• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Enforcement Report for June 16, 2010

June 16, 2010                                                                                        10-23

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II
_______________________________ 
PRODUCT 
Saladitos (Salted Dried Prunes) in 35.2 lb bulk cases. Recall # F-2230-2010
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Chia I Foods Co. Ltd., City of Industry, CA, by letter dated December 2, 2009.
Manufacturer: Dong Bou Foodstuff Industrial Co., Ltd., Xinxing, China. California initiated recall is ongoing.
REASON
The product contains elevated levels of lead.
VOLUME OF PRODUCT IN COMMERCE
629 cases
DISTRIBUTION
Unknown. Distribution records not retained.
___________________________________
PRODUCT 
Torn & Glasser Saladitos Dried Prunes; Product was in a cardboard box on which was affixed a white sticker with black print that read in part ***#220-290 Saladitos Dried Prunes. Ingredients: Dried Plums & Salt. Net Wt. 10 lb***3389. Recall # F-2231-2010
CODE
Julian Code (2748-2749)
RECALLING FIRM/MANUFACTURER
Torn and Glasser, Inc., East Rancho Dominguez, CA, by fax dated October 13, 2009.  Texas initiated recall is ongoing. 
REASON
The product contains elevated levels of lead.
VOLUME OF PRODUCT IN COMMERCE
150 cartons
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS III
___________________________________
PRODUCT 
Front Panel 1lb Can: Crab Meat Pasteurized Net Wt. 17 oz. (1 lb.) AVOIR. Side Panel 1lb Can: Wild Caught; Hand Picked Perishable Keep Constantly Refrigerated at 32F Sealed-To retain its delicious flavor. Pasteurized-T retains its freshness, Product of Venezuela. Unopened-In A modern refrigerator, this can of crab meat can be kept several weeks. Opened-if covered and returned immediately to the refrigerator this can of crab meat can be kept several days. Top of 1 lb Can - Stick on Label: Pasteurized Crab Meat Wild Caught, FACTOR IAS DEL L AGO, C.A.P. CLAW Sea Star, Net Wt. 16 oz (1 lb.) AVOIR. Product of Venezuela. USPC 7 594003 460044 Top of 1lb Can - without stick on label: Pasteurized Crab Meat Sea Star Crab Meat Back Fin Codema UPC 7 594003 460037. Recall # F-2227-2010
CODE
Lot 94045
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kingmar Seafood Corp., Miami, FL, by fax on April 27, 2010.
Manufacturer: FACTORIA DEL LAGO C.A., MARACAIBO, Venezuela. Firm initiated recall is ongoing.
REASON
Kingmar Seafood Corporation, Miami, FL has recalled SEASTAR Brand Pasteurized Claw Crab Meat, 1lb cans for decomposition.
VOLUME OF PRODUCT IN COMMERCE
42 cartons
DISTRIBUTION
PR

___________________________________
PRODUCT 
Quesos La Ricura brand Chunky Cheese, Net Wt. 16 oz. (454g), UPC 7 69087 00002 9 --- Ingredients: Pasteurized Milk, Lactic Cultures, Salt, Calcium Chloride, Rennet. The cheese is packaged in flexible plastic bags. This is a fresh cheese which is brined. NOTE: The product is labeled in English on one side as "Chunky Cheese" and in Spanish on the back as "Cuajada en Terron". A small white stick-on label is placed on the product with the Sell By (expiration) date code. Recall # F-2228-2010
CODE
SELL BY JUN 05 2010 (expiration date) 5
RECALLING FIRM/MANUFACTURER
Quesos La Ricura Ltd., Hicksville, NY, by telephone and fax on April 8, 2010. New York initiated recall is ongoing.
REASON
Positive phosphatase finding in Chunky Cheese based on sampling and analysis by New York State Department of Agriculture & Markets' Division of Milk Control and Dairy Services. This is indicative of improper pasteurization.
VOLUME OF PRODUCT IN COMMERCE
1512 lbs. (total of 42 crates, 36 lbs. per crate, 16 oz. bags)
DISTRIBUTION
FL, TX, CA
___________________________________
PRODUCT 
Aquacare H2O, 8 oz. (237 ml), Nectar Consistency, Thickened Water. Product is Pasteurized Refrigerate After Opening. Use Product within 14 days after opening. Taste Life Again, Aquacare H2O, 8 oz. (237 ml), Honey Consistency, Thickened Water. Product is Pasteurized Refrigerate After Opening. Use Product within 14 days after opening. Recall # F-2229-2010
CODE
Units: CSI120909A, CSI020810A, CSI021510A, CSI021810A
RECALLING FIRM/MANUFACTURER
Clearly Superior, Inc., Superior, WI, by letter dated April 1, 2010. Firm initiated recall is ongoing.
REASON
Clearly Superior, Inc., is reporting that some 8 oz bottles of AquaCare H2O, thickened water, both honey and nectar consistency were found to contain non-hazardous spoilage mold.
VOLUME OF PRODUCT IN COMMERCE
98 cases (24-8 oz bottles per case)
DISTRIBUTION
IL

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II
___________________________________
PRODUCT 
1) Tylenol Extra Strength Caplets (acetaminophen) 500 mg, a) 24 count bottle (NDC 50580-449-05, UPC #300450449054); b) 24+12 count bottle (NDC 50580-449-31, UPC #300450444318); c) 50 count bottle (NDC 50580-449-07, UPC #300450449078); d) 50 count bottle (NDC 50580-451-50, UPC #350580451502); e) 50+25 count bottle (NDC50580-449-75, UPC #300450444752); f) 100 count bottle (NDC 50580-449-09, UPC #300450449092); g) 100+25 count bottle (NDC 50580-49-00, UPC #300450449009); h) 150 count bottle (NDC 50580-449-23, UPC #300450449238); i) 150+50 count bottle (NDC 50580-449-46, UPC 300450449467); j) 225 count bottle (NDC 50580-449-27, UPC #300450444271); k) 325 count bottle (NDC 50580-449-32, UPC #300450444325). Recall # D-560-2010;

2) Tylenol Extra Strength Cool Caplets, (acetaminophen), 500 mg, a) 50 count bottle (NDC 50580-710-50, UPC #300450444509); b) 100 count bottle (NDC 50580-710-10, UPC #300450444103). Recall # D-561-2010;

3) Tylenol Extra Strength EZ Tabs, (acetaminophen), 500 mg each, a) 24 count bottle (NDC 50580-422-24, UPC #300450422248); b) 50 count bottle (NDC 50580-422-50, UPC #300450422507); c) 50+25 count bottle (NDC 50580-422-75, UPC #300450422750). Recall # D-562-2010;

4) Tylenol Extra Strength Rapid Release Gels (acetaminophen) 500 mg, a) 24 count bottles (NDC 50580-488-24, UPC #300450488244); b) 50 count bottles (NDC 50580-488-50, UPC #300450488503); c) 100+20 count bottles (NDC 50580-488-20, UPC #300450488176); d) 150 count bottles (NDC 50580-488-15, UPC #300450488152); e) 290 count bottles (NASCAR NDC 50580-488-29, UPC #300450488299); f) 290 count bottles (NDC 50580-488-29, UPC #300450488213). Recall # D-563-2010;

5) Tylenol Extra Strength Tablets, (acetaminophen), 500 mg each, Crushable, Dye Free, 60 count, NDC 50580-499-68, UPC #300450499684. Recall # D-564-2010;

6) Tylenol Caplets (acetaminophen), 325 mg each, 50 count bottles, (NDC 50580-501-50, UPC #350580501504), NSN 6505-01-017-1625 - For Hospital and Government Use Only. Recall D-565-2010;

7) Tylenol Regular Strength Tablets (acetaminophen), 325 mg, 100 count bottle (NDC 50580-496-60, UPC #300450496607). Recall # D-566-2010;

8) Tylenol 8HR Extended Release Caplets, (acetaminophen), 650 mg each, Capsule-Shaped Bi-Layer Tablets, a) 24 count (NDC 50580-297-24, UPC 300450297266); b) 100 count bottles (NDC 50580-297-10, UPC #300450297112). Recall # D-567-2010;

9) Tylenol 8 Hour Extended Release Caplets, (acetaminophen), 650 mg each, 24 count bottles, NDC 50580-297-24, UPC #300450297242, Capsule Shaped Tablets. Recall # D-568-2010;

10) Tylenol Arthritis Pain Extended Release Caplets, (acetaminophen), 650 mg each, 2) 50 count bottles (NDC 50580-112-50, UPC #300450838506); b) 150 count bottles (NDC 50580-112-15, UPC #300450838155); c) 225 count bottles (NDC 50580-112-37, UPC #300450838377); d) 290 count bottles (NDC 50580-112-29, UPC #300450838292). Recall # D-569-2010;

11) Tylenol PM Extra Strength Caplets (acetaminophen 500 mg and diphenhydramine HCl 25 mg), a) 24 count bottles (NDC 50580-482-24, UPC #300450482242); b) 24+12 count bottles (NDC 50580-482-31, UPC #300450482310); c) 50 count bottles (NDC 50580-482-50, UPC #300450482501); d) 100 count bottles (NDC 50580-482-10, UPC #300450482105); e) 100+20 count bottles, (NDC 50580-482-13, UPC #300450482136); f) 150 count (NDC 50580-482-15, UPC #300450482150); g) 225 count bottles (NDC 50580-482-35, UPC #300450482358). Recall # D-570-2010;

12) Tylenol PM Extra Strength Geltabs, (acetaminophen 500 mg and diphenhydramine HCl 25 mg), a) 24 count bottles, (NDC 50580-176-24, UPC #300450176240); b) 50 count bottles, (NDC 50580-176-50, UPC #300450176509); and c) 50+20 count bottles (NDC 50580-176-70, UPC #300450176707). Recall # D-571-2010;

13) Tylenol PM Extra Strength Rapid Release Gelcaps (acetaminophen 500 mg and diphenhydramine HCl 25 mg), a) 20 count bottles (NDC 50580-244-20, UPC #300450244208); b) 40 count bottles (NDC 50580-244-40, UPC #300450244406). Recall # D-572-201;

14) Children's Tylenol Meltaways, (acetaminophen) 80 mg, 30 count bottles, Bubblegum Burst flavor, NDC 50580-519-30, UPC #300450519306. Recall # D-573-2010;

15) Children's Tylenol Meltaways, (acetaminophen), 80 mg, 30 count bottles, Grape flavor. Recall # D-574-2010;

16) Tylenol Day & Night Value Pack contains Tylenol Extra Strength Caplets (acetaminophen 500 mg) 50 count bottle and Tylenol PM Caplets (acetaminophen 500 mg and diphenhydramine HCl 25 mg) 24 count bottle, (NDC 50580-527-10, UPC #300450527103). Recall # D-575-2010;

17) Tylenol Arthritis Pain Extended Release Geltabs, (acetaminophen), 650 mg, a) 20 count bottles (NDC 50580-292-20, UPC #300450292209); b) 40 count bottles (NDC 50580-292-40, UPC #300450292407); and c) 80 count bottles (NDC 50580-292-80, UPC #300450292803). Recall # D-576-2010
CODE
1) Lots: a) AAA408, ABA169, ABA568, ADA192, AHA048, and AJA145; b) ABA565, AHA040, and AJA028; c) AJA021, AFA176, AFA325, AHA072, and AEA206; d) 24862, 24881, 24901, 24970, 25994, 26054, 26213, 26305, 26356, 26377, 26515, and 26541; e) ACA599, and ACA755; f) AMA008, SSA013, and SSA150; g) SDA203, and SHA035; h) AAA419, SPA007, and SEA199; i) SFA071; j) SSA011; k) SPA005, SPA058, SFA295, 09BMC018,09CMC048, 09FMC082, 09FMC084, AAA405,ADA014, ADA087,ADA270, ADA271,ADA417, AEA348, AFA102, AJA045, ALA028, SFA179, SFA237, SFA295, SHA002, SJA025, SJA189, SJA232, SLA004, SLA160, SLA296, SMA173, SMA174, SSA055, SPA038, and SPA386;

2) Lots: a) ABA029, ACA563, ADA190, AHA081, AJA095 and AJA175; b) ALA249;

3) Lots: a) ABA154, ADA193, AFA243 and AHA039; b) ADA013, AEA259, AHA091, AJA010 and AJA123; c) ACA562, ACA743 and ALA173;

4) Lots: a) ABA020, ABA371, ADA280, and AHA082; b) ACA451, AEA061, AEA244, AFA103, AFA240, AHA046, AGA080, AJA040, and AJA041; c) ALA253, and AMA015; d) ASA015; e) (NASCAR) SEA191, SEA192, SFA025, SFA026, SFA136, SLA052, and SLA198; f) 09AMC008, AAA049, AAA360, ADA022, ADA178, ADA272, ADA482, AEA194, AFA010, AFA292, AHA035, AHA089, AJA167, ALA095, ALA096, SFA296, SHA039, SHA234, SLA270, SMA236, SPA037, SPA357, SSA019, SSA030, and SSA054;

5) Lot AEA243;

6) Lots: 24777, Exp 10/31/2010; 24900, Exp 12/31/2010; 24971, Exp 03/31/2011; 25971, Exp 06/30/2011; 26019, Exp 07/31/2011; 26133, Exp 09/30/2011; 26271, Exp 01/31/2012; 26422, Exp 03/31/2012; 26482, Exp 03/31/2012; and 26521, Exp 07/31/2012;

7) Lots: ABA148, Exp 10/31/2012; ABA266, Exp 10/31/2012; ABA373, Exp 11/30/2012; ACA432, Exp 01/31/2013; AFA101, Exp 04/30/2013; AHA070, Exp 05/31/2013; AJA009, Exp 06/30/2013; ALA099, Exp 05/31/2013; and AMA018, Exp 07/31/2013;

8) Lots: a) ASM379, Exp 09/30/2012; AMM322, Exp 12/31/2011; ALM325, Exp 06/30/2012; AEM105, Exp 04/30/2012; AEM087, Exp 04/30/2012; ADM031, Exp 02/29/2012; and ACM056, Exp 02/28/2012; and b) ACM037, Exp 01/31/2012; AFM351, Exp 04/30/2012; AHM316, Exp 05/31/2012; AHM376, Exp 06/30/2012; AHM422, Exp 06/30/2012; ALM388, Exp 06/30/2012; ALM458, Exp 06/30/2012; AMM368, Exp 09/30/2012; and AMM435, Exp 09/30/2012;

9) Lot: ADM032, Exp 12/31/2011;

10) Lots: a) 08KMC123, Exp 08/31/2011; and 09DMC066, Exp 01/31/2012; b) 09GMC101, Exp 04/30/2012; 09XMC114, Exp 07/31/2012; 09XMC116, Exp 05/31/2012; ASA065, Exp 09/30/2012; and ASA304, Exp 10/31/2012; c) 07BMC009, Exp 12/31/2009; 07EMC027, Exp 02/28/2010; 09EMC073, Exp 02/28/2012; 09HMC108, Exp 02/29/2012; ASA088, Exp 07/31/2012; ASA119, Exp 09/30/2012; and ASA293, Exp 07/31/2012; d) AEA180, Exp 02/28/2011; AHA076, Exp 04/30/2012; AHA077, Exp 04/30/2012; AJA019, Exp 06/30/2012; AJA116, Exp 05/31/2012; AJA117, Exp 05/31/2012; ALA029, Exp 06/30/2012; AMA025, Exp 07/31/2012; AMA270, Exp 08/31/2012; APA011, Exp 09/30/2012; APA214, Exp 09/30/2012; and APA266, Exp 10/31/2012;

