM-1153, IM-1160, IM-1168, IM-1179, IM-1181, IM-1182, IM-1183, IM-1184, IM-1185, IM-1187, IM-1188, IM-1189, IM-1190, IM-1191, IM-1192, IM-1193, IM-1194, IM-1195, IM-1196, IM-1197, IM-1198, IM-1199, IM-1200, IM-1201, IM-1156, IM-1164, IM-1174, IM-1182, IM-1202, IM-1203, IM-1204, IM-1205, IM-1206, IM-1207, IM-1208, IM-1063, IM-1070, IM-1121, IM-1123, IM-1151, IM-1162, IM-1186, IM-1188, IM-1209, IM-1210, IM-1211, IM-1212, IM-1213, IM-1115, IM-1141, IM-1171, IM-1199, IM-1205, IM-1206, IM-1218, IM-1016, IM-1157, IM-1171, IM-1172, IM-1192, IM-1213, IM-1222, IM-1214, IM-1215, IM-1216, IM-1217, IM-1219, IM-1220, IM-1221, IM-1230, IM-1231, IM-1018, IM-1167, IM-1169, IM-1184, IM-1198, IM-1218, IM-1232, IM-1233, IM-1223, IM-1224, IM-1225, IM-1226, IM-1227, IM-1228, IM-1229, IM-1246, IM-1234, IM-1235, IM-1236, IM-1238, IM-1086, IM-1098, IM-1195, IM-1204, IM-1214, IM-1217, IM-1219, IM-1248, IM-1237, IM-1239, IM-1240, IM-1241, IM-1242, IM-1243, IM-1244, IM-1245, IM-1247, IM-1057, IM-1178, IM-1196, IM-1216, IM-1223, IM-1233, IM-1249, IM-1250, IM-1251, IM-1252, IM-1253, IM-1254, IM-1255, IM-1256, IM-1114, IM-1143, IM-1200, IM-1208, IM-1228, IM-1229, IM-1244, IM-1254, IM-1255, IM-1257, IM-1258, IM-1259, IM-1260, IM-1261, IM-1262, IM-1263, IM-1264, IM-1264, IM-1266, IM-1267, IM-1268, IM-1269, IM-1270, IM-1271, IM-1272, IM-1190, IM-1252, IM-1273, IM-1279, IM-1061, IM-1122, IM-1211, IM-1227, IM-1236, IM-1238, IM-1242, IM-1297, IM-1298, IM-1299, IM-1289, IM-1274, IM-1275, IM-1276, IM-1277, IM-1278, IM-1280, IM-1281, IM-1282, IM-1283, IM-1284, IM-1285, IM-1286, IM-1287, IM-1288, IM-1290, IM-1291, IM-1292, IM-1293, IM-1294, IM-1295, IM-1296, IM-1206, IM-1226, IM-1272, IM-1299, IM-1300, IM-1301, IM-1302, IM-1303, IM-1304, IM-1305, IM-1306, IM-1307, IM-1308, IM-1309, IM-1310, IM-1311, IM-1318, IM-1312, IM-1313, IM-1314, IM-1315, IM-1316, IM-1317, IM-1332, IM-1333, IM-1334, IM-1335, IM-1117, IM-1133, IM-1136, IM-1146, IM-1163, IM-1170, IM-1201, IM-1202, IM-1217, IM-1219, IM-1222, IM-1225, IM-1232, IM-1241, IM-1253, IM-1260, IM-1262, IM-1271, IM-1276, IM-1279, IM-1286, IM-1289, IM-1293, IM-1319, IM-1320, IM-1321, IM-1322, IM-1323, IM-1324, IM-1325, IM-1326, IM-1327, IM-1224, IM-1250, IM-1328, IM-1329, IM-1330, IM-1331, IM-1336, IM-1337, IM-1338, IM-1339, IM-1340, IM-1341, IM-1342, IM-1343, IM-1344, IM-1345, IM-1346, IM-1347, IM-1348, IM-1349, IM-1232, IM-1235, IM-1311, IM-1318, IM-1322, IM-1350, IM-1351, IM-1352, IM-1353, IM-1354, IM-1355, IM-1356, IM-1357, IM-1358, IM-1360, IM-1361, IM-1362, IM-1359, IM-1363, IM1364, IM-1158, IM-