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U.S. Department of Health and Human Services

Safety

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Enforcement Report for March 9, 2011

March 9, 2011                                                                                        11-10

 

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II
___________________________________
PRODUCT
Product is a powdered French Dip Au Jus Mix, packaged in a 1.1 oz size foil packet or in a 6 oz clear plastic bottle. 1) The 1.1 oz. foil packet has a UPC 070381000685. 2) The 6 oz clear plastic bottle has a UPC 07381800681. Labeling reads in part: "Johnny's***French Dip (POWDERED) Au Jus Mix***DIRECTIONS Add contents of package to ***water, bring to a boil and serve. Ingredients: hydrolyzed vegetable protein ***yeast extract, salt***. Contains: Soy, Wheat & Milk. Recall # F-0488-2011  
CODE
1) Code date packets are 02212 and code date on the box is 220112. This code signifies the product will be expired on 22nd day of the year 2012; 2) Code date on the 6 oz jars is 0332. This code signifies the product will be expired on 33rd day of the year 2012.
RECALLING FIRM/MANUFACTURER
Johnny's Fine Foods Inc., Tacoma, WA, by press release and letters on February 26, 2010. FDA initiated recall is ongoing.
REASON
The product was manufactured using Hydrolyzed Vegetable Protein (HVP) recalled by Basic Food Flavors, Inc because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
252 cases of 6 oz. and 291 cases of 1.1 oz.
DISTRIBUTION
CA, IA, OR, UT, WA, and WI

___________________________________
PRODUCT
French Baguette, 14 oz., in a clear plastic bag with blue and red print, UPC 5280276543. Recall # F-0489-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Oakwood Baking Co., Detroit, MI. by telephone on December 30, 2010. FDA initiated recall is ongoing.
REASON
The product contains wheat flour, but the label lists flour and does not specifically declare the allergen, wheat flour.
VOLUME OF PRODUCT IN COMMERCE
840 baguettes
DISTRIBUTION
MI
___________________________________
PRODUCT
Spicy Thai Dressing, packaged in plastic 8 oz. bottle, 12 bottles/case, UPC 000000742368. Recall # F-0490-2011
CODE
All lot thru date code 04/15/2011
RECALLING FIRM/MANUFACTURER
Whole Foods Market Mid-Atlantic Kitchen, Landover, MD, by e-mail on January 18, 2011. Firm initiated recall is complete.
REASON
A retail food product was manufactured with a sub-ingredient containing wheat, an allergen which was not declared on the label.
VOLUME OF PRODUCT IN COMMERCE
144 bottles
DISTRIBUTION
MD, VA, NJ, KY, OH, Washington, D.C.
___________________________________
PRODUCT
Yellowfin Tuna Loin Block, Wild Caught, Product of Indonesia, 15 lb. UPC 10664183001208; Reel Fresh select quality seafood. Recall # F-0491-2011
CODE
Unit: 015156
RECALLING FIRM/MANUFACTURER
Superior Foods, Co., Kentwood, MI, by telephone on November 26, 2010. FDA initiated recall is ongoing.  
REASON
There were two reported scrombotoxin poisonings reported to a health department. Follow up samples reported positive for histamine. FDA initiated an inspection of the firm and informed them of the test results. The firm decided to recall the product.
VOLUME OF PRODUCT IN COMMERCE
1410 pounds
DISTRIBUTION
MI, IN and OH
___________________________________
PRODUCT
Various bakery product desserts including Tira Misu Cake, Heaven & Hell Torte, Hoke Pokey Cake, Chocolate Cupcakes with Swirl Icing, Tira Misu Trifle Cups and Chocolate Mousse Trifle Cups (also known was mini dessert shooters); these fresh bakery products do not have labeling or date codes. Recall # F-0493-2011
CODE
All desserts manufactured from November 1, 2010 through December 30, 2010.
RECALLING FIRM/MANUFACTURER
Rolf's Patisserie, Lincolnwood, IL, by press release on December 23, 2010 and by press release, e-mail, telephone and letters on December 24, 2010. Illinois initiated recall is ongoing.  
REASON
Products produced by Rolf's Patisserie have been connected to several outbreaks of Staphylococcus aureus (S. aureus) food poisoning.
VOLUME OF PRODUCT IN COMMERCE
126,575 desserts
DISTRIBUTION
IL, IN, MI, MN, MO, NB, WI

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS III
___________________________________
PRODUCT
Perricone MD Nutriceuticals 99 Bite Bar -Dr Perricone's Bite Bar A Nutrient Rich Whole Food Fresh Lemon Flavor, Net WT. 0.81 oz (23 g) 70 Calories. UPC Code: 651473525103 . Box of 30 Sample Box of 1 Bars - UPC Code: 651473525004. Recall # F-0492-2011
CODE
Use by dates of March 2011 through October 2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: NV Perricone LLC, Meriden, CT, by telephone or e-mail on December 2, 2010.
Manufacturer: J S L Foods Inc., Los Angeles, CA. Firm initiated recall is complete,   
REASON
Undeclared sulfites
VOLUME OF PRODUCT IN COMMERCE
16,867 (box of 30 bars), 19,970 (one bar samples)
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS I
___________________________________
PRODUCT
Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL, Supplied in 25, 30, and 60 x 3 mL Sterile Unit Dose Vial shelf cartons, For Oral Inhalation Only, Rx Only, NDC 0591-3797-83. Recall # D-281-2011
CODE
Lot numbers: 0N81, 0N82, 0N83, 0N84, 0NE7, 0NE8, 0NE9, 0NF0, Exp 10/12; 0P12, 0P13, 0P46, 0P47, 0PF0, Exp 11/12; and 0S15 Exp 12/12. NDC: 0591-3797-83, 0591-3797-30 and 0591-3797-60
RECALLING FIRM/MANUFACTURER
The Ritedose Corp., Columbia, SC, by letter on/about December 24, 2010 and press release on December 30, 2010. Firm initiated recall is ongoing.
REASON
The Product is Misbranded: The concentration of the product is 2.5 mg/3 mL; however, the embossing on the single use vials states 0.5 mg/3 mL. The correct concentration of 2.5 mg/3 mL is labeled on the primary foil overwrap pouches and shelf cartons.
VOLUME OF PRODUCT IN COMMERCE
5,773,590 vials
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Mr. Magic Male Enhancer (YiziQiang Extract, Aakg, B-6, Eurycoma, Gota Kola) capsules; 480 mg; Dietary Supplement. Packaged in 3,6,12, 20-count bottles; 1-count foil cards, and a display box containing 24 x 1-count foil cards. OTC, 1) Mr. Magic 1 ct. One (1) Capsule Cards - Item #12300, UPC #648658123001; 2) Mr. Magic 3 ct. Capsule Bottles - Item #12301, UPC #648658123018; 3) Mr. Magic 6 ct. Capsule Bottles - Item #12302: UPC Code # 648658123025; 4) Mr. Magic 12 ct. Capsule Bottles - Item #12303; UPC #648658123032; 5) Mr. Magic Display of 24 x1 ct. Capsule Cards - Item #12304: UPC #648654123043; 6) Mr. Magic 20 ct. Capsule Bottles - Item #12305: UPC#648658123056. Recall # D-292-2011
CODE
1) Lots #251209 exp. 01/01/13 and #9041401 exp. 01/2012 or 04/2012; 2) Lots #8121904 exp. 12/2011 and #9041401 exp. 01/2012 or 04/2012; 3) Lots #8121904 exp. 12/2011 and #9041401 exp. 01/2012 or 04/2012; 4) Lots # 8121904 exp.12/2011 and #9041401 exp. 01/2012 or 04/2012; 5) Lots #251209 exp. 01/01/13 and #9041401 exp. 01/2012 or 04/2012; 6) Lots #8121904 exp. 12/2011 and Lot #9041401 exp. 01/2012 or 04/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Glow Industries Inc., Perrysburg, OH, by press release on August 18, 2010 and letter on August 19, 2010.
Manufacturers: GT Pro Nutrition, West Jordan, UT;
Biogenixs, Cadillac, MI. FDA initiated recall is ongoing.  
REASON
Marketed Without an Approved NDA/ANDA: FDA sample analyses determined that the product contains hydroxythiohomosildenafil and sulfoaildenafil, analogues of the FDA approved drug, Sildenafil.
VOLUME OF PRODUCT IN COMMERCE
251,473 capsules
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II
___________________________________
PRODUCT
Physicians Total Care Arthrotec 75/200mcg, repacked size #30 Tablets, NDC 054868-4165-00; and repacked size #60 tablets, NDC 054868-4165-00. Recall # D-255-2011
CODE
Lot numbers 5H1W Exp.2/28/2013; 515Q, 51B4, 51JE, Exp. 9/30/2012
RECALLING FIRM/MANUFACTURER
Physicians Total Care, Inc., Tulsa, OK, by fax on July 19, 2010. Firm initiated recall is complete.
REASON
Identified lots may contain broken tablets.
VOLUME OF PRODUCT IN COMMERCE
12 bottles
DISTRIBUTION
KY, NC
___________________________________
PRODUCT
Arixtra Patient Starter Kits titled, Looking Ahead with ARIXTRA, kit contains an education booklet, a puncture-proof container, alcohol wipes and prescribing information for ARIXTRA, Recall # D-273-2011
CODE
Starter Kit Numbers: XRA698R0, XRA582R0, XRA582R1, XRA381R0 and XRA381R1
RECALLING FIRM/MANUFACTURER
GlaxoSmithKline Inc., Zebulon, NC, by press release on January 24, 2011 and letters on January 26, 2011. FDA initiated recall is ongoing.
REASON
Microbial contamination of non sterile product; the Kits are being recalled because the alcohol prep pads have the potential to be contaminated with Bacillus cereus.
VOLUME OF PRODUCT IN COMMERCE
185,390 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) ROLAIDS Extra Strength plus Gas Relief Softchews, in each chew Calcium carbonate 1177mg, Simethicone 80mg, Tropical Fruit flavor, 6 count package, NDC 50580-742-06, UPC Code 312547065733; 12 count (2 packs of 6) NDC 50580-742-12, UPC Code 312547065757;  and 36 count (6 packs of 6) NDC 50580-742-36, UPC Code 312547065771. Recall # D-274-2011;

2) ROLAIDS Extra Strength Softchews, in each chew Calcium Carbonate 1177mg, Wild Cherry flavor, 6 count packs, NDC 50580-741-06, UPC Code 312547655200; 18 count (3 packs of 6 count), NDC 50580-741-18, UPC Code 312547655255;  and 42 count (7 packs of 6), NDC 50580-741-42, UPC Code 312547655316. Recall # D-275-2011;

3) ROLAIDS Extra Strength Softchews, in each chew Calcium carbonate 1177mg, Cherry flavor, 6 count, NDC 50580-741-06, - UPC Code 312547655200; 18 count bag, NDC 50580-741-18, UPC Code 300450649188;  and 36 count bag, NDC 50580-741-36, UPC Code 300450649362. Recall # D-276-2011;