11) Lots: a) AJA026, Exp 06/30/2011; ABA021, Exp 11/30/2010; ABA368, Exp 11/30/2010; and AJA025, Exp 11/31/2011; b) AJA027, Exp 05/31/2011; c) AFA005, Exp 04/30/2011; AFA280, Exp 03/31/2011; AFA289, Exp 04/30/2011; and AFA357, Exp 03/31/2011; d) AJA174, Exp 06/30/2011; and ALA250, Exp 08/31/2011; e) ALA251, Exp 08/31/2011; f) SEA188, Exp 01/31/2010; g) ABA415, Exp 11/30/2010; ACA033, Exp 12/31/2010; ACA440, Exp 12/31/2010; ACA441, Exp 12/31/2010; ADA179, Exp 02/28/2011; ADA418, Exp 02/28/2011; AEA073, Exp 03/31/2011; AFA278, Exp 04/30/2011; AFA319, Exp 04/30/2011; AHA067, Exp 04/30/2011; AJA181, Exp 06/30/2011; ALA255, Exp 08/31/2011; AMA053, Exp 08/31/2011; AMA176, Exp 08/31/2011; AMA349, Exp 09/30/2011; APA010, Exp 09/30/2011; APA216, Exp 10/31/2011; SFA084, Exp 04/30/2011; SHA044, Exp 04/30/2011; SHA157, Exp 05/31/2011; SHA230, Exp 05/31/2011; SJA026, Exp 05/31/2011; SLA050, Exp 07/31/2011; SLA272, Exp 07/31/2011; SMA081, Exp 07/31/2011; and SSA158, Exp 09/30/2010;

12) Lots: a) ABA001, Exp 11/30/2010; ABA370, Exp 11/30/2010; AFA310, Exp 05/31/2011; AHA083, Exp 05/31/2011; and AJA051, Exp 05/31/2011; b) AFA177 Exp 05/31/2011; and AFA326, 05/31/2011; c) AJA098, Exp 05/31/2011;

13) Lot: a) ABA002, Exp 11/30/2010; ABA265, Exp 11/30/2010; ADA281, Exp 02/28/2011; and AFA327, Exp 03/31/2011; b) ACA422, Exp 12/31/2010; AEA077, Exp 3/31/2011; AEA258, Exp 3/31/2011; AFA059, Exp 4/30/2011; AFA192, Exp 12/31/2010; AHA172, Exp 3/31/2011;

14) Lots: AHA069, Exp 04/30/2011 and SPA022, Exp 08/31/2010;

15) Lots: AHA023, Exp 03/31/2011 and AHA057, Exp 03/31/2011;

16) Lot: AFC005;

17) Lots: a) 09BMC031, Exp 12/31/2011; b) 08KMC130, Exp 08/31/2011 and 09BMC024 Exp 09/30/2011; c) ALM345, Exp 08/31/2012; APM305, Exp 9/30/2012; APM419, Exp 10/31/2012; ASM357, Exp 07/31/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: McNeil Consumer Healthcare, Div of McNeil-PPC, Inc., Fort Washington, PA, posted on website on November 6, 2009, by press release on December 18, 2009 and by letters on November 9, 2009, December 18, 2009 and January 15, 2010. 
Manufacturer: Mcneil Healthcare, LLC, Las Piedras, PR. Firm initiated recall is ongoing.
REASON
Chemical Contamination; presence of a chemical called 2,4,6-tribromoanisole.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide, Canada, Uruguay, Fiji, Dominican Republic, Trinidad, Guatemala, Jamaica, Guam, and UAE

___________________________________
PRODUCT 
Dolonox Compressed Medical Gas Mixture (50% Nitrous Oxide USP and 50% Oxygen USP) contained in a Size E steel compressed medical gas cylinder (2015 psig). Recall # D-589-2010
CODE
1) Serial number 309787C, Lot Number: N/A, No Exp. Date; 2) Serial Number ME14551, Lot Number: N/A, No Exp. Date; 3) Serial Number CCC0937914, Lot Number: N/A, No Exp. Date; 4) Serial Number 158050C, Lot Number: N/A, No Exp. Date
RECALLING FIRM/MANUFACTURER
Nitrox, Inc., Lynnwood, WA, by visit on April 19, 2010. Firm initiated recall is complete.
REASON
Marketed without an approved NDA/ANDA. The firm manufactured and distributed a compressed medical gas mixture. In addition, one cylinder lacked the labeling which identifies the gas contents as Dolonox as well as the directions for safe handling. The product was also manufactured with proper CGMP's in place.
VOLUME OF PRODUCT IN COMMERCE
Four size E steel cylinders, containing approximately 1400 psi of Dolonox
DISTRIBUTION
WA

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III
___________________________________
PRODUCT 
1) Oxcarbazepine tablets, 150 mg, 100 count bottles, Rx Only; NDC 68462-137-01. Batch numbers 02100198 and 02100199, Expiration 12/2011; 02100473, 01011474 and 02100481. Recall # D-587-2010;

2) Oxcarbazepine tablets, 300 mg, 100 count bottles, Rx Only; NDC 68462-138-01. Batch numbers 02100065, 02100084, 02100089, 02100109, 02100119, 02100141. Recall # D-588-2010
CODE
1) Expiration 1/2012;
2) Expiration 12/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Glenmark Pharmaceuticals Inc., Mahwah, NJ, by letters on April 15, 2010.
Manufacturer: Glenmark Generics Ltd., Covale-Bardex, India. Firm initiated recall is ongoing.
REASON
Incorrect or Missing Package Insert: a typographical error was found in the "How Supplied" section of the package outsert, showing the wrong imprint description for 150mg, 300mg and 600mg tabs.
VOLUME OF PRODUCT IN COMMERCE
90840 x 100 count bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II 
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1381-10
CODE
Unit: 72M595038
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc - Birmingham Region, Birmingham, AL, by fax on December 31, 2009. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1383-10
CODE
Unit: 03GE22792
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA, by letter December 09, 2009. 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
IL, GA  
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1385-10
CODE
Unit: 72M644166
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Huntsville, AL, by fax on January 26, 2010. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1386-10
CODE
Unit: 72M742080
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Huntsville, AL, by fax on January 26, 2010. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Source Plasma. Recall # B-1387-10
CODE
Unit: 2920272565
RECALLING FIRM/MANUFACTURER
PlasmaCare, Inc., Pittsburgh, PA, by e-mail on October 13, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who received a tattoo within 12 months of donating, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1388-10
CODE
Units: 2524419, 2537768
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center Inc., Lexington, KY, by letter on January 5, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who visited a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
KY
___________________________________
PRODUCT 
1) Platelets. Recall # B-1389-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1390-10
CODE
1) and 2) Unit: 2534283
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center Inc., Lexington, KY, by letter on January 14, 2010. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
KY

___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1391-10
CODE
Units: 2538674A, 2538674B, 2440841, 2461015A, 2461015B
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center Inc., Lexington, KY, by letter on January 21, 2010. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
KY
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1392-10
CODE
Units: 2495246, 2566894  
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center Inc., Lexington, KY, by letter on January 29, 2010. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
KY
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1393-10
CODE
Units: 238852, 2439038, 2455159, 2499047
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center Inc., Lexington, KY, by letter on February 23, 2010. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
KY
___________________________________
PRODUCT 
1) Platelets. Recall # B-1394-10;
2) Red Blood Cells. Recall # B-1395-10;
3) Red Blood Cells Leukocytes Reduced. Recall # B-1396-10
CODE
1) and 3) Unit: 0754322;
2) Units: 0845494, 0787632
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter on August 25, 2009 and October 05, 2009 and email on February 3, 2010 and March 8, 2010.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units  
DISTRIBUTION
TX, MN
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1398-10
CODE
Unit: 72M741396
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by fax on January 12, 2010. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1401-10
CODE
Unit: 72M873473
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc - East Alabama Region, Opelika, AL, by facsimile on January 5, 2010.  Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1402-10
CODE
Unit: 72M884266
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc – Birmingham Region, Birmingham, AL, by facsimile on January 18, 2010. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1403-10
CODE
Unit: 72M983822
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Mobile, AL, by facsimile on February 5, 2010. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1404-10
CODE
Unit: 72M689080
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by facsimile on February 2, 2010. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1405-10
CODE
Unit: 72M990677
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on February 5, 2010. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1406-10
CODE
Unit: 72N245952
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by facsimile on March 5, 2010. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1407-10
CODE
Unit: 72M588256
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on February 24, 2010. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
1) Red Blood Cells. Recall # B-1408-10;
2) Fresh Frozen Plasma. Recall # B-1409-10
CODE
1) and 2) Unit: 6136713
RECALLING FIRM/MANUFACTURER
Hemacare Corp., Van Nuys, CA, by letter dated January 22, 2010. 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
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1410-10
CODE
Unit: 12FG42121
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC, by letter dated December 2, 2009, by facsimile on December 2, 2009, and by letter dated January 4, 2010.
Manufacturer: American Red Cross Blood Services, Durham, NC. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC 
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1413-10
CODE
Unit: 72N103163
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by fax on March 1, 2010. Firm initiated recall is complete.
REASON
Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1414-10
CODE
Unit: 72M94932X
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by fax on February 23, 2010. Firm initiated recall is complete.
REASON
Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1415-10
CODE
Unit: 72M633557
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by fax on February 20, 2010. Firm initiated recall is complete.
REASON
Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL

___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1416-10
CODE
Unit: 72M972868
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by fax on February 20, 2010. Firm initiated recall is complete.
REASON
Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1417-10
CODE
Unit: 72M912706
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by fax on February 20, 2010. Firm initiated recall is complete.
REASON
Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1418-10
CODE
Unit: 72M871873
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers – Wiregrass Region, Dothan, AL, by fax on February 17, 2010. Firm initiated recall is complete.
REASON
Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1419-10
CODE
Unit: 72M877472
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc – Birmingham Region, Birmingham, AL, by fax on February 15, 2010. Firm initiated recall is complete.
REASON
Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1420-10
CODE
Unit: 72N296269
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Mobile, AL, by fax on February 8, 2010. Firm initiated recall is complete.
REASON
Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL 
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1421-10
CODE
Unit: 72M868451
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Mobile, AL, by fax on February 5, 2010. Firm initiated recall is complete.
REASON
Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1422-10
CODE
Unit: 72M606856
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc – Birmingham Region, Birmingham, AL, by fax on February 2, 2010. Firm initiated recall is complete.
REASON
Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1423-10
CODE
Unit: 72N29680X
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Mobile, AL, by fax on February 24, 2010. Firm initiated recall is complete.
REASON
Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL

___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1424-10
CODE
Unit: W038109026624
RECALLING FIRM/MANUFACTURER
Recalling Firm: Florida's Blood Centers, Inc., Orlando, FL, by telephone on November 17, 2009 and letters dated November 20, 2009 and December 11, 2009.
Manufacturer: Florida's Blood Centers, Inc., Sebring, FL. 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 
Platelets Pheresis Leukocytes Reduced. Recall # B-1427-10
CODE
Unit: 151209789
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc - Lubbock Center, Lubbock, TX by fax on April 27, 2008. Firm initiated recall is complete.
REASON
Blood product, contaminated with P. acnes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1428-10
CODE
Unit: 151208932
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by fax on April 20, 2008. 
Manufacturer: Blood Systems, Inc - Lubbock Center, Lubbock, TX. Firm initiated recall is complete.
REASON
Blood product, contaminated with P. acnes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT 
Source Plasma. Recall # B-1429-10
CODE
Units: I56009010, I56008001, I56013568, I56013220, I56013070, I56014727, I56014536, I56012710, I56012406, I56012202, I56011624, I56011538, I56010643, I56010603, I56010081, I56009601, I56009421, I56009163, 392024806, 392024519,392024360,392023993, 392023885, 392023528, 392023302, 392023025, 392022863, 392022497, 392022309, 392022055, 392021901, 392021628, 392021438, 392020289, 392020152, 392019787, 392019536, 392019354, 392019045, 392018894, 392018605, 392018502, 392018181, 392017941, 392017713, 392017543, 392017310, 392016846, 392016698, 392016353, 392016190, 392015892, 392015684, 392015443, 392015300, 392014971, 392014887, 392014474, 392014367, 392013471, 392013288, 392012960, 392012794, 392012569, 392012368, 392012034, 392011306, 392010624, 392011896, 392010184, 392010022, 392009293, 392008544, 392008340, 392007488, 392007312, 392007029, 392006423, 392006114, 392002497, 392002254, 392002087, 392001836, 392001729, 392001459, 392001325, 392001123, 392000963, 392000739, 392000576, I56024163, I56024048, I56023511, I56023407, I56023247, I56023130, I56022945, I56022832, I56022613, I56021894, I56021805, I56021598, I56021541, I56021369, I56021266, I56021106, I56020827, I56020729, I56020361, I56020168, I56019995, I56019837, I56019618, I56019423, I56019365, I56019172, I56019129, I56018840, I56018751, I56018595, I56018515, I56018300, I56018049, I56017918, I56017753, I56015596, I56015529 and I56014261
RECALLING FIRM/MANUFACTURER
Recalling Firm: Talecris Plasma Resources Inc., Research Triangle Park, NC, by fax on April 24, 2008.
Manufacturer: Talecris Plasma Resources Inc., Rockford, IL. Firm initiated recall is complete
REASON
Blood products, collected from a donor who was previously permanently deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
128 units
DISTRIBUTION
NC and Austria
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1434-10
CODE
Unit: 53GN82348
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake & Potomac Reg., Baltimore, MD, by fax on September 10, 2009 and follow-up letter dated October 23, 2009. 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
MD
___________________________________
PRODUCT 
1) Fresh Frozen Plasma. Recall # B-1438-10;
2) Red Blood Cells. Recall # B-1439-10
CODE
1) and 2) Units: 004F42060
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by fax on December 11, 2009 and December 17, 2009. 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
NY, ME
___________________________________
PRODUCT 
Plasma Frozen within 24 hours (FP24). Recall # B-1440-10
CODE
Unit: 7375617
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Melbourne, FL, by telephone and letter dated November 17, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT 
Source Plasma. Recall # B-1486-10
CODE
Units: 4920198227, 4920196062, 4920195831, 4920194386, 4920193638, 4920192943, 4920191433, 4920191141, 4920189989, 4920189137, 4920188652, 4920187523, 4920187285, 4920185930, 4920185134, 4920183956, 4920180532, 4920180153, 4920178805, 4920178007, 4920177050, 4920176808, 4920175479, 4920174944, 4920169659, 4920168711, 4920168121, 4920167283, 4920165983, 4920165243, 4920163932, 4920163439, 4920162391, 4920162154, 4920161170, 4920160166, 4920159830, 4920158652, 4920158163, 4920157419, 4920157098
RECALLING FIRM/MANUFACTURER
Recalling Firm: CSL Plasma. Boca Raton, FL, by email on June 25, 2009. 
Manufacturer: CSL Plasma, Springfield, OH. Firm initiated recall is complete.
REASON
Blood products, collected using an abbreviated screening process for which the donor was not eligible, were distributed.
VOLUME OF PRODUCT IN COMMERCE
41 units
DISTRIBUTION
IL, Germany, Switzerland