1165, IM-1215, IM-1240, IM-1277, IM-1283, IM-1365, IM-1366, IM-1367, IM-1281, IM-1299, IM-1307, IM-1323, IM-1328, IM-1331, IM-1335, IM-1340, IM-1346, IM-1349, IM-1354, IM-1358, IM-1368, IM-1369, IM-1370, IM-1371, IM-1372, IM-1191, IM-1239, IM-1246, IM-1275, IM-1278, IM-1280, IM-1291, IM-1310, IM-1324, IM-1373, IM-1374, IM-1375, IM-1376, IM-1298, IM-1312, IM-1363, IM-1377, IM-1378, IM-1379, IM-1380, IM-1381, IM-1382, IM-1383, IM-1285, IM-1304, IM-1341, IM-1355, IM-1364, IM-1367, IM-1376, IM-1384, IM-1385, IM-1386, IM-1387, IM-1255, IM-1257, IM-1266, IM-1274, IM-1301, IM-1338, IM-1348, IM-1363, IM-1385, IM-1388, IM-1389, IM-1390, IM-1391, IM-1392, IM-1393, IM-1394, IM-1308, IM-1320, IM-1347, IM-1359, IM-1395, IM-1396, IM-1397, IM-1398, IM-1399, IM-1400, IM-1401, IM-1290, IM-1333, IM-1402, IM-1403, IM-1404, IM-1405, IM-1406, IM-1407, IM-1408, IM-1337, IM-1350, IM-1365, IM-1409, IM-1410, IM-1411, IM-1412, IM-1413, IM-1354, IM-1375, IM-1390, IM-1414, IM-1415, IM-1416, IM-1359, IM-1360, IM-1366, IM-1372, IM-1387, IM-1392, IM-1417, IM-1418, IM-1419, IM-1420, IM-1421, IM-1423, IM-1422, IM-1273, IM-1282, IM-1336, IM-1371, IM-1380, IM-1405, IM-1409, IM-1424, IM-1425, IM-1426, IM-1427, IM-1428, IM-1429, IM-1430, IM-1431, IM-1432, IM-1433, IM-1434, IM-1367, IM-1435, IM-1436, IM-1438, IM-1439, IM-1440, IM-1310, IM-1321, IM-1441, IM-1442, IM-1443, IM-1444, IM-1445, IM-1446, IM-1351, IM-1373, IM-1402, IM-1415, IM-1447, IM-1448
RECALLING FIRM/MANUFACTURER
Recalling Firm: Numed Inc., Hopkinton, NY, by e-mail and letter dated September 24, 2009.
Manufacturers: Numed Inc., Hopkinton, NY, and Mangar Industries In., New Britain, PA. Firm initiated recall is ongoing.
REASON
The firm received a complaint from the sole direct account that while performing an inventory review it was observed that the packaging of the IMPACT catheter was cracked and deteriorating. The product was still in its packaging and never used. The customer referred to it as looking like "paint crackle." The risk is that for continued sterility to be assured, the packaging must remain intact.
VOLUME OF PRODUCT IN COMMERCE
7,367 units
DISTRIBUTION
PA
____________________________________
PRODUCT
1) Repose G2 Bone Screw System, Sterile, REF 76353200; The Repose G@ Bone Screw System is composed of the Repose Bone Screw (a miniature, self-tapping screw attached to polypropylene suture), the Repose Bone Screw Inserter (a battery operated, disposable device that deploys the screw), the Repose Suture Passer, and the Repose Tongue Retractor. Recall # Z-0535-2010;

