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U.S. Department of Health and Human Services

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Enforcement Report for February 9, 2011

February 9 2011                                                                                        11-06

 

RECALLS AND FIELD CORRECTIONS:  COSMETICS - CLASS III
___________________________________
PRODUCT
Rainbath Refreshing Shower and Bath Gel - Original, 40 oz, 360 units per pallet, (UPC on the individual selling unit carton) 10070501378936 (UPC on the corrugated pallet wrap), SAP code: 683879300. Recall # F-0383-2011
CODE
Lot numbers: 2440L, 2320L, 0900L; Serial number: 7050104145  
RECALLING FIRM/MANUFACTURER
Neutrogena Corp., Los Angeles, CA, by telephone on January 4, 2011. FDA initiated recall is ongoing. 
REASON
The recall was initiated as a precautionary measure after routine testing conducted after the product lots were manufactured determined that there was a small potential for one of the raw materials used in the product to contain bacteria.
VOLUME OF PRODUCT IN COMMERCE
14,346 units
DISTRIBUTION
AZ, CA, FL, GA, IL, MD, NJ, TX, UT, & WA

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I
___________________________________
PRODUCT
1) Bright Water Buffalo Krab Dip, 7 oz packed in clear plastic container, UPC 8 1971100001 4. Recall # F-0372-2011;

2) Bright Water Southwest Krab Dip, 7 oz packed in clear plastic container, UPC 8 1971100002 1. Recall # F-0373-2011
CODE
1) Expiration Date 12/21/2010;
2) Expiration Date 12/29/2010
RECALLING FIRM/MANUFACTURER
Inland Seafood, Inc., Tucker, GA, by press release on December 21, 2010.  Georgia initiated recall is ongoing.
REASON
The product may be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
220 cases total (9 units per case)
DISTRIBUTION
GA, NC, SC, TN, VA
___________________________________
PRODUCT
1) Wegmans---CILANTRO---net wt. 1/4 oz---Product of USA---Wash Before Use--- UPC 625647801041. This is fresh cilantro packaged in plastic bags. Recall # F-0374-2011;

2) Wegmans---CURLY PARSLEY---net wt. 1/4 oz---Product of USA---Wash Before Use---UPC 625647801102. This is fresh curly parsley packaged in plastic bags. Recall # F-0375-2011;

3) This product was packed under two labels and packing sizes. 1) Wegmans---ITALIAN PARSLEY---net wt. 1/4 oz---Product of USA---Wash Before Use---UPC 625647801256. This is fresh Italian parsley packaged in plastic bags. 2) Boncheff---ITALIAN PARSLEY---Product of USA---net wt. 1/2 oz--- UPC 625647801256. This is fresh Italian parsley packaged in 14 plastic clam shell containers/0.5oz per package. Recall # F-0376-2011
CODE
1) Lot #: 1002361;
2) Lot #: 1002387;
3) 1) Lot #: 1002348; 2) Lot #: 1002387
RECALLING FIRM/MANUFACTURER
Boncheff Greenhouses, Etobicoke Ontario, Canada, by telephone on December 28, 2010, press release on January 5, 2011 and by letters on January 6, 2011. Firm initiated recall is ongoing.  
REASON
Product has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
42 cses/12 bgs/.25 oz WegCilantro; 52 cses/12 bgs/.25 We CurlyParsley; 69 cses/12bgs/.25 oz WegmanItalianParsley; 14 plastic cont/0.5 oz Boncheff Italian Par
DISTRIBUTION
NY
___________________________________
PRODUCT
Whole Sesame Seed, 18 oz polyethylene bottles, item Number: 932433, packed 6 bottles/case, bottles labeled in part***McCormick Culinary***. Recall # F-0381-2011
CODE
Units: 5472AK, 5472BK, 5472CK
RECALLING FIRM/MANUFACTURER
Recalling Firm: McCormick & Company, Inc., Hunt Valley, MD, by letter dated December 23, 2010.
Manufacturer: LA CIE McCormick Canada Co, London Ontario, Canada. FDA initiated recall is ongoing.
REASON
Product may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1559 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
HDC label Cantaloupes, Carton Sizes: 9s, 12s, 15s, 18s (melons per carton), 1/19 bushel. Fresh cantaloupes grown in Mexico & packed in cardboard cartons. Recall # F-0382-2011
CODE
Lot #: 0000105GIA01329
RECALLING FIRM/MANUFACTURER
Recalling Firm: Vandervoet & Associates, Inc., Rio Rico, AZ, by telephone, letter and fax beginning December 24, 2010.
Manufacturer: Giadela SPR de RL, Hermosillo, Mexico. Firm initiated recall is ongoing.
REASON
Product has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
9,128 Approximately
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II
___________________________________
PRODUCT
Stewart Sandwiches, Egg Salad, 4.25 oz, in plastic wedge package with clear film cover, Keep Refrigerated. Recall # F-0377-2011
CODE
Dec 22 2010, Dec 23 2010, Dec 24 2010, Dec 27 2010, Dec 28 2010, Dec 29 2010, Dec 30 2010, Dec 31 2010, Dec 22 2010, and Jan 03 2011
RECALLING FIRM/MANUFACTURER
Royal Deli Foods Inc., Perrysburg, OH, by telephone on December 29, 2010. FDA initiated recall is ongoing.
REASON
The FDA notified the firm that they did not declare the sub-ingredients for pickle relish, which includes Yellow #5, on the finished product label.
VOLUME OF PRODUCT IN COMMERCE
94 Sandwiches
DISTRIBUTION
OH
___________________________________
PRODUCT
Jack & Jill Vanilla Flavored Ice Cream, 4 Fl. oz. (118 ml)/24 ct. Recall # F-0378-2011
CODE
6-4-2011
RECALLING FIRM/MANUFACTURER
Garber Ice Cream Company Inc., Winchester, VA, by telephone on June 17, 2010. Firm initiated recall is complete.
REASON
Vanilla flavored ice cream was mislabeled as lactose free and no sugar added.
VOLUME OF PRODUCT IN COMMERCE
270 count
DISTRIBUTION
NJ
___________________________________
PRODUCT
Apple Cider in 1 gallon and 1/2 gallon containers, sold under the following brands Aseltines, Spartan, Meijer and Riverridge. UPCs 5169600128, 1121301900, 4125004827, 3626400128. Recall # F-0380-2011
CODE
Sell by dates of 1/15/2011
RECALLING FIRM/MANUFACTURER
Aseltine Cider Company, Inc., Comstock Park, MI, by letter on December 17, 2010.  Firm initiated recall is ongoing.
REASON
Sample analysis of finished product found 91 ppb patulin level. The limit is 50 ppb.
VOLUME OF PRODUCT IN COMMERCE
12,000 gallons
DISTRIBUTION
MI

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS III
___________________________________
PRODUCT
Jack & Jill Lemon Water Ice, 4 Fl. oz. (118 ml) foam cups, 24 ct/case. Recall # F-0379-2011
CODE
9-3-2010
RECALLING FIRM/MANUFACTURER
Garber Ice Cream Company Inc., Winchester, VA, by telephone on October 26, 2010. Firm initiated recall is complete.
REASON
Raspberry Water Ice is mislabeled as Lemon Water Ice.
VOLUME OF PRODUCT IN COMMERCE
693 units
DISTRIBUTION
NJ
___________________________________
PRODUCT
1) Tillamook NW Berry Patch FBPP0526 is a yogurt fruit prep. The product is packaged in 3200 lb. totes. The product is labeled in part: "TILLAMOOK NW BERRY PATCH FBPP0526, NET WEIGHT: 3200 LBS...STORE AT AMBIENT TEMPERATURE, NOT TO EXCEED 85 DEG F...INGREDIENTS: WATER SUGAR, RASPBERRIES. STRAWBERRIES, MODIFIED CORN STARCH, WlLD BLUEBERRIES, BLACK CURRENT JUICE CONCENTRATE, NATURAL FLAVORS. CITRIC ACID, POTASSIUM SORBATE (PRESERVATIVE), SODIUM BENZOATE (PRESERVATIVE), AND CARMINE". Recall # F-0384-2011;  

2) Premium Mixed Berry YP is a yogurt fruit prep, item FMYP0508. Product is packaged in 50 lb. pails. The product is labeled in part: "PREMIUM MIXED BERRY YP FMYP0508, NET WEIGHT: 50 LBS...STORE AT AMBIENT TEMPERATURE NOT TO EXCEED 85 DEGREES F... INGREDIENTS: SUGAR, WATER, BLACKBERRIES, RASPBERRIES, STRAWBERRIES, WILD BLUEBERRIES, MODIFIED FOOD STARCH, NATURAL FLAVOR, BLACK CURRANT JUICE CONCENTRATE, CITRIC ACID, POTASSIUM SORBATE (PRESERVATIVE), AND SODIUM BENZOATE (PRESERVATIVE)". Recall # F-0385-2011;

3) PREMIUM WILD BLUEBERRY YP, FBYP0513, a yogurt Prep. Product is packaged in 50 lb. pails. The product is labeled in part: "PREMIUM MIXED BERRY YP FMYP0513, NET WEIGHT: 50 LBS...STORE AT AMBIENT TEMPERATURE NOT TO EXCEED 85 DEGREES F...INGREDIENTS: SUGAR, WILD BLUEBERRIES, WATER, MODIFIED FOOD STARCH, BLACK CURRANT JUICE CONCENTRATE, NATURAL FLAVOR, CITRIC ACID, POTASSIUM SORBATE (PRESERVATIVE), AND SODIUM BENZOATE (PRESERVATIVE)". Recall # F-0386-2011;

4) TILLAMOOK MARIONBERRY YP FMYF0670, is a yogurt Prep. Product is packaged in 3200 lb. totes. The product is labeled in part: "TILLAMOOK MARIONBERRY YP FMYF0670, NET WEIGHT: 3200 LBS ...STORE AT AMBIENT TEMPERATURE NOT TO EXCEED 85 DEGREES F ...INGREDIENTS: WATER, SUGAR, MARIONBERRIES, MODIFIED FOOD STARCH, NATURAL FLAVOR, BLACK CURRANT JUICE CONCENTRATE, CITRIC ACID, POTASSIUM SORBATE (PRESERVATIVE), AND SODIUM BENZOATE (PRESERVATIVE)". Recall # F-0387-2011;

5) Natural Blackberry Variegate FBLV0775, is a yogurt Prep. Product is packaged in 50 lb. pails. The product is labeled in part: "NATURAL BLACKBERRY VARIEGATE FBLV0775. NET WEIGHT: 50 LBS...STORE REFRIGERATED AT 36-40 DEG F....INGREDIENTS: Organic Evaporated Cane Juice, Blackberries, Water, Organic Tapioca Starch, Natural Flavor, Citric Acid, and Black Currant Juice Concentrate". Recall # F-0388-2011;

6) Premium Wild Blueberry Yogurt PREP FBYP0880, is a yogurt Prep. Product is packaged in 50 lb. pails. The product is labeled in part: "PREMIUM WILD BLUEBERRY YOGURT PREP FBYP0880, NET WEIGHT: 50 LBS...STORE AMBIENT TEMPERATURE (NOT TO EXCEED 85 DEG. F.) ...INGREDIENTS: SUGAR, WILD BLUEBERRIES, WATER, RICE STARCH, BLACK CURRANT JUICE CONCENTRATE, NATURAL FLAVOR, CITRIC ACID, POTASSIUM SORBATE (PRESERVATIVE), AND SODIUM BENZOATE (PRESERVATIVE)". Recall # F-0389-2011;

7) WF Mixed Berry Yogurt PREP FMYP0407, is a yogurt Prep. Product is packaged in 2600 lb. totes. The product is labeled in part: "WF MIXED BERRY YOGURT PREP FMYP0407, NET WEIGHT: 2600 LBS...STORE AMBIENT TEMPERATURE NOT TO EXCEED 85 DEGREES F ...INGREDIENTS: WATER, SUGAR, RASPBERRIES, MODIFIED FOOD STARCH, BLUEBERRIES, STRAWBERRIES, BLACK CURRANT JUICE CONCENTRATE, NATURAL FLAVORS, CITRIC ACID, POTASSIUM SORBATE (PRESERVATIVE), SODIUM BENZOATE (PRESERVATIVE), AND CARMINE". Recall # F-0390-2011;

8) Natural Sweetened Blackberry Blueberry Puree FBBPO787 is a yogurt Prep. Product is packaged in 45 lb. pails. The product is labeled in part: "NATURAL SWEETENED BLACKBERRY BLUEBERRY PUREE FBBPO787, NET WEIGHT: 45 LBS...STORE UNDER REFRIGERATION (at 36-40 deg. F.) OR FROZEN (at or below 0 deg. F.)...INGREDIENTS: WATER, BLACKBERRY JUICE CONCENTRATE, BLUEBERRY JUICE CONCENTRATE, SUGAR, BLACKBERRIES, BLACK CURRANT JUICE CONCENTRATE, WILD BLUEBERRIES, AND FRUIT JUICE (COLOR)". Recall # F-0391-2011;

9) Natural Blueberry Pomegranate Ice Cream Base FBPB0779. Product is packaged in 50 lb. pails. The product is labeled in part: "NATURAL BLUEBERRY POMEGRANATE ICE CREAM BASE FBPB0779, NET WEIGHT: 50 LBS...STORE REFRIGERATED AT 36-40 DEG. F.)... INGREDIENTS: Wild Blueberries, Pomegranate Juice Concentrate, Organic Evaporated Cane Juice, Water, Natural Flavors, Citric Acid, Blueberry Juice Concentrate, Black Currant Juice Concentrate, Organic Tapioca Starch, and Fruit Juice for Color". Recall # F-0392-2011;

10) LMD Natural Strawberry Variegate FSBV0490 is a yogurt prep. Product is packaged in 50 lb. pails. The product is labeled in part: "LMD Natural Strawberry Variegate FSBV0490, NET WEIGHT: 50 LBS...STORE REFRIGERATED Between 36-40 DEG. F...INGREDIENTS: WATER, CORN SYRUP, SUGAR, ORGANIC RICE STARCH, STRAWBERRIES, BLACK CURRANT JUICE CONCENTRATE, CITRIC ACID, NATURAL FLAVOR, RED BEET CONCENTRATE (COLOR), GUAR GUM, AND SALT". Recall # F-0393-2011;