___________________________________
PRODUCT 
Source Plasma. Recall # B-1493-10
CODE
Units: 4080244491, 4080241784, 4080241086, 4080238994, 4080237396, 4080236451
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma Inc., Boca Raton, FL. by email on July 31, 2008. 
Manufacturer: ZLB Bioplasma Inc., Dayton, OH. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose scheduled physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
IL
___________________________________
PRODUCT 
Source Plasma. Recall # B-1496-10
CODE
Unit: 4030250588
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma Inc., Boca Raton, FL, by email on July 11, 2008. 
Manufacturer: ZLB Bioplasma Inc., Louisville, KY. Firm initiated recall is complete.
REASON
Blood product, untested for Hepatitis B surface antigen (HBsAg), and the antibodies to the human immunodeficiency virus type 1/2 (anti-HIV-1/2), Hepatitis C virus encoded antigen (anti-HCV), Hepatitis B core antigen (anti-HBc), and Syphilis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III 
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1382-10
CODE
Unit: W038309136793
RECALLING FIRM/MANUFACTURER
Mississippi Valley Reg Building Center, Davenport, IA, by telephone and fax on December 24, 2009. Firm initiated recall is complete.
REASON
Blood product, which did not have red cell preservative solution added but which was labeled AS-5, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IA
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-1384-10
CODE
Unit: 03GE22792
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA, by letter December 09, 2009. 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
IL, GA
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-1397-10
CODE
Units: 0845494, 787632, 0754322
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter on August 25, 2009 and October 05, 2009 and email on February 3, 2010 and March 8, 2010.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Switzerland
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-1411-10
CODE
Unit: 12FG42121
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC, by letter dated December 2, 2009, by facsimile on December 2, 2009, and by letter dated January 4, 2010.
Manufacturer: American Red Cross Blood Services, Durham, NC. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-1412-10
CODE
Unit: 20Z15664
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Salt Lake City, UT, by fax on October 16, 2009 and by follow-up letter on October 23, 2009. 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
MI
___________________________________
PRODUCT 
Red Blood Cells. Recall # B-1425-10
CODE
Units: W012009011421; W012009011423; W012009011422
RECALLING FIRM/MANUFACTURER
Department of Army US Army Blood Bank Center, Fort Hood, TX, by letter dated October 14, 2009 and telephone on February 4, 2010. Firm initiated recall is complete.
REASON
Blood products, collected in expired collection bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NJ

___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1426-10
CODE
Unit: 6899621
RECALLING FIRM/MANUFACTURER
BloodNetUSA, Inc., Lakeland, FL, by telephone on November 8, 2009. Firm initiated recall is complete.
REASON
Blood product, leukoreduced after the specified post collection time limit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1435-10
CODE
Unit: W071209052232
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter dated December 18, 2009. Firm initiated recall is complete.
REASON
Blood product, with an unacceptably low red cell recovery, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II
___________________________________
PRODUCT 
1) Stryker Reflex Hybrid Screw Extractor; Not Sterile. The threaded tip of the Reflex Hybrid Screw Extractor has been found to fracture the head of the screw, causing problems in removing the screw and possible damage to the screw and/or plate while attempting to remove the screw. Ref # 48511905. Recall # Z-0762-2010

2) Stryker Reflex Hybrid Screw Extractor Inner Shaft; Not Sterile. The threaded tip of the Reflex Hybrid Screw Extractor has been found to fracture the head of the screw, causing problems in removing the screw and possible damage to the screw and/or plate while attempting to remove the screw. Ref # 48511905B. Recall # Z-0763-2010
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Spine, Allendale, NJ, by letter on October 12, 2009 and October 26, 2009.
Manufacturer: Stryker Spine SAS, Cestas, France. Firm initiated recall is ongoing.
REASON
The threaded tip of the Reflex Hybrid Screw Extractor has been found to fracture the head of the screw, causing problems in removing the screw and possible damage to the screw and/or plate while attempting to remove the screw.
VOLUME OF PRODUCT IN COMMERCE
2,774 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Abbott i-STAT ACT Celite Cartridges. In vitro diagnostic test used to monitor moderate and high-level heparin therapy through analysis of arterial and venous whole blood samples. Catalog number: 07G01-1. Recall # Z-0813-2010;

2) Abbott i-STAT ACT Kaolin Cartridges. In vitro diagnostic test which uses fresh whole blood to monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery. Catalog number: 07G81-01. Recall # Z-0814-2010
CODE
Catalog number only
RECALLING FIRM/MANUFACTURER
Abbott Point of Care Inc., Princeton, NJ, by letter beginning August 18, 2009. Firm initiated recall is ongoing.
REASON
Labeling discrepancy: The manual instruction state that the line should be flushed with 5 mL of saline and the first 5 mL of blood or six dead space volumes should be discarded. The Cartridge Test Information sheets that it should be 2 mL of blood - which is incorrect.
VOLUME OF PRODUCT IN COMMERCE
696,675 Celite Cartridges; 1,110,775 Kaolin Cartridges
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
1) Oxoid dry Spot Staphytect Plus, Catalog #DR0100M, 120 tests/kit.. Latex slide agglutination test for the differentiation of staphylococcus aureus by detection of clumping factor, Protein A and certain polysaccarides found in methicillin-resistant S. aureus (MRSA) from those staphylococci that do not possess these properties. Recall # Z-0817-2010

2) Staphytect Plus, packaged in 100- and 500-test boxes, Catalog #DR0850M (100 tests) and #DR0850B (500 tests). Latex slide agglutination test for the differentiation of staphylococcus aureus by detection of clumping factor, Protein A and certain polysaccarides found in methicillin-resistant S. aureus (MRSA) from those staphylococci that do not possess these properties. Recall # Z-0818-2010
CODE
1) Lot Number: J055610, Exp June 2011;

2) 100-test boxes - Lot Numbers: J539110, Exp. Nov 2009, and J591710, Exp. Jan 2010; 500-test boxes - Lot Numbers: J577920, Exp. Jan 2010; and J610620, Exp. May 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Remel, Inc., Lenexa, KS, by letters dated July 20, 2009 and October 19, 2009. 
Manufacturer: Oxoid, Ltd., Basingstoke, United Kingdom. Firm initiated recall is complete.
REASON
The products may give false positive results with some non-Staphylococcus aureus strains.
VOLUME OF PRODUCT IN COMMERCE
77 kits
DISTRIBUTION
Nationwide

___________________________________
PRODUCT 
1) Mistique Infusion Catheter, MIC5-90-5-035, Sterile EO. Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient. Recall # Z-0872-2010;

2) Mistique Infusion Catheter, MIC5-90-20-038, Sterile EO. Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient. Recall # Z-0873-2010;

3) Mistique Infusion Catheter, MIC5-90-20-035, Sterile EO. Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient. Recall # Z-0874-2010;

4) Mistique Infusion Catheter, MIC5-90-10-038, Sterile EO. Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient. Recall # Z-0875-2010;

5) Mistique Infusion Catheter, MIC5-90-10-035, Sterile EO. Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient. Recall # Z-0876-2010;

6) Mistique Infusion Catheter, MIC5-45-5-035, Sterile EO. Intended to administer infusions of 0various therapeutic solutions into the peripheral vasculature of a patient. Recall # Z-0877-2010;

7) Mistique Infusion Catheter, MIC5-45-5-038, Sterile EO. Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient. Recall # Z-0878-2010;

8) Mistique Infusion Catheter, MIC5-45-20-038, Sterile EO. Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient. Recall # Z-0879-2010;

9) Mistique Infusion Catheter, MIC5-45-20-035, Sterile EO. Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient. Recall # Z-0880-2010;

10) Mistique Infusion Catheter, MIC5-45-10-038, Sterile EO. Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient. Recall # Z-0881-2010;

11) Mistique Infusion Catheter, MIC5-45-10-035, Sterile EO. Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient. Recall # Z-0882-2010;

12) Mistique Infusion Catheter, MIC5-135-5-038, Sterile EO. Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient. Recall # Z-0883-2010;

13) Mistique Infusion Catheter, MIC5-135-5-035, Sterile EO. Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient. Recall # Z-0884-2010;

14) Mistique Infusion Catheter, MIC5-135-20-038, Sterile EO. Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient. Recall # Z-0885-2010;

15) Mistique Infusion Catheter, MIC5-135-20-035, Sterile EO. Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient. Recall # Z-0886-2010;

16) Mistique Infusion Catheter, MIC5-135-10-038, Sterile EO. Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient. Recall # Z-0887-2010;

17) Mistique Infusion Catheter, MIC5-135-10-035, Sterile EO. Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient. Recall # Z-0888-2010;

18) Mistique Infusion Catheter, K12-MIC13510, Sterile EO. Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient. Recall # Z-0889-2010;

19) Mistique Infusion Catheter, K12-MIC13505, Sterile EO. Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient. Recall # Z-0890-2010;

20) Mistique Infusion Catheter, K12-MIC09010, Sterile EO. Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient. Recall # Z-0891-2010

21) Mistique Infusion Catheter, K12-MIC09005, Sterile EO. Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient. Recall # Z-0892-2010;

22) Mistique Infusion Catheter, K12-MIC04510, Sterile EO. Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient. Recall # Z-0893-2010;

23) Mistique Infusion Catheter, K12-MIC04505, Sterile EO. Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient. Recall # Z-0894-2010
CODE
1) Lot Number: F523168;

2) Lot Numbers: F732798, F715392, F568274, F515704, F541196, F552587, F557349, F763048, and F557387;

3) Lot Number: F523170;

4) Lot Numbers: F683490, F620279, F659617, F512118, F559073, and F666178;

5)  Lot Numbers: F677080, F749396, F560799, F616268, F694690, F523169, F557356, and F656388;

6)  Lot Number: F523165;

7) Lot Numbers: F694689, F683489, F757981, F697877, and F683488;

8) Lot Number: F523174;

9) Lot Number: F523167;

10) Lot Numbers: F694691, F598718, F557386, and F576150;

11) Lot Number: F523166;

12) Lot Number: F765406;

13) Lot numbers: F523173, F727966, and F739396;

14) Lot Numbers: F523177, F681155, F753189, and F647919;

15) Lot Numbers: F691136, F523171, and F725674;

16) Lot Numbers: F751137 and F523176;

17) Lot Numbers: F557385, F568273, F677668, F717753, F681154, F523172, and F652149;

18) Lot Numbers: F682090, F707520, F651485, and F531675;

19) Lot Numbers: F675641, F550489, and F586944;

20) Lot Numbers: F624962, F515920, F525523, F592079, F534925, F541246, F538162, F601959, F630042, F758859, and F765403;

21) Lot Numbers: F725685, F613221, F682088, F717755, F651484, F515919, F525522, F616416, F586945, F598771, F568275, F586078, F598764, F601954, F630041, F638412, F645779, and F758857;

22) Lot Numbers: F732526, F725684, F743323, F707518, F691778, F717754, F638411, F682086, F580922, F598763, F601956, F630040, F651483, F758855, and F624961;

23) Lot Numbers: F732525, F725683, F743322, F690659, F707516, F515918, F525521, F580921, F592073, F601955, F638410, and F651482
RECALLING FIRM/MANUFACTURER
Merit Medical Systems, Inc., South Jordan, UT, by telephone and letter on January  6, 2010. Firm initiated recall is ongoing.
REASON
Infusion catheters may become brittle and break during use.
VOLUME OF PRODUCT IN COMMERCE
264 units (US), 1125 units (International)
DISTRIBUTION
AL, CA, IN, LA, MO, MS, NC, NY, OH, PA, SC, UT, and VA and countries of India, Japan, Poland, San Marino, and UK
___________________________________
PRODUCT 
1) 10 degree Tibial Augment Wedge, a component of Ortho Balanced Knee Modular Tibial System. The device is a component of Balanced Knee Modular Tibial System and is indicated for patients suffering from severe knee pain and disability. The indications for use are: 1) loss of joint configuration and joint function, 2) Osteoarthritis of the knee joint, 3) Rheumatoid arthritis of the knee joint, 4) Post-traumatic arthritis of the knee joint, 5) Moderate valgus, varus, or flexion deformities and 6) Revision procedures where other treatments or devices have failed. Recall # Z-1228-2010;

2) 5mm Tibial Augment Block, a component of Ortho Balanced Knee Modular Tibial System. The device is a component of Balanced Knee Modular Tibial System and is indicated for patients suffering from severe knee pain and disability. The indications for use are: 1) loss of joint configuration and joint function, 2) Osteoarthritis of the knee joint, 3) Rheumatoid arthritis of the knee joint, 4) Post-traumatic arthritis of the knee joint, 5) Moderate valgus, varus, or flexion deformities and 6) Revision procedures where other treatments or devices have failed. Recall # Z-1229-2010
CODE
1) Serial numbers: 567-1101; 567-1102; 567-1103; 567-1104; 567-1105; 567-1106; 567-1201; 567-1202; 567-1203; 567-1204; 567-1205 and 567-1206;

2) Serial Numbers: 567-5101; 567-5102; 567-5103; 567-5104; 567-5105; 567-5106; 567-5201; 567-5202; 567-5203; 567-5204; 567-5205 and 567-5206
RECALLING FIRM/MANUFACTURER
Ortho Development Corp., Draper, UT, by e-mail on March 19, 2009. Firm initiated recall is completed.
REASON
A component of knee prosthesis was assembled incorrectly.
VOLUME OF PRODUCT IN COMMERCE
790 units (368 / 5mm block) (422 / 10 degree wedge)
DISTRIBUTION
AZ, FL, OR, TX, UT and Japan
___________________________________
PRODUCT 
1) Envoy 500 Serum Control Kit. The device is used for monitoring the performance of clinical chemistry methods within the clinical range. Recall # Z-1233-2010;

2) ATAC Serum Control Kit. The device is used for monitoring the performance of clinical chemistry methods within the clinical range. Recall # Z-1234-2010
CODE
Level 1, Lot Number 9141010 and Level 2, Lot Number 9142010
RECALLING FIRM/MANUFACTURER
Vital Diagnostics, Inc., Lincoln, RI, by copies of Technical Bulletin 8100 and 5024 dated September 30, 2009. Firm initiated recall is ongoing.
REASON
Vital Diagnostics observed a bias in the Quality Control Consensus Program between published values for ALP on the ATAC 8000 and reported customer means. The ranges were adjusted to reflect the analyzer population.
VOLUME OF PRODUCT IN COMMERCE
1,673 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) PROMOS Inclination set, Size 20mm, REF 42 180, S&N75006722, Qty: (1), Sterile R. The device is used as a semi-constrained, metal/polymer cemented shoulder prosthesis. Recall # Z-1239-2010;