4) ROLAIDS Multi-Symptom Antacid plus Anti-Gas Softchews, Calcium carbonate 1177mg and Simethicone 80mg, Tropical Fruit flavor, 6 count package, NDC 50580-750-06, UPC Code 300450657060;  12 count bag, NDC 50580-750-12,  UPC Code 300450657121; and 24 count bag, NDC 50580-750-24, UPC Code 300450657244. Recall # D-277-2011
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., Fort Washington, PA, by letters on December 9, 2010.
Manufacturer: Best Sweet, Inc., Mooresville, NC. Firm initiated recall is ongoing.
REASON
Presence of Foreign Substance: metal and wood particles.
VOLUME OF PRODUCT IN COMMERCE
11,221,830 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Calcitriol 1mcg/mL Injection, packaged in amber glass ampules, 5 x 1mL single use ampules, for IV use only, Rx ONLY, NDC number 0143-9728-05. Recall # D-280-2011
CODE
Lot #00005 Expiration Date 2/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: West-ward Pharmaceutical Corp., Eatontown, NJ, by telephone on January 25, 2011 and by letters on January 28, 2011.
Manufacturer: Julphar, Gulf Pharmaceutical Industries, Ras Al Khaimah, United Arab Emirates. Firm initiated recall is ongoing.
REASON
Labeling: Wrong Barcode; the barcode on the carton labeled as Calcitriol 1 mcg/mL Injection is actually the barcode for Enalaprilat Injection 1.25mg/mL and the barcode on the ampule labeled as Calcitriol 1 mcg/mL Injection is actually the barcode for Terbutaline Sulfate Injection 1mg/mL
VOLUME OF PRODUCT IN COMMERCE
6300 case packs (5 ampules per case pack)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Rolaids Softchews, Extra Strength, Cherry Flavor, 36 count bag, Dist, NDC 50580-741-36. Recall # D-282-2011
CODE
Lot # 0053AG2, Exp 01/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: McNeil Consumer Healthcare, Div Of Mcneil-ppc, Inc., Fort Washington, PA, by letters on November 15, 2010.
Manufacturer: Best Sweet, Inc., Mooresville, NC. FDA initiated recall is ongoing
REASON
Crystallization: The firm received complaints for a hard white substance in the product, which analysis revealed was crystallized sugar.
VOLUME OF PRODUCT IN COMMERCE
57,120 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Simvastatin Tablets USP, 10 mg, a) 1000 count bottle (NDC 0093-7153-10), b) 30 count bottle (NDC 0093-7153-56), Rx only. Recall # D-284-2011
CODE
Lot #s: a) 22S001, Exp 03/12; 22S002, Exp 03/12; 22S003, Exp 03/12; 22S022, Exp 07/12; b) 22S024, Exp 07/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letters on December 16, 2010.
Manufacturer: Teva Pharmaceutical Industries, Jerusalem, Israel. Firm initiated recall is ongoing
REASON
Tablet Thickness: There is the potential of some tablets not meeting the weight specification.
VOLUME OF PRODUCT IN COMMERCE
11.590 bottles (1000 count: 10,726 bottles; 30 count: 864 bottles)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Simvastatin Tablets, USP, 10 mg, packaged in cartons of 10 blister cards containing 10 tablets each (100 tablets), Rx only, NDC 51079-454-20. Recall # D-285-2011
CODE
Lot #: 0M447, Exp 03/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: UDL Laboratories, Inc., Rockford, IL, recall letter on December 21, 2010.
Manufacturer: Teva Pharmaceutical Industries, Jerusalem, Israel. Firm initiated recall is ongoing.
REASON
Tablet Thickness: There is a potential for some of the tablets not meeting weight specification.
VOLUME OF PRODUCT IN COMMERCE
3,793 cartons
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Pravastatin Sodium Tablets, USP, 40 mg, 90 count bottles, Rx only, NDC 0093-7202-98. Recall # D-286-2011
CODE
Lot #s: 33Y095, Exp 03/12; 33Y104, Exp 03/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on December 16, 2010.
Manufacturer: Teva Pharmaceutical Industries, Jerusalem, Israel. Firm initiated recall is ongoing.
REASON
Tablet Thickness: Some tablets may not meet weight specification.
VOLUME OF PRODUCT IN COMMERCE
51,365 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Topiramate tablets, 100 mg, 60 tablets, Rx only; NDC 13668-033-60, UPC 3 13668-033-60 1. Recall # D-287-2011;
2) Citalopram tablets, 20 mg, 500 tablets, Rx only, NDC: 13668-010-05, UPC 3 13668-010-05. Recall # D-288-2011
CODE
1) and 2) Lot numbers: BF710007, BF710008, BF710011 and BF710012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Torrent Pharma Inc., Kalamazoo, MI, by email or fax on September 30, 2010.
Manufacturer: Torrent Pharmaceuticals Ltd. Indrad Village, Gujarat State, India. Firm initiated recall is complete.
REASON
Label Mix-up: A bottle labeled as Torrent's citalopram hydrobromide 20 mg contained Torent's topiramate 100 mg tablets. The lot number BF710012 on the label and the insert attached to the bottle both correspond to the topiramate tablets.
VOLUME OF PRODUCT IN COMMERCE
39,048 bottles
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
Bausch & Lomb Soothe Xtra Hydration, Lubricant Eye Drops, Dry Eye Therapy, 3 mL sample size and 15 mL trade size, a) Item number: 622233 (15 mL): b) Item number: 622234 (3 mL). Recall # D-289-2011
CODE
a) Lot numbers: GC0124, Exp 09/11; GD0146, Exp 10/11; GF0121, GF0157, Exp 12/11; GJ0023, Exp 03/12; GK0044 Exp 04/12; b) Lot numbers: GC0135, GC0142, Exp 03/11; GE0049, GE0050, GE0074, Exp 05/11; GF0063, GF0064, GF0065, GF0021, Exp 06/11; GG0035, GG0036, GG0055, Exp 07/11; GJ0003, GJ0004, Exp 09/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bausch & Lomb Inc., Greenville, SC, by Media Advisory, website, email and direct mail on December 30, 2010.
Manufacturer: Bausch & Lomb Greenville, Greenville, SC. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility: Due to the presence of mold found on the tips of (2) opened bottles, the firm is recalling all lots. Testing by Bausch & Lomb on the opened, partially used product has identified the particles as mold. Through routine testing, the firm has not found any contamination indicating the mold came from the manufacturing plant. In addition, the manufacturing site underwent an FDA inspection in December 2010 and no indication of any contamination was found by the inspectors
VOLUME OF PRODUCT IN COMMERCE
1,258,896 bottles (993,360 /3 mL bottles and 265,536 /15 mL bottles)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Metronidazole Tablets, USP, 250 mg, 250 count bottle, Rx only, NDC 50111-333-06. Recall # D-290-2011
CODE
Lot # 312566, Exp 05/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on October 26, 2010.
Manufacturer: Pliva Krakow S.A., Krakow, Poland. Firm initiated recall is ongoing.
REASON
Low Tablet Weight: Some tablets may not meet weight specification
VOLUME OF PRODUCT IN COMMERCE
1,434 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Campral Delayed-Release Tablets, (Acamprosate calcium), 333 mg/tab, packaged in a) 180 ct. dose packs (3 blister cards X 60 tablets per card) and b)100 ct dose packs (10 blister cards X10 tablet per card). Rx. NDC # 0456333060 for the 180 ct. (3X60) and NDC # 0456333063 for the 100 ct (10X10) packaging. Recall # D-291-2011
CODE
a) Lot 1069782 EXP 02/12 and b) Lot 1066737 EXP 02/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Forest Pharmaceuticals Inc., Earth City, MO, by letter on December 30, 2010.
Manufacturer: Forest Pharmaceuticals Inc., Cincinnati, OH; Merck Sante, Semoy, France. Firm initiated recall is ongoing.
 

REASON
Failed dissolution testing at 12-month testing interval
VOLUME OF PRODUCT IN COMMERCE
2290 unit dose paks (180 tablets) Lot 1069782 and 2986 unit dose paks (100 tablets) Lot 1066737
DISTRIBUTION
Nationwide and PR

___________________________________
PRODUCT
1) CWI Alcohol Pads, packaged in boxes of 10 (Item 160400) and 50 (Item 16063). The alcohol pads are individually wrapped and labeled as Triad Medium Alcohol Prep Pad. Recall # D-293-2011;

2) Applebee's First Aid Kit, Item 25004, containing 1 box of 50 Alcohol Prep Pads. Recall # D-294-2011;

3) One Person 72 Hour Emergency Preparedness Kit, Item 25010. The label inside of the kit reads Part #25059, First Aid Kit, Emergency, containing 3 alcohol towelettes. Recall # D-295-2011;

4) Four Person 72 Hour Emergency Preparedness Kit, Item 25011; the label inside of the kit reads Part #25060, First Aid Kit, Emergency, containing 6 alcohol towelettes. Recall # D-296-2011;

5) Auto Emergency Kit, Item 25012; The label inside of the kit reads Part #25059, First Aid Kit, Emergency, containing 3 alcohol towelettes. Recall # D-297-2011;

6) Backpack First Aid Kits labeled as: 1) Mini NISH Backpack First Aid Kit, Part #25019; and 2) CWI Mini Backpack First Aid Kit, Part #25020. The label inside of the kits reads Mini Backpack Refill-First Aid Kit for use in #25020 and #25019, Product #16030, containing 2 alcohol towelettes. Recall # D-298-2011;

7) Mini First Aid Kit, Part #25025, containing 2 alcohol pads. Recall # D-299-2011;

8) First Aid Kit, Office Mini, Part #25027, containing 10 alcohol pads. Recall # D-300-2011;

9) Standard Pandemic Flu Kit, Item #25058, containing a plastic bag of 20 alcohol pads (Item 16064). Recall # D-301-2011;

10) CWI Office First Aid Kit, Item NSN 6545-01-433-8399, containing 1 box of 10 alcohol pads (Item 160400). Recall # D-302-2011;

11) 50-piece first aid kits containing a plastic bag of 10 alcohol prep pads with other components (Item C-2000000464-A). The first aid kits are labeled as follows: (1) Coleman 50 Piece First Aid Kit, Model #2000000464; (2) Coleman 50 Piece First Aid Kit, Model #20000001786; and (3) Stearns 50 Piece First Aid Kit, Model #20000002993. Recall # D-303-2011;

12) 80 Piece First Aid Kit, Model #2000000467, containing a plastic bag of 14 alcohol prep pads (Item C-2000000467-B). Recall # D-304-2011;

13) Mini Backpack Refill-First Aid Kit, for use in #25020 and #25019, Product #16030, containing 2 alcohol towelettes. Recall # D-305-2011
CODE
All alcohol prep pads with the Triad label.
RECALLING FIRM/MANUFACTURER
Cooperative Workshops Inc., Sedalia, MO, by letters via e-mail or mail dated January 27, 2011, February 7, 2011, February 11, 2011. Firm initiated recall is ongoing.   
REASON
Microbial Contamination of Non-Sterile Products: Kits were manufactured using a recalled component (alcohol pads).
VOLUME OF PRODUCT IN COMMERCE
94,904 kits, 3 mini backpack refills (Item 16030), 3/10-pad resupply boxes (Item 160400), and 48/50-pad boxes (Item 16063)
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III
___________________________________
PRODUCT
Hydromorphone Hydrochloride, USP, CII, 10 mg/mL, a)1 mL single dose vials (NDC 0555117-05), b) 5 mL single dose vials (NDC 0555-1117-06, c) 50 mL single dose vial (NDC 0555-1117-07), Rx only. Recall # D-283-2011
CODE
Lot #s: a) 730503F, Exp 1/1/11; 771 F, Exp 5/1/11; 81153F, Exp 9/1/11; 812103F, Exp 9/1/11; 812253F, Exp 9/1/11; b) 721453F, Exp 12/1/10; 761553F, Exp 4/1/11; 791403F, Exp 7/1/11; c) 711253F, Exp 11/1/10; 721403F, Exp 12/1/10; 730703F, Exp 1/1/11; 741403F, Exp 2/1/11; 791303F, Exp 7/1/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letters on November 12, 2010 and November 19, 2010.
Manufacturer: Hospira Inc., Lake Forest, IL. Firm initiated recall is ongoing
REASON
Impurities/Degradation Products: Product doesn't meet impurity specifications.
VOLUME OF PRODUCT IN COMMERCE
304,573 vials (1 mL: 125,790 vials, 5 mL: 114,850 vials, 50 mL: 63,933 vials)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
SPIRIVA HandiHaler, (tiotropium bromide inhalation powder), 18 mcg (as tiotropium) per capsule, 90 capsules (9 blister cards), Rx only, NDC 0597-0075-47. Recall # D-353-2011
CODE
Lot # 908679, Exp 04/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, by letters on February 7, 2011.
Manufacturer: Boehringer Ingelheim Pharma GMBH & Co., Ingelheim, Germany. Firm initiated recall is ongoing.
REASON
Does not deliver proper metered dose: A routine stability testing at the 12 month time point yielded a result of 63% for a single capsule for Delivered Dose (DD) testing.
VOLUME OF PRODUCT IN COMMERCE
28,336 cartons
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS II
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0350-11
CODE
Units: 225433818, 225433818
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Las Vegas, NV, by letter on September 1, 2005 and February 7, 2006.
Manufacturer: United Blood Services, Henderson, NV. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NV
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0743-11
CODE
Unit: W038110275682
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on December 22, 2010 and letter on December 23, 2010. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0764-11
CODE
Unit: LK02934
RECALLING FIRM/MANUFACTURER
Stanford Medical School Blood Center, Palo Alto, CA, by telephone on March 14, 2007. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0808-11
CODE
Units: 7667055(BAG1); 7667055(BAG2)
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, Inc., New York, NY, by telephone on October 9, 2007. 
Manufacturer: New York Blood Center, Inc., Long Island City, NY. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Propionibacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0811-11
CODE
Units: 7913615(BAG1); 7913615(BAG2)
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, Inc., New York, NY, by telephone on February 21, 2008 and fax on March 17, 2008.
Manufacturer: New York Blood Center, Inc., Long Island City, NY. Firm initiated recall is complete
REASON
Blood products, which were possibly contaminated with Bacillus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY
___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-0866-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0867-11
CODE
1) Units: 3680967, 3681882;
2) Units: 3680967, 2676764, 2678230, 2420173, 3681882, 3682293, 3682780
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by facsimile and letter dated July 26, 2005. Firm initiated recall is complete.
REASON
Blood products, for which the Syphilis testing was not correctly performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
CA, MA, NY, and Austria
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0868-11;
2) Recovered Plasma. Recall # B-0869-11
CODE
1) and 2) Unit: 3709523
RECALLING FIRM/MANUFACTURER
Recalling Firm: Central California Blood Center. Fresno, CA, by facsimile and letter dated July 6, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on risk factors for Creutzfeldt-Jakob Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA, Austria
___________________________________
PRODUCT
1) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0870-11;
2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0871-11
CODE
1) Unit: 221028458;
2) Units: 225472328, 225472328, 225472328
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Las Vegas, NV, by telephone on March 4, 2005 and letter on April 6, 2005. Firm initiated recall is complete.
REASON
Blood products, collected in a system that may have a potential defect which could compromise the sterility of the closed system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NV
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0921-11
CODE
Unit: W115111029797Y
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by fax on December 21, 2010. Firm initiated recall is complete.
REASON
Blood product, labeled leukoreduced without the assurance that it met the criteria for a leukoreduced product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0923-11
CODE
Units: 8013065B; 8013065A
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by fax on January 12, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0924-11
CODE
Unit: W043210067445
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by fax on January 17, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Source Plasma. Recall # B-0927-11
CODE
Units: 0690114793; 0690115232; 0690115737; 0690116067; 0690117002; 0690117337
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Lincoln, NB, by letter dated December 6, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a body piercing within 12 months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
Spain, CA
___________________________________
PRODUCT
Platelet Pheresis Leukocytes Reduced. Recall # B-0933-11
CODE
Unit: 229049893
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Las Vegas, NV, by telephone on March 25, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that subsequently tested positive for Corynebacterium species, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NV
___________________________________
PRODUCT
Platelet Pheresis Leukocytes Reduced. Recall # B-0935-11
CODE
Unit: W012510200064
RECALLING FIRM/MANUFACTURER
Walter Reed Army Medical Center Blood Bank, Washington, D.C., by letter on November 22, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
___________________________________
PRODUCT
1) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0939-11;
2) Fresh Frozen Plasma (Apheresis). Recall # B-0940-11
CODE
1) and 2) Units: 225549535, 225574523
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Las Vegas, NV, by telephone on January 2, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NV, AZ
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0941-11;
2) Recovered Plasma. Recall # B-0942-11
CODE
1) and 2) Unit: W038110298456
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Ocala, FL, by fax and letter on December 2, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
France, FL
DISTRIBUTION
2 units
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0943-11;
2) Fresh Frozen Plasma. Recall # B-0944-11
CODE
1) and 2) Unit: W035410061985
RECALLING FIRM/MANUFACTURER
Community Blood Center dba Community Tissue Services, Dayton, OH, by telephone on December 14, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH
___________________________________
PRODUCT
Source Plasma. Recall # B-0948-11
CODE
Units: 0100687101, 0100684646, 0100684175, 0100683030, 0100682195, 0100681751, 0100680751, 0100677461, 0100676770, 0100676232, 0100675443, 0100674306, 0100673928, 0100672157, 0100670219, 0100669882, 0100669016, 0100668690, 0100667802, 0100667500
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Chattanooga, TN, by facsimile on March 3, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
20 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0958-11
CODE
Units: 229042318, 229042318
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Las Vegas, NV, by telephone and facsimile on February 28, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that subsequently tested positive for Corynebacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NV
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0959-11
CODE
Unit: Y14438
RECALLING FIRM/MANUFACTURER
Stanford Medical School Blood Center, Palo Alto, CA, by letter on January 25, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had lived in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0966-11;
2) Fresh Frozen Plasma. Recall # B-0967-11
CODE
1) and 2) Unit: 49FS00618
RECALLING FIRM/MANUFACTURER
American National Red Cross, SW Region – HT, Tulsa, OK, by fax on November 13, 2010 and follow-up letters on December 17, 2010 and February 17, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX, OK
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0975-11
CODE
Unit: W1151110212382
RECALLING FIRM/MANUFACTURER
Lifesouth Community Blood Centers, Inc., Mobile, AL, by facsimile on December 29, 2010. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0977-11;
CODE
Unit: 12GF38257
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC, by letter dated December 29, 2010 and by facsimile on December 29, 2010. 
Manufacturer: American Red Cross Blood Services, Wilmington, NC. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, TN
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0979-11
CODE
Unit: W037910556834
RECALLING FIRM/MANUFACTURER
LifeServe Blood Center, Des Moines, IA, by telephone on January 17, 2011. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IA