11) Premium Blackberry YP FBYP0506 is a yogurt prep. Product is packaged in 50 lb. pails. The product is labeled in part: "PREMIUM BLACKBERRY YP FBYP0506, NET WEIGHT: 50 LBS...STORE AMBIENT TEMPERATURE NOT TO EXCEED 85 DEGREES F...INGREDIENTS: INGREDIENTS; SUGAR, BLACKBERRIES, WATER, MODIFIED FOOD STARCH, NATURAL FLAVORS, BLACK CURRANT JUICE CONCENTRATE, CITRIC ACID, POTASSIUM SORBATE (PRESERVATIVE), AND SODIUM BENZOATE (PRESERVATIVE)". Recall # F-0394-2011;

12) Fresh & Healthy Blueberry YP FBYP0916 is a yogurt prep. Product is packaged in 50 lb. Pails. The product is labeled in part: "FRESH & HEALTHY BLUEBERRY YP FBYP0916...NET WEIGHT: 50 LBS...STORE AT AMBIENT TEMPERATURE NOT TO EXCEED 85 DEGREES F...INGREDIENTS: SUGAR, BLUEBERRIES, WATER, MODIFIED FOOD STARCH, BLACK CURRANT JUICE CONCENTRATE, NATURAL FLAVOR, CITRIC ACID, POTASSIUM SORBATE (PRESERVATIVE), AND SODIUM BENZOATE (PRESERVATIVE)". Recall # F-0395-2011
CODE
1) Lot codes: 088017, 088018, 088019, 112012, 112013, 112014, 159013, 159014, 159015, 180009, 180010, 180011, 214009, 214010, 214011, 235015, 257012, 257013, 257014, 284012, 284013, and 284014;

2) Lot codes: 092030, 160015, 175018, and 257017;

3)  Lot Codes: 096021, 158004, and 158005;

4) Lot Codes: 098009, 098010, 098011, 098012, 098013, 098014, 139015, 139016, 139017, 139018, 139019, 139020, 159001, 159002, 159003, 159004, 159005, 159006, 179014, 179015, 179016, 179017, 179018, 179019, 179020, 203011, 203012, 203013, 203014, 203015, 203016, 203017, 203018, 215003, 215004, 215005, 215006, 215007, 215008, 215009, 270004, 270005, 270006, 270007, 270008, and 270011;

5) Lot Codes: 100017 and 100018;

6) Lot Codes: 104020, 104021, and 104022;

7) Lot Codes: 106002, 106003, and 215015;

8) Lot Codes: 116013, 172016, and 216016;

9) Lot Codes: 137021, 137022, 183027, 183028, 221021, and 243013;

10) Lot Code: 145023;

11) Lot Codes: 159021, 175016, 189021, and 189022;

12) Lot Code: 161030
RECALLING FIRM/MANUFACTURER
Ever Fresh Fruit Co, Boring, OR by telephone on October 21, 2010 and telephone and visit on October 22, 2010, by letter on October 25, 2010, and by e-mail, letter and telephone on October 27, 2010. Firm initiated recall is ongoing.
REASON
Product may contain pesticide THPI-Tetrahydrophthalimide, a thermal decomposition product of Captan. There is no tolerance allowed for THPI in Black Currant Concentrate.
VOLUME OF PRODUCT IN COMMERCE
267, 208 lb.
DISTRIBUTION
OR, WA

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II
___________________________________
PRODUCT
1) Heparin Sodium, USP (Porcine Intestines). Caution: For Manufacturing and Processing use only. Federal Law Prohibits dispensing without a Prescription. Preserve in tight containers and store below 40 degrees C. Preferably at room temperature. Recall # D-213-2011;

2) EXPANDED GAG, Caution: For Manufacturing, Processing or Repackaging. Preserve in tight containers and in a cool, dry place. Mucopolysaccharides (also known as glycosaminoglycans, or "GAG") intermediate product, a sidestream of the Heparin process. Recall # D-214-2-11
CODE
1) Lot numbers: 1035-0771, 1035-0778, 1035-0780;
2) Lot number: 1049-0087
RECALLING FIRM/MANUFACTURER
Scientific Protein Laboratories, LLC, Waunakee, WI, by telephone on October 13, 2010 and letter, dated October 15, 2010; EXPANDED: by telephone on October 21, 2010, letter on October 26, 2010, and by email on October 27, 2010. FDA initiated recall is ongoing.
REASON
SPL is initiating this recall because additional testing of retained samples of this API lot (1035-0771) indicated a small amount of oversulfated chondroitin sulfate (OSCS). Lots 1035-0778 and 1035-0780 are being recalled because additional testing of retained samples of crude heparin contained in these API lots indicated a trace amount of oversulfated chondroitin sulfate (OSCS). EXPANDED: SPL has expanded their recall to include one lot of Sulfated Mucopolysaccharides intermediate product (lot 1049-0087). Testing of lot 1049-0087 indicated a small amount of oversulfated chondroitin sulfate (OSCS).
VOLUME OF PRODUCT IN COMMERCE
37,701 mmu, EXPANDED 78.89 kg
DISTRIBUTION
IL, NJ, NY, PA and Canada EXPANDED: Italy
___________________________________
PRODUCT
Synarel (nafarelin acetate) nasal solution, 2mg/mL (as nafarelin base), Spray for Intranasal Use Only, Each actuation delivers approximately 200 mcg nafarelin, Rx only, NDC 0025-0166-08. Recall # D-220-2011
CODE
Lot Numbers: C090734, Exp: 03/31/11; and C091149, Exp: 07/31/11
RECALLING FIRM/MANUFACTURER
Pfizer Us Pharmaceutical Group, New York, NY, by letter on September 28, 2010. Firm initiated recall is ongoing.
REASON
Defective Container: Bottles may have defective pump assembly which may result in an inaccurate delivery of drug dose.
VOLUME OF PRODUCT IN COMMERCE
3,439 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10mL (NDC 63323-325-10) and 20mL (NDC 63323-325-20) Single Dose Vial, Rx only, also labeled as Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10mL vial DIN 02236926 and 20mL vial DIN 02236926. Recall # D-221-2011;

2) Cyanocobalamin Injection, USP, 1,000mcg/mL, 1mL Multi Dose Vial, NDC 63323-044-01. Recall # D-222-2011;

3) Heparin Sodium Injection, USP, 10,000 USP Units/mL, 1mL Multi Dose Vial, DIN 02264307. Recall # D-223-2011;

4) Heparin Sodium Injection, USP, 20,000 USP Units/mL, 1mL Multi Dose Vial, Rx only, NDC 63323-916-06. Recall # D-224-2011;

5) Heparin Sodium Injection, USP, 5,000 USP Units/mL, 3mL Multi Dose Vial, Rx only, NDC 63323-262-01. Recall # D-225-201;

6) Pyridoxine HCl Injection, USP, 100mg/mL, 1mL Multi Dose Vial, Rx only, NDC 63323-180-01. Recall # D-226-2011;

7) Sodium Bicarbonate 4.2% (2.5mEq/5mL), 5mL Single Dose Vial, Rx only, NDC 63323-026-05. Recall # D-227-2011;

8) Thiamine HCL Injection, USP, 100mg/mL, 2mL Multi Dose Vial, Rx Only, NDC 63323-013-02. Recall # D-228-2011;

9) Tobramycin Injection, USP, 20mg/2mL (10mg/mL), 2mL Multi Dose Vial, Rx Only, NDC 63323-305-02. Recall # D-229-201;

10) Tobramycin Injection, USP, 40mg/mL, a) 2mL Multi Dose Vial (NDC 63223-306-02) and b) (Novaplus label NDC 63323-306-55) and 30mL Multiple Dose Vial (NDC 63323-306-30) and c) (Novaplus label NDC 63323-306-56), d) 50mL Pharmacy Bulk (NDC 63323-307-51) Rx Only. Recall # D-230-2011
CODE
1) 10 mL lots: 407043 (exp. 08/10), 407107 (exp. 09/10), 407146 (exp. 09/10), 407183 (exp. 09/10), 407538 (exp. 11/10); PPC Lot# 407042 (exp.02/11) 407182 (exp. 03/11) and 407537 (exp. 05/11) and 20 mL lots: 407041 (exp. 08/10), 407076 (exp 08/10), 407144 (exp 09/10) 407213 (exp 09/10), 407363 (exp 10/10), 407480 (exp 11/10); PPC Lot# 407038 (exp. 02/11) and 407212 (exp. 03/11);

2) Lot# 406913 (exp. 01/11), 407483 (exp. 05/11), and 408030 (exp. 09/11)

3) Lot # 406894 (exp. 01/11), 407145 (exp. 03/11), 407404 (exp. 04/11), and 407597 (exp. 06/11);

4) Lot# 407364 (exp. 04/11), 407365 (exp. 04/11), 407978 (exp. 09/11), and 407979 (exp. 09/11);

5) Lot# 406870 (exp. 01/11), 406871 (exp. 01/11), 406902 (exp. 01/11), 406903 (exp. 01/11), 406904 (exp. 01/11), 406905 (exp. 01/11), 406929 (exp. 01/11), 406949 (exp. 02/11), 406950 (exp. 02/11), 406951 (exp. 02/11), 406981 (exp. 02/11), 406982 (exp. 02/11), 407003 (exp. 02/11), 407005 (exp 02/11), 407022 (exp 02/11), 407023 (exp 02/11), 407024 (exp 02/11), 407025 (exp 02/11), 407066 (exp. 02/11), 407067 (exp. 02/11), 407101 (exp. 03/11), 407116 (exp. 03/11), 407118 (exp. 02/11), 407148 (exp. 03/11), 407174 (exp. 03/11), 407175 (exp. 03/11), 407252 (exp. 04/11), 407300 (exp. 03/11), 407358 (exp. 04/11), 407360 (exp. 04/11), 407361 (exp. 04/11), 407414 (exp. 04/11), 407439 (exp. 05/11), 407440 (exp. 05/11), 407441 (exp. 05/11), 407484 (exp. 05/11), 407488 (exp. 05/11), 407503 (exp. 05/11), 407507 (exp. 05/11), 407720 (exp. 07/11), 407721 (exp. 07/11), 40773 (exp. 07/11), 407788 (exp. 08/11), 407824 (exp. 08/11), 407825 (exp. 08/11), 407827 (exp. 08/11), 407837 (exp. 07/11), 407839 (exp. 07/11), 407859 (exp. 08/11), 407887 (exp. 08/11), 407888 (exp. 08/11), 408042 (exp. 09/11), 408071 (exp. 09/11), 408099 (exp. 10/11), 408130 (exp. 10/11), 408186 (exp. 10/11) and 408192 (exp 10/11);

6) Lot# 407006 (exp. 08/10);

7) Lot# 405865 (exp. 12/10), 406130 (exp. 02/11), 406263 (exp. 03/11), 406663 (exp. 05/11), 407590 (exp. 12/11);

8) Lot# 407026 (exp. 02/11) and 407075 (exp. 02/11);

9) Lot# 406008 (exp. 07/10);

10) a) Lot# 406009 (exp. 07/10) and 407106 (exp. 03/11); b) Lot# 406302 (exp. 09/10); Lot# 406885 (exp. 01/11), c) Lot# 406884 (exp. 01/11); d) Lot# 407536 (exp. 05/11)
RECALLING FIRM/MANUFACTURER
Recalling Firm: App Pharmaceuticals LLC, Schaumburg, IL, by letter dated May 20, 2010.
Manufacturer: APP Pharmaceuticals, LLC, Grand Island, NY. FDA initiated recall is ongoing.
REASON
CGMP Deviations: Incomplete documentation associated with test results.
VOLUME OF PRODUCT IN COMMERCE
15,643,745 units
DISTRIBUTION
Nationwide, New Zealand and Canada
___________________________________
PRODUCT
Armour Thyroid (thyroid tablets, USP), 1/2 grain (30 mg) , each tablet contains 19 mcg levothyroxine (T4) and 4.5 mcg liothyronine (T3), 100-count bottle, NDC 0456-0458-01. Recall # D-231-2011
CODE
Lot #: 1077413, Exp. 9/30/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Forest Pharmaceuticals Inc., Earth City, MO, by telephone and letters on October 6, 2010.  
Manufacturer: Forest Pharmaceuticals Inc., Cincinnati, OH. Firm initiated recall is ongoing.
REASON
Labeling: Label error on declared strength; some bottles are mislabeled as containing 1/2-grain tablets but actually contain 1-grain tablets. The entire lot is being recalled even though some bottles are labeled correctly because bottles of 1/2-grain and 1-grain could be shrink-wrapped together.
VOLUME OF PRODUCT IN COMMERCE
31,172 bottles approx.
DISTRIBUTION
Nationwide, PR, Belgium and the United Kingdom

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III
___________________________________
PRODUCT
1) Lorazepam Tablets, USP, 0.5 mg, a) UD 100-count Tablets (10 x 10) per box, NDC 63739-154-10; b) UD 750-count Tablets (25 x 30) per box, NDC 63739-154-01; Rx only, SKY. Recall # D-215-2011;

2) Lorazepam Tablets, USP, 1 mg, UD 100-count (10 x 10) per box, Rx only, SKY; NDC 63739-155-10. Recall # D-216-2011;

3) Lorazepam Tablets, USP, 2 mg, UD 100-count Tablets (10 x 10) per box, Rx only, SKY; NDC 63739-156-10. Recall # D-217-2011
CODE
1) Lot #: a) 000066385, 000067254, 000064808, 000064855, Exp 01/11; 000070770, Exp 08/11; b) 000067191, Exp 01/11;

2) Lot #: 000064856, 000064857, Exp 12/10; 000066384, 000065964, Exp 01/11; 000099888, Exp 05/11;

3) Lot #: 000066386, 000064858, Exp 01/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mckesson Packaging Services, Concord, NC, by letter on November 30, 2010.
Manufacturer: Sandoz Inc., Princeton, NJ. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: The product may not meet the specifications for impurity levels throughout the assigned shelf life.
VOLUME OF PRODUCT IN COMMERCE
104,989 unit-dose boxes
DISTRIBUTION
IL, KY, LA, NH, NJ and NY
___________________________________
PRODUCT
1) Acyclovir Capsules, USP, 200 mg, 100-count bottles, Rx only; NDC 0093-8940-01. Recall # D-218-2011;