2) PROMOS Inclination set, Size 22mm, REF 42 184, S&N75006723, Qty: (1), Sterile R. The device is used as a semi-constrained, metal polymer cemented shoulder prosthesis. Recall # Z-1240-2010;

3) PROMOS Inclination set, Size 24mm, REF 42 184, S&N75006724, Qty: (1), Sterile R. The device is used as a semi-constrained, metal polymer cemented shoulder prosthesis. Recall # Z-1241-2010;

4) PROMOS Inclination set, Size 26mm, REF 42 186, S&N75006725, Qty: (1), Sterile R. The device is used as a semi-constrained, metal/polymer cemented shoulder prosthesis. Recall # Z-1242-2010;
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith & Nephew Inc., Memphis, TN, by letter, email and/or telephone on January 23, 2009. 
Manufacturer: Smith & Nephew Orthopaedics AG, Aarau, Switzerland. Firm initiated recall is ongoing.
REASON
Firm received complaints of Inclination Set Screws fracturing.
VOLUME OF PRODUCT IN COMMERCE
3,025 units
DISTRIBUTION
Nationwide, Australia, Austria, Belgium, China, Denmark, France, Germany, Greece, Great Britain, Italy, Netherlands, Portland, Portugal, Spain, Sweden and Switzerland

___________________________________
PRODUCT 
ARCHITECT System Software v5.00 and v5.10, List Number 5F48-22 and 5F48-23; Part Number 7-204717-01 and 7-204717-02 when used with PM Algorithm LLS Brd, part number 7-94255-01 and PM LLS kit, U10 Chip and Ejectors, part number 7-200788-01. The Abbott ARCHITECT System is designed to perform automated: Chemistry tests utilizing photometry and potentiometric technology, and immunoassay tests utilizing CMIA detection technology. Recall # Z-1316-2010
CODE
Part and List numbers only
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX, by letter on September 11, 2009. Firm initiated recall is ongoing.
REASON
ARCHITECT System Software v5.00 and v5.10 are incompatible with ARCHITECT LLS Board. Software patch re-establishes correct parameters.
VOLUME OF PRODUCT IN COMMERCE
104 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
HeartStart MRx Defibrillator Monitor (Models M3535A, M3536A and M3536J) used with Philips 14.8-Volt Lithium Ion Battery (ModeI M3538A). The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician. Recall # Z-1317-2010
CODE