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS III
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0872-11
2) Recovered Plasma. Recall # B-0873-11
CODE
1) and 2) unit: 5632627
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, inc-cellular Therapy Laboratory, New York, NY, by facsimile on August 9, 2005.
Manufacturer: New York Blood Center, Inc., Elmsford, NY. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had dental surgery and bone replacement within twelve months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY, CA
___________________________________
PRODUCT
Source Plasma. Recall # B-0909-11
CODE
Units: 0100680098, 0100679429, 0100678960, 0100678195, 0100677804, 0100675753, 0100675555, 0100674588, 0100674014, 0100657176, 0100656857
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Chattanooga, TN, by facsimile on March 19, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0922-11
CODE
Unit: 311345374
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc/dba United Blood Services, Meridian, MS, by the Electronic Delivery Note (EDN) system on December 22, 2010.
Manufacturer: Blood Systems Inc/dba United Blood Services, Tupelo, MS. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland

___________________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0932-11
CODE
Unit: 229043140
RECALLING FIRM/MANUFACTURER
Blood Systems Inc., Las Vegas, NV, by telephone on March 22, 2007. Firm initiated recall is complete.
REASON
Blood product, which may not have been placed into the freezer within required time frame, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ
___________________________________
PRODUCT
Platelets Pooled Leukocytes Reduced. Recall # B-0936-11
CODE
Unit # W043810W0438109
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH, by letter on January 20, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-0949-11;
2) Red Blood Cells Leukocytes Reduced. Recall # 0950-11 
CODE
1) and 2) Units: W037710080146; W037710063573
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, UC Medical Center, Cincinnati, OH, by telephone on November 25, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
OH
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0976-11
CODE
Unit: 12GF38257
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC, by letter dated December 29, 2010 and by facsimile on December 29, 2010. 
Manufacturer: American Red Cross Blood Services, Wilmington, NC. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, TN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0978-11
CODE
Unit: W066510601462
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK, by facsimile on January 3, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for Leishmaniasis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AK

RECALLS AND FIELD CORRECTIONS:  DEVICES – CLASS I
___________________________________
PRODUCT
1) Peripherally Inserted Central Venous Catheter Tray Silicone, Sterile, Part Number: CPICSY401�HOPKINS�0911 00; Global Part Number 13169. Recall # Z-1096-2011;

2) Spectrum Central Venous Catheter Tray, Minocydine/Rifampin Antibiotic Impregnated, Double Lumen, 9.5Fr/15cm, Sterile, Part Number: C�UDLMY�953J�ABRM�FST; Global Part Number G13481; Size 9.5Fr/15cm. Recall #  Z-1097-2011;

3) Spectrum Central Venous Catheter Tray, Minocydine/Rifampin Antibiotic Impregnated, Double Lumen, 7.5Fr/20cm, Sterile, Part Number: C�UDLMY�751J-RSC-ABRM-FST; Global Part Number G13482; Size 7.5Fr/20cm. Recall # Z-1098-2011; 

4) Cook Central Venous Catheter Tray, Double Lumen Polyurethane, 4.0Fr/8cm, Sterile, Part Number: C-UDLMY-401J-CCT; Global Part Number G26927. Recall # Z-1099-2011;

5) Cook Central Venous Catheter Tray, Double Lumen Polyurethane, 4.0Fr/12cm, Sterile, Part Number: C-UDLMY-401J-RSC-CCT; Global Part Number G26932. Recall# Z-1100-2011;

6) Cook Central Venous Catheter Tray, Double Lumen Polyurethane, 5.0Fr/8cm, Sterile, Part Number: C-UDLMY-501J-CCT; Global Part Number G26934. Recall # Z-1101-2011;

7) Cook Central Venous Catheter Tray, Double Lumen Polyurethane, 5.0Fr/12cm, Sterile, Part Number: C�UDLMY�501J�RSC�CCT; Global Part Number G26937. Recall # Z-1102-2011;

8) Cook Central Venous Catheter Tray, Triple Lumen Polyurethane, 5.0Fr/8cm, Sterile. Part Number: C�UTLMY�501J�CCT; Global Part Number G26941. Recall # Z-1103-2011;

9) Cook Central Venous Catheter Tray, Triple Lumen Polyurethane, 5.0Fr/15cm, Sterile, Part Number: C�UTLMY�501J�LSC�CCT; Global Part Number G26943. Recall # Z-1104-2011;

10) Cook Central Venous Catheter Tray, Triple Lumen Polyurethane, 5.0Fr/12cm, Sterile, Part Number: C�UTLMY�501J�RSC�CCT; Global Part Number G26945. Recall # Z-1105-2011;

11) Spectrum Soft Central Venous Catheter Tray Minocyciine/Rifampin Antibiotic Impregnated, Double lumen Polyurethane, 4.0Fr/8cm, Sterile, Part Number: C�SDLMY �401 J�ABRM�FST; Global Part Number G29413. Recall # Z-1106-2011;

12) Spectrum Soft Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated, Double lumen Polyurethane, 4.0Fr/15cm, Sterile, Part Number: C�SDLMY�401J�LSC�ABRM�FST; Global Part Number G29416. Recall # Z-1107-2011;

13) Spectrum Soft Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated, Double lumen Polyurethane, 4.0Fr/5cm, Sterile, Part Number: C�SDLMY�401J�PED�ABRM�FST; Global Part Number G29418. Recall # Z-1108-2011;

14) Spectrum Soft Central Venous Catheter Tray Minocyciine/Rifampin Antibiotic Impregnated, Double lumen Polyurethane, 4.0Fr/12cm, Sterile, Part Number: C-SDLMY-401J-RSC-ABRM-FST; Global Part Number G29420. Recall # Z-1109-2011;

15) Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated, Double lumen Polyurethane, 7.5Fr/25cm, Sterile, Part Number: C�UDLMY�751J�LSC�ABRM�FST; Global Part Number G29517; Recall # Z-1110-2011;

16) Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated, Double lumen Polyurethane, 7.5Fr/20cm, Sterile, Part Number: C�UDLMY�751J�RSC�ABRM�FST�A; Global Part Number G29518,. Recall # Z-1111-2011;

17) Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated, Double lumen Polyurethane, 7.5Fr/15cm, Sterile, Part Number: C�UDLMY� 751 J�ABRM�FST�A; Global Part Number G30081. Recall # Z-1112-2011;

18) Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated, Double lumen Polyurethane, 7.5Fr/20cm, Sterile. Part Number: C-UDLMY-751J-190-PIG-RSC-ABRM-FST-A; Global Part Number G30088, Recall # Z-1113-2011;

19) Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated, Double lumen Polyurethane, 7.5Fr/15cm, Sterile, Part Number: C-UDLMY-751J-190-PIG-ABRM-FST-A; Global Part Number G30102, Recall # Z-1114-2011;

20) Cook Medical Central Venous Catheter Tray, 5 Lumen Polyurethane, 10Fr/15cm, Sterile, Part Number: C-UQLMY-1001J-CCT; Global Part Number G32392. Recall # Z-1115-2011;

21) Cook Medical Central Venous Catheter Tray, 5 Lumen Polyurethane, 10Fr/20cm, Sterile, Part Number: C-UQLMY-1001J-RSC-CCT; Global Part Number G32394. Recall #
Z-1116-2011;

22) Cook Spectrum PICC Tray, Minocycline/Rifampin Impregnated, Silicone Peripherally Inserted Central Venous Catheter, 5.0Fr/60cm, Sterile, Part Number: PICSY�501�MPIS�ABRM; Global Part Number G36222. Recall # Z-1117-2011;

23) Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, 5 Lumen Polyurethane, 10.0Fr/15cm, Sterile, Part Number: C�UQLMY�1001J�ABRM�FST; Global Part Number 643128. Recall # Z-1118-2011;

24) Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, 5 Lumen Polyurethane, 10.0Fr/20cm, Sterile, Part Number: C�UQLMY-1001J�RSC�ABRM�FST; Global Part Number G43131, Recall # Z-1119-2011;

25) Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, 5 Lumen Polyurethane, 10.0Fr/20cm, Sterile, Part Number: C�UQLMY�1001J�RSC�ABRM�FST�A; Global Part Number G43132. Recall # Z-1120-2011;

26) Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, 5 Lumen Polyurethane, 10.0Fr/25cm, Sterile, Part Number: C�UQLMY�1001J�LSC�ABRM�FST�A; Global Part Number G43135. Recall # Z-1121-2011;

27) Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Double Lumen Polyurethane, 5.0 Fr/8 cm, Sterile, Part Number: C�UDLMY�501J�-ABRM�HC-FST; Global Part Number G43981. Recall # Z-1122-2011;

28) Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Double Lumen Polyurethane, 5.0 Fr/5 cm, Sterile, Part Number: C-UDLMY-501J-PED-ABRM-HC-FST; Global Part Number G43982.Recall # Z-1123-2011;

29) Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Double Lumen Polyurethane, 4.0 Fr/8 cm, Sterile, Part Number: C-UDLMY-401J-ABRM-HC-FST; Global Part Number G43991. Recall # Z-1124-2011;

30) Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Double Lumen Polyurethane, 4.0 Fr/5 cm, Sterile, Part Number: C-UDLMY-401J-PED- ABRM-HC-FST; Global Part Number G43992. Recall # Z-1125-2011;

31) Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Double Lumen Polyurethane, 4.0 Fr/12 cm, Sterile, Part Number: C-UDLMY-401J-RSC- ABRM-HC-FST; Global Part Number G43993.  Recall # Z-1126-2011;

32) Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Double Lumen Polyurethane, 4.0 Fr/15 cm, Sterile, Part Number: C-UDLMY-401J-LSC- ABRM-HC-FST; Global Part Number G43994. Recall # Z-1127-2011;

33) Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Double Lumen Polyurethane, 5.0 Fr12cm, Sterile, Part Number: C-UDLMY-501J-RSC- ABRM-HC-FST; Global Part Number G44003. Recall # Z-1128-2011;

34) Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Double Lumen Polyurethane, 5.0 Fr 15 cm, Sterile, Part Number: C-UDLMY-501J-LSC- ABRM-HC-FST; Global Part Number G44004. Recall # Z-1129-2011;

35) Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Triple Lumen Polyurethane, 5.0 Fr /8 cm, Sterile, Part Number: C-UTLMY-501J- ABRM-HC-FST; Global Part Number G44013. Recall # Z-1130-2011;

36) Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Triple Lumen Polyurethane, 5.0 Fr /5 cm, Sterile, Part Number: C-UTLMY-501J-PED-ABRM-HC-FST; Global Part Number G44014. Recall # Z-1131-2011;

37) Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Triple Lumen Polyurethane, 5.0 Fr /12 cm, Sterile, Part Number: C-UTLMY-501J-RSC-ABRM-HC-FST; Global Part Number G44015. Recall # Z-1132-2011;

38) Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Triple Lumen Polyurethane, 5.0 Fr /15 cm, Sterile, Part Number: C-UTLMY-501J-LLSC-ABRM-HC-FST; Global Part Number G44016. Recall # Z-1133-2011;

39) Arterial Pressure Monitoring Tray, 2.5 Fr/ 2.5 cm Polyethylene Catheter, Sterile, Part number: C-PMSY-250-HOPKINS, Global part number: G44036. Recall # Z-1134-2011;