2) Repose G2 Bone Screw, Sterile, REF 76310200. Recall # Z-0536-2010
CODE
1) Lot # 62450300;
2) Lot # 62450200
RECALLING FIRM/MANUFACTURER
Medtronic Xomed, Inc., Jacksonville, FL, by telephone on July 27, 2009. Firm initiated recall is ongoing.
REASON
Product recall due to improper labeling.
VOLUME OF PRODUCT IN COMMERCE
20 units
DISTRIBUTION
GA, AZ, KY, PA, WI, NH, MN, CA, TX
__________________________________
PRODUCT
GE Healthcare Voluson E6, GE Voluson E8, and GE Voluson E8 Expert Diagnostic Ultrasound Systems. Recall # Z-0541-2010
CODE
Serial Numbers: D10471 D00512 D00810 D01019 D01033 D01037 D03107 D03133 D03163 D03411 D03694 D03701 D03812 D03851 D03995 D03997 D04071 D04164 D04210 D04242 D04285 D04306 D04406 D04857 D04935 D04976 D05102 D10018 D10175 D10185 D10187 D10188 D10190 D10191 D10192 D10199 D10209 D10234 D10238 D10241 D10245 D10266 D10267 D10268 D10271 D10272 D10273 D10274 D10275 D10276 D10277 D10278 D10282 D10283 D10284 D10286 D10288 D10291 D10297 D10298 D10307 D10315 D10322 D10323 D10324 D10327 D10334 D10340 D10344 D10346 D10354 D10370 D10373 D10376 D10378 D10383 D10393 D10396 D10401 D10406 D10408 D10416 D10421 D10423 D10426 D10428 D10430 D10434 D10436 D10442 D10443 D10447 D10449 D10450 D10452 D10454 D10457 D10460 D10461 D10464 D10467 D10468 D10506 D10514 D10515 D10517 D10519 D10520 D10521 D10522 D10529 D10530 D10532 D10534 D10535 D10536 D10538 D10542 D10546 D10548 D10549 D10550 D10551 D10552 D50147 D50151 D50172 D50174 D50176 D50177 D50178 D50179 D50180 D50181 D50182 D50183 D50184 D50185 D50186 D50187 D50188 D50189 D50191 D50192 D50193 D50194 D50208 D50221 D50226 D50227 D50228 D50229 D50232 D50240 D50247 D50248 D50249 D50250 D50251 D50252 D50254 D50258 D50259 D50261 D50263 D50264 D50265 D50272 D50273 D50282 D50283 D50294 D50295 D50296 D50300 D50302 D50304 D03271 D05429 D10215 D10239 D10304 D10331 D10349 D10350 D10356 D10358 D10359 D10369 D10371 D10372 D10446 D10499 D50198 D10326 D10341 D10488 D10490 D10257 D10511 D10518 D10541 D04534 D50301 D00238 D04550 D05217 D10143 D10180 D10193 D10213 D10217 D10400 D10417 D50320 D50321 D50322 D50325 D00875 D00881 D10311 D10313 D03412 D04342 D10312 D10403 D10453 D50246 D50292 D05196 D05197 D10294 D50138 D10230 D10410 D10495 D10456 D10526 D10543 D10547 D05007 D10260 D10253 D04703 D04704 D05482 D10224 D10292 D10296 D10299 D50114 D50167 D50168 D50222 D04091 D50308 D50310 D10418 D10125 D10126 D10195 D10481 D03155 D03192 D05077 D50269 D50319 D50326 D50234 D50242 D50243 D50244 D50305 D50141 D10104 D10140 D10145 D10146 D10161 D10164 D10166 D10167 D10168 D10169 D10171 D10172 D10179 D04701 D10142 D10302 D10127 D00507 D00690 D01016 D04388 D04831 D04839 D04846 D04868 D04886 D04959 D05025 D05322 D05338 D05340 D05342 D05343 D05353 D05371 D05391 D05549 D05550 D05560 D05561 D05563 D05581 D05582 D05587 D05590 D10152 D10153 D10157 D10203 D10208 D10216 D10218 D10219 D10221 D10222 D10223 D10228 D10231 D10237 D10242 D10246 D10248 D10262 D10264 D10265 D10269 D10270 D10281 D10295 D10330 D10387 D10389 D10390 D10392 D10394 D10397 D10399 D10404 D10409 D10413 D10455 D10458 D10459 D10462 D10508 D10510 D10528 D10531 D10560 D10561 D10564 D50153 D50155 D50158 D50166 D50169 D50195 D50197 D50199 D50200 D50201 D50202 D50203 D50204 D50207 D50209 D50210 D50211 D50212 D50216 D50217 D50218 D50238 D50241 D50275 D50276 D50324 D50330 D50331 D50334 D50335 D50336 D10362 D00879 D03526 D05551 D05552 D05566 D10109 D10251 D10252 D10289 D10321 D10332 D10333 D10491 D10498 D10558 D10565 D50163 D50205 D50267 D05406 D10363 D10368 D10165 D10206 D00394 D04075 D10240 D00349 D00719 D00723 D00728 D10105 D10106 D10243 D10263 D10308 D10380 D10504 D10512 D10544 D50104 D50107 D50175 D50213 D50262 D50309 D50316 D10345 D04022 D04801 D04969 