Serial Numbers: US0021 0909 US0021 0894 US00322954 US00206879 US00203138 US00319893 US00100311 US00323917 US00538637 US00533428 US00535621 US00332641 US00536014 US00320320 US00202952 US00330262 US00322176 US00326871 US00209570 US00317499 US00329340 US00320644 US00332469 US00327987 US00323486 US00317282 US00330537 US00321624 US00321926 US00328904 US00535196 US00333096 US00330222 US00322335 US00320373 US00536592 US00533452 US00536700 US00101064 US00317626 US00533737 US00212144 US00535463 US0021 0779 US00319258 US00324472 US00330738 US00207015 US00537102 US00326352 US00100876 US00326680 US00535661 US00210247 US00328226 US00319922 US00214570 US00317391 US00323121 US00315286 US00324716 US00325554 US00316760 US00322685 US00332634 US00322452 US00322693 US00332903 US00206835 US00206318 US00330021 US00535512 US00535700 US00327393 US00327122 US00332901 US00100505 US00316285 US00323168 US00204295 US00331605 US00323209 US00536727 US00322136 US00319992 US00322774 US00206765 US00203146 US00331577 US00316774 US00321676 US00326810 US00535662 US00536741 US00533817 US00535420 US00327807 US00536549 US00538344 US00328856 US00331918 US00536735 US00207778 US00209293 US001 01928 US00328008 US00327097 US00324587 US00535415 US00535990 US00206056 US00321061 US00537116 US00320384 US00327256 US00208300 US00333006 US00100295 US00100656 US00537816 US00535222 US00329190 US00331652 US00535280 US00318260 US00102709 US00331895 US00535109 US00101938 US00333080 US00323893 US00202913 US00331805 US00102037 US00101299 US00323043 US00318464 US00327461 US00326571 US00327065 US00534883 US00535983 US00203139 US00534438 US00329878 US00213392 US00322021 US00322721 US00205715 US00316333 US00323130 US00332953 US00533743 US00533901 US00538638 US00329335 US00326882 US00317788 US00327457 US00324008 US00535936 US00102675 US00322877 US00329746 US00322922 US00536272 US00333122 US00101183 US00320011 US00212632 US00325686 US00100522 US00208185 US00208113 US00317744 US00535788 US00204366 US00325578 US00204137 US00322683 US00536886 US00205711 US00321187 US00534581 US00212888 US00331685 US00535255 US00326286 US00319983 US00538601 US00328979 US00319964 US00535154 US00211089 US00323195 US00205998 US00535546 US00316837 US00320377 US00331221 US00327496 US00332243 US00538642 US00214609 US00537229 US00331819 US00331069 US00326051 US00213811 US00534781 US00324771 US00206165 US00318928 US00207002 US00330815 US00326526 US00533859 US00538312 US00325801 US00322391 US00320556 US0021 0674 US00206795 US00317465 US00319842 US00332110 US00535098 US00331898 US00326509 US00328001 US00327535 US00209543 US00331919 US00323461 US00330460 US00214195 US00323879 US00320899 US00321518 US00535813 US00317480 US00211 030 US00213439 US00323285 US00325243 US00317680 US00320437 US00317990 US00328838 US00329092 US00536461 US00537798 US00533853 US0021 0780 US00535257 US00535758 US00538483 US00323806 US00317479 US00318396 US00214183 US00331601 US00323862 US00332969 US00101720 US00537284 US00535229 US00206361 US00534248 US00534821 US00535986 US00317563 US00534824 US00215049 US00207003 US00213530 US00318283 US00321891 US00318858 US00203795 US00206320 US00536281 US00213815 US00317936 US00211500 US00100548 US00101102 US00322103 US00323263 US00322367 US00206191 US00211646 US00317085 US00208805 US00317488 US00328146 US00320209 US00329477 US00325124 US00533406 US00329339 US00537736 US00208660 US00212334 US00102424 US00204621 US00535363 US00326521 US00327569 US00324374 US00537252 US0021 0459 US00325582 US00322921 US00328951 US00208524 US00534774 US00331766 US00332237 US00537775 US00538358 US00202840 US00326737 US00208670 US00320907 US00316568 US00328974 US00332411 US00332885 US00534446 US00208508 US00535764 US00328875 US00318187 US00323974 US00213274 US00326968 US00332917 US00536599 US00208063 US00332535 US00206606 US00322883 US00208029 US00316345 US00325704 US00327693 US00533423 US00317739 US00537604 US00102392 US00536545 US00327764 US00319892 US00323455 US00533706 US0021 0680 US00213171 US00212571 US00317727 US00329525 US00332421 US00213173 US00207371 US00317219 US00213462 US00328153 US00536039 US00214974 US00100204 US00101031 US00315532 US00210782 US00213219 US00209707 US00207376 US00536011 US00534929 US00327340 US00204600 US00324350 US00205741 US00208465 US00100309 US001 02114 US00325396 US00327637 US00317328 US00538366 US00538590 US00208733 US00322149 US00536505 US00535081 US00320240 US00323572 US00324189 US00321924 US00324786 US00212968 US00206304 US00205656 US00324781 US00321230 US00332956 US00212965 US00329098 US00316927 US00206375 US00101908 US00317540 US00318459 US00316804 US00331935 US00320641 US00100415 US00319439 US00210524 US00535969 US00205698 US00214587 US00326574 US00323044 US00215059 US00328223 US00317319 US00319932 US00317784 US00102051 US00318097 US00533424 US00212409 US00533486 US00318036 US00206474 US00536594 US00533154 US00328949 US00324095 US00100149 US00332221 US00100688 US00332030 US00330479 US00206757 US00537108 US00329348 US00328152 US00318635 US00318772 US00326547 US00205009 US00214999 US00325624 US00534031 US00328162 US00329858 US00209106 US00537107 US00537283 US00326592 US00533524 US00317893 US00206947 US00322863 US00208681 US00325487 US00320494 US00213813 US00316942 US00328961 US00321028 US00208496 US00323673 US00213486 US00535675 US00323343 US00328602 US00317696 US00206536 US00538574 US00534484 US00208979 US00213252 US00534488 US00323041 US00330511 US00214205 US00329289 US00331896 US00318262 US00534030 US00207828 US00207132 US00327542 US00100642 US00207314 US00534442 US00206675 US00325713 US00331731 US00326959 US00321245 US00320551 US00535256 US00538646 US00320414 US00315787 US00319058 US00206457 US0021 0885 US00323807 US00322855 US00329692 US00205984 US00328950 US00323311 US00320587 US00102306 US00536061 US00318551 US00202762 US00533228 US00100150 US00538372 US00326864 US00102299 US00331842 US00322856 US00326605 US00331746 US00535490 US00212107 US00323534 US00537490 US00315360 US00328830 US00329353 US00206376 US00319776 US00533596 US00538609 US00100507 US00332245 US00535985 US00537791 US00330439 US00322715 US00322962 US00328515 US00204420 US001 01 017 US00319546 US00206753 US00320468 US00213678 US00317602 US00320319 US00534870 US00324177 US00208106 US00204266 US00333002 US00326564 US00536088 US00538651 US001 01160 US00206466 US00317489 US00320305 US00325454 US00331010 US00332488 US0021 0547 US00210144 US00323164 US00329360 US00101074 US00533699 US00322439 US00208147 US00320324 US00325235 US00330646 US00318365 US00316697 US00333020 US00204079 US00211071 US00204081 US00331926 US00212896 US00331994 US00100752 US00331933 US00100769 US00330809 US00317559 US00326310 US00208023 US00101662 US00209321 US00317647 US00316244 US00215070 US00535725 US00208606 US00101499 US00535635 US00330334 US00328613 US00536583 US00325432 US00324409 US00534979 US00206363 US00327077 US00538506 US00207929 US00316304 US00331241 US00206103 US00329860 US00202902 US00533500 US00320206 US00324717 US00214905 US00331265 US00328224 US00212744 US00203865 US00328948 US00100729 US00318136 US00211459 US00206162 US00319963 US00210650 US00330228 US00213452 US00100430 US00102409 US00318008 US00325514 US00322435 US00534075 US00326025 US00324003 US00102102 US00319088 US00537196 US00332781 US00318099 US00207857 US00536282 US00327074 US00330538 US00328133 US00320539 US00322567 US00316881 US00206115 US00317606 US00332586 US00320010 US00538468 US00533530 US00206874 US00533655 US00207418 US00534448 US00536128 US00101817 US00535647 US00327453 US00533503 US00322617 US00320220 US00327056 US00537234 US00331995 US00316287 US00325910 US00100701 US00534259 US00538565 US00535417 US00206246 US00535056 US00317679 US00100756 US00323568 US00325201 US00537140 US00326550 US00331 025 US00536009 US00331572 US00215042 US00329894 US00534274 US00535278 US00319872 US00320415 US00212916 US00101193 US00537708 US00316936 US00533838 US00320583 US00332466 US00207976 US00101734 US00332858 US00204151 US00100133 US00535470 US00317657 US00535198 US00535206 US00330771 US00332897 US00538339 US00536480 US00322771 US00213636 US00325689 US00207022 US00330446 US00318233 US00533748 US00318967 US00320266 US00214968 US00207604 US00102136 US00332331 US00535971 US00315813 US00209493 US00208435 US00210755 US00332324 US00536264 US00317568 US00212411 US00207338 US00327646 US00323166 US00331764 US00332054 US00205701 US00533426 US001 00705 US00323138 US00315851 US00332702 US00204060 US00535205 US00318422 US00324782 US00100833 US00210341 US00330949 US00214811 US00324310 US00325107 US00322603 US00212064 US00211156 US00536169 US00211755 US00331715 US00320724 US00538461 US00325120 US00331584 US00317449 US00536095 US00319898 US00319435 US00535045 US00330250 US00214864 US00538564 US00538550 US00209635 US00318235 US00315526 US00332898 US00204425 US00214751 US00327805 US00317624 US00538828 US00324469 US00214539 US00330836 US00100706 US00317274 US00324278 US00534767 US00327371 US00318105 US00213498 US00328397 US00206267 US00323918 US00330165 US00535818 US00536484 US00320063 US00213674 US00538480 US00319219 US00318461 US00331993 US00214142 US00317969 US00320781 US00316973 US00100531 US00100812 US00535426 US00320370 US00322626 US00326807 US00331660 US00318344 US00330829 US00536109 US00328800 US00538481 US00101236 US00324013 US00332272 US00332937 US00331618 US00321282 US00207118 US00207054 US00536189 US00533494 US0021 0675 US00533483 US00318585 US00534487 US00324442 US00100414 US00204078 US00210887 US0033081 0 US00328682 US00100986 US00332230 US00538462 US00538440 US00536556 US00209125 US00332596 US00209405 US00203673 US00537120 US00535192 US00322427 US00537236 US00205173 US00322590 US0031571 0 US00203335 US00209133 US00535958 US00317467 US00534894 US00327076 US00204080 US00208981 US00533697 US00325086 US00214955 US00331383 US00208018 US00537246 US00207854 US00535087 US00535667 US00323286 US00328861 US00538794 US00212501 US00100104 US00330827 US00535581 US00214734 US00329881 US00325907 US00538363 US00328218 US00318639 US00322592 US00323608 US00534480 US00535260 US00331717 US00535721 US00533656 US00202791 US00326133 US00536560 US00209241 US00324886 US00321224 US00207155 US00320255 US00331745 US00102293 US00101495 US001 02189 US00102634 US00535965 US00332554 US00332071 US00328283 US00213078 US00212759 US00102557 US00332462 US00327647 US00537603 US00536190 US00330785 US00325516 US00538731 US00214097 US00537247 US00323076 US00324926 US00330835 US00316882 US00327472 US00214773 US00330311 US00210480 US00206097 US00331723 US00330838 US00212769 US00214598 US00319960 US00536010 US00330887 US00102364 US00100202 US00101224 US00533482 US00535645 US00535080 US00318549 US00325047 US00210829 US00322560 US00322214 US00209448 US00536478 US00100509 US00209524 US00208160 US00326728 US00320466 US00214130 US00325071 US00535629 US00537224 US00328930 US00319982 US00536906 US00538369 US00535252 US00535775 US00331570 US00327670 US00332550 US00331522 US00327540 US00318203 US00322986 US00203235 US00318760 US00329230 US00207698 US00330834 US00332899 US00320381 US00327238 US00321481 US00209049 US00207699 US00331403 US00212360 US00538819 US00329561 US00317040 US00537267 US00316887 US00331866 US00101816 US00327055 US00331774 US00203790 US00538453 US00330248 US00102644 US00208140 US00324167 US00328011 US00100985 US00327699 US00327491 US00212423 US00209033 US00327470 US00101172 US00209098 US00325804 US00202948 US00316636 US00325330 US00315486 US00535106 US00213165 US00536265 US00332015 US00214569 US00102657 US00538498 US00205730 US00331963 US00322729 US00205876 US00318895 US00203828 US00536219 US00332031 US00328208 US00206853 US00328113 US00534881 US00203142 US00323407 US00325319 US00100731 US00331009 US00320465 US00537000 US00319077 US00327971 US00320580 US00212093 US00315692 US00326535 US00204630 US00101178 US00210905 US00538627 US00202749 US00332661 US00205106 US00536365 US00319216 US00329571 US00102684 US00319159 US00327809 US001 01182 US00535681 US00207316 US00329232 US00214747 US0021 0539 US00214618 US00535170 US00209567 US00533468 US00535058 US00535427 US00320569 US00533597 US00207836 US00211487 US00333003 US00328163 US00328859 US00322584 US00332371 US00323965 US00206128 US00206315 US00101344 US00332112 US00319441 US00100153 US00536838 US00325049 US00205201 US00538641 US00538580 US00324089 US00330828 US00328730 US00203754 US00325395 US00536086 US00320749 US00212179 US00209550 US00317017 US00535731 US00533638 US00332264 US00535996 US00324877 US00331917 US001 01513 US00327804 US00332223 US00534726 US00101268 US00100325 US00535328 US00331293 US00207148 US00208278 US00327159 US00534247 US00100775 US00102192 US00326995 US00332720 US00324088 US00209495 US00212401 US00317476 US00535442 US00205731 US00332017 US00214952 US00332880 US00318733 US00533533 US00210721 US00326863 US00320841 US00535665 US00324937 US00320978 US00325849 US00324552 US00316783 US00318084 US00318063 US0021 0436 US00321929 US00321631 US00210212 US00323126 US00332952 US00210889 US00204458 US00332861 US00203805 US00214599 US00329233 US00331783 US00202767 US00535063 US00206161 US00206459 US00326049 US00325254 US00333005 US00333040 US00329588 US00330824 US00212367 US00101711 US00212176 US00320898 US00320464 US00322859 US00535410 US00206751 US00320246 US00320980 US00316781 US00332240 US00317932 US00214603 US00318267 US00316425 US00330247 US00322908 US00207065 US00320149 US00316838 US00214186 US00535652 US00535115 US00100347 US00327468 US00101793 US00207142 US00327622 US00327635 US00330752 US00212731 US00100645 US00329286 US00330811 US00330812 US00330936 US00322713 US00322443 US00330813 US00332020 US00331576 US00318284 US00213515 US00326962 US00322619 US00534730 US00320440 US00328319 US00323305 US00322697 US00327599 US0021 0543 US00329355 US00535061 US00207350 US00206750 US00327648 US00536506 US001 01185 US00211120 US00322339 US00322116 US00212263 US00537233 US00212876 US00101174 US00212112 US00202957 US00325794 US00327981 US00330750 US00330952 US00537244 US00331790 US00322102 US00318123 US00325318 US00206151 US00319035 US00533628 US00533746 US00535929 US00204687 US00324892 US00206878 US00210792 US00212441 US00316643 US00211505 US00331765 US00328495 US00212901 US00332881 US00327459 US00332176 US00325221 US00330443 US00205202 US00332847 US00327082 US00213055 US00318776 US00320804 US00320376 US00534822 US00332699 US00537126 US00536487 US00533438 US00328962 US00208039 US00102009 US00323425 US00316283 US00536105 US00100348 US00325388 US00534745 US00101695 US0021 0720 US00317271 US00538544 US00323513 US00536830 US00332768 US00332479 US00101795 US00332489 US00213016 US00328368 US00207163 US00321433 US00533771 US00536907 US00535259 US00212084 US00533976 US00211076 US0021 0458 US00535727 US00534417 US00212418 US00538820 US00209595 US00534113 US00322157 US00536166 US00323001 US00319589 US00321155 US00208914 US00206367 US00322158 US00538465 US00325084 US00535523 US00320144 US00323094 US00327187 US00327546 US00323611 US00332066 US00318805 US00330989 US00318614 US00329404 US00100648 US00214976 US00331992 US00332936 US00102444 US00319218 US00206761 US00331606 US00330230 US00534061 US00535091 US00535279 US00538838 US00207713 US00535715 US00318274 US00538476 US00328971 US00207081 US00322623 US00330123 US00331226 US00326733 US00327247 US00332329 US00330526 US00322512 US00536511 US00320485 US00208551 US00325721 US00322492 US00535569 US00322917 US00327079 US00538573 US00100546 US00204594 US00538648 US00533498 US00205744 US00319193 US00318285 US00327597 US00535984 US00536726 US00205728 US00323809 US00535329 US00207206 US00317687 US00533422 US00206593 US00330888 US00206556 US00331244 US00102671 US00325132 US00325103 US00203092 US00320776 US00534784 US00331571 US0021 0456 US00324180 US00206082 US00332234 US00330744 US00323699 US00331 052 US00538431 US00538699 US00211730 US00325680 US00322001 US00331 053 US00328518 US00102431 US00316694 US00213490 US00533128 US00317439 US00315121 US00319483 US00534421 US00534926 US00209288 US00212014 US00327543 US00538586 US00214140 US00206393 US00205725 US00206552 US00329159 US00330839 US00538672 US001 01177 US00536832 US00207953 US00207138 US00326815 101066 US00318445 US00535787 US00102305 US00320484 US00317346 US00209784 US00327678 US00537502 US00214736 US00325232 US00538693 US00203792 US00324063 US00317039 US00209138 US00100111 US00537321 US00536701 US00212903 US00332503 US00204294 US00325389 US00206008 US00316826 US00332478 US00206465 US00332984 US00538279 US00212636 US00329101 US00208048 US00538478 US00202923 US00320979 US00214685 US00535797 US00331934 US00319504 US00214957 US00535802 US00100718 US00101469 US00328829 US00214910 US00322853 US00317880 US00209590 US00320143 US00316859 US00325457 US00102640 US00207401 US00535761 US00327538 US00533768 US00332509 US00331132 US00536843 US00317487 US00317977 US00534996 US00209095 US00537282 US00325718 US00208149 US001 02518 US00328196 US00316666 US00533600 US001 01713 US00317444 US00321786 US00324723 US00320868 US00324390 US00324586 US00206744 US00328050 US00208095 US00206508 US00322160 US00538475 US00320407 US00318736 US00211731 US00214799 US00537232 US00100431 US00328054 US00320467 US001 00233 US00209077 US00533756 US00325116 US00322403 US00318481 US00212410 US00537235 US00328584 US00320257 US00208438 US00100270 US00203793 US00320325 US00210897 US00317222 US00215051 US00323120 US00102039 US00329237 US00205006 US00318735 US00205367 US00332044 US00321429 US00208296 US00202953 US00332654 US00535786 US00538577 US00534132 US00324262 US00326332 US00330826 US00319507 US00212311 US00211744 US00321007 US00538432 US00328536 US00325219 US0021 0929 US00325522 US00536945 US00330449 US00208148 US00325537 US00100308 US00211565 US00329326 US00321765 US00320552 US00323961 US00535991 US00318349 US00328514 US00329156 US00101335 US00319647 US00536799 US00327583 US00322126 US00209326 US00208033 US00535824 US00317240 US00535889 US00327721 US00101661 US00535330 US00321607 US00325707 US00535135 US00212891 US00536950 US00331619 US00319315 US00320550 US00101456 US00536037 US00209389 US00206820 US00332415 US00214619 US00208853 US00323118 US00204489 US00209837 US00325146 US00331639 US00207045 US00102249 US00322725 US00319846 US00211775 US00325034 US00534347 US00323901 US00206822 US00330590 US00329827 US00326412 US00536797 US00328846 US00331276 US00212810 US00326715 US00323828 US00211 051 US00332369 US00327115 US00331671 US00325783 US00533599 US001 02014 US00330808 US00100504 US00328494 US00205760 US00322334 US00324125 US00315768 US00100306 US00320210 US00316297 US00206895 US00213503 US00318066 US00100768 US00203838 US00204658 US00327073 US00204625 US00322692 US00315490 US00101602 US00214879 US00332756 US00322861 US00537276 US00209273 US00209591 US00211576 US00324062 US00330594 US00332986 US00332855 US00330473 US00533795 US00329584 US00331539 US00205584 US00318115 US00330965 US00328547 US00101783 US00331785 US00213465 US00330937 US00534482 US00209417 US00316952 US00535801 US00206364 US00327089 US00327116 US00315284 US00534474 US00328160 US00318132 US00329911 US00331620 US00325287 US00538636 US00101288 US00323804 US0021 0343 US00331209 US00535905 US00214847 US00206447 US00533869 US00535934 US00538598 US00326185 US00214571 US00538837 US00319587 US00327086 US00332464 US00533767 US00324620 US00328026 US00204455 US00331921 US00331650 US00203810 US00538397 US00206077 US00332983 US00325134 US00320623 US00537471 US00208488 US00535819 US00100651 US001 00419 US00534733 US00535223 US00533749 US00210656 US00322756 US00320064 US00326713 US00100293 US00326966 US00321033 US00204461 US00327236 US00211921 US00318699 US00318135 US00317312 US00324879 US00214936 US00538629 US00322874 US00327541 US00329524 US00535191 US00214436 US00101491 US00210771 US00208702 US00534766 US00321936 US00203691 US00318007 US00533526 US00215040 US00102282 US00537004 US00328640 US00330514 US00324977 US00331285 US00213393 US00203077 US00537008 US00209328 US00323291 US00538584 US00323208 US00319986 US00100136 US00328220 US00211683 US00332545 US00100143 US00535816 US00100814 US00211506 US00537134 US00323287 US00214194 US00534250 US00316319 US00318137 US00206672 US00322892 US00324534 US00101277 US00317731 US00321938 US00101943 US00102285 US00332373 US00323092 US00332852 US00327048 US00321630 US00330941 US00325239 US00324183 US00325512 US00330915 US00317630 US00324094 US00209506 US00331802 US00538554 US00535674 US00325172 US00537940 US00316591 US00538406 US00327640 US00330753 US00330261 US00318426 US00207385 US0021 0433 US00102553 US00533427 US00322680 US00332219 US00537226 US00102346 US00330253 US00100732 US00536624 US00533825 US00205098 US00538582 US00315487 US00328973 US0021 0749 US00209604 US00538639 US00328737 US00535226 US00316471 US00214206 US00317558 US00101013 US00100307 US00323563 US00317481 US00535430 US00536195 US00328616 US00328785 US00321371 US00208119 US00325195 US00323344 US00327057 US00535845 US00208047 US00102047 US00538618 US00536018 US00209423 US00536079 US00331877 US00317539 US00101813 US00332232 US00318769 US00202872 US00535297 US00213407 US00207740 US00324270 US00320459 US00318264 US00331635 US00317988 US00537832 US00535838 US00537139 US00317681 US00332497 US00332035 US00320128 US00535919 US00213118 US00328528 US00322404 US00318835 US00322133 US00533703 US00100447 US00212918 US00316288 US00322600 US00322106 US00203967 US00102324 US00317564 US00327053 US00100767 US00102044 US00315135 US00330943 US00332061 US00326390 US00100725 US00214187 US00207267 US00322186 US00332215 US00329292 US00319089 US00535232 US00101482 US00317618 US00323805 US00212304 US00211528 US00328728 US00209324 US00534111 US00321146 US00320813 US00203662 US00321921 US00325284 US00535757 US00211607 US00102446 US00536036 US00330749 US00322342 US00535624 US00329530 US00211523 US00534754 US00100702 US00535586 US00329193 US00534534 US00212859 US00327094 US00205695 US00213225 US00322261 US00533981 US00320482 US00329147 US00205753 US00215046 US00323262 US00538840 US00535646 US00211094 US00326872 US00535026 US00210601 US00204329 US00207415 US00327462 US00333021 US00324265 US00102502 US00538474 US00332117 US00330192 US00332115 US00214601 US00324660 US00328012 US00325170 US00325488 US00328399 US00533794 US00323453 US00316324 US00208777 US00207489 US00215047 US00331925 US00324463 US00533233 US00322743 US00316237 US00329333 US00322392 US00323962 US00320687 US00332494 US00327050 US00325228 US00331915 US00318272 US00537281 US00331199 US00102264 US00325198 US00536094 US00536623 US00316649 US00332384 US00331999 US00317105 US00319080 US00317470 US00320686 US00204346 US00213022 US00317619 US00210516 US00319090 US0032259i US00320911 US00328914 US00330786 US00330923 US00206766 US0021 0397 US00332930 US00325531 US00534975 US00320486 US00317797 US00332914 US00538460 US00213119 US00328623 US00320793 US00325603 US00317632 US00325077 US00210908 US00330032 US00533736 US00206042 US00331288 US00538543 US00214219 US00324395 US00327229 US00533654 US00533510 US001 01500 US00322699 US00206368 US00327023 US00326965 US00318247 US00319215 US00535253 US00327664 US00101878 US00536844 US00326426 US00331 074 US00213672 US00326569 US00316219 US00317773 US00100709 US00331897 US00320791 US00538836 US00330630 US00534405 US00533807 US00317354 US00205688 US00323802 US00205022 US00317735 US00536002 US00318317 US00318012 US00329354 US00319821 US00212268 US00327269 US00316915 US00534263 US00202761 US00208723 US00319909 US00208445 US00534729 US00535471 US00331931 US00328955 US00330330 US00204435 US00534249 US00538538 US00101187 US00319521 US00204287 US00330631 US00204107 US00318447 US00535749 US00204139 US00325087 US00538546 US00331733 US00318265 US00209129 US00332217 US00535815 US00326145 US00331847 US00536752 US00322057 US00535416 US00322016 US00331826 US00214808 US00534483 US00214823 US00210981 US00331391 US00538442 US00102073 US00332227 US00327448 US00533532 US00534542 US00330049 US00329522 US00318130 US00208510 US00537106 US00325317 US00101118 US00534779 US00320259 US00208112 US00207222 US00332070 US00538371 US00533682 US00330916 US00326638 US00322332 US00322620 US00318676 US00322201 US00100550 US00212797 US00207750 US00329100 US00203232 US00202748 US00323089 US00206503 US00331772 US00533611 US00534418 US00206219 US00329238 US00315521 US00207088 US00206224 US00534509 US00100425 US00326640 US00203804 US00325683 US00330603 US00534771 US00208159 US00533998 US00327669 US00332516 US00208144 US00210518 US00317889 US00204356 US00214963 US00315509 US00536077 US00318427 US00324803 US00535272 US00322744 US00212415 US00317226 US00538842 US00323091 US00535804 US00322336 US00208163 US00332225 US00327923 US00534393 US00211703 US00327160 US00325400 US00212941 US00327156 US00207194 US00317534 US00332343 US00324437 US00319871 US00536531 US00205708 US00533787 US00537250 US00214660 US00326384 US00328953 US001 01699 US00326573 US00535577 US00332567 US00322284 US00206563 US00321583 US00210505 US00209808 US00202871 US00100237 US00212807 US00330814 US00317621 US00318138 US00535917 US00536547 US00317280 US00208904 US00324391 US00321248 US00538346 US00318106 US00533763 US00330830 US00316295 US00328604 US00332229 US00322722 US00100726 US00533963 US00204960 US00331284 US00332040 US00101624 US00535974 US00327080 US00538457 US00323906 US00318238 US00211001 US00214586 US00321213 US00330840 US00320130 US00329229 US00535273 US00537231 US00204627 US00534306 US00320205 US00317661 US00330940 US00320571 US00211752 US00537104 US00101682 US00328720 US00101176 US00100356 US00535542 US00536742 US00324776 US00315706 US00322259 US00316621 US00322079 US00327544 US00327726 US00322105 US00323887 US00320593 US00321519 US00214572 US00325114 US00204406 US00318970 US00332211 US00206322 US00535248 US00536914 US00322599 US00328715 US00332062 US00331459 US00318278 US00535644 US00535088 US00212169 US00327458 US00315215 US00322684 US00332038 US00322598 US00319485 US00211977 US00202811 US00322173 US00534777 US00321080 US00207080 US00321149 US00206254 US00534035 US00327454 US00331204 US00538649 US00533672 US00316623 US00323609 US00538700 US00326709 US00323132 US00330580 US00325711 US00100857 US00534980 US00320816 US00210012 US00204555 US00329336 US00214589 US00321516 US00537254 US00214790 US00319927 US00320472 US00213461 US00330947 US00100321 US00331996 US00205738 US00100665 US00320093 US00537806 US00329528 US00316775 US00327561 US00534520 US00328377 US00535550 US00212993 US00206472 US00533956 US00317435 US00322399 US00535071 US00538493 US00533710 US00211252 US00329722 US00536552 US00319845 US00325147 US00321117US00331401 US00207941 US00535842 US00328211 US00212978 US00316967 US00206073 US00329341 US00206319 US00205993 US00321157 US00326816 US00100266 US00101289 US00207108 US0021 0384 US00319930 US00320722 US00315959 US00320557 US00317486 US00537135 US00209204 US00205131 US00202892 US00100875 US00326045 US00315564 US00535835 US00214575 US00329337 US00536024 US00320476 US00326879 US00319480 US00317004 US00329424 US00205004 US00328277 US00329589 US00328695 US00320267 US00322675 US00205636 US00210460 US00213391 US00536286 US00323458 US00101222 US00330216 US00208121 US00211152 US00329683 US00211137 US00327547 US00328097 US00327092 US00328793 US00323533 US00318507 US00203929 US0021 0965 US00323976 US00214276 US00322042 US00316922 US00329024 US00315210 US00535428 US00320009 US00331420 US00330124 US0021 0377 US00318859 US00325799 US0021 0273 US00207030 US00320044 US00204595 US00537286 US00537127 US00332886 US00535566 US00100745 US00319650 US00533495 US00318841 US00533657 US00317915 US00202850 US00536892 US00318843 US00207704 US00210513 US00325754 US00203106 US00315485 US00326865 US00321173 US00213174 US00211919 US00212638 US00326380 US00332894 US00323877 US00536275 US00329040 US00322254 US00323857 US00323992 US00325286 US00318953 US00316485 US00212713 US00322009 US00319590 US00325446 US00208162 US00538732 US00214620 US00534465 US00325492 US00213806 US00533397 US00315534 US00534874 US00320910 US00209103 US00331207 US00316653 US00206789 US00536137 US00322621 US00331259 US00330252 US00102443 US00101705 US00538576 US00214885 US00206471 US00323994 US00203695 US00324204 US00205177 US00322253 US00207053 US00206866 US00214311 US00321176 US00320624 US00318965 US00329038 US00329002 US00326408 US00323035 US00316088 US00536897 US00214096 US00320303 US00320679 US00535938 US00324581 US00323989 US00202768 US00318556 US00534797 US00317443 US00212066 US00326793 US00203700 US00212102 US00323977 US00323238 US00330617 US00324000 US00330130 US00323171 US00323432 US00324203 US00212432 US00214048 US00209516 US00534260 US00327982 US00536764 US00537137 US00536926 US00328311 US00323986 US00536274 US00538600 US00327435 US00212437 US00536287 US00204871 US00329487 US00206437 US00101953 US00316641 US00533411 US00325322 US00214180 US00333036 US00322880 US00322340 US00331202 US00535112 US00211032 US00536119 US00331261 US00211010 US00324659 US00535668 US00318558 US00533639 US00209012 US00323990 US00323547 US00321116 US00205648 US00538316 US00320564 US00321 905 US00536138 US00534278 US00324066 US00207728 US00538284 US00329549 US00102692 US00533449 US003151 93 US001 02134 US00326738 US00203866 US00100254 US00317711 US00534283 US0021 0783 US00322940 US00206899 US00329022 US00101297 US00213478 US00202763 US00332945 US00535040 US00537263 US00535263 US00331861 US00207826 US001 00366 US00320058 US00535925 US00320598 US00535826 US00100595 US00538874 US00213567 US00535370 US00211587 US00101923 US00213842 US00206034 US00211123 US00101639 US00101151 US00535295 US00101623 US00318436 US00214201 US00211246 US00204557 US00208856 US00211757 US00206114 US00317042 US00102080 US00207004 US0021 0630 US00330961 US00538307 US00319980 US00207105 US00538726 US00538280 US00332514 US00320811 US00533721 US00325255 US00207645 US00102519 US00206897 US00102715 US00315180 US00330132 US00214797 US00211028 US00101223 US00330579 US00207036 US00536734 US00538424 US00101835 US00317733 US00208727 US00101506 US00202830 US00330224 US00318439 US00203697 US00206249 US00321684 US00101329 US00316316 US00538682 US00332068 US00210775 US00535500 US00332551 US00327962 US00329585 US00208269 US00535518 US00213858 US00332046 US00102347 US00203687 US00329401 US00208414 US00321211 US00537258 US00212184 US00316829 US00214789 US00538725 US00535792 US00316958 US00203686 US00206050 US00203780 US00332662 US00322010 US00331899 US00535262 US001 01504 US00211053 US00331825 US00101745 US00210911 US00323821 US00203806 US00535737 US00206594 US00203099 US00206014 US00208128 US00322187 US00329374 US00535023 US00206391 US00538744 US00328916 US00538511 US00330459 US00318083 US00209782 US00324616 US00214464 US00206261 US00101145 US00317743 US00533733 US00214179 US00321432 US00208815 US00322686 US00206858 US00317906 US00206481 US00317987 US00102647 US00319376 US00534276 US00204046 US00317615 US00316441 US00102628 US00212050 US00102682 US00325534 US0021 0760 US00328002 US00537081 US00316276 US00315990 US00534517 US00306281 US00537792 US00538345 US00321748 US00213255 US00214997 US00324863 US00327537 US00321514 US00204262 US00535783 US00322969 US00318320 US00326018 US00322363 US00323667 US00102680 US00209496 US00537905 US00211732 US00321209 US00209502 US00209497 US00213083 US00316656 US00102648 US00322184 US00327131 US00331603 US00316953 US00213230 US00329558 US00209108 US00329016 US00330254 US00321256 US00203442 US00331318 US00536578 US00213944 US00100950 US00536787 US00536097 US00331227 US00538315 US00320801 US00101824 US00101493 US00100937 US00330440 US00100618 US00538657 US00538810 US00316290 US00330593 US00330982 US00327527 US00322299 US00538806 US00208073 US00207352 US00332748 US00213517 US00322303 US00328290 US00208770 US00536210 US00102673 US00324783 US00534536 US001 01340 US00329516 US00315141 US00322741 US00207957 US00209315 US00316427 US00315228 US00100912 US00328976 US00211518 US0021 0540 US00535002 US00100553 US00100604 US00206040 US00538805 US00315494 US00324548 US00321442 US00212353 US00535298 US00203943 US00211023 US00204563 US00328983 US00538023 US00202753 US00534555 US00213884 US00536020 US00211244 US00202777 US00328099 US00208125 US00206796 US00212921 US00208662 US00324928 US00100613 US00204393 US00321622 US00212080 US00318713 US00317321 US00100623 US00535798 US00210434 US00212168 US00207208 US00322668 US00323014 US00212157 US00319547 US00533573 US00332571 US00209246 US00101139 US00324191 US00317790 US00100755 US00535406 US00317678 US00535381 US00101642 US00316657 US00202846 US00100602 US00211488 US00322199 US00206262 US00100594 US00206449 US00538663 US00324005 US00330223 US00208214 US00325500 US00101497 US00328774 US00533461 US00330438 US00207166 US00212738 US00535616 US00329559 US00537113 US00323071 US0021 0982 US00319076 US00214316 US00214248 US00327132 US00534413 US00333071 US00330889 US00323186 US00331453 US00321788 US00331641 US00537938 US00533418 US00315184 US00535369 US00538812 US0021 0647 US00206870 US00213335 US00535717 US00533698 US00320619 US00536883 US00212834 US00317935 US00208270 US00326475 US00538683 US00206448 US00325359 US00533755 US00325052 US00330070 US00205059 US00320404 US00326744 US00208623 US00321596 US00535533 US00315318 US00212003 US00325491 US00537843 US00318086 US00538785 US00537841 US00327255 US00537842 US00330748 US00330979 US00205827 US00320652 US00332482 US00208215 US00325122 US00533741 US00534832 US00330914 US00209792 US00328370 US00205999 US00329028 US00208166 US00534731 US00323123 US00329087 US00209572 US00208107 US00328121 US00329067 US00536280 US00317577 US00320607 US00534104 US00333117 US00535978 US00328707 US00325438 US00214054 US00533747 US00206996 US00537257 US00319223 US00534233 US00538021 US00324264 US00213565 US00214419 US00331452 US00536006 US00536003 US00212027 US00315344 US00538242 US00536512 US00536483 US00315137 US00327338 US00209614 US00321335 US00212300 US00328516 US00328858 US00329629 US00326698 US00326022 US00323083 US00212004 US00327701 US00535230 US00321682 US00332673 US00317794 US00214795 US00533848 US00208108 US00326568 US00328663 US00325466 US00330178 US00214830 US00213100 US00537834 US00209826 US00206541 US00319926 US00538707 US00316625 US00321751 US00100252 US00102626 US00536222 US00208698 US00538834 US00211322 US0021 0268 US00534735 US00208765 US00537948 US00209111 US00209387 US00213666 US001 01889 US00534553 US00317695