40) Central Venous Catheter Tray, Double Lumen Polyurethane, 4.0 Fr/ 8 cm, Sterile, Part number: C-UDLMY-401J- CHILDRENS-HCT, Global part number: G44038. Recall # Z-1135-2011;

41) Central Venous Catheter Tray, Double Lumen Polyurethane 5.0 Fr/ 8 cm, Sterile, Part number: C-UDLMY-501J- CHILDRENS-HCT, Global part number: G44040. Recall # Z-1136-2011;

42) Central Venous Catheter Tray, Double Lumen Polyurethane 5.0 Fr/ 12 cm, Sterile, Part number: C-UDLMY-501J- RSC-CHILDRENS-HCT, Global part number: 44041. Recall # Z-1137-2011;

43) Central Venous Catheter Tray, Polyurethane Catheter, 3.0 Fr/ 8 cm, Sterile, Part number: C-PUMY-301J-CHILDRENS-HCT, Global Part number: G44042. Recall # Z-1138-2011;

44) Central Venous Catheter Tray, Polyurethane Catheter, 4.0 Fr/ 9cm, Sterile, Part number: C-PUMY-401J-CHILDRENS-A--HCT, Global Part number: G44044. Recall # Z-1139-2011;

45) Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated with Minipuncture Access, 8.0 Fr/ 15cm, Sterile, Part number: C-UDLMY-801J-MNP-ABRM-HC-FST, Global part number G44066. Recall # Z-1140-2011;

46) Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated with Minipuncture Access, 8.0 Fr/ 20cm, Sterile, Part number: C-UDLMY-801J-RSC-MNP-ABRM-HC-FST, Global part number G44067. Recall # Z-1141-2011;

47) Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated with Minipuncture Access, 8.0 Fr/ 15cm, Sterile, Part number: C-UDLMY-801J--MNP-ABRM-HC-FST-A, Global part number G44069. Recall # Z-1142-2011;

48) Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated with Minipuncture Access, 8.0 Fr/ 20cm, Sterile, Part number: C-UDLMY-801J--RSC-MNP-ABRM-HC-FST-A, Global part number G44070. Recall # Z-1143-2011;

49) Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated with Minipuncture Access, 8.0 Fr/ 25cm, Sterile, Part number: C-UDLMY-801J--LSC-MNP-ABRM-HC-FST-A, Global part number G44071. Recall # Z-1144-2011;

50) Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter 7.0 Fr/ 15cm, Sterile, Part number: C-UTLMY-701J-ABRM-HC-FST-A-RD, Global part number G44126. Recall # Z-1145-2011;

51) Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 25cm, Sterile, Part number: C-UTLMY-701J--LSC-ABRM-HC-FST-A-RD, Global part number G44127. Recall # Z-1146-2011;

52) Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 20cm, Sterile, Part number: C-UTLMY-701J--RSC--ABRM-HC-FST-A-RD, Global part number G44128. Recall # Z-1147-2011;

53) Central Venous Tray, Triple Lumen Polyurethane Catheter, 7.0 Fr/ 15cm, Sterile, Part number: C-UTLMY-701J-CCT-RD, Global part number G47815. Recall # Z-1148-2011;

54) Central Venous Tray, Triple Lumen Polyurethane Catheter, 7.0 Fr/ 25cm, Sterile, Part number: C-UTLMY-701J-LSC-CCT-RD, Global part number G47818.  Recall # Z-1149-2011;

55) Central Venous Tray, Triple Lumen Polyurethane Catheter, 7.0 Fr/ 20cm, Sterile, Part: C-UTLMY-701J--RSC-CCT-RD, Global part number G47822. Recall # Z-1150-2011;

56) Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 15cm, Sterile, Part number: C-UTLMY-701J-ABRM-HC-FST-RD, Global part number G47831. Recall # Z-1151-2011;

57) Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 25cm, Sterile, Part number: C-UTLMY-701J-LSC-ABRM-HC-FST-RD, Global part number G47832. Recall # Z-1152-2011;

58) Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 20cm, Sterile, Part number: C-UTLMY-701J-RSC-ABRM-HC-FST-RD, Global part number G47833. Recall # Z-1153-2011;

59) Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter with Minipuncture Access, 7.0 Fr/ 20cm, Sterile, Part number: C-UTLMY-701J-RSC-MNP-ABRM-HC-FST-A-RD, Global part number G47839. Recall # Z-1154-2011;

60) Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane, 7.0 Fr/ 15cm, Sterile, Part number: C-UTLMY-701J-190-PIG-ABRM-FST-A-RD, Global part number G47845. Recall # Z-1155-2011;

61) Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane, 7.0 Fr/ 20cm, Sterile, Part number: C-UTLMY-701J-190-PIG-RSC-ABRM-FST-A-RD, Global part number G47846. Recall # Z-1156-2011;

62) Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Double Lumen Polyurethane, 4.0 Fr/ 8cm, Sterile, Part number: C-SDLMY-401J-ABRM-IHI-FST, Global part number G48047. Recall # Z-1157-2011;

63) Spectrum Soft Central Venous Tray, Minocycline/Rifampin Impregnated Double Lumen Polyurethane, 4.0 Fr/ 12cm, Sterile, Part number: C-SDLMY-401J-RSC-ABRM-IHI-FST, Global part number G48050. Recall # Z-1158-2011;

64) Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Double Lumen Polyurethane, 4.0 Fr/ 8cm, Sterile, Part number: C-UDLMY-401J-ABRM-HC-IHI-FST, Global part number G48053. Recall # Z-1159-2011;

65) Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Double Lumen Polyurethane, 4.0 Fr/ 15cm, Sterile, Part number: C-UDLMY-401J-LSC-ABRM-HC-IHI-FST, Global part number G48056. Recall # Z-1160-2011;

66) Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Double Lumen Polyurethane, 4.0 Fr/ 5cm, Sterile, Part number: C-UDLMY-401J-PED-ABRM-HC-IHI-FST, Global part number G48059. Recall # Z-1161-2011;

67) Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Double Lumen Polyurethane, 4.0 Fr/ 12cm, Sterile, Part number: C-UDLMY-401J-RSC-ABRM-HC-IHI-FST, Global part number G48061. Recall # Z-1162-2011;

68) Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Double Lumen Polyurethane, 5.0 Fr/ 8cm, Sterile, Part number: C-UDLMY-501J-ABRM-HC-IHI-FST, Global part number G48064. Recall # Z-1163-2011;

69) Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Double Lumen Polyurethane, 5.0 Fr/ 15cm, Sterile, Part number: C-UDLMY-501J-LSC-ABRM-HC-IHI-FST, Global part number G48067. Recall # Z-1164-2011;

70) Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Double Lumen Polyurethane, 5.0 Fr/ 5cm, Sterile, Part number: C-UDLMY-501J-PED-ABRM-HC-IHI-FST, Global part number G48069. Recall # Z-1165-2011;

71) Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Double Lumen Polyurethane, 5.0 Fr/ 12cm, Sterile, Part number: C-UDLMY-501J-RSC-ABRM-HC-IHI-FST, Global part number G48076. Recall # Z-1166-2011

72) Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Double Lumen Polyurethane with Minipuncture Access, 8.0 Fr/ 15cm, Sterile, Part number: C-UDLMY-801J-MNP-ABRM-HC-IHI-FST-A, Global part number G48097. Recall # Z-1167-2011;

73) Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated 5 Lumen Polyurethane, 10.0 Fr/ 15cm, Sterile. Part number: C-UQLMY-1001J-ABRM-IHI-FST, Global part number G48107. Recall # Z-1168-2011;

74) Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated 5 Lumen Polyurethane, 10.0 Fr/ 15cm, Sterile. Part number: C-UQLMY-1001J-ABRM-IHI-FST-A, Global part number G48109. Recall # Z-1169-2011;

75) Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane, 5.0 Fr/ 8cm, Sterile, Part number: C-UTLMY-501J-ABRM-HC-IHI-FST, Global part number G48113. Recall # Z-1170-2011;

76) Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane, 5.0 Fr/ 15cm, Sterile, Part number: C-UTLMY-501J-LSC-ABRM-HC-IHI-FST, Global part number G48117. Recall # Z-1171-2011;

77) Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Five Lumen Polyurethane, 5.0 Fr/ 15cm, Sterile, Part number: C-UQLMY-1001J-RSC-ABRM-IHI-FST-A, Global part number G48120. Recall # Z-1172-2011;

78) Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane, 5.0 Fr/ 5cm, Sterile, Part number: C-UTLMY-501J-PED-ABRM-HC-IHI-FST, Global part number G448122. Recall # Z-1173-2011;

79) Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane, 5.0 Fr/ 5cm, Sterile, Part number: C-UTLMY-501J-RSC-ABRM-HC-IHI-FST, Global part number G48124. Recall # Z-1174-2011;

80) Central Venous Tray, Triple Lumen Polyurethane, 9.0 Fr/ 15cm, Sterile, Part number: C-UTLMY-901J-CCT-RD, Global part number G48997; Recall # Z-1175-2011;  

81) Central Venous Catheter Tray, Triple Lumen Polyurethane, 9.0 Fr/ 25cm, Sterile, Part number: C-UTLMY-901J-LSC-CCT-RD, Global part number G48998. Recall # Z-1176-2011;

82) Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated Triple Lumen Polyurethane, 9.0 Fr/ 25cm, Sterile, Part number: C-UTLMY-901J-LSC-ABRM-FST-RD, Global part number G49004; Recall # Z-1177-2011;  

83) Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Triple Lumen Polyurethane, 9.0 Fr/ 20 cm, Sterile, Part number: C-UTLMY-901J-RSC-ABRM-FST-RD, Global part number G49005. Recall # Z-1178-2011;

84) Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Triple Lumen Polyurethane, 9.0 Fr/ 15cm, Sterile, Part number: C-UTLMY-901J-ABRM-FST-A-RD, Global part number G49009; Recall # Z-1179-2011;

85) Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, Triple Lumen Polyurethane, 9.0 Fr/ 20cm, Sterile, Part number: C-UTLMY-901J-RSC-ABRM-FST-A-RD, Global part number G49010. Recall # Z-1180-2011;

86) Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter, 5.0 Fr/ 60 cm, Sterile, Part number: C-UPICSY-5.0-CT-NT, Global part number G49163. Recall # Z-1181-2011;

87) Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter, 5.0 Fr/ 60 cm, Sterile, Part number: C-UPICSY-5.0-CT-OTW, Global part number G49164. Recall # Z-1182-2011;

88) Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter, , 5.0 Fr/ 60 cm, Sterile, Part number: C-UPICDSY-5.0-CT, Global part number G49168. Recall # Z-1183-2011;

89) Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter, 5.0 Fr/ 60 cm, Sterile, Part number: C-UPICDSY-5.0-CT-NT, Global part number G49169. Recall # Z-1184-2011;

90) Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter, 5.0 Fr/ 9 cm, Sterile, Part number: C-UPICDSY-5.0-CT-OTW, Global part number G49170. Recall # Z-1185-2011;

91) Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter, 4.0 Fr/ 60 cm, Sterile, Part number: C-UPICSY-4.0-CT-NT, Global part number G49175. Recall # Z-1186-2011;

92) Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter, , 4.0 Fr/ 60 cm, Sterile, Part number: C-UPICSY-4.0-CT-OTW Global part number G49176. Recall # Z-1187-2011;

93) Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter, 4.0 Fr/ 60 cm, Sterile, Part number: C-UPICDSY-4.0-CT Global part number G49180. Recall # Z-1188-2011;  

94) Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter, 4.0 Fr/ 60 cm, Sterile, Part number: C-UPICDSY-4.0-CT-NT Global part number G49181. Recall # Z-1189-2011;

95) Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 15 cm Power Injectable, Sterile, Part number: C-UTLMY-701J-ABRM-HC-IHI-FST-RD, Global part number G49802. Recall # Z-1190-2011;

96) Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 15 cm Power Injectable, Sterile, Part number: C-UTLMY-701J-ABRM-HC-IHI-FST-A-RD, Global part number G49803. Recall # Z-1191-2011;

97) Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 20 cm Power Injectable, Sterile, Part number: C-UTLMY-701J-RSC-ABRM-HC-IHI-FST-A-RD, Global part number G49804.  Recall # Z-1192-2011;

98) Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 20 cm Power Injectable, Sterile, Part number: C-UTLMY-701J-RSC-ABRM-HC-IHI-FST-RD, Global part number G49805. Recall # Z-1193-2011;

99) Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 25 cm Power Injectable, Sterile, Part number: C-UTLMY-701J-LSC-ABRM-HC-IHI-FST-RD, Global part number G49806. Recall # Z-1194-2011;

100) Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 25 cm Power Injectable, Sterile, Part number: C-UTLMY-701J-LSC-ABRM-HC-IHI-FST-A-RD, Global part number G49807. Recall # Z-1195-2011;

101) Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Double Lumen Polyurethane Catheter, 7.0 Fr/ 25 cm, Sterile, Part number: C-UDLMY-801J-ABRM-HC-FST-A, Global part number G50819. Recall # Z-1196-2011;

102) Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Double Lumen Polyurethane Catheter, 8.0 Fr/ 20 cm, Sterile, Part number: C-UDLMY-801J-RSC-ABRM-HC-FST-A, Global part number G50820. Recall # Z-1197-2011;

103) Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Double Lumen Polyurethane Catheter, 8.0 Fr/ 15 cm, Sterile, Part number: C-UDLMY-801J-ABRM-HC-IHI-FST-A, Global part number G50821. Recall # Z-1198-2011;

104) Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Double Lumen Polyurethane Catheter, 8.0 Fr/ 20 cm, Sterile, Part number: C-UDLMY-801J-ABRM-HC-IHI-FST-A, Global part number G50821. Recall # Z-1199-2011;

105) Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 5.0 Fr/ 8 cm, Sterile, Part number: C-UTLMYJC-501J-ABRM-HC-FST, Global part number G51255. Recall # Z-1200-2011;

106) Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 5.0 Fr/ 8 cm, Sterile, Part number: C-UTLMYJC-501J-PED-ABRM-HC-IHI-FST, Global part number G51264. Recall # Z-1201-2011;

107) Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 15cm, Sterile, Part number: C-UTLMYJC-701J-ABRM-HC-FST-A-RD, Global part number G51265. Recall # Z-1202-2011;

108) Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 15cm, Sterile, Part number: C-UTLMYJC-701J-ABRM-HC-IHI-FST-A-RD, Global part number G51267. Recall # Z-1203-2011;

109) Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 15cm, Sterile, Part number: C-UTLMYJC-701J-RSC-ABRM-HC-FST-A-RD, Global part number G51268. Recall # Z-1204-2011;

110) Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 25cm, Sterile, Part number: C-UTLMYJC-701J-LSC-ABRM-HC-IHI-FST-A-RD, Global part number G51269. Recall # Z-1205-2011;

111) Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 7.0 Fr/ 20cm, Sterile, Part number: C-UTLMYJC-701J-RSC-ABRM-HC-IHI-FST-A-RD, Global part number G51270. Recall # Z-1206-2011;

112) Central Venous Catheter Tray Five Lumen Polyurethane, 10.0 Fr/ 20cm, Sterile, Part number: C-UQLMY-1001J-RSC-CCT-RD, Global part number G51536. Recall # Z-1207-2011;

113) Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, 5 Lumen Polyurethane, 10 Fr/ 15 cm, Sterile, Part Number C-UQLMY-1001J-ABRM-HC-FST-RD, Global Part Number G51540. Recall # Z-1208-2011;

114) Spectrum Central Venous Catheter Tray Minocycline/Rifampin Impregnated 5 Lumen Polyurethane, 10.0 Fr/ 20cm, Sterile, Part number: C-UQLMY-1001J-RSC-ABRM-HC-FST-RD, Global part number G51542. Recall # Z-1209-2011;

115) Spectrum Central Venous Catheter Tray Minocycline/Rifampin Impregnated 5 Lumen Polyurethane, 10.0 Fr/ 15 cm, Sterile, Part number: C-UQLMY-1001J-ABRM-HC-FST-A-RD, Global part number G51543. Recall # Z-1210-2011;

116) Spectrum Central Venous Catheter Tray Minocycline/Rifampin Impregnated 5 Lumen Polyurethane, 10.0 Fr/ 20 cm, Sterile, Part number: C-UQLMY-1001J-RSC-ABRM-HC-FST-A-RD, Global part number G51545. Recall # Z-1211-2011;

117) Spectrum Central Venous Catheter Tray Minocycline/Rifampin Impregnated 5 Lumen Polyurethane, 10.0 Fr/ 15 cm, Sterile, Part number: C-UQLMY-1001J-ABRM-HC-IHI-FST-A-RD, Global part number G51546. Recall # Z-1212-2011;

118) Spectrum Central Venous Catheter Tray Minocycline/Rifampin Impregnated 5 Lumen Polyurethane, 10.0 Fr/ 20 cm, Sterile, Part number: C-UQLMY-1001J-RSC-ABRM-HC-IHI-FST-A-RD, Global part number G51548. Recall # Z-1213-2011;

119) Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 9 Fr/ 15 cm, Sterile, Part number: C-UTLMY-901J-ABRM-HC-FST-RD, Global part number G51585. Recall # Z-1214-2011;

120) Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 9 Fr/ 15 cm, Sterile, Part number: C-UTLMY-901J-ABRM-HC-FST-A-RD, Global part number G51586. Recall # Z-1215-2011;

121) Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 9 Fr/ 20 cm, Sterile, Part number: C-UTLMY-901J-RSC-ABRM-HC-FST-A-RD, Global part number G51587. Recall # Z-1216-2011;

122) Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 9 Fr/ 25 cm, Sterile, Part number: C-UTLMY-901J-LSC-ABRM-HC-FST-A-RD, Global part number: G51588. Recall # Z-1217-2011;

123) Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane Catheter, 9 Fr/ 20 cm, Sterile, Part number: C-UTLMY-901J-RSC-ABRM-HC-IHI-FST-A-RD, Global part number: G51590. Recall # Z-1218-2011
CODE
1) Lot number: F2349680;

2) Lot numbers: F2316459, F2319929, F2322337, F2328457, F2332975, F2335094, F2378952.

3) Lot numbers: F2361610, F2372057, F2379389;

4) Lot numbers: F2322846, F2326430, F2328194, F2335728, F2336763, F2341757, F2343674, F2346292, F2349568, F2354567, F2356644, F2359427, F2364945 and F2382246;

5) Lot numbers: F2322847, F2328196, F2341763, F2349570, F2359449, F2365678, F2366174, F2366175, F2366176, F2367620, F2368180, F2368181, F2368836, F2369650, F2369814, F2369815 and F2370815;

6) Lot number: F2236764; 

7) Lot number: F2324970;

8) Lot numbers: F2323225, F2328206, F2334938, F2349595 F2352781 and F2363783;

9) Lot numbers: F2317780, F2324989, F2328207, F2343675, F2349596, F2349597 F2360190, F2363785, F2368193 and F2384119;

10) Lot numbers: F2317782, F2339221, F2343678, F2349601 F2356651, F2360192, F2362194 and F2368194;

11) Lot numbers: 2228497, 2228500, 2236164, 2241967, 2251148, 2252533, 2256877, 2275432, 2294027, 2312977, 2317385, 2326672 and 2328409;

12) Lot numbers: F2343099, F2345874, F2347009, F2352408, F2360243 and F2368121;

13) Lot numbers: 2241236, 2248317, 2254320, 2270312, 2273787, 2279123, 2321675 and 2336067;

14) Lot numbers: 2240337, 2251145, 2251988, 2254438, 2273788, 2290141 and 2310878;

15) Lot numbers: F2345339, F2363774;

16) Lot numbers: F2317767, F2322852, F2339813, F2343616, F2346299, F2347030, F2354581, F2359452, F2366179, F2378033, F2380795 and F2383261;

17) Lot numbers: 2276911, 2318837 and 2259335;

18) Lot numbers: F2333050, F2335735, F2341771, F2349573;

19) Lot numbers: 2243895, 2248315, 2251994, 2255604, 2263471, 2277887, 2290205, 2318717.

20) Lot numbers: 2274646, 2276336;

21) Lot number: 2227459;

22) Lot numbers: F2360265, F2360266;

23) Lot numbers: 2233292, 2235714, 2240454, 2267335, 2271331, 2271332, 2271333, 2275552, 2276335, 2277141, 2277142, 2283584, 2283585 and 2314076;

24) Lot numbers: 2235715, 2254450, 2260852, 2260962, 2286980, 2292869, 2294124 and 2294906;

25) Lot numbers:: 2242154, 2233293, 2246936, 2248189, 2248190, 2264661, 2264662, 2280917, 2282619, 2296281, 2327657 and F2328396;

26) Lot numbers: 2272965 2283586;

27) Lot numbers: 2239285, 2239286, 2246213, 2248245, 2251150, 2255155, 2256099, 2262184, 2262214, 2267171, 2272022, 2275422, 2276826, 2279972, 2282637, 2286936, 2289356, 2290125, 2294584, 2294587, 2296246, 2304969, 2315323, 2316753, 2321452, 2325090 and 2332347;

28) Lot numbers: 2243905, 2252486, 2254311, 2259321, 2263387, 2269786, 2275439, 2282402, 2284654, 2297817, 2303833, 2315324 2319566 and 2329777;

29) Lot numbers: 2239671, 2240332, 2241244, 2242374, 2242385, 2244239, 2246215, 2247660, 2251149, 2251993, 2253260, 2254294, 2255154, 2255167, 2256085, 2256086, 2256091, 2256094, 2256106, 2258322, 2263457, 2266466, 2268899, 2270663, 2275438, 2275487, 2278553, 2279206, 2282639, 2282640, 2282641, 2285514, 2285550, 2291774, 2294744, 2296185, 2302089, 2304442, 2307476, 2308272, 2309333, 2309424, 2313807, 2316752, 2318742, 2318831, 2321683, 2327490, 2330564, 2332346, 2337150 and 2279206X;

30) Lot numbers: 2227693, 2239036, 2241246, 2243904, 2246221, 2248312, 2254310, 2256092, 2256098, 2258323, 2264568, 2267967, 2270680, 2275430, 2275449, 2276888, 2280759, 2282646, 2282655, 2284659, 2284706, 2294745, 2299209, 2300746, 2302090, 2305911, 2312984 2315418, 2318765, 2321684, 2328529 and 2335168;

31) Lot numbers: 2239672, 2240535, 2242733, 2247662, 2248313, 2252474, 2254446, 2256875, 2259331, 2262108, 2262211, 2275423, 2276823, 2282408, 2290114, 2291776, 2300741, 2315939, 2318834 and 2330565;

32)  Lot numbers: F2319920, F2326431, F2326432, F2333044, F2341758, F2343601, F2343602, F2344571, F2352776, F2354568, F2363767, F2364946, F2369649, F2372051, F2380048, F2380790 and F2384349;

33) Lot numbers: 2238143, 2239207, 2240537, 2241784, 2252487, 2257544, 2267174, 2267995, 2273799, 2275424, 2276829, 2282636, 2286935, 2287725, 2290145, 2302073, 2311589, 2321689 and 2282636X; 

34) Lot numbers: F2329031, F2333046, F2341765, F2341766, F2343606, F2343607, F2346296, F2354573, F2354574, F2359450, F2363769, F2363770, F2363771, F2365679, F2368837, F2375051, F2377328, F2377977, F2378032, F2379385, F2380791, F2382156, F2382264, F2384352 and F2385292;

35) Lot numbers: 2236492, 2239042, 2241780, 2242710, 2245829, 2248319, 2251996, 2253748, 2254332, 2256109, 2262101, 2262195, 2268923, 2275436, 2276878, 2280761, 2292796, 2297829, 2298487, 2300876, 2308264, 2314046, 2321296 and 2330569;

36) Lot numbers: 2239451, 2242712, 2244223, 2246769, 2248941, 2263473, 2270643, 2290133, 2303828, 2317363 and 2328399;

37) Lot numbers: 2236157, 2239667, 2239684, 2240543, 2245799, 2251151 2253300, 2254334, 2257545, 2266259, 2268925, 2279208, 2291778, 2298488, 2306597, 2315326 and 2318840;

38) Lot numbers: 2239666, 2242701, 2248940, 2253262, 2254312, 2255610, 2262114, 2263390, 2275431, 2280744, 2285512, 2309427, 2321454 and 2332349;

39) Lot number: 2308262;

40) Lot number: F2355271;

41) Lot number: F2337716;  

42) Lot numbers: F2337715 and F2355280;

43) Lot number: F2356767;  

44) Lot numbers: F2344678, F2355281 and F2359611;

45) Lot number: F2374436;

46) Lot number: F2315341;

47) Lot numbers: 2253338, 2308215;

48) Lot numbers: 2238963, 2238964, 2238967, 2238970, 2240532, 2248247, 2291832 and 2296248;

49) Lot number: 2308181;

50) Lot number: 2241830, 2241946, 2241947, 2244225, 2244835, 2244836, 2244837, 2244839, 2245830, 2253342, 2255605, 2255607, 2255738, 2255739, 2266266, 2267178, 2267969, 2268001, 2275493, 2276215, 2276880, 2276913, 2282406, 2282407, 2282422, 2282423, 2301416, 2301420, 2302127, 2304966, 2305905, 2307487, 2309428, 2313825, 2314047, 2315396, 2315399, 2318757, 2318842, 2321308, 2322431, 2322484, 2325091, 2326801, 2328402, 2328536, 2332350, 2335175, 2336043 and 2282407X;

51) Lot number: 2231288, 2247663, 2255742, 2259415, 2273798, 2296820, 2317379, 2331449 and 2247663X;

52) Lot numbers: 2231979, 2231980, 2231999, 2238977, 2238978, 2238979, 2238980, 2238981, 2238982, 2243443, 2244830, 2244831, 2244832, 2245780, 2245781, 2246223, 2246583, 2246584, 2246585, 2246586, 2246587, 2246588, 2246589, 2246590, 2246744, 2246745, 2246746, 2246747, 2246756, 2246757, 2246758, 2246759, 2246801, 2246802, 2246803, 2246804, 2246805, 2246806, 2246807, 2246808, 2246819, 2246820, 2246821, 2246822, 2246823, 2246824, 2246825, 2247317, 2247318, 2247669, 2247670, 2249285, 2249286, 2249287, 2249288, 2249289, 2250281, 2250282, 2252448, 2254304, 2254305, 2254306, 2254307, 2254308, 2254313, 2254314, 2254315, 2254316, 2267158, 2267159, 2270627, 2270628, 2270629, 2270630, 2273791, 2273792, 2273793, 2273794, 2273795, 2273796, 2276867, 2276868, 2279126, 2279127, 2279128, 2279129, 2279130, 2279131, 2279132, 2280740, 2280741, 2281671, 2281672, 2281674, 2281675, 2281676, 2286376, 2286384, 2286385, 2287302, 2287303, 2289365, 2289366, 2289373, 2289374, 2289375, 2289376, 2289874, 2289875, 2289876, 2289877, 2289878, 2289879, 2289880, 2289881, 2290914, 2300161, 2302129, 2302130, 2303849, 2304971, 2305912, 2307488, 2307489, 2309357, 2309431, 2309432, 2309433, 2312069, 2312070, 2312071, 2312987, 2313826, 2315397, 2315400, 2315401, 2315402, 2317380, 2317391, 2317392, 2317456, 2317457, 2317458, 2318844, 2319573, 2319595, 2320314, 2320315, 2323365, 2323366, 2324256, 2324278, 2324279, 2324280, 2325097, 2326802, 2326803, 2327439, 2327440, 2327494, 2327495, 2327496, 2328415, 2328538, 2328539, 2328540, 2331475, 2332337, 2332353, 2332354, 2332355, 2336045, 2246223X, 2246747X and 2289880X;