D05407 D10229 D10254 D10305 D10306 D10475 D50156 D50285 D50297 D00190 D00234 D00441 D03407 D03425 D05346 D05510 D05539 D05543 D10137 D10138 D10139 D10141 D10148 D10150 D10154 D10159 D10160 D10162 D10176 D10177 D10178 D10183 D10255 D10374 D10377 D10425 D10433 D50004 D50008 D50009 D50109 D50112 D50113 D50115 D50120 D50132 D50133 D50136 D50137 D50140 D50160 D50161 D50162 D50225 D50230 D50231 D50235 D50260 D50274 D50277 D50278 D50279 D50288 D50289 D10414 D00196 D00201 D00205 D00216 D00219 D00286 D00916 D01068 D03684 D03974 D04106 D04114 D04328 D04349 D04746 D04871 D04911 D05095 D05122 D05205 D05396 D05490 D05491 D05540 D05542 D05567 D05568 D05571 D10101 D10158 D10181 D10184 D10186 D10194 D10197 D10200 D10211 D10212 D10232 D10235 D10249 D10280 D10287 D10293 D10300 D10301 D10303 D10310 D10317 D10318 D10319 D10325 D10328 D10329 D10336 D10337 D10339 D10342 D10343 D10347 D10348 D10381 D10385 D10386 D10388 D10391 D10402 D10411 D10420 D10441 D10444 D10448 D10451 D10470 D10473 D10474 D10476 D10477 D10478 D10479 D10480 D10483 D10484 D10485 D10486 D10487 D10497 D10500 D10503 D10516 D10525 D50129 D50130 D50149 D50150 D50152 D50157 D50164 D50165 D50171 D50190 D50206 D50214 D50223 D50224 D50237 D50291 D50293 D50298 D50299 D50303 D50306 D50323 D50154 D50219 D10309 D50236 D00211 D03402 D05319 D05585 D10395 D10407 D50196 D10247 D10207 D10439 D10210 D10432 D10121 D10226 D10227 D10250 D10256 D10259 D10261 D10285 D10361 D10424 D10469 D10482 D10494 D10501 D10507 D10509 D10533 D10537 D10539 D10540 D10545 D10566 D10258 D10419 D10472 D10524 D00229 D04842 D05589 D50233 D00832 D10415 D50170 D50215 D00377 D05313 D10108 D10205 D10335 D50317 D50327 D00149 D00477 D00482 D00676 D03109 D04548 D04549 D10022 D10027 D10032 D10128 D10173 D10196 D10202 D10204 D10214 D10220 D10225 D10233 D10236 D10244 D10279 D10314 D10320 D10429 D10431 D10440 D10445 D10492 D10513 D10555 D10556
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Medical Systems, LLC, Waukesh, WI, by letters dated October 22, 2009.
Manufacturer: GE Medical Systems, Kretziechnik GmbH & Co OHG, Zipf, Austria. Firm initiated recall is ongoing.
REASON
GE Healthcare has recently become aware of an incorrect operating procedure associated with software versions 9.0.0, 9.0.1, and 9.0.2 of the Voluson E6 or Voluson E8 Diagnostic Ultrasound Systems that may impact patient safety. When using the combination of 2D-CRI and PW with a steered Doppler angle, the displayed velocity scale is incorrect. The consequence can be an underestimation of flow velocities in the range of 30-60%. This operating procedure is typically used for quantification of carotid stenosis. The degree of the stenosis may be inaccurately quantified which may result in a delay in treatment.
VOLUME OF PRODUCT IN COMMERCE
715 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Polycarbonate prescription lenses (single vision, progressive, and trifocal). Recall # Z-0542-2010
CODE
SKU #'s: 3703154, 4286102, 4286103, 4286104 and 4286106
RECALLING FIRM/MANUFACTURER
Recalling Firm: Luxottica, Mason, OH, by letters on November 24, 2009. Firm initiated recall is ongoing.
REASON
The lenses made for sunglass frames (Liberty Sport Slam or MaxMorpheus) do not meet the lens thickness specification established by the frame manufacturer. The lens thickness range from 1.0 to 1.9 millimeters instead of the required 2.0 millimeter minimum. There is a potential risk that the lenses could break or disengage from the frame in the event of an impact.
VOLUME OF PRODUCT IN COMMERCE
276 polycarbonate prescription lenses (138 pairs of lenses)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Philips Avalon Fetal Monitor FM 20, Catalog Number: M2702A. Recall # Z-0549-2010;