2) Acyclovir Tablets, USP, 800 mg, 500-count bottles, Rx only; NDC 0093-8947-05. Recall # D-219-2011
CODE
1) Lot #: 35315261A, 35315263A, Exp 04/12;
2) Lot #: 35315369A, Exp 04/12
RECALLING FIRM/MANUFACTURER
Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on November 17, 2010. Firm initiated recall is ongoing.
REASON
Presence of Foreign Substance: Presence of food grade gasket material may be present in the product.
VOLUME OF PRODUCT IN COMMERCE
28,938 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS II
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0686-11
CODE
Unit: 198198091
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Reno, NV, by telephone on December 1, 2006. Firm initiated recall is complete.
REASON
Blood product, which did not meet the minimum weight requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NV
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0699-11
CODE
Unit: 8750634
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone on October 17, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Whole Blood CPDA-1. Recall # B-0702-11
CODE
Unit: 5557715
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by telephone on December 6, 2004. 
Manufacturer: Blood Centers of the Pacific-Marin Center, San Rafael, CA. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0730-11;
2) Platelets Pooled Leukocytes Reduced. Recall # B-0731-11
CODE
1) Unit: W120610310716;
2) Unit: W120610380706
RECALLING FIRM/MANUFACTURER
Michigan Blood, Saginaw, MI, by fax dated November 15, 2010. Firm initiated recall is complete.  
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE

2 units
DISTRIBUTION
MI

___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0732-11
CODE
Unit: W037910179458
RECALLING FIRM/MANUFACTURER
LifeServe Blood Center, Des Moines, IA, by telephone on November 22, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0733-11
CODE
Unit: W068510104909
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA, by facsimile on December 20, 2010. 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
WA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0734-11
CODE
Unit: W066510602040
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK, by fax on November 29, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AK
___________________________________
PRODUCT
1) Plasma. Recall # B-0737-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0738-11
CODE
1) and 2) Unit: 6050188
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by telephone on October 25, 2005.
Manufacturer: Blood Centers of the Pacific, Fairfield, CA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA and Austria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0744-11
CODE
Unit: 6024882
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by letter dated March 28, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0745-11
CODE
Unit: 2880745
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone on May 17, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0746-11
CODE
Units: 1604371; 1604371
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone on May 9, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0747-11
CODE
Units: 198210174; 198210174
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Reno, NV, by telephone on May 4, 2007.  Firm initiated recall is complete.
REASON
Blood product, possibly contaminated with P. acnes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NV
___________________________________
PRODUCT
1) Plasma Frozen. Recall # B-0749-11;
2) Cryoprecipitated AHF. Recall # B-0750-11;
3) Plasma. Recall # Recall # B-0751-11;
4) Red Blood Cells (Apheresis Leukocytes Reduced. Recall # B-0752-11;
5) Red Blood Cells. Recall # B-0753-11;
6) Fresh Frozen Plasma. Recall # B-0754-11
CODE
1) Unit: W038510802868;
2) Unit: W038510801483;          
3) Units: W038510801483; 5304070;           
4) Units: W038508801002; W038508801002; 8014671; 8014671; 8013787; 8013787; 8013005; 8013005;
5) Units: W038510802868; W038510801483; 5304070; 2033005;
6) Unit: 2033005
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by fax on September 13, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
Israel; Korea, Republic Of (South), SC, TN, GA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0755-11
CODE
Unit: W088410038137
RECALLING FIRM/MANUFACTURER
Blood Bank Of Hawaii, Honolulu, HI, by letter dated October 6, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
HI
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0758-11;
2) Recovered Plasma. Recall # B-0759-11
CODE
1) and 2) Unit: 1615343
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone on May 1, 2007. 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
CA, Austria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0760-11 
CODE
Unit: 1642853
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone on May 4, 2007. Firm initiated recall is complete. 
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0761-11
CODE
Unit: 6029328
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by letter dated April 30, 2007.
Manufacturer: Blood Centers of the Pacific, Walnut Creek, CA. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0762-11
CODE
Unit: 4895538
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by letter dated March 28, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0763-11
CODE
Unit: 6024868
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone on May 24, 2007. 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
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0765-11
CODE
Unit: 6530183
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone and follow up letter on December 16 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor taking the drug Proscar, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0767-11;
2) Plasma Frozen. Recall # B-0768-11
CODE
1) and 2) Unit: 49GK18485
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Tulsa, OK, by fax on September 7, 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
2 units
DISTRIBUTION
OK, MO
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0774-11;
2) Plasma Frozen. Recall # B-0775-11
CODE
1) and 2) Unit: 003K64847
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA, by telephone on October 30, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0777-11;
2) Platelets. Recall # B-0778-11
CODE
1) and 2) Unit: W270110527732
RECALLING FIRM/MANUFACTURER
Central Pennsylvania Blood Bank, Hummelstown, PA, by telephone and Regional Market Withdrawal Form on October 23, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0780-11
CODE
Unit: W115910056170
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by e-mail on December 1, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-0786-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0787-11;
3) Recovered Plasma. Recall # B-0788-11
CODE
1) Units: 4278469; 0799786;
2) Units: 6089539; 4799748; 4278469; 0799786; 0794858; 0790197; 0760503;
3) Units: 6089539; 0794858; 0790197; 0760503
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, telephone on July 11, 2005 and follow up letters dated July 26, 2005. Firm initiated recall is complete
REASON
Blood products, collected from a donor who was previously deferred due to a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
CA, Switzerland
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0790-11
CODE
Unit: W115910056612
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by fax on December 1, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0791-11
CODE
Unit: 5418837
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers - Lake Park, Lake Park, FL, by letter dated October 22, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
1) Red Blood Cells (Apheresis) Irradiated. Recall # B-0792-11;   
2) Fresh Frozen Plasma. Recall # B-0793-11
CODE
1) and 2) Unit: 8752588
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by telephone on July 21, 2005.
Manufacturer: Marin Center, San Rafael, CA. 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
CA
___________________________________
PRODUCT
1) Recovered Plasma. Recall # B-0797-11;
2) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0798-11
CODE
1) and 2) Unit: 5335972
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone and electronic notification on November 7, 2007 and by letter dated November 12, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a transfusion, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA, Austria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0879-11
CODE
Unit: W038110280052
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by letter on October 27, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who received a tattoo within 12 months of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS III
___________________________________
PRODUCT
Source Plasma. Recall # B-0121-11
CODE
Units: SQ110764, SQ108413
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank, Inc. of Wisconsin, Madison, WI, by facsimile on December 2, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0679-11
CODE
Unit: 7020534
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, Inc., New York, NY, by letter dated May 7, 2007. 
Manufacturer: New York Blood Center, Inc., Long Island City, NY. Firm initiated recall is complete.
REASON
Blood product, which was possibly contaminated with Propionibacterium acnes, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0721-11;
2) Plasma Frozen. Recall # B-0722-11
CODE
1) Units: 9232072, 9232073, 9232074, 9232075, 9232076, 9232077, 9232078, 9232079, 9232080, 9232081, 9232082, 9232083;
2) Units: 9232072, 9232073, 9232074, 9232075, 9232076, 9232080, 9232078, 9232081, 9232082
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone on March 7, 2008 and by letter dated April 22, 2008. Firm initiated recall is complete.
REASON
Blood products, for which documentation of shipping temperature was omitted, were distributed.
VOLUME OF PRODUCT IN COMMERCE
21 units
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Plasma. Recall # B-0739-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0740-11
CODE
1) and 2) Unit: 8811476
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by letters dated January 3, 2006 and January 4, 2006. 
Manufacturer: Blood Centers of the Pacific, Redding, CA. Firm initiated recall is complete.
REASON
Blood products, collected in an expired collection bag, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Fresh Frozen Plasma (Apheresis). Recall # B-0741-11
CODE
Unit: 221760454
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Las Vegas, NV, by telephone on September 20, 2006. 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
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-0748-11
CODE
Unit: 5240069015
RECALLING FIRM/MANUFACTURER
IBR Plasma Centers, LLC, Moline, IL, by E-mail on November 3, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0769-11
CODE
Unit: W047008270064
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, inc-cellular Therapy Laboratory, New York, NY, by telephone on August 5, 2008.
Manufacturer: New York Blood Center, Inc., Elmsford, NY. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
Source Plasma. Recall # B-0776-11
CODE
Unit: WN0189023
RECALLING FIRM/MANUFACTURER
DCI Biologicals Wilmington, Inc., Wilmington, NC, by fax on November 19, 2010 and e-mail on December 17, 2010. Firm initiated recall is complete.  
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0779-11
CODE
Unit: W270110527732
RECALLING FIRM/MANUFACTURER
Central Pennsylvania Blood Bank, Hummelstown, PA, by telephone and Regional Market Withdrawal Form on October 23, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0784-11;
2) Blood and Blood Products for Reprocessing. Recall # B-0785-11
CODE
1) and 2) Unit: 6024344
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by fax and by telephone on July 13, 2007 and follow up letter dated July 16, 2007.
Manufacturer: Blood Centers of the Pacific, Fairfield, CA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA, Austria

RECALLS AND FIELD CORRECTIONS:  DEVICES – CLASS I
___________________________________
PRODUCT
Maquet Heartstring II Proximal Seal System (HS-1045). Intended use: medical device for use by cardiac surgeons during CABG procedures to maintain hemostasis and to facilitate the completion of a proximal anastomosis without application of an aortic clamp. Recall # Z-0940-2011
CODE
Lot numbers: 12895788, 12946718, 25002866, 25004647, 13029141, 25005045, 25005622
RECALLING FIRM/MANUFACTURER
Recalling Firm: Maquet Cardiovascular, LLC, Wayne, NJ, by letter dated May 5, 2010.
Manufacturer: Maquet Cardiovascular, San Jose, CA. Firm initiated recall is complete.
REASON
Deployment tube may detach during use due to insufficient adhesive, which may result in product failure to operate.
VOLUME OF PRODUCT IN COMMERCE
1,630 units
DISTRIBUTION
Nationwide, and Japan, Mexico, Germany, Switzerland, Israel

___________________________________
PRODUCT
Arstasls One Access System; Models: AAD100, AAD101, Part Numbers: FG-02279, FG-03010; The system consists of the following components: (1) Device Sheath/Anchor, (2) Shaft and (3) Handle with control features. The Arstasis One Access System is a sterile, single use system intended to provide access for the percutaneous introduction of devices into the peripheral vasculature and to promote hemostasis at the arteriotomy site as an adjunct to manual compression. The System is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures using SF or 6F Introducer sheaths. Recall # Z-0993-2011
CODE
Lot Numbers: 09I10268, 1OC26337, 09J06281, 10C12334
RECALLING FIRM/MANUFACTURER
Arstasis Inc., Redwood City, CA, via letters dated October 19, 2010. Firm initiated recall is complete.
REASON
Device has the potential to fracture and sheath separation during use.
VOLUME OF PRODUCT IN COMMERCE
330 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS:  DEVICES – CLASS II
___________________________________
PRODUCT
1) Southmedic/Personna Safety Scalpel with Personna Plus Blades, Reorder No. 73-0610, Size #10, General Surgical Use, Sterile, unless package is damaged or opened. Recall # Z-0988-2011;

2) Southmedic/Personna Safety Scalpel with Personna Plus Blades, Reorder No. 73-0611, Size #11, General Surgical Use, Sterile, unless package is damaged or opened. Recall # Z-0989-2011;

3) Southmedic/Personna Safety Scalpel with Personna Plus Blades, Reorder No. 73-0615, Size #15, General Surgical Use, Sterile, unless package is damaged or opened. Recall # Z-0990-2011
CODE
1) Lot numbers: 070610, 82010, 82610, and 91710;
2) Lot numbers: 071510, 071510-1, 080910, 91010, 100410, 100710, 100810, and 101510;
3) Lot numbers: 070910, 081610, 90110, 91410, and 93010
RECALLING FIRM/MANUFACTURER
Southmedic, Inc., Barrie Ontario, Canada, by facsimile letter on September 3, 2010 and letters dated November 15, 2010. Firm initiated recall is ongoing.
REASON
Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile.
VOLUME OF PRODUCT IN COMMERCE
1330 cases of 120 scalpels
DISTRIBUTION
Nationwide, and Australia and Canada
___________________________________
PRODUCT
Stryker Endoscopy, Infravision Esophageal Kit, Model Numbers: 220180548, 220180540, 220180560. Recall # Z-1002-2011
CODE
Units: PSTR010710-1, PSTR081109-1, PSTR081109-2, PSTR081209-1, PSTR081309-2, PSTR082109-1, PSTR082709-1, PSTR082809-1, PSTR090809-1, PSTR091809-1, PSTR091809-2, PSTR092409-1, PSTR100309-1, PSTR100909-1, PSTR110609-1, PSTRI20709-2, PSTR121809-1, PSTR122209-1, STR021009-8R, STR022709-1R, STR022709-2R, and STR041709-4R
RECALLING FIRM/MANUFACTURER
Stryker Endoscopy, San Jose, CA, by letters on May 11, 2010.  Firm initiated recall is complete.
REASON
The silicone sheath component of the product detaches from the catheter upon removal of the e-kit from the body.
VOLUME OF PRODUCT IN COMMERCE
4125 units
DISTRIBUTION
Nationwide, and Canada, Singapore and Switzerland
___________________________________
PRODUCT
Varian brand C-Series Clinacs and Acuity, Exact Couch Top, Model Numbers: H69. Recall # Z-1003-2011
CODE
Units: H690002, H694936, H696287, H695791, H694466, H696406, H694937, H697423, H695540, H695617, H695747, H695780, H696166
RECALLING FIRM/MANUFACTURER
Varian Medical Systems Oncology Systems, Palo Alto, CA, by letter on April 19, 2010. Firm initiated recall is ongoing.
REASON
The product has been shipped since 2005 with the wrong label regarding max weight to be used on accessory rails.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
Japan only
___________________________________
PRODUCT
Optovue iVue optical coherence tomography system, computer controlled opthalmic imaging system, manufactured by Optovue, Fremont, CA Computer controlled opthalmic imaging system. Device scans the patient's eye using low coherence interferometer to measure the reflectivity of the retinal tissue. The cross sectional retinal tissue structure is composed of a sequence of A-scans. It has a traditional patient and instrument interface. The computer has a graphic user interface for acquiring and analyzing the image. The iVue offers three scans: Retina, Glaucoma and Cornea. For the cornea scan, a lens must be attached to the front of the device for proper scanning. This is the Cornea Anterior Module (CAM). Recall # Z-1004-2011
CODE
Serial numbers: 20305, 20307, 20340, 20335, 20306, 20313, 20339, 20337, 20338, 20341, 20311, 20271, 20343, 20312, 20309, 20310, 20308, 20336, 20344, 20349, 20346, 20347
RECALLING FIRM/MANUFACTURER
Optovue Inc., Fremont, CA, by letter dated July 20, 2010. Firm initiated recall is ongoing.
REASON
Use of the CAM attachment may result in a positioning anomaly and mistreatment in the eyes of the patient.
VOLUME OF PRODUCT IN COMMERCE
22 devices and 20 demo devices
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Acuson Antares PE Product Version 5.0. Model number 10032746. Intended for Abdominal, Intraoperative, Small Parts, Transcranial, OB/Gyn, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, and Peripheral Vascular applications. Recall # Z-1005-2011;