53) Lot number: 2242155;

54) Lot number: F2313884, F2325884, F2328415, F2351905, F2357862 and F2365096;

55) Lot number: 2237550, 2238016, 2240456, 2248191, 2253955, 2272121 2317013, 2318898 and 2322733;

56) Lot number: 2238150, 2238157, 2240345, 2241829, 2241831, 2241867, 2241944, 2241945, 2241948, 2245787, 2245831, 2246217, 2247688, 2248272, 2248321, 2248943, 2248944, 2250303, 2251986, 2251998, 2252008, 2253301, 2253343, 2255616, 2255740, 2256110, 2256160, 2256167, 2257546, 2259341, 2259414, 2264558, 2265389, 2265396, 2266276, 2268074, 2268926, 2270316, 2270318, 2270682, 2273807, 2275454, 2275455, 2275469, 2276890, 2277907, 2278555, 2278560, 2278670, 2279209, 2281658, 2281659, 2282539, 2283327, 2283328, 2286942, 2291834, 2291835, 2291836, 2291837, 2291839, 2291840, 2292792, 2292794, 2292797, 2294041, 2294603, 2294707, 2294715, 2294748, 2296188, 2297830, 2299453, 2300861, 2300862, 2303847, 2304440, 2304444, 2304445, 2308280, 2308350, 2309429, 2311575, 2311593, 2312986, 2315329, 2315344, 2315345, 2315938, 2315940, 2315950, 2316754, 2317390, 2317452, 2321297, 2321298, 2323347, 2323353, 2325092, 2326690, 2326710, 2327438, 2328414, 2328537, 2331452, 2331459, 2332351, 2334841, 2335176, 2337152 and 2282539X;

57) Lot number: 2227805, 2231998, 2233817, 2235524, 2235535, 2240333, 2240347, 2241835, 2244218, 2246770, 2247661, 2247664, 2247966, 2247967, 2247968, 2247969, 2253276, 2253302, 2255617, 2255743, 2259343, 2259344, 2268076, 2268927, 2269801, 2275440, 2276221, 2277892, 2278671, 2280762, 2282534, 2282648, 2282656, 2282660, 2285513, 2285517, 2285526, 2295485, 2299455, 2302128, 2308273, 2309356, 2311576, 2315347, 2317454, 2325084, 2326692, 2327493and 2332352;

58) Lot number: 2238983, 2243417, 2243419, 2243420, 2243421, 2243422, 2243433, 2243434, 2243435, 2243436, 2243437, 2243438, 2243439, 2243440, 2243441, 2243442, 2244219, 2244220, 2244221, 2244222, 2244833, 2244834, 2245777, 2245778, 2246224, 2246225, 2246226, 2246227, 2246228, 2246578, 2246579, 2246580, 2246591, 2246592, 2246738, 2246739, 2246740, 2246741, 2246742, 2246748, 2246749, 2246750, 2246751, 2246752, 2246753, 2246754, 2246760, 2246761, 2246762, 2246763, 2246764, 2246765, 2246766, 2246771, 2246772, 2246773, 2246774, 2246775, 2246776, 2246777, 2246809, 2246810, 2246811, 2246812, 2246813, 2246814, 2246815, 2246816, 2247305, 2247306, 2247307, 2247308, 2247309, 2247310, 2247311, 2247319, 2247320, 2247321, 2247322, 2247323, 2247324, 2250283, 2250284, 2252444, 2253263, 2253264, 2253265, 2253266, 2253277, 2253746, 2253747, 2254297, 2254298, 2255152, 2255599, 2255600, 2255602, 2255603, 2256793, 2256794, 2256795, 2256796, 2256797, 2256798, 2256799, 2264541, 2264542, 2264543, 2264544, 2264545, 2264546, 2264547, 2264548, 2264549, 2267160, 2267161, 2267162, 2267163, 2270308, 2270622, 2270623, 2270624, 2270625, 2270626, 2270631, 2270632, 2270633, 2272770, 2272771, 2275425, 2275426, 2275427, 2275428, 2275429, 2276851, 2276852, 2276853, 2276854, 2276858, 2276859, 2276860, 2276861, 2276862, 2276863, 2276864, 2276869, 2276870, 2276871, 2276872, 2276873, 2276874, 2276875, 2279124, 2279125, 2279133, 2279134, 2279135, 2279136, 2279137, 2279138, 2279139, 2279140, 2279141, 2279142, 2279143, 2279144, 2279145, 2279146, 2279152, 2279153, 2279154, 2279155, 2284627, 2284628, 2284632, 2286370, 2286371, 2286372, 2286373, 2286374, 2286375, 2286377, 2286378, 2286379, 2286380, 2286381, 2286382, 2286383, 2286865, 2286866, 2286867, 2286868, 2286869, 2286870, 2286871, 2286872, 2286873, 2286874, 2287299, 2287300, 2287702, 2287703, 2289367, 2289368, 2289369, 2289857, 2289858, 2289859, 2289860, 2289861, 2289862, 2289863, 2289864, 2289865, 2289866, 2289867, 2289868, 2289869, 2289870, 2289871, 2289872, 2290103, 2290104, 2290105, 2290106, 2290107, 2290108, 2290109, 2290910, 2290911, 2290912, 2290913, 2291780, 2291781, 2291782, 2291783, 2291784, 2291785, 2291786, 2294016, 2294017, 2294018, 2294019, 2294020, 2294022, 2294023, 2294024, 2294025, 2294030, 2294031, 2294032, 2294043, 2294044, 2294045, 2294046, 2294749, 2294750, 2294751, 2295486, 2296167, 2296168, 2296169, 2296190, 2296191, 2296192, 2296193, 2297509, 2297510, 2297511, 2297522, 2297523, 2297524, 2297525, 2297530, 2297531, 2297532, 2298489, 2298490, 2298497, 2298498, 2298499, 2299210, 2299217, 2299445, 2299446, 2299448, 2299449, 2299450, 2299456, 2299457, 2299458, 2299459, 2299460, 2299461, 2299462, 2301428, 2301429, 2302074, 2302075, 2302076, 2302077, 2302078, 2302079, 2302080, 2302092, 2302093, 2302094, 2302095, 2302131, 2302132, 2302133, 2303179, 2303180, 2303850, 2303851, 2303852, 2303853, 2303854, 2303855, 2305894, 2305895, 2305896, 2305897, 2305898, 2305899, 2305900, 2305913, 2305914, 2305915, 2305916, 2307479, 2307480, 2307501, 2308274, 2308275, 2308281, 2308282, 2308283, 2308284, 2308351, 2308352, 2308353, 2308354, 2309358, 2309359, 2309434, 2309435, 2309436, 2311596, 2311597, 2311598, 2312061, 2312062, 2312966, 2312988, 2312989, 2312990, 2313811, 2313812, 2313813, 2315348, 2315349, 2315350, 2315421, 2315422, 2315423, 2315424, 2317372, 2317393, 2317394, 2317395, 2317459, 2317460, 2317461, 2317462, 2319574, 2319596, 2319597, 2319598, 2319599, 2320316, 2321456, 2323367, 2324269, 2324270, 2326712, 2326713, 2326793, 2327441, 2327442, 2327497, 2327498, 2327499, 2327500, 2328416, 2328541, 2328542, 2328543, 2329812, 2330570, 2330571, 2331476, 2331477, 2332356, 2332357, 2332358, 2334842, 2334843, 2334844, 2335179, 2335180, 2335181, 2335182, 2335183, 2335184, 2335185, 2337164, 2246225X, 2270625X, 2289858X, 2289863X, 2289866X, 2294022X and 2294023X;

59) Lot numbers: 2241868; 2242713; 2244240; 2251182; 2253304; 2256168; 2266272; 2269791; 2292805; 2296229; 2296230; 2296234; 2296237; 2302082; 2308276; 2311579; 2311601; 2315952; 2329795;

60) Lot numbers: 2236494; 2240335; 2241865; 2243454; 2243479; 2247700; 2248271; 2248942; 2251989; 2253341; 2255612; 2255615; 2259340; 2266271; 2268000; 2269799; 2275491; 2277906; 2282472; 2286322; 2286941; 2291779; 2293489; 2296811; 2299444; 2303166; 2307478; 2311592; 2315327; 2318744; 2318841; 2329793; 2334332;

61) Lot numbers: 2244232; 2251997; 2265388; 2270315; 2272896; 2275492; 2286312; 2286323; 2293482; 2295471; 2296808; 2302068; 2306589; 2306590; 2306598; 2315328; 2317451; 2325082;

62) Lot number: F2368120;

63) Lot number: F2339218;

64) Lot numbers: 2310839; 2310849; 2310856; 2321265; 2321266; 2321270; F2316416; F2316417; F2322843; F2354566; F2359447;

65) Lot number: F2354569;

66) Lot numbers: F2350380; F2354570; F2363768; F2367619; F2372052; F2372053; F2377327;

67) Lot numbers: 2310840; 2310850; 2310857; F2316418; F2354571;

68) Lot number: F2354572;

69)  Lot numbers: F2323340; F2354575; F2363772;

70) Lot number: F2354577;

71) Lot numbers: F2323746 and F2354578;

72) Lot numbers: 2229418; 2229419; 2248250; 2259336;

73) Lot number: F2328395;

74) Lot number: F2337336;

75) Lot numbers: 2310841; 2310851; 2310858; F2323224; F2366204; F2377697;

76) Lot numbers: F2317779; F2354593; F2372087; F2384118;

77) Lot numbers: 2243564; 2260897; 2281791; 2287791; 2287792; 2288494; 2288495; 2318207; 2318208; 2287792X;

78) Lot numbers: 2310842; 2310852; 2310870; F2323226;

79) Lot numbers: 2310843; 2310853; 2310871; F2328209;

80) Lot numbers: F2319419; F2329600; F2342658;

81) Lot number: F2381713;

82) Lot numbers: 2236160 and 2239685;

83) Lot number: 2236522;

84) Lot numbers: 2233574, 2233583;

85) Lot number: 2238976;

86) Lot numbers: 2266449, 2308713, 2309331;

87) Lot numbers: 2263405 and 2277885;

88) Lot numbers: 2281646, 2281685, 2312954, 2314026;

89) Lot numbers: 2244226, 2246219, 2251161, 2255157, 2264598, 2267957, 2267971, 2275435, 2275476, 2278549, 2278570, 2287707, 2287709, 2292788, 2292791, 2298486, 2302064, 2302098, 2306592, 2313790, 2317361, 2317382, 2321273, 2325079, 2327447, 2334833 and 2335156;

90) Lot numbers: 2242381; 2250288; 2252456; 2255188, 2259981, 2269809 2276836, 2279174, 2282649, 2285530, 2300174, 2305907, 2314025, 2319587 and 2328553;  

91) Lot numbers: 2273800; 2334114;  

92) Lot number: 2303832;

93) Lot numbers: 2308697; 2308699; 2308705; 2309323;

94) Lot numbers: 2279157, 2309322;

95) Lot numbers: 2255608; 2264597; 2318703; 2326691;

96) Lot numbers: 2240346; 2241834; 2245786; 2248322; 2249284; 2251999; 2253344; 2255176; 2255741; 2259342; 2268075; 2269800; 2276914; 2277908; 2281660; 2282559; 2285525; 2286943; 2291838; 2293485; 2294042; 2297529; 2299454; 2303178; 2306599; 2309430; 2311594; 2315346; 2316748; 2317453; 2318707; 2318718; 2318843; 2321268; 2321271; 2321282; 2321283; 2321299; 2325081; 2325083; 2325094; 2329811; 2331460; 2335177;

97) Lot numbers: 2245779; 2246581; 2246582; 2246743; 2246755; 2246767; 2246768; 2246778; 2246817; 2247302; 2247312; 2254299; 2254300 ; 2255153 ;2255601; 2262104; 2262107; 2262109; ;2262110;2262115; 2262116; 2263203; 2263204; 2263205; 2263206; 2263207; 2263208; 2263209; 2263210; 2263211; 2263212; 2276847; 2276848; 2276849; 2276850; 2276855; 2276856; 2276857; 2276865; 2276866; 2279147; 2279148; 2279149; 2280748; 2281673; 2287298; 2287301; 2287701; 2287704; 2289355; 2289357; 2289358; 2289359; 2289370; 2289371; 2289873; 2290110; 2290111; 2291743; 2291744; 2291745; 2291746; 2291747; 2291748; 2291749; 2291755; 2291763; 2291764; 2291787; 2291788; 2293493; 2294752; 2294783; 2296170; 2296194; 2296821; 2296832; 2297512; 2297526; 2297533; 2298500; 2299447; 2299451; 2299463; 2299464; 2302081; 2302096; 2302134; 2304967; 2304972; 2305901; 2305902; 2305917; 2309321; 2309334; 2309339; 2309360; 2309437; 2311577; 2311578; 2311599; 2312951; 2312953; 2312956; 2312967; 2312991; 2313814; 2315320; 2315330; 2315351; 2315352; 2315425; 2315943; 2315944; 2315951; 2316749; 2316755; 2317373; 2317374; 2317396; 2317397; 2319575; 2319600; 2320292; 2320293; 2320301; 2320302; 2320317; 2331453; 2331462; 2331478; 2332359; 2335186; 2255153X; 2275441;