2) Philips Avalon Fetal Monitor FM 30, Catalog Number: M2703A. Recall # Z-0550-2010;

3) Philips Avalon Fetal Monitor FM 40, Catalog Number: M2704A. Recall # Z-0551-2010;

4) Philips Avalon Fetal Monitor FM 50, Catalog Number: M2705A. Recall # Z-0552-2010
CODE
All serial numbers.
RECALLING FIRM/MANUFACTURER
Philips Healthcare Inc., Andover MA, by letter on November 23, 2009. Firm initiated recall is ongoing.
REASON
Potential for inaccurate ultra-sound derived fetal heart rate readings in Philips Avalon Fetal Monitors. Although the types of inaccuracies described in these complaints reflect known limitations inherent to ultrasound fetal heart rate monitoring, the frequency of such complaints is greater for these devices than for the previous generation Philips Series 50 fetal monitors. Clinical decisions based on unrecognized inaccuracies in fetal heart traces may lead health care professionals to: Perform unnecessary interventions, such as cesarean delivery; Fail to identify the need for interventions; or Fail to identify fetal distress.
VOLUME OF PRODUCT IN COMMERCE
18940 units
DISTRIBUTION
Nationwide, Afghanistan, Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, French Guiana, Gabon, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kosovo, Kuwait, Latvia, Lebanon, Libyan, Arab Jamahiriya, Lithuania, Luxembourg, Macau, Malaysia, Martinique, Mauritius, Mexico, Moldova, Morocco, Namibia, Netherlands, Antilles, New Caledonia, New Zealand, Norway, Oman Pakistan Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar Reunion Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian, Arab Republic Taiwan, Thailand, Tunisia, Turkey, Turks and Caicos Islands, Ukraine, United Arab, Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam, Zambia
___________________________________
PRODUCT
Bausch & Lomb Boston Conditioning Solution, Original Formula. The product is packed in 1 fl oz (30 mL), 3 fl oz (90 mL), 3.5 fl oz (105 mL) and 4 fl oz (120 ml) bottles. Recall # Z-0553-2010
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bausch & Lomb Inc., Rochester, NY, by letter on/about November 6, 2009.
Manufacturer: Bausch & Lomb Inc., Greenville, SC. Firm initiated recall is ongoing.
REASON
The product failed to meet Out of Specification shelf life at the 9 months time point.
VOLUME OF PRODUCT IN COMMERCE
159,672 bottles
DISTRIBUTION
Nationwide, Canada and Hong Kong
___________________________________
PRODUCT
1) AccuSure, U-100 28 Gauge, 1/2cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6995-21. The device is intended to be used as an insulin syringe. Recall # Z-0569-2010;