US00206847 US00533650 US00327529 US00214232 US00211529 US00204631 US00323144 US00536589 US00538798 US00208539 US00102517 US00100921 US00332460 US00327251 US00537465 US00208866 US00323413 US00210893 US00535439 US00536737 US00209824 US00329879 US00206013 US00535355 US00209609 US00208221 US00315266 US00534481 US00208072 US00535493 US00101637 US00332961 US00538716 US00320635 US00536087 US00533957 US00536455 US00535817 US00534515 US00332675 US00536445 US00536595 US00538661 US00321742 US00321580 US00325073 US00213172 US00316247 US00535360 US00330586 US00328997 US00100823 US00319033 US00318142 US00100246 US00538814 US00202841 US00321052 US00538342 US00325089 US00331922 US00536598 US00328164 US00211124 US00324004 US00535941 US00327446 US00536188 US00538741 US00536730 US00538423 US00533454 US00327212 US00533456 US00536502 US00535511 US00208426 US00535755 US00538334 US00537880 US00533662 US00535347 US00535843 US00535027 US00332506 US00537317 US00320809 US00318838 US00537754 US00328717 US00328733 US00534261 US00328978 US00206446 US00533636 US00206787 US00537772 US00317961 US00537943 US00207167 US00317265 US00204075 US00330980 US00536230 US00536600 US00329686 US00212772 US00533540 US00206869 US00207074 US00208186 US00323223 US00318239 US00534388 US00329687 US00206160 US00332919 US00322695 US00326795 US00208099 US00206324 US00331582 US00102330 US00535472 US00206039 US00317423 US00331270 US00321927 US00209402 US00535024 US00204408 US00209425 US00537265 US00538821 US00214051 US00538784 US00328999 US00209540 US00213129 US00320269 US00320040 US00533801 US00206156 US00100871 US00328212 US00329685 US00533744 US00327997 US00100939 US00332330 US00202956 US00213535 US00331201 US00208896 US00101640 US00333091 US00317468 US00320152 US00316245 US00537197 US00212574 US00214568 US00535517 US00327289 US00208630 US00208169 US00329001 US00333120 US00100658 US00100941 US00535412 US00323569 US00328934 US00535648 US00534134 US00320612 US00331591 US00327961 US00320602 US00327921 US00534872 US00100155 US00535762 US00208889 US00212329 US00320806 US00536894 US00536271 US00101103 US00535519 US00205108 US00210481 US00322076 US00330599 US00536194 US00534998 US00535440 US00213529 US00203694 US00331236 US00536090 US00329006 US00330985 US00213251 US00101208 US00329398 US00206113 US00327880 US00331231 US00102053 US00101879 US00320208 US00333068 US00317723 US00209974 US00332913 US00321948 US00203674 US00321072 US00323923 US00102107 US00327085 US0021 0270 US00536392 US00209672 US00533770 US00210891 US00213670 US00321306 US00213945 US00202849 US00210262 US00534981 US00323820 US0021 0432 US00102038 US00537768 US00322085 US00316250 US00101100 US00206470 US00212333 US00101922 US00326454 US00204469 US00208504 US00101141 US00208103 US00538774 US00214536 US00331317 US00214998 US00101641 US00213528 US00318774 US00101315 US00203817 US00321076 US00100922 US00534549 US00328168 US00202951 US00316494 US00315087 US00315088 US00101455 US00322701 US00332960 US00206861 US00330076 US00328977 US00536191 US00324550 US00534510 US001 00966 US00319190 US00212662 US00101314 US00538283 US00538786 US00100869 US00214718 US00214470 US00204154 US00536273 US00206483 US00204182 US00318323 US00209124 US00535300 US00212449 US00211 037 US00102512 US00210730 US00315186 US00538696 US00537188 US00101620 US00101203 US00330602 US00327573 US00323406 US00329989 US00537733 US00328134 US00332283 US00538827 US00330020 US00330573 US00209398 US00208917 US00324436 US00536604 US00538778 US00535930 US00318526 US00535082 US00535380 US00320489 US00538719 US00536601 US00538664 US00535765 US00315923 US00318034 US00328786 US00204560 US00536017 US00204403 US00533229 US00213079 US00212023 US00206830 US00101201 US00317052 US00535411 US00317517 US00206256 and US00100830
RECALLING FIRM/MANUFACTURER
Philips Healthcare Inc., Andover, MA, by letter on March 4, 2010. Firm initiated recall is ongoing.
REASON
Batteries older than 2 years have a higher potential for intermittent electrical contact, may contribute to an interruption in monitoring or therapy if the monitor/defibrillator is operating on battery.
VOLUME OF PRODUCT IN COMMERCE
37,674 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
1) V-Probe, Endocare Cryo V Probe model # Cryo 206V. The product is used in a minimally invasive, percutaneous approach to treating prostate cancer in low, moderate and high risk patients. Prostate Cryoablation uses extremely cold temperatures to destroy cancerous tissue. Recall # Z-1400-2010;