98) Lot numbers: 2289360; 2289361; 2289372; 2290112; 2294047; 2295470; 2295472; 2296081; 2296082; 2296096; 2297812; 2297813; 2297819; 2299200; 2300032; 2300736; 2301421; 2308256; 2308260; 2308355; 2311600; 2313815; 2317364; 2318712; 2318746; 2324271; 2326794; 2328390; 2328392; 2328397; 2328544; 232979; 2330540; 2330572; 2335187;

99) Lot numbers: 2227542; 2232166; 2253303; 2289354; 2289364; 2290119; 2290134; 2290929; 2296189; 2297811; 2297814; 2301412; 2311572; 2311595; 2317455; 2321300; 2328387; 2328389; 2328396; 2330537; 2331461;

100) Lot numbers: 2227738; 2236497; 2268077;

101) Lot numbers: 2219452; 2227560; 2238972; 2239033; 2239051; 2270311; 2287706; 2291833; 2301411; 2307458; 2315398;

102) Lot numbers: 2239052; 2242388; 2273786; 2273790; 2289353; 2290128;

103) Lot numbers: 2243451; 2273789; 2273801; 2282638; 2282642; 2282644; 2282647; 2287304; 2287314; 2289362; 2290118; 2290127; 2294601; 2296238; 2296247; 2307486; 2309426; 2282647X;

104) Lot numbers: 2273797; 2289363; 2290129; 2294602; 2308263; 2314043;

105) Lot number: F2361148;

106) Lot Number: F2365655;

107) Lot numbers: 2232159; 2238973; 2238984; 2239292;

108) Lot numbers: 2232160; 2238985; 2239294; 2240329; 2263201; 2292806; 2320283;

109) Lot numbers: 2238974; 2238986; 2239293;

110) Lot number: F2336774;

111) Lot numbers: 2232162; 2238987; 2239295; 2239814; 2275434;

112) Lot number: 2272971;

113) Lot Numbers: 2272962; 2272963;

114) Lot numbers: 2272968; 2272969;

115) Lot number: 2272961;

116) Lot numbers: 2272966; 2272967; 2298187;

117) Lot numbers: 2272964;

118) Lot numbers: 2272970; 2325324;

119) Lot numbers: 2262186; 2266446; 2287307; 2297816; 2310872; 2327422;

120) Lot numbers: 2250305; 266445; 2266451; 2266468; 2275433; 2275442; 2275470; 2287305; 2287306; 2287309; 2312039; 2315321; 2324248; 2324252;

121) Lot numbers: 2245788; 2256873, 2270656; 2271261; 2279156; 2290126; 2312063; 2318704; 2322407; 2326671; 2328388; 2331444; 2331447;

122) Lot numbers: F2368896; F2371431;

123) Lot numbers: 2310844; 2310846; 2310948; 2310855; 2310873; 2311602; F2336773
RECALLING FIRM/MANUFACTURER
Cook, Inc., Bloomington, IN, by letters dated October 4, 2010. Firm initiated recall is ongoing.
REASON
The kits and trays contain 0.9% Sodium Chloride Injection USP 5 mL fill in 6 mL flush syringes that have been recalled by Excelsior Medical. During a routine test for syringe sterility, a possible integrity failure was discovered which may be a dimensional issue. All products being recalled has passed Excelsior release testing, including sterility testing. If there is an integrity issue, the potential exists for leakage and possible loss of sterility.
VOLUME OF PRODUCT IN COMMERCE
51,473 trays
DISTRIBUTION
Nationwide, Chile, Colombia, Panama, Barbados, Canada, Guatemala, and Saudi Arabia
___________________________________
PRODUCT
1) XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix 10 x 15 cm Rectangle Catalog #: 1161015. Recall # Z-1379-2011;

2) XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix 15 x 20 cm Rectangle Catalog #: 1161520. Recall # Z-1380-2011;

3) XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix 19 x 28 cm Rectangle Catalog #: 1161928. Recall # Z-1381-2011;

4) XenMatrix Surgical Graft ,Sterile, Porcine Dermal Matrix 19 x 35 cm Rectangle Catalog #: 1161935. Recall # Z-1382-2011
CODE
1) Lot numbers begin with the following 4 letters: HUTF, HUTI, HUTJ, HUTK, HUTL, HUUA, HUUB, HUUC, HUUD, HUUE, HUUF, HUUG, HUUH, and HUUJ;

2) Lot numbers begin with the following 4 letters: HUTF, HUTI, HUTJ, HUTK, HUTL, HUUA, HUUB, HUUC, HUUD, HUUE, HUUF, HUUG, HUUH, and HUUJ;

3) Lot numbers begin with the following 4 letters: HUTF, HUTI, HUTJ, HUTK, HUTL, HUUA, HUUB, HUUC, HUUD, HUUE, HUUF, HUUG, HUUH, and HUUJ;

4) Lot numbers begin with the following 4 letters: HUTF, HUTI, HUTJ, HUTK, HUTL, HUUA, HUUB, HUUC, HUUD, HUUE, HUUF, HUUG, HUUH, and HUUJ
RECALLING FIRM/MANUFACTURER
Recalling Firm Davol, Inc., Sub. C. R. Bard, Inc., Warwick, RI, by letter dated January 6, 2011.    
Manufacturer: Brennen Medical Inc., Saint Paul, MN. Firm initiated recall is ongoing.
REASON
Davol cannot guarantee that all Xenomatic product released from July to October 2010 meets FDA guidelines for endotoxin limits; and therefore, the grafts are potentially contaminated with bacteria.
VOLUME OF PRODUCT IN COMMERCE
5,227 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DEVICES – CLASS II
___________________________________
PRODUCT
BrightSpeed Excel/Edge/Elite Select Computed Tomography X-Ray System. For head, whole body X-ray Computed Tomography applications. Gantry model numbers 5191001, 5191002, 5191003, and 5191003-2. Recall # Z-0286-2011
CODE
None
RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WI, by letter on May 1, 2010. Firm initiated recall is ongoing.
REASON
Failure to properly document the CTDI in the Technical Reference or User Manual.
VOLUME OF PRODUCT IN COMMERCE
103 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Hemochron Signature Elite Whole Blood Microcoagulation (IVD) System. The system is intended to be used only with test cuvettes that are available from ITC. Recall # Z-0893-2011
CODE
Serial numbers SE2830 to SE2854 (inclusive); SE2880 to SE4789 (inclusive); SE0260, SE0366, SE0567, SE0764, SE0843, SE0970, SE1086, SE1198, SE1208, SE1212, SE1438, SE1456, SE1580, SE1711, SE2029, SE2136, SE2602, and SE2618
RECALLING FIRM/MANUFACTURER
International Technidyne Corp., Edison, NJ, by letters, dated February 24, 2010. Firm initiated recall is ongoing.
REASON
There is a mismatch between the class of the laser barcode scanner and the labeling of the Hemochron Signature Elite: some of the devices were inadvertently equipped with class II laser barcode scanner instead of the intended class I barcode scanner.
VOLUME OF PRODUCT IN COMMERCE
1,640 instruments
DISTRIBUTION
Nationwide, United Arab Emirates, Belgium, Canada, Switzerland, Germany, Denmark, France, United Kingdom, Ireland, Iceland, Italy, Kuwait, Liechtenstein, Netherlands, Oman, Qatar, Saudi Arabia, Sweden, and Singapore
___________________________________
PRODUCT
IMPAX CV Results Manager/Results Manager Administration Tool. The IMPAX Cardiovascular suite is a cardiovascular information system providing image archiving and image display and modality study-specific structured reporting. The suite is comprised of modular software that runs on industry standard personal computers and servers, utilizing Windows 2000/2003/XP operating systems. Image data storage/display utilizes DICO< (Digital Imaging and Communications in Medicine) data primarily from independent medical devices. Recall # Z-1435-2011
CODE
Software Versions: RM 2.03, 2.04 & 2.06
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp. Greenville, SC, by letters dating from April 15, 2009 to August 26, 2009.
Manufacturer: AGFA healthcare Corp., Westerly, RI. Firm initiated recall is ongoing.
REASON
User could modify a measurement's units and that change would not be reflected in echocardiography formulas used within the Adult echocardiography RM.                                                                                                                         
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
IL, MT, NY, OR, SC
___________________________________
PRODUCT
1) Curlin Infusion Administration Set, REF 340-4111, Sterile EO. The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Z-1439-2011;

2) Curlin Infusion Administration Set, REF 340-4114, Sterile EO. The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Z-1440-2011;

3) Curlin Infusion Administration Set, REF 340-4115, Sterile EO. The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Z-1441-2011;             

4) Curlin Infusion Administration Set, REF 340-4126, Sterile EO. The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Z-1442-2011;

5) Curlin Infusion Administration Set, REF 340-4127, Sterile EO. The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Z-1443-2011;

6) Curlin Infusion Administration Set, REF 340-4128, Sterile EO. The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Z-1444-2011;

7) Curlin Infusion Administration Set, REF 340-4128-V, Sterile EO. The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Z-1445-2011;

8) Curlin Infusion Administration Set, REF 340-4130, Sterile EO. The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Z-1446-2011;                

9) Curlin Infusion Administration Set, REF 340-4130-V, Sterile EO. The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Z-1447-2011;

10) Curlin Infusion Administration Set, REF 340-4134, Sterile EO. The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Z-1448-2011;

11) Curlin Infusion Administration Set, REF 340-4137, Sterile EO. The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Z-1449-2011;

12) Curlin Infusion Administration Set, REF 340-4144, Sterile EO. The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Z-1450-2011;

13) Curlin Infusion Administration Set, REF 340-4162, Sterile EO. The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Z-1451-2011;

14) Curlin Infusion Administration Set, REF 340-4164, Sterile EO. The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Z-1452-2011;              

15) Curlin Infusion Administration Set, REF 340-4167, Sterile EO. The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Z-1453-2011;

16) Curlin Infusion Administration Set, REF 340-4168, Sterile EO. The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Z-1454-2011;

17) Curlin Infusion Administration Set, REF 340-4169, Sterile EO. The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Recall # Z-1455-2011;

18) Curlin Infusion Administration Set, REF 340-4176, Sterile EO. The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications. Recall # Z-1456-2011
CODE
1) Lot Codes: CF1026001, D011109, D012438;

2)  Lot Codes: CF1019715, CF1028109, CF1028110, CRF10042001, CRF10110001, CRF10121001, CRF10123001, CRF10124001, CRF10132003, CRF10133002, CRF10134001, CRF10163003, CRF10165001, CRF10167002, CRF10168001, CRF10169003, CRF1017501, CRF1017602, CRF1017702, CRF1017901, CRF1018002, D018718, D100319, D100320;

3) Lot Codes: D005013, D010911, D017304, D017317;

4) Lot Codes: CF1020408, CF1020910, CF1021001, CF1023901, CRF10119001, CRF10120001, CRF10120003, CRF10172002, CRF1017401, D008216, D008512, D009806, D010321, D010416, D013714, D013715, D015325, D015326, D016002, D017913, D018714, D022810, D022811, D023620, D024418, D024513, D027110;

5) Lot Codes: CF1022601, D008217, D015328;

6) Lot Codes: CF1018201, CF1018802, CF1018805, CF1019015, CF1019016, CF1020802, CF1022208, CF1022801, CRF10130001, CRF10132001, CRF10134001, CRF10135001, CRF10137001, CRF10145001, CRF10155003, CRF10156001, CRF10158002, CRF10159001, CRF10160001, D100317, D100318;

7) Lot Codes: CF1019019, CF1019023, CF1021804, CF1022206, CRF10100001, CRF10102001, CRF10104001, CRF10139003, CRF10160002, CRF10161003, D004617, D005006, D006004, D011801, D012439, D013007, D014707, D015905, D016003, D016604, D016713, D017419, D018101, D019323, , D020024, D020235, D020236, D020237, D021601, D027014;

8) Lot Codes: CF1020403, CF1027402, CRF10149002, CRF10151002, D004711, D005613, D005614, D008513, D010320, D010912, D010913, D012437, D013005, D013440, D013441, D014705, D016606, D016607, D020016, D020017, D020722, D021012, D021013, D021607, D026422, D026423, D027306;

9) Lot Codes: CF1020102, CF1020103, CRF10098001, CRF10144001, CRF10145001, D005005, D005014, D009501, D010305, D010319, D011110, D011111, D013442, D014706, D017318, D017420, D017421, D018005, D019321, D019322, D020235, D020923, D020924, D021404, D022201, D022202, D022203, D024921, D024922;

10) Lot Codes: CF1022901, D004616, D004714, D008511, D009805, D016001, D016605, D018715, D017148;

11) Lot Codes: D001909, D932716;

12) Lot Codes: CF1020106, CF1020107, D018718;

13) Lot Codes: D006005, D020303; 

14) Lot Codes: CF1020405, CRF10116001, CRF10117001, CRF10118002, CRF10162002, CRF10163001, D003905, D010910, D012440, D013006, D013716, D021702, D025613;

15) Lot Codes: CRF1018302, CRF1018307;

16) Lot Code: D100712;

17) Lot Code: D100713;