2) ACUSON S2000, Model number 10041461. Intended for Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/Gyn, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. Recall # Z-1006-2011;

3) Acuson with Physio Module, Model 10430054. Recall # Z-1007-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View, CA, by letter beginning October 2, 2009. Firm initiated recall is ongoing.
REASON
ECG waveform does not accurately align with 2D, M-Mode or Spectral Images.
VOLUME OF PRODUCT IN COMMERCE
67 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery System, with MultiPlan Treatment Planning System Software version 3.5 Medical charged-particle radiation therapy system, intended for treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. Recall # Z-1008-2011
CODE
All systems with multiplan tratment planning system software version 3.5.
RECALLING FIRM/MANUFACTURER
Accuray Inc, Sunnyvale, CA, by letter dated December 29, 2009. Firm initiated recall is ongoing.
REASON
If electron density values are left empty, the calculation of radiation dose in a patient will be modeled as air-like density material rather than correct density. A plan may be created and saved, thus creating the risk of mistreatment.
VOLUME OF PRODUCT IN COMMERCE
71 units
DISTRIBUTION
Nationwide and Canada, Turkey, India, Italy, France, the Netherlands, the UK, India, Spain, Greece, Saudi Arabia, Switzerland, Germany and China
___________________________________
PRODUCT
AutoSuture SURGIPRO Polyproylene Mesh Clear 3" x 5" Sterile REF SPM 35 Surgipro Flat Sheet mesh is a non-absorbable, polypropylene surgical mesh exhibiting high burst strength and tensile strength. Surgipro comes in multiple designs, including multi-filament and open weave. All designs are knitted in such a fashion as to provide bi-directional elasticity, while allowing the mesh to be cut to any shape without unraveling. Mesh is intended to assist in the repair and/or reinforcement of hernia and other fascial defects requiring the additional support of a non-absorbable mesh during and after wound healing. Recalling Firm: Z-1009-2011
CODE
Lot Number: A0K0490 Exp Date: 2015-10
RECALLING FIRM/MANUFACTURER
Covidien LP, North Haven, CT, via letter dated November 15, 2010. Firm initiated recall is ongoing.
REASON
Sterility compromised due to breach in sterile barrier.
VOLUME OF PRODUCT IN COMMERCE
132 units
DISTRIBUTION
Nationwide, Canada and Italy
___________________________________
PRODUCT
Fraxel re:store� Dual Laser System----a laser surgical instrument for use in general and plastic surgery and in dermatology. Model Numbers: MC-SYS-SR1500-D-US; MC-SYS-SR1500-D-US-LOANER; MC-SYS-SR1500-D-UPG-US; MC-SYS-SR 1500-0-1 NTL; MC-SYS-SR1500-D-I-LOANER; MC-SYS-SR1500-D-UPG-INTL; The Fraxel re:store� Dual Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue. Recall # Z-1010-2011
CODE
Serial Numbers: F1196J, J0007, J0010-J0058, J0060-J0203, J0205, J0207-J0209, J0211-J0337, J0339-J0359, J0361-J0414, J0417-J0419, J0426
RECALLING FIRM/MANUFACTURER
Solta Medical, Inc., Hayward, CA, by letters, dated December 15, 2010, December 17, 2010 and the third one dated December 20, 2010. Firm initiated recall is ongoing.
REASON
The product has the potential to cause inadvertent laser firing which may lead to patient/operator injury if the problem recurs.
VOLUME OF PRODUCT IN COMMERCE
352 units
DISTRIBUTION
Nationwide, and Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Egypt, Germany, Greece, Hong Kong, India, Italy, Japan, Korea, Kuwait, Mexico, Netherlands, New Zealand, Pakistan, Philippines, Poland, Russia, Singapore, South Africa, Spain, Thailand, Turkey, Ukraine, United Kingdom, and Vietnam
___________________________________
PRODUCT
ABL90 FLEX Blood Analyzer Part Number: 393-090. Intended for use by trained technologists, nurses, physicians and therapists and for use in a laboratory environment, near patient or point-of-care setting. Also, Intended for in vitro testing of samples of heparinized whole blood. Recall # Z-1011-2011
CODE
Serial numbers: 393-090R0059N007, 393-090R0061N008 & 393-090R0061N009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America Inc., Westlake, OH, by letters on November 16, 2010.  
Manufactaurer:Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is ongoing.
REASON
Due to a software error, a patient mix up can occur on the ABL90. If a sample is pre-registered and the sample "fails" the next result will inherit the patient data from the previous result.
VOLUME OF PRODUCT IN COMMERCE
432 units
DISTRIBUTION
Nationwide, and Australia, Austria, Belgium, Denmark, Finland, France, Germany, Indonesia, Italy, Japan, Kuwait, Malaysia, Netherlands, Norway, Poland, Russia, Spain, Sweden, Switzerland, United Arab Emirates and United Kingdom
___________________________________
PRODUCT
Arrow WH-02220 - Epidural Catheterization Kit with FlexTip Plus(R) Catheter Intended use: Permits acccess to epidural space, Epidural Anesthesia Kit. Recall # Z-1012-2011
CODE
Lot # RF0063961
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arrow International Inc., Reading, PA, by letter dated November 11, 2010. 
Manufacturer: Arrow International Inc., Asheboro, NC. Firm initiated recall is ongoing.
REASON
Sterility may be compromised.
VOLUME OF PRODUCT IN COMMERCE
2,320 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) VAD Kit Reorder DT8915, Sterile. Intended use: Vascular access port kit. Recall # Z-1013-2011;

2) Port Access Tray "for use with power ports" Reorder DT9405C, Sterile. Intended use: Vascular access port kit. Recall # Z-1014-2011;

3) Port Blood Draw Tray "for use with power ports", Reorder DT9410C, Sterile. Intended use: Vascular access port kit. Recall # Z-1015-2011;

4) Minor Dressing Tray, Reorder DT14405, Sterile. Intended use: Vascular access port kit. Recall # Z-1016-2011;

5) Port Dressing Tray, Reorder DT12885, Sterile. Intended use: Vascular access port kit. Recall # Z-1017-2011;

6) Port/PICC Access Kit, Reorder CV13240, Sterile. Intended use: Vascular access port kit. Recall # Z-1018-2011
CODE
1) Unit: 2010112950;

2) Units: 2010032280, 2010030280, 2010030380, 2010030480, 2010012580, 2010011180 and 2010030180;

3) Units: 2009120880 and 2010012580;

4) Units: 2009111880, 2010020880, 2009121680, 2010021680, 2009121580, 2009111780, 2009111680, 2010011880, 2010021580;

5) Units: 2010021580, 2010050380, 2010060180, 2010060280 and 2009120780;