2) AccuSure, U-100 28 Gauge, 1cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6996-21. Recall # Z-0570-2010;

3) AccuSure, U-100 29 Gauge, 1/2cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6997-21. Recall # Z-0571-2010;

4) AccuSure, U-100 29 Gauge, 1cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6998-21. Recall # Z-0572-2010;

5) AccuSure, U-100 30 Gauge, 1/2cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6999-21. Recall # Z-0573-2010;

6) AccuSure, U-100 30 Gauge, 1cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-7000-21. Recall # Z-0574-2010;

7) AccuSure, U-100 31 Gauge, 1/2cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-7001-21. Recall # Z-0575-2010;

8) AccuSure, U-100 31 Gauge, 1cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-7002-21. Recall # Z-0576-2010
CODE
All lots
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals, Huntsville, AL, by press release on October 27, 2009 and by letter on October 30, 2009. Firm initiated recall is ongoing.
REASON
Needles are becoming dislodged from the barrels.
VOLUME OF PRODUCT IN COMMERCE
2,378,676 cartons of 100
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Invacare Storm TDX SR Power Wheelchair with Stability Lock, Model numbers: TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-HD, TDXSR-MCG, TDXSR-MCG-HD, TDXSRV-HD. Recall # Z-0579-2010
CODE
Serial Numbers: 08BE000082; 08BE000088; 08BE000089; 08BE000090; 08BE000323; 08BE001102; 08BE001105; 08BE002283; 08BE002803; 08BE003025; 08BE003250; 08BE003251; 08BE003472; 08BE003473; 08BE003632; 08BE004402; 08BE004414; 08BE004415; 08BE004835; 08BE005297; 08DE002040; 08EE000277; 08EE001539; 08EE001540; 08EE001775; 08FE003254; 08FE003257; 08FE003668; 08FE004681; 08GE003570; 08GE003936; 08HE001169; 08HE005013; 08IE001081; 08IE001316 & 08IE002729
RECALLING FIRM/MANUFACTURER
Invacare Corp., Elyria, OH, by letter on September 15, 2009. Firm initiated recall is ongoing.
REASON
For some Invacare chairs, the stability lock feature may not be engaging properly or consistently. If the stability lock feature does not engage properly, the wheelchair may do one or more of the following: (1) veer to one side; (2) rock forward onto its front riggings; (3) drive in an unintended circular motion; and/or (4) fall forward or to one side. In these cases there is a risk to injury for the user.
VOLUME OF PRODUCT IN COMMERCE
36
DISTRIBUTION
AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, MA, ME, MI, MN, MO, MS, NC, ND, NM, NY, OH, SC, TX and Canada
___________________________________
PRODUCT
1) Enpath Lead Adaptor, Ref: 501214. The contents of the inner package have been sterilized by ethylene-oxide gas. Recall # Z-0580-2010;

2) Enpath Myopore Sutureless Myocardial Pacing Lead, Ref: 511211. The contents of the inner package have been sterilized by ethylene-oxide gas. Recall # Z-0581-2010
CODE
1) Serial numbers: 148236, 148237, 148238, 148239, 148240, 148241, 148242, 148243, 148036, 148038, 148039, 148040, 148041, 148042, 148043, 148044, 148045, 148046, 148047, 148048, 148049, 148050, 148051, 148052, 148053, 148054, 148055, 148056, 148057, 148058, 148059, 148060, 148061, 148063, 148064, 148065, 148066, 148067, 148068, 148069, 148070, 148071, 148072, 148074, 148075;