2) V-Probe, Endocare Cryo V Probe, single unit model # CVA2400. The product is used in a minimally invasive, percutaneous approach to treating prostate cancer in low, moderate and high risk patients. Prostate Cryoablation uses extremely cold temperatures to destroy cancerous tissue. Recall # Z-1401-2010
CODE
1) Lot Numbers 08-0522;
2) Lot Numbers 08-0539
RECALLING FIRM/MANUFACTURER
Endocare, a Wholly Owned Subsidiary of HealthTronics, Inc., Irvine, CA, by letter on December 5, 2008. Firm initiated recall is complete.
REASON
Endocare received a report of a patient death that occurred during a prostate cryoablation procedure. An autopsy attributed the cause of death to an air embolism. The safety notice for the cryoprobes was issued to refocus attention on the Indications and Safety Review included with the Physician Training Materials and to reinforce additional safety information.
VOLUME OF PRODUCT IN COMMERCE
22,741 units
DISTRIBUTION
Nationwide

___________________________________
PRODUCT 
1) CELL-DYN 1700, list numbers 03H5301 and 03H53-03. Recall # Z-1628-2010;

2) CELL-DYN 1700CS (Closed Sampler), list numbers 03H57-01, 03H57-03. Recall # Z-1629-2010;

3) CELL-DYN 1800, list numbers 07H77-01, 07H77-03. Recall # Z-1630-2010
CODE
1) Control Number 53278U96 53388U96 54924U96 50092U96 50230U96 50411U96 50617U96 50690U96 50770U96 50829U96 50849U96 50863U96 50867U96 50964U96 51012U96 51059U96 51160U96 51243U96 51484U96 51498U96 51509U96 51583U96 51828U96 51873U96 51886U96 51918U96 52119U96 52199U96 52294U96 52297U96 52364U96 52383U96 52390U96 52611U96 52716U96 52832U96 52894U96 53022U96 53069U96 53187U96 53238U96 53243U96 53280U96 53285U96 53307U96 53327U96 53431U96 53474U96 53481U96 53543U96 53582U96 53627U96 53647U96 53705U96 53787U96 53790U96 53796U96 53803U96 53818U96 53916U96 54017U96 54044U96 54133U96 54156U96 54177U96 54194U96 54198U96 54211U96 54266U96 54298U96 54302U96 54329U96 54371U96 54380U96 54384U96 54432U96 54448U96 54450U96 54468U96 54489U96 54499U96 54518U96 54563U96 54578U96 54587U96 54590U96 54591U96 54606U96 54611U96 54618U96 54687U96 54702U96 54732U96 54743U96 54744U96 54745U96 54747U96 54762U96 54774U96 54790U96 54806U96 54818U96 54839U96 54893U96 54904U96 54951U96 54953U96 54967U96 54968U96 54982U96 55067U96 55132U96 55147U96 55185U96 55205U96 55266U96 55299U96 55303U96 55308U96 55311U96 55344U96 55400U96 55428U96 55466U96 55510U96 55511U96 55519U96 55520U96 55522U96 55523U96 55552U96 55555U96 55622U96 55639U96 55644U96 55679U96 55804U96 55805U96 55844U96 55866U96 55869U96 55880U96 55955U96 55961U96 56110U96 56140U96 56145U96 56164U96 56169U96 56204U96 56269U96 56365U96 56393U96 56407U96 56418U96 56424U96 56478U96 56495U96 56500U96 56604U96 56625U96 56658U96 56690U96 56699U96 56728U96 56772U96 56820U96 56821U96 56840U96 56846U96 56848U96 56859U96 56861U96 56870U96 56872U96 56873U96 56934U96 56941U96 56980U96 56981U96 56986U96 56991U96 56994U96 57107U96 57141U96 57142U96 57170U96 57187U96 57230U96 57262U96 57331U96 57335U96 57360U96 57403U96 57564U96 57565U96 57566U96 57567U96 57568U96 57569U96 57563U96 51565U96 51593U96 51913U96 51982U96 52098U96 53587U96 53988U96 54041U96 54117U96 55003U96 55080U96 55242U96 55262U96 55268U96 55277U96 55598U96 55631U96 55673U96 55757U96 55815U96 56692U96 56866U96 57334U96 55155U96 55236U96 55294U96 55385U96 55410U96 55413U96 55421U96 55912U96 55964U96 56015U96 562217U96 56567U96 56734U96 56835U96 57437U96 55292U96 56757U96 50368U96 50373U96 50826U96 51175U96 51647U96 52737U96 53273U96 53500U96 53663U96 53670U96 53717U96 53732U96 53862U96 54247U96 55018U96 55032U96 55274U96 55305U96 55342U96 55412U96 55642U96 55794U96 56175U96 56188U96 56248U96 56334U96 56380U96 56526U96 56541U96 56982U96 53389U96 54287U96 55295U96;

2) Control Number 42285V 42283V 42261V 42262V 42279V 42184V96 40655V96 42268V 42284V 42267V 40437V96;