18) Lot Code: CRF10125003, CRF10163002, CRF1018704, D100714
RECALLING FIRM/MANUFACTURER
Zevex International, Inc., Salt Lake City, UT, by letter dated January 24, 2011. Firm initiated recall is ongoing. 
REASON
Defect in tubing may trigger false Air-In-Line warning.
VOLUME OF PRODUCT IN COMMERCE
1,432,870 devices (Nationwide), 73,060 devices (Internationally).
DISTRIBUTION
AR, CA, FL, IA, KS, MS, NE, NY, OH, OK, TN, TX, UT, Australia, Croatia, France, Germany, Kuwait, New Zealand, Qatar, Saudi Arabia, South Africa, United Arab Emirates, and UK.
___________________________________
PRODUCT
Vu a-POD Intervertebral Body Fusion Device. Packaged as surgical kits containing all implants and instruments required for a procedure. Also packaged as individual instruments and implants in poly bags distributed as replenishment for surgical kits. Indicated for use as an adjunct for fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. Model #'s: 21-11-2708, 21-21-2710, 21-23-3510, 21-40-0110, 21-LT-3508, 21-11-2710, 21-21-2712, 21-23-3512, 21-40-0120, 21-LT-3510, 21-11-2712, 21-21-2714, 21-23-3514, 21-40-0130, 21-LT-3512, 21-11-3108, 21-21-2716, 21-23-3516, 21-40-0131, 21-LT-3514, 21-11-3110, 21-21-3108, 21-23-3908, 21-40-0135, 21-LT-3516, 21-11-3112, 21-21-3110, 21-23-3910, 21-40-0140, 21-LT-3908, 21-11-3114, 21-21-3112, 21-23-3912, 21-40-0150, 21-LT-3910, 21-11-3116, 21-21-3114, 21-23-3914, 21-40-0160, 21-LT-3912, 21-11-3508, 21-21-3116, 21-23-3916, 21-40-0165, 21-LT-3914, 21-11-3510, 21-21-3508, 21-24-2708, 21-40-0170, 21-LT-3916, 21-11-3512, 21-21-3510, 21-24-2710, 21-40-0180, 21-TA-2708, 21-11-3514, 21-21-3512, 21-24-2712, 21-40-0190, 21-TA-2710, 21-11-3516, 21-21-3514, 21-24-2714, 21-40-0190-3, 21-TA-2712, 21-11-3908, 21-21-3516, 21-24-2716, 21-40-0200, 21-TA-2714, 21-11-3910, 21-21-3908, 21-24-3108, 21-40-0215, 21-TA-2716, 21-11-3912, 21-21-3910, 21-24-3110, 21-40-0245, 21-TA-3108, 21-11-3914, 21-21-3912, 21-24-3112, 21-40-0290, 21-TA-3110, 21-11-3916, 21-21-3914, 21-24-3114, 21-40-0400, 21-TA-3112, 21-20-2708, 21-21-3916, 21-24-3116, 21-40-0500, 21-TA-3114, 21-20-2710, 21-22-3112, 21-24-3508, 21-50-0100, 21-TA-3116, 21-20-2712, 21-22-3114, 21-24-3510, 21-50-0110, 21-TA-3508, 21-20-2714, 21-22-3116, 21-24-3512, 21-50-0210, 21-TA-3510, 21-20-2716, 21-22-3512, 21-24-3514, 21-50-0310, 21-TA-3512, 21-20-3108, 21-22-3514, 21-24-3516, 21-50-0410, 21-TA-3514, 21-20-3110, 21-22-3516, 21-24-3908, 21-99-0001, 21-TA-3516, 21-20-3112, 21-22-3912, 21-24-3910, 21-99-0002, 21-TA-3908, 21-20-3114, 21-22-3914, 21-24-3912, 21-99-0002-2-1, 21-TA-3910, 21-20-3116, 21-22-3916, 21-24-3914, 21-99-0002-3-1, 21-TA-3912, 21-20-3508, 21-23-2708, 21-24-3916, 21-99-0002-3-2, 21-TA-3914, 21-20-3510, 21-23-2710, 21-25-3112, 21-LT-2708, 21-TA-3916, 21-20-3512, 21-23-2712, 21-25-3114, 21-LT-2710, 21-XT-3112, 21-20-3514, 21-23-2714, 21-25-3116, 21-LT-2712, 21-XT-3114, 21-20-3516, 21-23-2716, 21-25-3512, 21-LT-2714, 21-XT-3116, 21-20-3908, 21-23-3108, 21-25-3514, 21-LT-2716, 21-XT-3512, 21-20-3910, 21-23-3110, 21-25-3516, 21-LT-3108, 21-XT-3514, 21-20-3912, 21-23-3112, 21-25-3912, 21-LT-3110, 21-XT-3516, 21-20-3914, 21-23-3114, 21-25-3914, 21-LT-3112, 21-XT-3912, 21-20-3916, 21-23-3116, 21-25-3916, 21-LT-3114, 21-XT-3914, 21-21-2708, 21-23-3508, 21-40-0100, 21-LT-3116 & 21-XT-3916. Recall # Z-1475-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integra LifeSciences Corp., Plainsboro, NJ, by letter on October 19, 2010.  
Manufacturer: Theken Spine LLC, Akron, OH. Firm initiated recall is ongoing.
REASON
The IFU provided with the device contains incorrect information in the Indications for Use Section, stating the following: The Theken Spine Vu a"POD Intervertebral Body Fusion Device is intended for use as a stand alone implant when used with the SpinPlate provided in the set.
VOLUME OF PRODUCT IN COMMERCE
2,163 peaces
DISTRIBUTION
AL, AZ, CA, CT, ID, KS, MO, NH, NV, NY, OH, OK, TX & UT
___________________________________
PRODUCT
ADVIA Centaur CA 125 II Assay packaged in 100 and 500 test kits as follows: Product code: 09427226 (128532) 100 test kit Product code: 01678114 (128533) 500 Test kit. Recall # Z-1477-2011
CODE
Lot Code: 144 Affected kit lot numbers: 62431144, 63124144, 63519144, 63876144, 62450144 and 63822144 Expiry Date: 15 September 2011
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., East Walpole, MA, by letters on December 14, 2010. Firm initiated recall is ongoing.
REASON
Positive bias (40-55%) with patient results greater than the upper limit of normal and less than the upper limit of normal.
VOLUME OF PRODUCT IN COMMERCE
2960 kits
DISTRIBUTION
Nationwide, Canada, Argentina, Austria, Belgium, China, Denmark, France, Germany, Great Britain, Greece, India, Italy, Japan, Korea, Lavitia, Lithuania, Malaysia, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Romania, Saudi Arabia, Switzerland, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Czech Republic, Taiwan, Turkey, Uganda, and Venezuela

___________________________________
PRODUCT
DiaSorin ETI-ANA Screen Kit, 96 Test, Model Number N0093. Model number N0093, manufacture dates 09/17/2009 and 10/12/2009.Recall # Z-1478-2011
CODE
Lot numbers: 24592003and 24592035
RECALLING FIRM/MANUFACTURER
Bio-Rad Laboratories Inc., Hercules, CA, by e-mail on March 1, 2010. Firm initiated recall is complete.
REASON
Inaccurate results-- Consumer complaints of increased positivity rates with the ANA screening kit.
VOLUME OF PRODUCT IN COMMERCE
999 units
DISTRIBUTION
Italy
___________________________________
PRODUCT
a) Neotrode Wire Attached, Catalog Number: 1731-003; b) Neotrode II Wire Attached, Catalog Number: 1741-003; c) Neonatal Wire Attached, Catalog Number: 2321-003; d) Softrace Pediatric Wire Attached, Catalog Number: 2331-003; e) Softrace Limb Band, Catalog Number: 2310-003; f) TRU-LINK ECG Electrode (Neonatal Pre-Wired), Catalog Number: 685-0037-00; for use with electrocardiographic monitoring equipment to detect neonatal/pediatric heart action voltages. Recall # Z-1493-2011
CODE
a) Lot Code: 0904014 thru 1008134; b) Lot Code: 0904014 thru 1008114; c) Lot Code: 0904014 thru 1007234; d) Lot Code: 0904014 thru 1007214; and e) Lot Code: 0904014 thru 1007064; f) Lot Code: 0904014 thru 1008274  
RECALLING FIRM/MANUFACTURER
Recalling Firm: ConMed Corp., Utica, NY, by letter dated September 23, 2010.
Manufacturer: Consolidated Medical Equipment Co., Chihuahua, Mexico. Firm initiated recall is ongoing.
REASON
Poor signal or loss of signal. Certain recalled devices have a loose wire attachment that may lead to intermittent or poor signal quality.
VOLUME OF PRODUCT IN COMMERCE
9,009,000 Pediatric/Neonatal ECG Electrodes with Attached Wire
DISTRIBUTION
Nationwide, Dubai, Ecuador, Egypt, Germany, Holland, Indonesia, Israel, Italy, Jamaica, Kenya, Korea, Lithuania, Malaysia, Mexico, New Zealand, Norway, Qatar, Saudi Arabia, Singapore, South Africa, Sweden, Switzerland, US Virgin Islands, Canada and Belgium
___________________________________
PRODUCT
a) Male Driver 4.0mm (catalog # MDr140L) and b) Male Driver 3.2mm (catalog # MDr132L), an instrument used for the insertion of the Fassier-Duval Telescopic IM System intramedullary nail, for bone fixation. Recall # Z-1494-2011
CODE
a) Lot Code 270730-02; b) Lot Code 270730-01
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pega Medical Inc., Laval, Canada, by e-mail, telephone and letters on January 29, 2010.
Manufacturer: Lavezzi Precision, Inc., Glendale Heights, IL, Firm initiated recall is ongoing.
REASON
Possible breakage. Structural weakness has been detected on the Male Driver 3.2mm and 4.0mm sizes. In certain cases, this weakness could lead to a premature failure of the instrument if it is submitted to large torsional loads higher than the normal forces required to introduce the male component.
VOLUME OF PRODUCT IN COMMERCE
4 units of MDr132L (3.2 mm) and 3 units of MDr140 (4.0 mm)
DISTRIBUTION
GA, OK, TN, UT
___________________________________
PRODUCT
PhD System EIA/IFAversion 2.1A software, model number 426-0246, a component of the Bio-Rad PhD System. EIA and IFA processing system that consists of a PhD fluid handling station (s) linked to a network computer via Ethernet hub. The computer provides work list generation, data management, data reduction and microplate reader control functions. Recall # Z-1495-2011
CODE
Software version 2.1A
RECALLING FIRM/MANUFACTURER
Bio-Rad Laboratories Inc., Hercules, CA, by letter dated September 29, 2009. Firm initiated recall is ongoing.
REASON
Incorrect patient results are being generated from out-of-range samples tested with competitive enzyme immunoassays on the PhD system with software version 2.1A.
VOLUME OF PRODUCT IN COMMERCE
262 units
DISTRIBUTION
Nationwide, Australia, New Zealand, Singapore, China, France, Sweden, and Canada
___________________________________
PRODUCT
1) Dermabond Topical Skin Adhesive, 2-Octo Cyanoacrylate, Sterile, Rx only, Product code: DHV12. Recall # Z-1496-2011;

2) High Viscosity Dermabond ProPen Topical Skin Adhesive 2-Octo Cyanoacrylate, Sterile, Rx only, Product code: DPP6.  Recall # Z-1497-2011
CODE
1) Lot # Exp. Date CJE22 7/31/2012, CJP430 7/31/2012, CJR302 7/31/2012, CJR488 7/31/2012, CJR604 7/31/2012, CKB001 7/31/2012, CKB157 8/31/2012, CKB231 8/31/2012,  CKB492 8/31/2012, CKB584 8/31/2012, CKB681 8/31/2012, CKB820 8/31/2012, CKB966 8/31/2012, CKE195 8/31/2012, CKE335 8/31/2012, CKE336 8/31/2012, CKE655 8/31/2012, CKE842 8/31/2012, CKP038 8/31/2012, CKP201 8/31/2012, CKP358 8/31/2012;

2) Lot # Product Expiration Date: CJP639 7/31/2012, CJR201 7/31/2012, CKB291 8/31/2012, CKB882 8/31/2012, CKE426 8/31/2012, CKE893 8/31/2012, CKP445 8/31/2012
RECALLING FIRM/MANUFACTURER
Ethicon, Inc., Somerville, NJ, by letters on February 2, 2011. Firm initiated recall is ongoing.
REASON
Some units of Dermabond Topical Skin Adhesive and Dermabond ProPen Topical Skin Adhesive contain discolored product.
VOLUME OF PRODUCT IN COMMERCE
725,772 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS:  DEVICES – CLASS III
___________________________________
PRODUCT
Veridex, Cell Search Circulating Tumor Cell Control Kit. Product code 7900003. Recall # Z-1472-2011
CODE
Lot number: C512
RECALLING FIRM/MANUFACTURER
Veridex, LLC, Raritan, NJ, by letter on November 11, 2010. Firm initiated recall is ongoing.
REASON
There is a discrepancy between the assigned range of values on the high control label and the range listed on the Cell control Assigned Value Label for the Cell Search Circulating Tumor Cell Control Kit.
VOLUME OF PRODUCT IN COMMERCE
150 kits
DISTRIBUTION
Nationwide, Canada, France, UK, Germany, Italy, China, Spain & Portugal

RECALLS AND FIELD CORRECTIONS:  VETERINARY – CLASS I
___________________________________
PRODUCT
Merrick Beef Filet Squares and Merrick Texas Hold 'Ems, Dog Treats, 10 oz., UPC 2280860016. Recall # V-101-2011
CODE
All lots sold prior to August 20, 2010.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tejas Industries Inc., Hereford, TX, by press release on August 13, 2010 and by letter on August 4, 2010.
Manufacturer: Tejas Industries Inc., Plainview, TX. FDA initiated recall is ongoing.
REASON
Product has the potential to contain Salmonella.
VOLUME OF PRODUCT IN COMMERCE
6,856 cases, 12 bags per case
DISTRIBUTION
Nationwide and Canada

END OF ENFORCEMENT REPORT FOR MARCH 9, 2011

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