6) Units: 2010032280, 2010051080 and 2009122880
RECALLING FIRM/MANUFACTURER
Recalling Firm: Centurion Medical Products, Howell, MI, by letter dated November 12, 2010.
Manufacturers: Centurion Medical Products Corp., Yuma, AZ;
Centurion Medical Products, Salisbury, NC. Firm initiated recall is ongoing.
REASON
The firm is conducting a recall of kits that contain the MONOJECT PREFILL ADVANCED flush syringes containing heparin. The syringes are under recall because of testing that showed "that the crude heparin used to produce a specific batch of purified heparin sodium USP contained low level of Over-Sulfated Chondroitin Sulfate (OSCS)".
VOLUME OF PRODUCT IN COMMERCE
4,290 units
DISTRIBUTION
OH, WI, IL, MO and TX
___________________________________
PRODUCT
PCR Eleva. The marketing brochure is labeled in parts: "Philips Medical Systems is part of Royal Philips Electronics...Philips Medical Systems Nederland B.V". Provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Recall # Z-1019-2011
CODE
Site Numbers: 10386, 85175, 86027, 86028, 86029, 86030, 86239, 86240, 101892, 102832, 102935, 103769, 105172, 105354, 105400, 105401, 105701, 105709, 505051, 505128, 505716, 506103, 519108, 519109, 519110, 519111, 519112, 520528, 520672, 520673, 520704, 520931, 521891, 532267, 532268, 532269, 536615, 537619, 537627, 537633, 537650, 538445, 538505, 538506, 538507, 538508, 538701, 538702, 538773, 538979, 538980, 539061, 539430, 539431, 539432, 539433, 539434, 539436, 539437, 539438, 539439, 539440, 539441, 539442, 539443, 539444, 539449, 539450, 539451, 539452, 539453, 539619, 539664, 539740, 539741, 540174, 540294, 540352, 540357, 540358, 540359, 540360, 540369, 540428, 540429, 540430, 540489, 540496, 540637, 540902, 540966, 540997, 540998, 541035, 541066, 541240, 541252, 541254, 541255, 541307, 541324, 541326, 541346, 541349, 541389, 541390, 541391, 541392, 541393, 541398, 541399, 541400, 541437, 541616, 541618, 541713, 541714, 541826, 541828, 541829, 541889, 541893, 541901, 541902, 541904, 541909, 541915, 542108, 542164, 542165, 542166, 542167, 542168, 542169, 542170, 542188, 542189, 542190, 542246, 542247, 542249, 542254, 542377, 542383, 542410, 542600, 542639, 542640, 542641, 542642, 542665, 543413, 543414, 543416, 543417, 543418, 543419, 543421, 543424, 543457, 543603, 543604, 543605, 543606, 543612, 543613, 543614, 543615, 543631, 543632, 543693, 543719, 543758, 543825, 543830, 543831, 543927, 543940, 544089, 544115, 544194, 544281, 544282, 544381, 544490, 544491, 544526, 544588, 544592, 544595, 544685, 544686, 544688, 544689, 544690, 544691, 544694, 544875, 544940, 545015, 545016, 545054, 545055, 545263, 545287, 545352, 545353, 545354, 545356, 545361, 545362, 545363, 545364, 545379, 545380, 545381, 545430, 545431, 545566, 545567, 545825, 545845, 545886, 545887, 545888, 545892, 545893, 545908, 546003, 546167, 546168, 546169, 546170, 546171, 546172, 546173, 546174, 546175, 546483, 546484, 546485, 546486, 546487, 546488, 546489, 546619, 546678, 546690, 547179, 547412, 547670, 547672, 547702, 547829, 547830, 547831, 547847, 547848, 547849, 547863, 547868, 547869, 547883, 547964, 548106, 548109, 548256, 548257, 548259, 548325, 548327, 548328, 548578, 548623, 548748, 548750, 548774, 548856, 548857, 548858, 548987, 549111, 549256, 549266, 549267, 549268, 549324, 549351, 549377, 549388, 549529, 549530, 549554, 549647, 549710, 549821, 549870, 549898, 550042, 550043, 550090, 550114, 550115, 550134, 550135, 550266, 550267, 550268, 550269, 550270, 550272, 550273, 550274, 550275, 550295, 550296, 550305, 550320, 550335, 550341, 550342, 550386, 550816, 550817, 550929, 550938, 550939, 550958, 551002, 551003, 551018, 551276, 551343, 551354, 551356, 551411, 551419, 551430, 551432, 551438, 551439, 551440, 551442, 551509, 551520, 551521, 551542, 551672, 551834, 551839, 551966, 552076, 552083, 552119, 552120, 552144, 552145, 552174, 552212, 552213, 552253, 552254, 552400, 552415, 552443, 552521, 552522, 552654, 552655, 553053, 553120, 553208, 553209, 553210, 553291, 553331, 553332, 553333, 553334, 553335, 553338, 553339, 553386, 553388, 553444, 553641, 553643, 553721, 553901, 553927, 554091, 554095, 554325, 554404, 554405, 554406, 554445, 554446, 554530, 554531, 554532, 554533, 554534, 554535, 554536, 554537, 554538, 554558, 554582, 554595, 554613, 554616, 554617, 554618, 554623, 554624, 554625, 554626, 554627, 554632, 554657, 554718, 554795, 554796, 554800, 554801, 554857, 554876, 555017, 555121, 555270, 555385, 555386, 555388, 555389, 555390, 555408, 555476, 555510, 555522, 555665, 555666, 555697, 555709, 555745, 555782, 556018, 556090, 556091, 556133, 556163, 556164, 556175, 556176, 556178, 556179, 556233, 556519, 556551, 556665, 556793, 556837, 556843, 556860, 556864, 556869, 556957, 557023, 557162, 557164, 557285, 557286, 557287, 557288, 557350, 557571, 558415, 558421, 558516, 558517, 558518, 558519, 558520, 559769, 559941, 559942, 559966, 41443580, 41443588, 41443651, 41443724, 41443730, 41443733, 41443734, 41443736, 41443740, 41443780, 41443903, 41444566, 41444659, 41444757, 41445116, 41445143, 41445155, 41445331, 41445391, 41445406, 41445485, 41445586, 41445722, 41445738, 41445813, 41445824, 41445825, 41445831, 41445847, 41445858, 41445859, 41445861, 41445862, 41445867, 41445868, 41445869, 41445920, 41445926, 41445930, 41445932, 41446133, 41446318, 41541166, 41622509, 41704403, 41711727, 41747703, 41780360, 41781481, 41782214, 41782216, 41795153, 41796624, 41896219, 41938045, 42047944, 42047945, 42047946, 42057214, 42057216, 42057217, 42066438, 42066439, 42066440, 42066441, 42122306, 42123337, 42132637, 42132835, 42132836, 42132837, 42132841, 42248659, 42326712, 42373510, 42373516, 42392282, 42572848, 42573637, 42575723, 42608440, 42616791, 42636410, 42636411, 42636457, 42681385, 42733785, 42785029, 42799764, 42799768, 42799772, 42799784, 42799787, 42799822, 42824083, 42861599, 42865625, 42865626, 42865627, 42865628, 42866042, 42868067, 42868068, 42868069, 42869023, 42869024, 42869040, 42869090, 42869099, 42877564, 42892349, 42892350, 42892351, 42892352, 42975073, 42976502, 43016231, 43084789, 43191088, 43191785, 43209144, 43209145, 43209146, 43209147, 43209148, 43209149, 43209150, 43209151, 43209152, 43209153, 43209154, 43209155, 43273958, 43304526, 43394975, 43453755, 43453756, 43495013, 43504224, 43557517, 43637238, 43645552, 43670905, 43691426, 43691427, 43691428, 43693170, 43693190, 43717665, 43718623, 43794689, 43848154, 43860972, 43902585, 43902654, 43927326, 43959688, 43959689, 43959690, 44038390, 44038393, 44064829, 44216825, 44281797, 44328596, 44337100, 44469259, 44469264, 44488265, 44488344, 44500965, 44561177, 44561178, 44604134, 44615336, 44620447, 44620448, 44621154, 44621155, 44621161, 44623917, 44642293, 44654099, 44706046, 44743559, 44781013, 44869929, 44869930, 44869931, 44892290, 45074597, 45140095, 45168464, and 45311836
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letter on January 30, 2009.  
Manufacturer: Philips Medical Systems Gmbh, DMC, Hamburg, Germany. Firm initiated recall is ongoing.
REASON
There is a risk of selecting the wrong patient, when patient is selected in the patient list and the examination tab pressed with background query are running at the same time.
VOLUME OF PRODUCT IN COMMERCE
681 units
DISTRIBUTION
Nationwide and United Arab Emirates
___________________________________
PRODUCT
i-STAT Level 2 Control Value Assignment Sheets Human Consumption. a) Abbott List Number: 06F13-01;  b) Abbott List Number: 025715. Recall # Z-1020-2011
CODE
a) Lot number B09342 - CLEW A20 artwork 726778-01A.pdf; Lot number B09154 - CLEW A20 artwork 726774-01A.pdf; Lot number B09342 - CLEW A18 artwork 726668-01A.pdf. Expiration: 11/2010; b) CLEW A20 Compact Disc containing value assignment sheets
RECALLING FIRM/MANUFACTURER
Abbott Point of Care Inc., Princeton, NJ, by letter on August 3, 2010. Firm initiated recall is ongoing.
REASON
Three i-STAT Level 2 Control Value Assignment Sheets and the i-STAT CLEW A20 Software System Manual Update CD contain the incorrect range for pCO2, BUN and Glucose for the i-STAT EC8+, 6+, EC4+, E3 and G cartridge types.
VOLUME OF PRODUCT IN COMMERCE
8293 assignment sheets
DISTRIBUTION
Nationwide, and Argentina, Austria, Belgium, Bolivia, Brazil, Chile, China, Columbia, El Salvador, France, Georgia Republic, Germany, Hong Kong, Israel, Italy, Kuwait, Mexico, Netherlands, New Zealand, Panama, Paraquay, Peru, Poland, South Africa, Sweden, Switzerland, Taiwan, Turkey, UAE, UK, Uruguay, and Yemen
___________________________________
PRODUCT
Vital Connect 4.0 & 4.1, radiological image processing software A Medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired from a variety of imaging devices including: CT MR, CR/DR/DX, SC, US, NM, PET, XA and RF, etc. Vital connect has the following intended use: Vessel Probe is intended for viewing the anatomy and pathology of a patient's coronary arteries. Clinicians select any artery to view the following anatomical references: the highlighted vessel in 3D, two rotate-able curved MPR vessel views displayed at angles orthogonal to each other, and cross sections of the vessel. Recall # Z-1021-2011
CODE
Any VitalConnect version or the Vitrea Core component of Vitrea Enterprise Suite (VES) 1.2 adn VES 1.3
RECALLING FIRM/MANUFACTURER
Images, Inc., Plymouth, MN, by letter dated August 23, 2010. Firm initiated recall is ongoing.
REASON
There is a potential alignment error of fused PET/CT images in the Vitrea Core component of Vitrea Enterprise Suite 1.2 and 1.3. The error occurs during panning of the fused PET/CT images. Because the PET data has a larger voxel size than the CT data, it is possible to pan the CT image in more frequent, smaller steps than the PET image, so that the fused PET image does not move until the CT data has moved a distance equivalent to the size of the larger PET data. Therefore, while panning, until the PET image moves, the visual representation of PET will not align accurately with the CT data and the fused PET/CT image may not appear in its correct location.
VOLUME OF PRODUCT IN COMMERCE
178 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
PEAK brand PlasmaBlade EXT, Tissue Dissection Device, Catalogue Number: PS215-040. Recall # Z-1022-2011
CODE
Lot Numbers: 11673, 12061, 12237, 12393, 12485
RECALLING FIRM/MANUFACTURER
Peak Surgical, Inc., Palo Alto, CA, by telephone on May 19, 2009. Firm initiated recall is complete.  
REASON
A customer reported that a patient suffered a burn while using the device.
VOLUME OF PRODUCT IN COMMERCE
493 units
DISTRIBUTION
CA, CO, FL, IL, MD, MN, NV, NY, OH, OK, TN, TX, UT, WA, and Turkey and Ireland
___________________________________
PRODUCT
Radiation therapy device. Medical charged particle radiation therapy system with software version. Model Numbers: Multi Plan Treatment Planning System, Software version 3.0, 3.1, 3.5.0, and 3.5.1. For the treatment planning and image guided radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. Item Number: 025000. Recall # Z-1023-2011
CODE
Serial Number: C0150
RECALLING FIRM/MANUFACTURER
Accuray Inc., Sunnyvale, CA, by letter dated January 18, 2010. Firm initiated recall is ongoing.
REASON
When a user modified the align center of an existing plan during the treatment planning process the effective depths of each beam in the plan were not updated by the system. These depths were incorrect and led to an incorrect dose calculation. Software patch /update to address this issue. Implementation at affected sites will initiate, once the patch is available.
VOLUME OF PRODUCT IN COMMERCE
99 units
DISTRIBUTION
Nationwide and Canada, Turkey, India, Russia, Italy, France, Belgium, Netherlands the UK, Spain, Athens, Saudi Arabia, Switzerland, the Ukraine, Germany, Korea and Hong Kong
___________________________________
PRODUCT
Laryngoscope Handle, Reusable, Rx, Product Code 4558GSP or 4559LED. Used for tracheal tube intubations during anesthesia, intensive care, and emergency medical airway management. Recall # Z-1024-2011
CODE
Lot numbers; 5113Q, 5113R, 5113T, 5125Y, 5128F, 5129J, 5137P, 5139M, 5140P, 5144A, 5154V, 5154X, 5154Y, 5158K, 5161J, 5176T, 5180Z, 5182D, 5183L, 5184U, 5191X
RECALLING FIRM/MANUFACTURER
Vital Signs Colorado Inc., Englewood, CO, by letter dated December 20, 2010. Firm initiated recall is ongoing.
REASON
Battery which powers the laryngeal scope light may dislodge resulting in loss of illumination.
VOLUME OF PRODUCT IN COMMERCE
2,202 units
DISTRIBUTION
Nationwide, Australia, Belgium, Canada, Dominican Republic, Ecuador, Germany, Hong Kong, Latvia, New Zealand, Taiwan, Turkey, and the UK
___________________________________
PRODUCT
1) Bausch & Lomb, Renu Fresh Multi-purpose Solution, 2 fl oz (60 mL), Travel Kit, Daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses. Recall # Z-1025-2011;

2) Up&Up Multipurpose Solution, no-rub formula, 12 Fl oz (355 mL), Sterile, Daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses. Recall # Z-1026-2011
CODE
1) Lot number: GH0066;
2) Lot number: GH0078
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bausch & Lomb Inc., Rochester, NY, by visit on December 8, 2010 and by letter on/about December 22, 2010.
Manufacturer: Bausch & Lomb Inc., Greenville, SC. Firm initiated recall is ongoing.
REASON
There is a potential for some packages to not meet sterility requirements.
VOLUME OF PRODUCT IN COMMERCE
213,792 bottles
DISTRIBUTION
Nationwide, Taiwan and Brazil

___________________________________
PRODUCT
SEQUENCER component of MOSAIQ versions 1.30 (all builds), 1.40 (all builds), 1.50 (all builds), 1.60 (all builds), and 2.0 (all builds). The intended use of SEQUENCER (a verification system) is to assist in the process of patient treatment on a radiotherapy treatment machine. SEQUENCER provides the capability to notify the users of actions that need to take place prior to treatment, to display reference images for set up purposes, and to auto setup the machine to predefined settings. Actual settings are read from the treatment machine, via the machine's communication interface, and compared to the predefined values. If a mismatch occurs between the planned values and the actual machine settings, treatment is prohibited. At appropriate times during the treatment, the actual delivered values are recorded to provide treatment tracking. Treatments are initiated by the operator, via the machine control system, only after the user has verified that the treatment setup is correct. SEQUENCER does not bypass any checks put in place by the machine's control system. Recall # Z-1027-2011
CODE
MOSAIQ version 1.30 (all builds), MOSAIQ version 1.40 (all builds), MOSAIQ version 1.50 (all builds), MOSAIQ version 1.60 (all builds, and MOSAIQ version 2.0 (all builds)
RECALLING FIRM/MANUFACTURER
Impac Medical Systems Inc., Sunnyvale, CA, by letter on/about July 17, 2009. Firm initiated recall is ongoing.
REASON
Potential for improper treatment. A software error may result in potential major underdosing to targeted areas from jaw blockage of the MLC aperture (jaw intrusion), and dosing to non-targeted areas from interstitial leaf leakage (jaw extrusion).
VOLUME OF PRODUCT IN COMMERCE
40 sites
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
The ThermiSense Model 5700-A5 is a nasal cannula that detects thermal variation during breathing cycles and transmits those variations to a remote Alice-5 Polysomnograph via electrical connectors to monitors an adult patient's breathing rate in a sleep laboratory study. Recall # Z-1028-2011
CODE
Lot: 110810
RECALLING FIRM/MANUFACTURER
Salter Laboratories, Division of Regulatory Affairs, Arvin, CA, by dated December 20, 2010. Firm initiated recall is ongoing.
REASON
The incorrect length and connector were utilized in lot 110810 of the ThermiSense Alice 5, making the product unusable as it will not interface with the sleep labs equipment.
VOLUME OF PRODUCT IN COMMERCE
41 units
DISTRIBUTION
CA, CO, DE, ID, IN, KY, MD, MO, and OH
___________________________________
PRODUCT
SEQUENCER for Mosaiq interfaced to Electa SL75-5 machines. Sequencer Verify and Record System is to assist in the process of patient treatment on a radiotherapy treatment machine with software control. Recall # Z-1029-2011
CODE
Sequencer for MOSAIQ versions: 1.20, 1.30; 1.50, 1.60 and 2.00, interfacing to an Elekta SL 75-5 Linacs
RECALLING FIRM/MANUFACTURER
Impac Medical Systems Inc., Sunnyvale, CA, by letter on March 10, 2010. Firm initiated recall is ongoing.
REASON
Computer interface is defected. Computer based verification system for recording patient treatment on a radiotherapy treatment machine fails to record treated field.
VOLUME OF PRODUCT IN COMMERCE
40 units
DISTRIBUTION
Nationwide, Canada, Germany, and France
___________________________________
PRODUCT
Precise Treatment Table is intended as a universal patient treatment support and positioning table for radiation therapy and simulation use. It is for use with existing Elekta Linear Accelerators and Simulators and adaptable to third party radiotherapy products. Recall # Z-1030-2011
CODE
Units: 124023, 124024, 124025, 124027, 124031, 124035, 124041, 124044, 124053, 124052, 124054, 124062, 124065, 124066, 124067, 124070, 124072, 124083, 124087, 124089, 124093, 124104, 124111, 124114, 124115, 124119, 124128, 124135, 124136, 124139, 124140, 124141, 124142, 124145, 124146, 124150, 124152, 124153, 124162, 124167, 124171, 124177, 124178, 124180, 124182, 124197, 124207, 124210, 124218, 124227, 124229, 124230, 124240, 124241, 124247, 124248, 124251, 124281, 124286, 124289, 124294, 124295, 124298, 124304, 124306, 124318, 124328, 124329, 124339, 124342, 124344, 124352, 124353, 124358, 124370, 124375, 124377, 124383, 124385, 124389, 124391, 124401, 124402, 124404, 124406, 124408, 124409, 124412, 124416, 124419, 124428, 124430, 124431, 124433, 124435, 124436, 124439, 124443, 124445, 124446, 124448, 124449, 124452, 124453, 124459, 124465, 124470, 124471, 124472, 124473, 124476, 124477, 124482, 124483, 124484, 124486, 124489, 124492, 124497, 124499, 124501, 124510, 124512, 125041, 125049, 125050, 125061, 125072, 125078, 125085, 125086, 125088, 125090, 125093, 125097, 125099, 125106, 125111, 125114, 125116, 125117, 125120, 125121, 125122, 125129, 125139, 125140, 124142, 125143, 125145, 125147, 125148, 125154, 125160, 125163, 125166, 125175, 125179, 125186, 125191, 125194, 125198, 125209, 125215, 125219, 125225, 125229, 125231, 125234, 125237, 125238, 125239, 125240, 125241, 125242, 125243, 125245, 125258, 125264, 125267, 125278, 125306, 125310, 125311, 125320, 125322, 125324, 125327, 125333, 125342, 125351, 125352, 125362, 125366, 125369, 125370, 125376, 125378, 125396, 125398, 125399, 125400, 125412, 125414, 125415, 125423, 125426, 125431, 125446, 125452, 125466, 125467, 125473, 125474, 125475, 125479, 125481, 125487, 125488, 125489, 125490, 125498, 125499, 125500, 125501, 125502, 125508, 125509, 125515, 125516, 125517, 125521, 125529, 125530, 125536, 125538, 125541, 125542, 125543, 125546, 125548, 125553, 125554, 125556, 125570, 125575, 125590, 125597, 125606, 125610, 125617, 125621, 125625, 125626, 125633, 125634, 125640, 125642, 125648, 125650, 125656, 125669, 125673, 125676, 125677, 125680, 125683, 125685, 125686, 125687, 125689, 125690, 125695, 125700, 125701, 125702, 125703, 125704, 125705, 125716, 125721, 125722, 125723, 125726, 125742, 125745, 125749, 125750, 125764, 125765, 125782, 125785, 125787, 125790, 125792, 125793, 125797, 125799, 125800, 125801, 125812, 125816, 125817, 125823, 125825, 125826, 125828, 125830, 125831, 125837, 125839, 125849, 125852, 125855, 125858, 125869, 125875, 125876, 125888, 125889, 125893, 125899, 125906, 125912, 125920, 125928, 133807, 133808, 133815, 133820, 133825, 133827, 134008, 134027, 134040, 134046, 134047, 134048, 134062, 134070, 134073, 134075, 134078, 134081, 134090, 134091, 134092, 134094, 134104, 134115, 134118, 134126, 134129, 134130, 134137, 134138, 134140, 134143, 134154, 134157, 134169, 134172, 134183, 134189, 134192, 134194, 134195, 134196, 134197, 134200, 134206, 134211, 134212, 134213, 134219, 134234, 134235, 134236, 134237, 134239, 134241, 134249, 134250, 134251, 134254, 134256, 134258, 134259, 134269, 134275, 134280, 134292, 134295, 134303, 134307, 134318, 134319, 134321, 134322, 134324, 134328, 134329, 134331, 134336, 134348, 134354, 134358, 134368, 134375, 134378, 134380, 134382, 134383, 134388, 134391, 134395, 134396, 134399, 134401, 134427, 134428, 134430, 134432, 134436, 134438, 134441, 134445, 134456, 134457, 134458, 134465, 134469, 134472, 134473, 134475, 134483, 134503, 134519, 134535, 134561, 134563, 134564, 134565, 134571, 134595, 134597, 134603, 134605, 134606, 134615, 134621, 134626, 134629, 134630, 134631, 134652, 134667, 134671, 134673, 134679, 134701, 134704, 134706, 134708, 134709, 134711, 134729, 134748, 134750, 134754, 134768, 134770, 134772, 134772, 134781, 134787, 134804, 134819, 134822, 134860, 136009, 136012, 136015, 136034, 136036, 136046, 136047, 136049, 136059, 136063, 136064, 136065, 136069, 136071, 136074, 136075, 136080, 136081, 136083, 136084, 136086, 136087, 136089, 136092, 136096, 136097, 136100, 136106, 136107, 136108, 136109, 136110, 136118, 136119, 136137, 136147, 136152, 136153, 136156, 136157, 136163, 136165, 136169, 136172, 136175, 136178, 136181, 136195, 136197, 136200, 136222, 136234, 136240, 136241, 136243, 136251, 136252, 136257, 136257, 136258, 136267, 136269, 136270, 136285, 136286, 136291, 136292, 136293, 136294, 136298, 136310, 136312, 136313, 136315, 136317, 136318, 136319, 136322, 136330, 136332, 136337, 136338, 136340, 136342, 136350, 136364, 136368, 136373, 136379, 136381, 136390, 136393, 136396, 136397, 136409, 136418, 136422, 136431, 136433, 136439, 136450, 136446, 136459, 136462, 136463, 136468, 136471, 136472, 136476, 136491, 136492, 136498, 136500, 136516, 136519, 136522, 136523
RECALLING FIRM/MANUFACTURER
Recalling Firm: Elekta, Inc., Norcross, GA, by letter dated December 24, 2008.
Manufacturer: Elekta Oncology Systems (Fmrl Philipps), Crawley, West Sussex, UK. Firm initiated recall is ongoing.
REASON
Possible error in the table longitudinal position.
VOLUME OF PRODUCT IN COMMERCE
597 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Presice Cryosurgical System, model FPRCH2047, and the following system is not approved in the US: CryoHit-P Cryoblation System, model FPRCH2058. The system is a software controlled cryoblation system designed to destroy targeted tissue using a minimally invasive percutaneous approach. Freezing and thawing of the tissue is achieved through the use of the Joule-Thompson effect, using a high-pressure gas distributed through closed-end needles placed into the patient’s target organ. Presice is intended for cryogenic destruction of tissue during surgical procedures. Presice is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. Presice has the following specific indications: " Urology (ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia "BPH"); " Oncology (ablation of cancerous or malignant tissue and benign tumors, and palliative intervention); "Dermatology (ablation or freezing of skin cancers and other cutaneous disorders. Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas small hemanglomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratoses, cavernous hemanglomas, perianal condylomata, and palliation of tumors of the skin.); " Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia); "General surgery (palliation of tumors of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenoma); * ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth); " Thoracic surgery (ablation of arrhythmic cardiac tissue cancerous lesions); * Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids). The Presice system may be used with an ultrasound device to provide real-time visualization of the cryosurgical procedure. Recall # Z-1031-2011;