2) Serial Numbers: 148399, 148400, 148401, 148402, 148403, 148404, 148405, 148406, 148407, 148408, 148409, 148410, 148411, 148412, 148413, 148414, 148415, 148416, 148417, 148418, 148419, 148420, 148421, 148422, 148423, 148424, 148427, 148430, 148431, 148433, 148434, 148435, 148436, 148437, 148438
RECALLING FIRM/MANUFACTURER
Greatbatch Medical, Minneapolis, MN, by telephone beginning September 1, 2009. Firm initiated recall is complete.
REASON
The silicone tubing of affected leads was processed outside of validated parameters. Although the material remains biocompatible, test data regarding the performance characteristics are not available.
VOLUME OF PRODUCT IN COMMERCE
80
DISTRIBUTION
CA, MN
___________________________________
PRODUCT
Oxygen Sensor, Catalog number: 5804. Recall # Z-0585-2010
CODE
Lot numbers 906018 and 906003
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teleflex Medical, Durham, NC, by letters on or about November 25, 2009.
Manufacturer: Sensidyne, Inc., Clearwater, FL. Firm initiated recall is ongoing.
REASON
Sensor causes the oxygen monitor to display prematurely a Low Sensor warning which indicates an early maintenance requirement for the instrument. This may result in interrupted treatment.
VOLUME OF PRODUCT IN COMMERCE
51
DISTRIBUTION
FL, KY, MI, OH, PA, SD, TN, Australia and Canada
___________________________________
PRODUCT
BD 30 ml Syringe; Luer-Lok Tip Catalog # 309650. Recall # Z-0586-2010
CODE
Lot number 9175046
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Co., Franklin Lakes, NJ, by letters on November 23, 2009 and December 8, 2009.
Manufacturer: BD Medical - Medical Surgical, Columbus, NB. Firm initiated recall is ongoing.
REASON
Reports received of open seals.
VOLUME OF PRODUCT IN COMMERCE
166,240 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Powerlink System with IntuiTrak Delivery System (Endovascular Graft): Model Number 34-34-80L. Recall # Z-0593-2010;

2) Powerlink System with IntuiTrak Delivery System (Endovascular Graft): Model Number 34-34-80LE. Recall # Z-0594-2010
CODE
1) Lots: W09-2966 AND W09-2998;
2) Lots: W09-2967 AND W09-3000
RECALLING FIRM/MANUFACTURER
Endologix Inc., Irvine, CA, by telephone and letter on November 25, 2009. Firm initiated recall is ongoing.
REASON
The product has the potential for the polyimide tubing to detach from the inner core due to the bond failure. If this occurs, it is likely that treatment will be interrupted. The firm's initial health hazard analysis indicated the event may cause temporary or medically reversible adverse health consequences or an outcome where the probability of serious adverse health consequences is remote.
VOLUME OF PRODUCT IN COMMERCE
17 devices
DISTRIBUTION
OR, PA, FL, TX, MI and LA
___________________________________
PRODUCT
1) Stryker MIS Bur, 2.0mm Neuro Diamond, sterile; REF 8420-107-120. Recall # Z-0595-2010;

2) Stryker MIS Bur, 2.5mm Neuro Diamond, sterile; REF 8420-107-125. Recall # Z-0596-2010;

3) Stryker MIS Bur, 3.0mm Neuro Diamond, sterile; REF 8420-107-130. Recall # Z-0597-2010;

4) Stryker MIS Bur, 3.5mm Neuro Diamond, sterile; REF 8420-107-135. Recall # Z-0598-2010;