2) SeedNet MRI Cryosurgical System, model FPRCH2035, and the following system is not approved in the US: CryoHit MRI Cryoblation System, model FPRCH2048. The system is a software controlled cryoblation system designed to destroy targeted tissue using a minimally invasive percutaneous approach. Freezing and thawing of the tissue is achieved through the use of the Joule-Thompson effect, using a high-pressure gas distributed through closed-end needles placed into the patient’s target organ. The SeedNet System is intended for cryogenic destruction of tissue during surgical procedures. The modified SeedNet is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. The modified SeedNet has the following specific indications: - Urology (ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia BPH); - Oncology (ablation of cancerous or malignant tissue and benign tumors, and palliative intervention); - Dermatology (ablation or freezing of skin cancers and other cutaneous disorders. Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas small hemanglomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratoses, cavernous hemanglomas, perianal condylomata, and palliation of tumors of the skin); - Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia); - General surgery (palliation of tumors of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions.); - ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth); - Thoracic surgery (ablation of arrhythmic cardiac tissue cancerous lesions); - Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids). The Modified SeedNet System may be used with a magnetic resonance imaging (MRI) device or an ultrasound device to provide real-time visualization of the cryosurgical procedure. Recall # Z-1032-2011
CODE
1) FRCH2047 PI0004 PI0008 PI0022 PI0016 PI0035 PI0013 PI0030 PI0037 PI0027 PI0024 PI0041 PI0042 PI0029 PI0047 PI0048 PI0015 PI0018 PI0049 PI0039 PI0051 PI0052 PI0059 PI0054 PI0055 PI0020 PI0053 PI0063 PI0044 PI0057 PI0068 PI0069 PI0070 PI0025 PI0017 PI0031 PI0019 PI0064 PI0036 PI0032 PI0081 PI0061 PI0043 PI0073 PI0082 PI0014 PI0062 PI0075 PI0071 PI0012 PI0050 PI0040 PI0045 PI0060 PI0072 PI0046 PI0033 PI0076 PI0034 PI0066 PI0021 PI0067 PI0080 FPRCH2058 PI0079 PI0074 PI0078 PI0077;

2) PRCH2035 MA0674 MA0598 MA0479 MA0698 MA0243 MA0332 MA0695 MA0716 MA0736 PRCH2048 MA0665 MA0664 MA0682 MA0686 MA0688 MA0690 MA0689 MA0687 MA0692 MA0694 MA0693 MA0713 MA0342 MA0719
RECALLING FIRM/MANUFACTURER
Recalling Firm: Galil Medical, Inc., Arden Hills, MN, letter dated December, 30, 2010.
Manufacturer: Galil Medical Ltd, Yokneam, Israel. Firm initiated recall is ongoing.
REASON
This voluntary correction has been initiated due to the discovery of a damaged optocoupler on one of our Presice Systems during periodic preventive maintenance. The optocoupler sends a signal across the locking mechanism in the Presice and Seednet MRI Systems, enabling the software to recognize if the channel on the system manifold is locked or unlocked. If an optocoupler is damaged or malfunctioning AND the locking mechanism is in an unlocked position, the software will not alert the user of the unlocked status. This can result in the needle connector being ejected rapidly when the gas begins flowing to the needle.
VOLUME OF PRODUCT IN COMMERCE
85 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Smiths Medical, CADD�-Solis Ambulatory Infusion Pump, Model Number: 2100 and 2110, Reorder Number 21-2101-00, 21-2101-0100-50, 21-2101-0100-51, 21-2101-0200-02, 21-2101-0200-03, 21-2111-0100-51, 21-2111-0200-02, 21-2102-51. The CADD�-Solis ambulatory infusion pump system is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/ surgical wound site), epidural space, or subarachnoid space infusion. The pump is intended for therapies that require a continuous rate of infusion, patient-controlled demand doses, or both (such as patient-controlled analgesia. Recall # Z-1033-2011
CODE
21-2101-51, Serial Numbers US 1007106 1007174 1007535 1007585 1007662 1008911 1008961 1009011 1010062 1007107 1007179 1007536 1007586 1007666 1008912 1008962 1009012 1010063 1007108 1007185 1007537 1007587 1007668 1008913 1008963 1009013 1010064 1007109 1007186 1007538 1007588 1007670 1008914 1008964 1009014 1010065 1007110 1007188 1007539 1007589 1007671 1008915 1008965 1009015 1010066 1007111 1007190 1007540 1007590 1007689 1008916 1008966 1009016 1010067 1007112 1007191 1007541 1007591 1008865 1008917 1008967 1009017 1010068 1007113 1007192 1007542 1007592 1008866 1008918 1008968 1009018 1010069 1007114 1007193 1007543 1007593 1008867 1008919 1008969 1009019 1010070 1007115 1007194 1007544 1007594 1008868 1008920 1008970 1009020 1010071 1007116 1007195 1007545 1007595 1008870 1008921 1008971 1009021 1010072 1007117 1007196 1007546 1007596 1008871 1008922 1008972 1009022 1010073 1007119 1007197 1007547 1007597 1008872 1008923 1008973 1009023 1010074 1007120 1007198 1007548 1007598 1008873 1008924 1008974 1009024 1010075 1007121 1007199 1007549 1007599 1008874 1008925 1008975 1009025 1010076 1007122 1007200 1007550 1007600 1008875 1008926 1008976 1009026 1010077 1007123 1007201 1007551 1007601 1008876 1008927 1008977 1009027 1010078 1007124 1007202 1007552 1007602 1008877 1008928 1008978 1009028 1010079 1007125 1007503 1007553 1007603 1008878 1008929 1008979 1009029 1010080 1007126 1007504 1007554 1007604 1008879 1008930 1008980 1009030 1010081 1007127 1007505 1007555 1007605 1008880 1008931 1008981 1009031 1010082 1007128 1007506 1007556 1007606 1008881 1008932 1008982 1009032 1010083 1007130 1007507 1007557 1007607 1008882 1008933 1008983 1009033 1010084 1007131 1007508 1007558 1007608 1008883 1008934 1008984 1009034 1010085 1007132 1007509 1007559 1007609 1008884 1008935 1008985 1009035 1010086 1007133 1007510 1007560 1007610 1008885 1008936 1008986 1009036 1010087 1007134 1007511 1007561 1007611 1008886 1008937 1008987 1009037 1010088 1007135 1007512 1007562 1007612 1008887 1008938 1008988 1009038 1010090 1007136 1007513 1007563 1007613 1008888 1008939 1008989 1009039 1010091 1007137 1007514 1007564 1007614 1008889 1008940 1008990 1010040 1010092 1007138 1007515 1007565 1007615 1008890 1008941 1008991 1010041 1010093 1007139 1007516 1007566 1007616 1008891 1008942 1008992 1010042 1010094 1007141 1007517 1007567 1007617 1008892 1008943 1008993 1010043 1010095 1007144 1007518 1007568 1007618 1008893 1008944 1008994 1010044 1010096 1007145 1007519 1007569 1007619 1008894 1008945 1008995 1010045 1010097 1007146 1007520 1007570 1007620 1008895 1008946 1008996 1010046 1010098 1007147 1007521 1007571 1007621 1008897 1008947 1008997 1010047 1010099 1007148 1007522 1007572 1007622 1008898 1008948 1008998 1010049 1010100 1007149 1007523 1007573 1007623 1008899 1008949 1008999 1010050 1010101 1007150 1007524 1007574 1007624 1008900 1008950 1009000 1010051 1010102 1007151 1007525 1007575 1007625 1008901 1008951 1009001 1010052 1010103 1007152 1007526 1007576 1007626 1008902 1008952 1009002 1010053 1010104 1007153 1007527 1007577 1007628 1008903 1008953 1009003 1010054 1010105 1007154 1007528 1007578 1007629 1008904 1008954 1009004 1010055 1010106 1007155 1007529 1007579 1007632 1008905 1008955 1009005 1010056 1010107 1007157 1007530 1007580 1007638 1008906 1008956 1009006 1010057 1010108 1007158 1007531 1007581 1007641 1008907 1008957 1009007 1010058 1010109 1007159 1007532 1007582 1007648 1008908 1008958 1009008 1010059 1010110 1007160 1007533 1007583 1007650 1008909 1008959 1009009 1010060 1010111 1007161 1007534 1007584 1007656 1008910 1008960 1009010 1010061 1010112 1010113 1010166 1010216 1010266 1010316 1010366 1010483 1010535 1010664 1010114 1010167 1010217 1010267 1010317 1010367 1010484 1010536 1010678 1010115 1010168 1010218 1010268 1010318 1010368 1010485 1010537 1010683 1010116 1010169 1010219 1010269 1010319 1010369 1010486 1010538 1010690 1010118 1010170 1010220 1010270 1010320 1010373 1010487 1010539 1010691 1010119 1010171 1010221 1010271 1010321 1010391 1010488 1010540 1010692 1010120 1010172 1010222 1010272 1010322 1010392 1010489 1010542 1010693 1010121 1010173 1010223 1010273 1010323 1010393 1010490 1010543 1010694 1010122 1010174 1010224 1010274 1010324 1010394 1010491 1010544 1010695 1010123 1010175 1010225 1010275 1010325 1010395 1010492 1010545 1010696 1010124 1010176 1010226 1010276 1010326 1010396 1010493 1010546 1010697 1010126 1010177 1010227 1010277 1010327 1010397 1010494 1010547 1010698 1010127 1010178 1010228 1010278 1010328 1010398 1010495 1010548 1010699 1010128 1010179 1010229 1010279 1010329 1010399 1010496 1010549 1010700 1010129 1010180 1010230 1010280 1010330 1010400 1010497 1010550 1010701 1010130 1010181 1010231 1010281 1010331 1010401 1010498 1010551 1010702 1010131 1010182 1010232 1010282 1010332 1010402 1010499 1010552 1010703 1010132 1010183 1010233 1010283 1010333 1010403 1010500 1010553 1010704 1010133 1010184 1010234 1010284 1010334 1010404 1010501 1010554 1010705 1010134 1010185 1010235 1010285 1010335 1010406 1010502 1010555 1010706 1010135 1010186 1010236 1010286 1010336 1010407 1010503 1010556 1010707 1010136 1010187 1010237 1010287 1010337 1010408 1010504 1010557 1010708 1010137 1010188 1010238 1010288 1010338 1010409 1010505 1010558 1010709 1010138 1010189 1010239 1010289 1010339 1010410 1010506 1010559 1010710 1010139 1010190 1010240 1010290 1010340 1010412 1010507 1010560 1010711 1010140 1010191 1010241 1010291 1010341 1010413 1010508 1010561 1010712 1010141 1010192 1010242 1010292 1010342 1010414 1010509 1010562 1010713 1010142 1010193 1010243 1010293 1010343 1010415 1010510 1010563 1010714 1010143 1010194 1010244 1010294 1010344 1010416 1010511 1010564 1010715 1010144 1010195 1010245 1010295 1010345 1010417 1010512 1010565 1010716 1010146 1010196 1010246 1010296 1010346 1010425 1010513 1010566 1010717 1010147 1010197 1010247 1010297 1010347 1010428 1010515 1010567 1010718 1010148 1010198 1010248 1010298 1010348 1010441 1010516 1010568 1010719 1010149 1010199 1010249 1010299 1010349 1010461 1010517 1010569 1010720 1010150 1010200 1010250 1010300 1010350 1010465 1010518 1010570 1010721 1010151 1010201 1010251 1010301 1010351 1010466 1010520 1010571 1010722 1010152 1010202 1010252 1010302 1010352 1010468 1010521 1010572 1010723 1010153 1010203 1010253 1010303 1010353 1010469 1010522 1010575 1010724 1010154 1010204 1010254 1010304 1010354 1010470 1010523 1010576 1010725 1010155 1010205 1010255 1010305 1010355 1010471 1010524 1010577 1010726 1010156 1010206 1010256 1010306 1010356 1010472 1010525 1010578 1010727 1010157 1010207 1010257 1010307 1010357 1010473 1010526 1010579 1010728 1010158 1010208 1010258 1010308 1010358 1010475 1010527 1010615 1010729 1010159 1010209 1010259 1010309 1010359 1010476 1010528 1010629 1010730 1010160 1010210 1010260 1010310 1010360 1010477 1010529 1010632 1010731 1010161 1010211 1010261 1010311 1010361 1010478 1010530 1010633 1010732 1010162 1010212 1010262 1010312 1010362 1010479 1010531 1010646 1010733 1010163 1010213 1010263 1010313 1010363 1010480 1010532 1010651 1010734 1010164 1010214 1010264 1010314 1010364 1010481 1010533 1010652 1010735 1010165 1010215 1010265 1010315 1010365 1010482 1010534 1010661 1010736 1010737 1010787 1010837 1010888 1010938 1010989 1011039 1011109 1011163 1010738 1010788 1010838 1010889 1010939 1010990 1011040 1011110 1011164 1010739 1010789 1010839 1010890 1010940 1010991 1011041 1011111 1011165 1010740 1010790 1010840 1010891 1010941 1010992 1011042 1011112 1011166 1010741 1010791 1010841 1010892 1010942 1010993 1011043 1011113 1011167 1010742 1010792 1010842 1010893 1010943 1010994 1011044 1011114 1011168 1010743 1010793 1010843 1010894 1010944 1010995 1011045 1011115 1011169 1010744 1010794 1010844 1010895 1010945 1010996 1011048 1011116 1011172 1010745 1010795 1010845 1010896 1010946 1010997 1011052 1011117 1011173 1010746 1010796 1010846 1010897 1010947 1010998 1011053 1011118 1011174 1010747 1010797 1010847 1010898 1010948 1010999 1011057 1011119 1011175 1010748 1010798 1010848 1010899 1010949 1011000 1011070 1011120 1011176 1010749 1010799 1010849 1010900 1010950 1011001 1011071 1011121 1011177 1010750 1010800 1010850 1010901 1010951 1011002 1011072 1011122 1011178 1010751 1010801 1010851 1010902 1010952 1011003 1011073 1011123 1011179 1010752 1010802 1010852 1010903 1010953 1011004 1011074 1011124 1011180 1010753 1010803 1010853 1010904 1010954 1011005 1011075 1011125 1011181 1010754 1010804 1010854 1010905 1010955 1011006 1011076 1011126 1011182 1010755 1010805 1010855 1010906 1010956 1011007 1011077 1011127 1011183 1010756 1010806 1010856 1010907 1010957 1011008 1011078 1011128 1011184 1010757 1010807 1010857 1010908 1010958 1011009 1011079 1011129 1011185 1010758 1010808 1010858 1010909 1010959 1011010 1011080 1011130 1011186 1010759 1010809 1010859 1010910 1010960 1011011 1011081 1011131 1011187 1010760 1010810 1010860 1010911 1010961 1011012 1011082 1011132 1011188 1010761 1010811 1010861 1010912 1010962 1011013 1011083 1011133 1011189 1010762 1010812 1010862 1010913 1010963 1011014 1011084 1011134 1011190 1010763 1010813 1010863 1010914 1010964 1011015 1011085 1011135 1011191 1010764 1010814 1010864 1010915 1010965 1011016 1011086 1011136 1011192 1010765 1010815 1010865 1010916 1010966 1011017 1011087 1011137 1011193 1010766 1010816 1010866 1010917 1010967 1011018 1011088 1011138 1011194 1010767 1010817 1010867 1010918 1010968 1011019 1011089 1011139 1011195 1010768 1010818 1010868 1010919 1010970 1011020 1011090 1011140 1011196 1010769 1010819 1010869 1010920 1010971 1011021 1011091 1011142 1011197 1010770 1010820 1010870 1010921 1010972 1011022 1011092 1011143 1011198 1010771 1010821 1010871 1010922 1010973 1011023 1011093 1011144 1011199 1010772 1010822 1010872 1010923 1010974 1011024 1011094 1011145 1011200 1010773 1010823 1010873 1010924 1010975 1011025 1011095 1011146 1011201 1010774 1010824 1010874 1010925 1010976 1011026 1011096 1011147 1011202 1010775 1010825 1010875 1010926 1010977 1011027 1011097 1011148 1011203 1010776 1010826 1010876 1010927 1010978 1011028 1011098 1011149 1011204 1010777 1010827 1010877 1010928 1010979 1011029 1011099 1011150 1011205 1010778 1010828 1010878 1010929 1010980 1011030 1011100 1011152 1011206 1010779 1010829 1010879 1010930 1010981 1011031 1011101 1011153 1011207 1010780 1010830 1010881 1010931 1010982 1011032 1011102 1011154 1011208 1010781 1010831 1010882 1010932 1010983 1011033 1011103 1011155 1011209 1010782 1010832 1010883 1010933 1010984 1011034 1011104 1011156 1011210 1010783 1010833 1010884 1010934 1010985 1011035 1011105 1011157 1011211 1010784 1010834 1010885 1010935 1010986 1011036 1011106 1011158 1011212 1010785 1010835 1010886 1010936 1010987 1011037 1011107 1011159 1011213 1010786 1010836 1010887 1010937 1010988 1011038 1011108 1011162 1011214 1011215 1011266 1011319 1011373 1011428 1011488 1011588 1011690 1011740 1011216 1011267 1011320 1011374 1011430 1011489 1011589 1011691 1011741 1011217 1011268 1011321 1011377 1011431 1011490 1011641 1011692 1011742 1011218 1011269 1011322 1011378 1011432 1011491 1011642 1011693 1011743 1011219 1011270 1011323 1011379 1011433 1011492 1011643 1011694 1011744 1011220 1011271 1011324 1011380 1011434 1011493 1011644 1011695 1011745 1011221 1011272 1011325 1011381 1011435 1011494 1011645 1011696 1011746 1011222 1011273 1011326 1011382 1011436 1011495 1011646 1011697 1011747 1011223 1011274 1011327 1011383 1011437 1011496 1011647 1011698 1011748 1011224 1011275 1011328 1011384 1011438 1011497 1011648 1011699 1011749 1011225 1011276 1011329 1011385 1011439 1011498 1011649 1011700 1011750 1011226 1011277 1011330 1011386 1011440 1011499 1011650 1011701 1011751 1011227 1011278 1011331 1011387 1011441 1011500 1011651 1011702 1011752 1011228 1011279 1011332 1011388 1011442 1011501 1011652 1011703 1011753 1011229 1011280 1011333 1011389 1011443 1011502 1011653 1011704 1011754 1011230 1011281 1011334 1011390 1011453 1011503 1011654 1011705 1011755 1011231 1011282 1011335 1011391 1011454 1011504 1011655 1011706 1011756 1011232 1011283 1011336 1011392 1011455 1011505 1011657 1011707 1011757 1011233 1011287 1011337 1011393 1011456 1011506 1011658 1011708 1011758 1011234 1011288 1011338 1011394 1011457 1011507 1011659 1011709 1011759 1011235 1011289 1011339 1011395 1011458 1011508 1011660 1011710 1011760 1011236 1011290 1011340 1011396 1011459 1011509 1011661 1011711 1011761 1011237 1011291 1011343 1011398 1011460 1011510 1011662 1011712 1011762 1011238 1011292 1011344 1011399 1011461 1011511 1011663 1011713 1011763 1011239 1011293 1011345 1011400 1011462 1011512 1011664 1011714 1011764 1011240 1011294 1011346 1011401 1011463 1011513 1011665 1011715 1011765 1011241 1011295 1011348 1011402 1011464 1011514 1011666 1011716 1011766 1011242 1011296 1011349 1011403 1011465 1011565 1011667 1011717 1011767 1011243 1011297 1011350 1011404 1011466 1011566 1011668 1011718 1011768 1011244 1011298 1011351 1011405 1011467 1011567 1011669 1011719 1011769 1011245 1011299 1011352 1011406 1011468 1011568 1011670 1011720 1011770 1011246 1011300 1011353 1011407 1011469 1011569 1011671 1011721 1011771 1011247 1011301 1011354 1011408 1011470 1011570 1011672 1011722 1011772 1011248 1011302 1011355 1011410 1011471 1011571 1011673 1011723 1011773 1011249 1011303 1011356 1011411 1011472 1011572 1011674 1011724 1011774 1011250 1011304 1011357 1011412 1011473 1011573 1011675 1011725 1011775 1011251 1011305 1011358 1011413 1011474 1011574 1011676 1011726 1011776 1011252 1011306 1011359 1011414 1011475 1011575 1011677 1011727 1011777 1011253 1011307 1011360 1011416 1011476 1011576 1011678 1011728 1011778 1011254 1011308 1011362 1011417 1011477 1011577 1011679 1011729 1011779 1011255 1011309 1011363 1011418 1011478 1011578 1011680 1011730 1011780 1011256 1011310 1011364 1011419 1011479 1011579 1011681 1011731 1011781 1011258 1011311 1011365 1011420 1011480 1011580 1011682 1011732 1011782 1011259 1011312 1011366 1011421 1011481 1011581 1011683 1011733 1011783 1011260 1011313 1011367 1011422 1011482 1011582 1011684 1011734 1011784 1011261 1011314 1011368 1011423 1011483 1011583 1011685 1011735 1011785 1011262 1011315 1011369 1011424 1011484 1011584 1011686 1011736 1011786 1011263 1011316 1011370 1011425 1011485 1011585 1011687 1011737 1011787 1011264 1011317 1011371 1011426 1011486 1011586 1011688 1011738 1011788 1011265 1011318 1011372 1011427 1011487 1011587 1011689 1011739 1011789 1011790 1011840 1011890 1011940 1011990 1012041 1012091 1012141 1012191 1011791 1011841 1011891 1011941 1011991 1012042 1012092 1012142 1012192 1011792 1011842 1011892 1011942 1011992 1012043 1012093 1012143 1012193 1011793 1011843 1011893 1011943 1011993 1012044 1012094 1012144 1012194 1011794 1011844 1011894 1011944 1011995 1012045 1012095 1012145 1012195 1011795 1011845 1011895 1011945 1011996 1012046 1012096 1012146 1012196 1011796 1011846 1011896 1011946 1011997 1012047 1012097 1012147 1012197 1011797 1011847 1011897 1011947 1011998 1012048 1012098 1012148 1012198 1011798 1011848 1011898 1011948 1011999 1012049 1012099 1012149 1012199 1011799 1011849 1011899 1011949 1012000 1012050 1012100 1012150 1012200 1011800 1011850 1011900 1011950 1012001 1012051 1012101 1012151 1012201 1011801 1011851 1011901 1011951 1012002 1012052 1012102 1012152 1012202 1011802 1011852 1011902 1011952 1012003 1012053 1012103 1012153 1012203 1011803 1011853 1011903 1011953 1012004 1012054 1012104 1012154 1012204 1011804 1011854 1011904 1011954 1012005 1012055 1012105 1012155 1012205 1011805 1011855 1011905 1011955 1012006 1012056 1012106 1012156 1012206 1011806 1011856 1011906 1011956 1012007 1012057 1012107 1012157 1012207 1011807 1011857 1011907 1011957 1012008 1012058 1012108 1012158 1012208 1011808 1011858 1011908 1011958 1012009 1012059 1012109 1012159 1012209 1011809 1011859 1011909 1011959 1012010 1012060 1012110 1012160 1012210 1011810 1011860 1011910 1011960 1012011 1012061 1012111 1012161 1012211 1011811 1011861 1011911 1011961 1012012 1012062 1012112 1012162 1012212 1011812 1011862 1011912 1011962 1012013 1012063 1012113 1012163 1012213 1011813 1011863 1011913 1011963 1012014 1012064 1012114 1012164 1012214 1011814 1011864 1011914 1011964 1012015 1012065 1012115 1012165 1012215 1011815 1011865 1011915 1011965 1012016 1012066 1012116 1012166 1012216 1011816 1011866 1011916 1011966 1012017 1012067 1012117 1012167 1012217 1011817 1011867 1011917 1011967 1012018 1012068 1012118 1012168 1012218 1011818 1011868 1011918 1011968 1012019 1012069 1012119 1012169 1012219 1011819 1011869 1011919 1011969 1012020 1012070 1012120 1012170 1012220 1011820 1011870 1011920 1011970 1012021 1012071 1012121 1012171 1012221 1011821 1011871 1011921 1011971 1012022 1012072 1012122 1012172 1012222 1011822 1011872 1011922 1011972 1012023 1012073 1012123 1012173 1012223 1011823 1011873 1011923 1011973 1012024 1012074 1012124 1012174 1012224 1011824 1011874 1011924 1011974 1012025 1012075 1012125 1012175 1012225 1011825 1011875 1011925 1011975 1012026 1012076 1012126 1012176 1012226 1011826 1011876 1011926 1011976 1012027 1012077 1012127 1012177 1012227 1011827 1011877 1011927 1011977 1012028 1012078 1012128 1012178 1012228 1011828 1011878 1011928 1011978 1012029 1012079 1012129 1012179 1012229 1011829 1011879 1011929 1011979 1012030 1012080 1012130 1012180 1012230 1011830 1011880 1011930 1011980 1012031 1012081 1012131 1012181 1012231 1011831 1011881 1011931 1011981 1012032 1012082 1012132 1012182 1012232 1011832 1011882 1011932 1011982 1012033 1012083 1012133 1012183 1012233 1011833 1011883 1011933 1011983 1012034 1012084 1012134 1012184 1012234 1011834 1011884 1011934 1011984 1012035 1012085 1012135 1012185 1012235 1011835 1011885 1011935 1011985 1012036 1012086 1012136 1012186 1012236 1011836 1011886 1011936 1011986 1012037 1012087 1012137 1012187 1012237 1011837 1011887 1011937 1011987 1012038 1012088 1012138 1012188 1012238 1011838 1011888 1011938 1011988 1012039 1012089 1012139 1012189 1012239 1011839 1011889 1011939 1011989 1012040 1012090 1012140 1012190 1012240 1012241 1012298 1012242 1012299 1012243 1012244 1012245 1012246 1012247 1012248 1012249 1012250 1012251 1012252 1012254 1012257 1012258 1012259 1012260 1012261 1012262 1012263 1012265 1012266 1012267 1012269 1012270 1012271 1012272 1012273 1012274 1012275 1012276 1012277 1012278 1012279 1012280 1012281 1012282 1012283 1012285 1012286 1012287 1012288 1012289 1012290 1012291 1012292 1012293 1012294 1012295 1012296 21-2111-0100-51 1007190 1012419 1012469 1012586 1012639 1012689 1012367 1012420 1012470 1012588 1012640 1012691 1012368 1012421 1012471 1012589 1012641 1012694 1012369 1012422 1012472 1012590 1012642 1012695 1012370 1012423 1012473 1012591 1012643 1012696 1012371 1012424 1012474 1012592 1012644 1012698 1012372 1012425 1012475 1012593 1012645 1012699 1012373 1012426 1012476 1012594 1012646 1012701 1012374 1012428 1012477 1012595 1012648 1012702 1012375 1012429 1012492 1012596 1012649 1012703 1012376 1012430 1012505 1012597 1012650 1012704 1012378 1012431 1012545 1012598 1012651 1012379 1012432 1012546 1012599 1012652 1012380 1012433 1012547 1012600 1012653 1012381 1012434 1012548 1012601 1012654 1012382 1012435 1012549 1012602 1012655 1012383 1012436 1012550 1012603 1012656 1012384 1012438 1012551 1012604 1012657 1012385 1012439 1012553 1012605 1012658 1012386 1012440 1012554 1012606 1012659 1012387 1012441 1012555 1012607 1012660 1012389 1012442 1012556 1012608 1012661 1012390 1012443 1012557 1012609 1012662 1012391 1012444 1012558 1012610 1012663 1012393 1012445 1012559 1012611 1012664 1012394 1012446 1012561 1012614 1012665 1012395 1012447 1012562 1012616 1012666 1012396 1012448 1012563 1012617 1012668 1012397 1012449 1012564 1012618 1012669 1012398 1012450 1012565 1012619 1012670 1012399 1012451 1012566 1012620 1012671 1012402 1012452 1012567 1012621 1012672 1012403 1012453 1012568 1012622 1012673 1012404 1012454 1012569 1012623 1012674 1012405 1012455 1012570 1012624 1012675 1012406 1012456 1012572 1012625 1012676 1012407 1012457 1012573 1012626 1012677 1012408 1012458 1012574 1012628 1012678 1012409 1012459 1012575 1012629 1012679 1012410 1012460 1012576 1012630 1012680 1012411 1012461 1012577 1012631 1012681 1012412 1012462 1012578 1012632 1012682 1012413 1012463 1012579 1012633 1012683 1012414 1012464 1012580 1012634 1012684 1012415 1012465 1012581 1012635 1012685 1012416 1012466 1012582 1012636 1012686 1012417 1012467 1012583 1012637 1012687 1012418 1012468 1012584 1012638 1012688 SERIAL NUMBER LIST OUS 21-2101-0100-50 1010679 1010670 1011550 1010680 1010671 1011551 1010681 1010672 1011552 1010682 1010673 1011553 1010684 1010674 1011554 1010685 1011515 1011555 1010686 1011516 1011556 1010687 1011517 1011557 1010688 1011518 1011558 1010437 1011519 1011559 1010634 1011520 1011560 1010635 1011521 1011561 1010636 1011522 1011562 1010637 1011523 1011563 1010638 1011524 1010639 1011525 1010640 1011526 1010641 1011527 1010642 1011528 1010643 1011529 1010644 1011530 1010645 1011531 1010647 1011533 1010648 1011534 1010649 1011535 1010650 1011536 1010653 1011537 1010654 1011538 1010655 1011539 1010656 1011540 1010657 1011541 1010658 1011542 1010659 1011543 1010660 1011544 1010662 1011546 1010663 1011547 1010665 1011548 1010666 1011549 21-2101-0200-02 1010432 1010421 1010435 1010436 1010438 1010439 1010440 1010433 1010434 21-2101-0200-03 1010380 1010382 1010375 1010376 1010377 1010378 1010379 1010384 1010385 1010370 1010371 1010372 1010374 21-2101-51 1010048 1007645 1007674 1010089 1007646 1007675 1010117 1007647 1007676 1010125 1007184 1007677 1010145 1007187 1007678 1011257 1007163 1007679 1007182 1007164 1007680 1007169 1007118 1007681 1007170 1007129 1007682 1007171 1007162 1007683 1007172 1007649 1007684 1007173 1007651 1007685 1007175 1007652 1007686 1007176 1007653 1007687 1007631 1007654 1007688 1007633 1007655 1007690 1007642 1007657 1007691 1007165 1007658 1007692 1007166 1007659 1007693 1007167 1007660 1007694 1007168 1007661 1007695 1007177 1007663 1007696 1007178 1007664 1007697 1007180 1007665 1007698 1007181 1007667 1007699 1007183 1007669 1007700 1007643 1007672 1007701 1007644 1007673 1007702 21-2111-0200-02 1012480 1012481 1012482 1012483 1012484 1012485 1012486 1012487 1012488 1012489 1012490 1012491 1012493 1012494 1012495 1012496 1012497 1012498 1012499 1012500 1012501 1012502 1012503 21-2102-51 1007140 1007142 1007143
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc., Saint Paul, MN, by letter dated January 13, 2011. Firm initiated recall is ongoing. 
REASON
Smiths Medical is conducting a voluntary correction of a limited number of CADD�-Solis Ambulatory Infusion Pumps. This voluntary correction is being conducted with the knowledge of the relevant Regulatory Agencies. Smiths Medical has become aware of an increased trend in reports of the Cassette Lock mechanism on certain CADD�-Solis Pumps becoming stuck in the locked position, making it nearly impossible to remove the medication cassette reservoirs (or administration set). The purpose of the Cassette Lock is to secure the medication cassette reservoir (or administration set) to the pump.
VOLUME OF PRODUCT IN COMMERCE
2,903 (2539 Nationwide; 364 Internationally)
DISTRIBUTION
Nationwide, Australia, Austria, Belgium, Canada, France, Germany, Great Britain, Ireland, Italy, Luxembourg, New Zealand, Qatar, Saudi Arabia, Switzerland and The Netherlands