5) Stryker MIS Bur, 3.0mm Neuro Diamond Course, sterile; REF 8420-107-230. Recall # Z-0599-2010
CODE
1) All lots distributed 1/30/06 through 3/4/09. Lots 06004017, 06034017, 06075017, 06086017, 06206017, 07002017, 07039017, 07067017, 07121017, 07219017, 07279017, 07320017, 07346017, 08007017, 08030017, 08044017, 08081017, 08205017, 08275017 and 09043017;

2) All lots distributed 1/30/06 through 3/4/09. Lots 05363017, 06032017, 06065017, 06103017, 06179017, 07113017, 07143017, 07233017, 07291017, 07337017, 08007017, 08046017, 08107017, 08254017 and 09029017;

3) All lots distributed 1/30/06 through 3/4/09. Lots 06004017, 06034017, 06037017, 06037027, 06093017, 06165017, 06177017, 06353017, 07017017, 07046017, 07092017, 07095017, 07109017, 07143017, 07205017, 07233017, 07242017, 07248017, 07260017, 07316017, 07344017, 07351017, 08022017, 08030017, 08042017, 08051017, 08081017, 08108017, 08115017, 08133017, 08140017, 08155017, 08182017, 08210017, 08233017, 08255017, 08290017, 08296017, 08323017, 08357017 and 09040017;

4) All lots distributed 1/30/06 through 3/4/09. Lots 05363017, 06037017, 06069027, 06094017, 06165017, 06240017, 06275017, 06305017, 06354017, 07029017, 07079017, 07080017, 07108017, 07143017, 07219017, 07233017, 07290017, 07333017, 08021017, 08038017, 08049017, 08098017, 08155017, 08156017, 08253017, 08337017 and 09054017;

5) All lots distributed 1/30/06 through 3/4/09. Lots 07352017, 08043017 and 08350027
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Instruments Div. of Stryker Corp., Kalamazoo, MI, by letters dated July 10, 2009 and July 13, 2009.
Manufacturer: Stryker Ireland, LTD, Instruments Div., Carrigtwohill, Co. Cork, Ireland. Firm initiated recall is ongoing.
REASON
The bur may fracture, resulting in fragments within the surgical site, injury to the patient or surgical team, or both.
VOLUME OF PRODUCT IN COMMERCE
5,438
DISTRIBUTION
Nationwide, Australia, Canada, England, France, Hong Kong, Japan, Netherlands, South Africa, Sweden, Switzerland and Taiwan
___________________________________
PRODUCT
AMO Tecnis 1-Piece Intraocular Lens (Model ZCB00). Recall # Z-0605-2010
CODE
All Serial numbers of tecnis 1-Piece Intraocular Lenses that were processed through lens surface treatment at the AMO PR facility between May 19 and October 16, 2009 - with serial numbers ending in 0906, 0907, 0908, and 0909. and subset with serial numbers ending in 0905 and 0910. Expiration/Use By Date (YYYY-MM): 2011-05, 2011-06, 2011-07, 2011-08, 2011-09, and 2011-10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Medical Optics Inc (AMO), Santa Ana, CA, by letters beginning November 6, 2009 and November 9, 2009.
Manufacturer: AMO Puerto Rico Manufacturing, Inc., Anasco, PR. Firm initiated recall is on going.
REASON
Some Tecnis 1-Piece IOLs (model ZCB00) have adhered to the lens optic after insertion into the eye. This can lead to a need for additional manipulation to separate the haptics from the optic during surgery which could lead to an injury.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide, Austria, Azerbaijan, Belgium, Canada, Switzerland, Cyprus, Czech Republic, Germany, Estonia, Spain, Finland, France, United Kingdom, Hungary, Ireland, Israel, Italy, Lebanon, Lichtenstein, Libya, Martinique, Netherlands, Poland, Palestine, Portugal, Saudi Arabic, Sweden, Slovenia, Turkey, and South Africa

END OF ENFORCEMENT REPORT FOR JANUARY 13, 2010

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