___________________________________
PRODUCT
1) Catheter Insertion Kit, REF: 6100A, Latex Free, Sterile. Intended use: Kit components to be used during Intermittent Urinary Catheterizations. Catalog number: 6100A. Recall # Z-1034-2011;

2) Irrigation Kit, Large, Latex, REF: 6111. Intended use: Kit components to be used during Intermittent Urinary Catheterizations. Catalog number: 6111. Recall # Z-1035-2011;

3) Irrigation Kit, Medium, Latex, REF: 6112. Intended use: Kit components to be used during Intermittent Urinary Catheterizations. Catalog number: 6112. Recall # Z-1036-2011;

4) Irrigation Kit, Small, Latex, REF: 6113. Intended use: Kit components to be used during Intermittent Urinary Catheterizations. Catalog number: 6113. Recall # Z-1037-2011;

5) Irrigation Kit, Large, Vinyl, REF: 6114. Intended use: Kit components to be used during Intermittent Urinary Catheterizations. Catalog number: 6114. Recall # Z-1038-2011;

6) Irrigation Kit, Medium, Vinyl, REF: 6115. Intended use: Kit components to be used during Intermittent Urinary Catheterizations. Catalog number: 6115. Recall # Z-1039-2011;

7) Irrigation Kit, Small, Vinyl, REF: 6116. Intended use: Kit components to be used during Intermittent Urinary Catheterizations. Catalog number: 6115. Recall # Z-1040-2011
CODE
1) Lot numbers: 11027, 11119, 11262, 11414, 11695, 11882, 12114, 12271, 12586, 12888, 13080, 13316, 13527, 13548, 13736, 13979, 14091, 14093, 14457, 14732, 14945, 14946, 15781, 15989, 16414, 16424, 16633, 16882, 17016, 17381, 17574, 17576, 17956, 18127, 18475, 19450, 19557, 11120, 11263, 11415, 11696, 11881, 12115, 12272, 12635, 12955, 13199, 13547, 13737, 14092, 14944, 14949, 15988, 16183, 16425, 16883, 17380, 17575, 17957, 18477, 18909, 19556, 19760, 11264, 11416, 12273, 13273, 14094, 11121, 11265, 11417, 11697, 11883, 12274, 12621, 12768, 13006, 13315, 13318, 13549, 13739, 14095, 14947, 15782, 15990, 17017, 17382, 17730, 18476, 18910, 19555, 19759, 20021, 11266, 11418, 12116, 12275, 12769, 13158, 13317, 13550, 13738, 14948, 15783, 15991, 16884, 17383, 17958, 18911, 19761, 11267, 11419, 12622;

2) Lot numbers: 11027, 11119, 11262, 11414, 11695, 11882, 12114, 12271, 12586, 12888, 13080, 13316, 13527, 13548, 13736, 13979, 14091, 14093, 14457, 14732, 14945, 14946, 15781, 15989, 16414, 16424, 16633, 16882, 17016, 17381, 17574, 17576, 17956, 18127, 18475, 19450, 19557;

3) Lot numbers: 11120, 11263, 11415, 11696, 11881, 12115, 12272, 12635, 12955, 13199, 13547, 13737, 14092, 14944, 14949, 15988, 16183, 16425, 16883, 17380, 17575, 17957, 18477, 18909, 19556, 19760;

4) Lot numbers: 11264, 11416, 12273, 13273, 14094;

5) Lot numbers: 11121, 11265, 11417, 11697, 11883, 12274, 12621, 12768, 13006, 13315, 13318, 13549, 13739, 14095, 14947, 15782, 15990, 17017, 17382, 17730, 18476, 18910, 19555, 19759, 20021;

6) Lot numbers: 11266, 11418, 12116, 12275, 12769, 13158, 13317, 13550, 13738, 14948, 15783, 15991, 16884, 17383, 17958, 18911, 19761;

7) Lot numbers: 11267, 11419, 12622
RECALLING FIRM/MANUFACTURER
Apogee Medical, Youngsville, NC, by letter dated January 18, 2010. Firm initiated recall is ongoing.
REASON
This recall has been initiated due to concerns expressed by the Food and Drug Administration regarding the validation of the gamma radiation sterilization cycles for these products of Sterile Lubricating Jelly.
VOLUME OF PRODUCT IN COMMERCE
4,548,013 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Vertex Max Drill Tube, Catalog Number 9733140, a component of the Navigated Vertex Max Drill Guide Kit, Catalog Number 9733370. Used in conjunction with the StealthStation navigation systems to assist in screw placement during spine surgery. Recall # Z-1042-2011
CODE
Lot number: 100721
RECALLING FIRM/MANUFACTURER
Medtronic Navigation, Inc., Louisville, CA, by letter on December 15, 2010.  Firm initiated recall is ongoing.
REASON
Incorrectly manufactured drill tube could cause incorrect screw placement during spinal surgery.
VOLUME OF PRODUCT IN COMMERCE
15 devices
DISTRIBUTION
GA, IL, IN, MN, MO, OH, OR, PA, TX and Denmark, Finland, Singapore, Spain, and UK

END OF ENFORCEMENT REPORT FOR FEBRUARY 9, 2011

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