3) Control Number 22705AY 23367AY 21349AY 22226AY 22131AY 21197AY 20412AY 22688AY 22706AY 21347AY 22017AY 21936AY 21354AY 22480AY 23795AY 22673AY 22694AY 23702AY 21758AY 23355AY 21957AY 22013AY 23536AY 21087AY 21975AY 22752AY 20808AY 23145AY 21974AY 22675AY 20437AY 20667AY 20651AY 20773AY 20774AY 20269AY 21922AY 23029AY 22225AY 20623AY 22000AY 23281AY 22720AY 22954AY 20418AY 20413AY 20906AY 21122AY 21124AY 21218AY 21155AY 21185AY 21286AY 21346AY 21732AY 21730AY 21769AY 22204AY 22230AY 21925AY 21888AY 21923AY 21995AY 22001AY 22050AY 22192AY 22255AY 23559AY 20032AY96 22572AY 22607AY 22608AY 22587AY 22598AY 22684AY 22634AY 22794AY 22882AY 21076AY96 23063AY 23222AY 23127AY 23131AY 23205AY 23180AY 23375AY 23472AY 23468AY 23481AY 23659AY 22397AY 23055AY 22452AY 21287AY 23731AY 23350AY 23564AY 23560AY 22538AY 22775AY 23798AY 22820AY 20333AY 23211AY 20910AY 20880AY 21309AY 23219AY 21890AY 22008AY 22109AY 22016AY 22126AY 22209AY 22327AY 22537AY 23147AY 22827AY 23025AY 22816AY 23092AY 23057AY 23215AY 23372AY 23563AY 23621AY 21739AY 22438AY 22328AY 20753AY 21307AY 21300AY 21301AY 21304AY 21297AY 21305AY 21288AY 21302AY 21303AY 21294AY 21295AY 21299AY 21750AY 21751AY 21902AY 22179AY 21903AY 21973AY 22222AY 22991AY 22261AY 22331AY 22504AY 22503AY 23070AY 23266AY 23080AY96 23534AY 23666AY 20835AY 22233AY 21224AY 21232AY 21212AY 21207AY 21276AY 23027AY 22220AY 21145AY 23831AY 23122AY 20113AY 23324AY 22536AY 21143AY 23056AY 21335AY 22709AY 21125AY 22336AY 22361AY 21308AY 22355AY 22459AY 20349AY 22567AY 22911AY 20994AY 21560AY 21213AY 20672AY 20659AY 21381AY96 22369AY 22843AY 23229AY 21928AY 22415AY 21478AY 21555AY 21790AY 22823AY 22499AY 22359AY 21734AY 21948AY 21969AY 22818AY 21566AY 23309AY 23059AY 21000AY 22707AY 21373AY 23541AY 23565AY 23631AY 23440AY 23524AY 23514AY 23542AY 23762AY 23763AY 22101AY 21850AY 23317AY 22219AY 20334AY 20656AY 20914AY 20840AY 21078AY 20836AY 20905AY 21280AY 21170AY 21277AY 21479AY 21704AY 21756AY 21822AY 21802AY 21809AY 21955AY 23745AY 22100AY 22103AY 22114AY 22106AY 22243AY 22376AY 22446AY 23357AY 22445AY 22468AY 22470AY 22511AY 22642AY 22725AY 22780AY 23476AY 22846AY 22960AY 23015AY 23062AY 23053AY 23383AY 23186AY 23207AY 23236AY 19165AY96 23374AY 23379AY 23459AY 23549AY 23752AY 23723AY 22442AY 21749AY 22533AY 22494AY 23486AY 22777AY 21753AY 22393AY 22753AY96 22993AY 23276AY 23555AY 23457AY 23310AY 22681AY 22678AY 23578AY 23704AY 23567AY 20746AY 23828AY 23829AY 23668AY 22680AY 22676AY 22677AY 21947AY 22231AY 22248AY 23660AY 22679AY 23237AY 22682AY 22732AY 23436AY 22612AY 20730AY 23467AY 22790AY 20784AY 20839AY 20806AY 20807AY 20841AY 23785AY 22414AY 22290AY 22213AY 22217AY 22400AY 22357AY 22793AY 23832AY 23079AY 22890AY 20763AY 21891AY 21152AY 23581AY 22606AY 22426AY 22181AY 22758AY 21396AY 23244AY 22782AY 20253AY96 20242AY 23227AY 23020AY 23132AY 20741AY 20747AY 23620AY 22674AY 20311AY 23395AY 21794AY 21846AY 21904AY 22546AY 23435AY 20769AY 22451AY 21725AY 22631AY 22580AY 23287AY 22778AY 21998AY96 20931AY 23398AY 23441AY 23465AY 23477AY 20648AY 23445AY 20252AY 20237AY 22395AY 20243AY 20234AY 21001AY 20770AY 22829AY 21380AY 23354AY 20270AY 23474AY 20257AY 20795AY 20608AY 20640AY 20686AY 20789AY 21069AY 21113AY 21117AY 21127AY 21126AY 21131AY 21193AY 21818AY 21361AY 21370AY 22887AY 21737AY 21832AY 21855AY 21883AY 21899AY 21884AY 21961AY 21965AY 21939AY 21930AY 22032AY 22041AY 22098AY 22096AY 22130AY 22176AY 22218AY 22270AY 22262AY 22299AY 23199AY 22353AY 22405AY 22406AY 22425AY 22453AY 22485AY 22785AY 22764AY 22912AY 22831AY 22832AY 22884AY 22920AY 23002AY 23040AY 23037AY 23038AY 23141AY 23178AY 23179AY 23225AY 23311AY 23407AY 23464AY 23462AY 23469AY 23580AY 23635AY 23667AY 23682AY 23693AY 23782AY 23823AY 23822AY 22242AY 21377AY 21375AY 20272AY 23088AY 22487AY 23101AY 21003AY 22749AY 22746AY 23574AY 22751AY 22737AY 22443AY 23724AY 22352AY 23482AY 22750AY 23005AY 23129AY 21962AY 20416AY 23840AY 21963AY 23537AY 23487AY 22734AY 23334AY 23332AY 23325AY 21992AY 23584AY 21763AY 23747AY 23437AY 23008AY 22417AY 21210AY 20330AY 23722AY 20649AY 23373AY 21104AY 23576AY 21116AY 22433AY 21369AY 23566AY 23539AY 21773AY 23573AY 22411AY 21924AY 22146AY 22268AY 23019AY 22314AY 22766AY 22753AY 21898AY 23004AY 23001AY 23333AY 22107AY 23226AY 23204AY 23061AY 23552AY 23456AY 23000AY 23628AY 23725AY 21073AY 22003AY 21475AY 23516AY 21919AY 20261AY 20240AY 20249AY 20228AY 20251AY 20383AY 20369AY 20609AY 20626AY 20751AY 20796AY 21764AY 20776AY 20932AY 21119AY 21362AY 21721AY 22110AY 21357AY 21374AY 21367AY 21710AY 21755AY 21878AY 21851AY 21934AY 22033AY 21983AY 21993AY 22053AY 22054AY 22124AY 22159AY 22221AY 22280AY 22323AY 20437AY96 22570AY 22650AY 22781AY 22754AY 22784AY 22783AY 22788AY 22802AY 22826AY 22913AY 22847AY 22910AY 23009AY 23185AY 23213AY 23418AY 23451AY 23455AY 23498AY 23540AY 23550AY 23605AY 23690AY 23797AY 23796AY 20900AY 21296AY 22027AY 23208AY 18293AY96 23321AY 22256AY 21174AY 21791AY 23260AY 23411AY 23671AY 23438AY 22341AY 23432AY 23743AY 20382AY 21283AY 23105AY 22585AY 22626AY 22801AY 23071AY 23228AY 23343AY 23439AY 23470AY 23535AY 22814AY 20253AY 22244AY 21348AY 20641AY 22888AY 23586AY 21746AY 20321AY 20125AY 18091AY96 21848AY 23273AY 22271AY 22029AY 22800AY 22529AY 23595AY 22031AY 20613AY 20780AY 21558AY 21389AY 21747AY 21880AY 22030AY 22147AY 22387AY 22578AY 22736AY 22688AY96 23328AY 23152AY 22360AY 20785AY 22045AY 20787AY 22449AY 20788AY 22418AY 21765AY 22708AY 23090AY 20312AY 20804AY 21153AY 21282AY 21289AY 21699AY 22795AY 22838AY 23081AY 23607AY 22202AY 22047AY 23488AY 22620AY 22048AY 21180AY 21171AY 23272AY 21368AY 20911AY 23134AY 22454AY 22274AY 21331AY 21525AY 21378AY 23670AY 20764AY 22733AY 22174AY 21148AY 23336AY 22432AY 23039AY 22923AY 21738AY 20308AY 21076AY 21339AY 21066AY 21382AY 21757AY 21896AY 22039AY 22118AY 22265AY 22506AY 23151AY 23177AY 23200AY 23318AY 23577AY 20759AY 22845AY 22391AY 23728AY 22535AY 20109AY 23261AY 22571AY 22568AY 22272AY 22356AY 22166AY 22881AY 22463AY 22813AY 23303AY 23366AY 23143AY 22149AY 22153AY 20762AY 21200AY 21385AY 21532AY 22155AY 21736AY 21852AY 21881AY 21893AY 22015AY 22171AY 22259AY 22364AY 22444AY 22611AY 22704AY 22739AY 22812AY 23282AY 23308AY 22481AY 20939AY 22214AY 21278AY 21106AY 21211AY 22129AY 23629AY 22121AY 21913AY 23413AY 23064AY 23448AY 23447AY 23446AY 20339AY 20422AY 20908AY 21707AY 21989AY 23018AY 23017AY 23203AY 23231AY 23233AY 23232AY 23655AY 23687AY 20744AY 21359AY 20654AY 23320AY 23377AY 20738AY 21892AY 22025AY 22026AY 22037AY 22115AY 22565AY 22619AY 23285AY 23504AY 23616AY 23744AY 22424AY 22440AY 22958AY 21754AY 22343AY 23121AY 23022AY 21991AY 22461AY 21977AY 20923AY 23196AY 22972AY 21393AY 21760AY 21831AY 21876AY 22224AY 22236AY 23269AY 22683AY 23556AY 19123AY96 23696AY 22943AY 20907AY 23192AY 23617AY 23633AY 22402AY 21186AY 22472AY 22477AY 22476AY 22478AY 22508AY 23135AY 21337AY 22757AY 20876AY 20874AY 21150AY 22095AY 22606AY96 23277AY 20663AY 22833AY 22319AY 22321AY 23074AY 22183AY 20765AY 21188AY 22022AY 21189AY 21187AY 23198AY 23191AY 23197AY 23194AY 23193AY 23195AY 21184AY 23218AY 23190AY 23278AY 21191AY 21172AY 21179AY 21306AY 21557AY 22804AY 21931AY 22111AY 22501AY 22475AY 22563AY 22741AY 22791AY 23058AY 23120AY 23149AY 23202AY 23201AY 23312AY 23753AY 21330AY 22484AY 23360AY 21340AY 22464AY 23359AY 23403AY 20743AY 21735AY 21927AY 21857AY 23148AY 22825AY 22342AY 20419AY 20740AY 21329AY 21352AY 21386AY 21364AY 21834AY 22160AY 22817AY 23230AY 23340AY 23431AY 23662AY 23836AY 20754AY 21358AY 23307AY 23344AY 21342AY 22252AY 22962AY 23406AY 23458AY 21423AY 21958AY 20274AY 22479AY 20668AY 20424AY 21262AY 22662AY 22390AY 23444AY 23130AY 22687AY 23729AY 22797AY 20646AY 21387AY 21406AY 21726AY 22205AY 22206AY 22254AY 22273AY 22287AY 22412AY 22672AY 22690AY 22637AY 23026AY 23069AY 23369AY 23450AY 23499AY 23525AY 23521AY 23568AY 23740AY 21801AY 20175AY 21839AY 22673AY96 22354AY 22447AY 21204AY 21115AY 22718AY 21886AY 21740AY 22748AY 21981AY 22117AY 23094AY 23471AY 22507AY 23235AY 23463AY 23461AY 23089AY 22961AY 21068AY 23021AY 20761AY 19714AY96 22940AY 20103AY 20611AY 23449AY 21940AY 22772AY 20661AY 22489AY 22279AY 22344AY 22419AY 21911AY 22819AY 22916AY 23384AY 23443AY 23703AY 20360AY 20312AY 20786AY 21071AY 21123AY 21291AY 21142AY 21700AY 21935AY 21895AY 22116AY 22246AY 22377AY 22379AY 22398AY 22617AY 22633AY 22743AY 22907AY 22973AY 22996AY 22999AY 23091AY 23184AY 23434AY 23223AY 23221AY 23275AY 23363AY 23401AY 23430AY 23748AY 23736AY 23739AY 20384AY 23738AY 21154AY 22372AY 21789AY 22803AY 22956AY 23183AY 23570AY 20335AY 22348AY 22293AY 22267AY 23286AY 23632AY 22717AY 22805AY 21198AY 21944AY 22640AY 21310AY 22370AY 22941AY 22547AY 20250AY 23634AY 23783AY 20779AY 22915AY 20768AY 23794AY 21190AY 22211AY 21748AY 22286AY 23837AY 20732AY 22325AY 23414AY 21918AY 21733AY 22320AY 20650AY 21360AY 20913AY 21705AY 22455AY 22456AY 22789AY 22955AY 23013AY 23214AY 23265AY 23638AY 23727AY 21741AY 21372AY 23475AY 21920AY 21328AY 23460AY 23582AY 22002AY 22156AY 22172AY 23618AY 21014AY 21422AY 21979AY 22773AY 23083AY 23378AY 23619AY 22408AY 22721AY 20107AY 23126AY 20755AY 23585AY 23331AY 23224AY 23397AY 20340AY 20341AY 23757AY 23656AY 23630AY 20652AY 21853AY 22235AY 23364AY 22510AY 23527AY 22164AY 23642AY 20940AY 22227AY 23497AY 22686AY 23533AY 23068AY 22719AY 23732AY 21379AY 23641AY 23526AY 20750AY 23551AY 20224AY 19236AY96 21854AY 23358AY 20233AY 23528AY 21793AY 21151AY 22123AY 22215AY 21067AY 22337AY 22945AY 21070AY 22798AY 23548AY 22322AY 22410AY 22486AY 23146AY 22237AY 23270AY 23538AY 22742AY 23608AY 23830AY 23531AY 23532AY 23834AY 23833AY 23012AY 21181AY 20644AY 20645AY 20748AY 23279AY 21121AY 21350AY 21343AY 21667AY 21702AY 21908AY 22119AY 22384AY 23530AY 22374AY 22767AY 22917AY 22914AY 23011AY 23030AY 23150AY 23080AY 23104AY 23142AY 23368AY 23396AY 23575AY 23579AY 23663AY 23799AY 22407AY 22366AY 22409AY 22413AY 22434AY 22437AY 22448AY 23558AY 23410AY 22104AY 21972AY 23342AY 22253AY 22264AY 22332AY 21984AY 22189AY 23174AY 23124AY 23124AY 23137AY 21192AY 21112AY 22052AY 22223AY 23742AY 23522AY 23746AY 22240AY 22774AY 22428AY 22671AY 20386AY 22423AY 22747AY 21549AY 22808AY 22441AY 21910AY 22362AY 23023AY 22609AY 23082AY 22756AY 20444AY 20683AY 20912AY 21105AY 21118AY 21273AY 21298AY 21395AY 21725AY 21766AY 21759AY 21849AY 21860AY 21897AY 22169AY 22163AY 22232AY 22257AY 22297AY 22385AY 22389AY 22422AY 22450AY 19991AY96 23442AY 23480AY 21946AY 21743AY 22420AY 22229AY 22006AY 22234AY 20655AY 23609AY 20775AY 22740AY 23007AY 21132AY 21674AY 22158AY 22283AY 22909AY 22908AY 22239AY 22771AY 23553AY 22992AY 22350AY 20309AY 21353AY 21365AY 22702AY 21175AY 21381AY 22318AY 21548AY 22466AY 23515AY 21345AY 21994AY 22102AY 22105AY 22786AY 23054AY 23274AY 22212AY 22241AY 21147AY 22997AY 21952AY 21926AY 22509AY 22787AY 23128AY 23386AY 23095AY 23569AY 23781AY 20844AY 23643AY 23316AY 23315AY 22460AY 21182AY 21183AY 21178AY 20647AY 21847AY 21676AY 23341AY 23140AY 22345AY 22269AY 22768AY 23073AY 23024AY 23102AY 23100AY 23677AY 22170AY 23622AY 21341AY 23216AY 22429AY 20286AY 20332AY 20273AY 20436AY 20368AY 20614AY 20637AY 20660AY 20658AY 20729AY 20739AY 21201AY 21203AY 21351AY 21344AY 21932AY 21929AY 21942AY 21960AY 22112AY 22287AY96 22635AY 22715AY 23099AY 22957AY 23041AY 23144AY 23319AY 23495AY 23554AY 21274AY 21708AY 20760AY 20756AY 21072AY 21856AY 22505AY 22689AY 22700AY 22844AY 22770AY 23500AY 22201AY 23042AY 20777AY 23501AY 23640AY 23330AY 23096AY 23502AY 22396AY 20323AY 20901AY 22473AY 22469AY 22482AY 22942AY 23764AY 21528AY 21392AY 23419AY 23483AY 22474AY 21293AY 22776AY 23484AY 21987AY 22210AY 23217AY 22815AY 20783AY 22569AY 21949AY 21394AY 22458AY 23210AY 23513AY 23329AY 23503AY 22300AY 23761AY 23637AY 23694AY 23557AY 23838AY 20350AY 22275AY 20752AY 20915AY 20778AY 21086AY 21327AY 21356AY 21363AY 21334AY 21338AY 21533AY 21561AY 21761AY 21819AY 21833AY 21838AY 21841AY 21840AY 21964AY 21982AY 22120AY 21999AY 22099AY 22108AY 22277AY 22165AY 22326AY 22378AY 22373AY 22388AY 22427AY 22577AY 22605AY 22625AY 22692AY 22744AY 22792AY 22799AY 22765AY 22810AY 22842AY 23103AY 23097AY 23175AY 23220AY 23267AY 23313AY 23348AY 23370AY 23466AY 23479AY 23669AY 23711AY 23721AY 23726AY 23754AY 23758AY 22755AY 20278AY 21706AY 21333AY 21336AY 23691AY 23485AY 20997AY 21290AY 21745AY 23014AY 21199AY 21943AY 20734AY 22462AY 22998AY 22467AY 21114AY 21397AY 23087AY 21666AY 23085AY 23611AY 21985AY 22562AY 20108AY 21205AY 20106AY 22349AY 22004AY 20256AY 21990AY 22622AY 22208AY 22841AY 22133AY 20235AY 23206AY 22946AY 20662AY 20669AY 21835AY 20356AY 23115AY 20851AY 21146AY 21889AY 20903AY 22416AY 21075AY 21703AY 22046AY 22614AY 22483AY 22964AY 22430AY 22439AY 22125AY 21726AY 23181AY 22557AY 23123AY 22886AY 22207AY 23689AY 22848AY 22564AY 23654AY 22691AY 21986AY 23084AY 23016AY 22222AY96 23784AY 18671AY96 22839AY 20665AY 20666AY 23453AY 23835AY 23454AY 23452AY 22340AY 22921AY 22457AY 21120AY 22716AY 20364AY 20105AY 20277AY 20111AY 20857AY 20425AY 23133AY 20610AY 20733AY 20664AY 20684AY 20731AY 21384AY 20749AY 20766AY 20767AY 20909AY 20995AY 21107AY 21149AY 21202AY 21281AY 21292AY 21371AY 21390AY 21388AY 22005AY 21531AY 21556AY 21687AY 21688AY 22435AY 21752AY 21709AY 21744AY 21827AY 21869AY 21901AY 21950AY 21907AY 22065AY 21988AY 21998AY 22266AY 22245AY 22228AY 22238AY 22278AY 23234AY 22324AY 22347AY 22556AY 22363AY 22380AY 22399AY 22403AY 22431AY 22436AY 22550AY 22549AY 23072AY 22566AY 22586AY 22613AY 22779AY 22769AY 22796AY 22806AY 22822AY 22922AY 22918AY 22939AY 22951AY 23006AY 23028AY 23078AY 23086AY 23098AY 23209AY 23314AY 23323AY 23349AY 23361AY 23365AY 23385AY 23433AY 23473AY 23523AY 23572AY 23610AY 23612AY 23613AY 23614AY 23615AY 23688AY 23737AY 23751AY 23843AY 23326AY 20736AY 20902AY 20790AY 21129AY 22113AY 22250AY 22285AY 22959AY 23060AY 23138AY 23376AY 21383AY 23730AY 22539AY 22542AY 23676AY 21366AY 21877AY 21284AY 21882AY 21009AY 23673AY 23661AY 22150AY 23335AY 20992AY 22191AY 19120AY96 23735AY 22534AY 22132AY 21285AY 22317AY 21981AY96 23093AY 23639AY 22315AY 20283AY 20737AY 20745AY 21173AY 21162AY 21196AY 21271AY 21355AY 21376AY 21701AY 21555AY

21675AY 21742AY 21800AY 21799AY 22154AY 22216AY 22386AY 22368AY 22471AY 22541AY 22544AY 22584AY 22919AY 23003AY 23136AY 22960AY96 23382AY 23692AY 23672AY 23664AY 23665AY 23674AY 18959AY96 23242AY 21279AY 22375AY 23243AY 23681AY 20653AY 22745AY 22517AY 23327AY 21956AY 22394AY 23680AY 23679AY 21729AY 22247AY 22465AY 23337AY 23675AY 21698AY 22346AY 22421AY 23189AY 20357AY 21265AY 21264AY 22145AY 22263AY 22298AY 22306AY 23734AY 23571AY 22809AY 21712AY 23176AY 22735AY 23733AY 20245AY 20104AY 21941AY 22188AY 22404AY 23529AY 22028AY 22610AY 23678AY 22963AY 21762AY
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Santa Clara, CA, by letters beginning June 8, 2009. Firm initiated recall is ongoing.
REASON
Use of Syringe LN 04H36-01 with the Die-cast syringe drive may result in leakage, leading to delay in reporting patient results.
VOLUME OF PRODUCT IN COMMERCE
4,114 units
DISTRIBUTION
Nationwide, Canada, Mexico, Anguilla, Australia, Argentina, Belize, Bernmuda, Brazil, China, Chile, Columbia, Costa Rica, Ecuador, El Salvador, Germany, Guatemala, Haiti, Honduras, Hong Kong, Japan, Paraguay, Peru, Puerto Rico, Singapore, South Korea, Uruguay, and Venezuela
___________________________________
PRODUCT 
Voiceware clip software update to certain Horizon Medical Imaging Systems. Intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video and associated medical information from various medical imaging systems. Recall # Z-1735-2010
CODE
Horizon Medical Imaging (HMI) versions: 4.5, 4.6.1, 5.0 without PTF-RR310-601, 11.0.3, 11.0.4, 11.0.5, 11.0.6, 11.0.6 FR EXP2 without PTF-HMI11-649, 11.0.7, 11.0.8 without PTF-HMI11-615, 11.5 and 11.5.1 without PTF-HMI115-613
RECALLING FIRM/MANUFACTURER
Mckesson Medical Imaging, Richmond British Columbia, Canada, by letter dated May 7, 2010. Firm initiated recall is ongoing.
REASON
Voice Clip issue: When the user is recording voice clips in Horizon Rad Station, there is a potential for voice clips to be saved to the incorrect study of the same patient.
VOLUME OF PRODUCT IN COMMERCE
100 units
DISTRIBUTION
Nationwide and Canada

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS III
___________________________________
PRODUCT 
Rabbit Kidney Culture, brand name: 'FreshCells'. The product is labeled as 'Rabbit Kidney' also known as 'Rbk', 2-square cm area of a cell monolayer covered with 2-mL culture medium. The product is packed in glass culture tubes 16x125mm, with screw caps. The product is distributed in EPS shipping racks which can hold up to 50 tubes each. Used routinely for in vitro diagnostic testing for virus and/or Chlamydia isolation and to aid in the diagnosis of diseases associated with infectious agents. Catalog Number: 48-0600. Recall # Z-0822-2010
CODE
Lot #480109
RECALLING FIRM/MANUFACTURER
Diagnostic Hybrids Inc., Athens, OH, by letter dated January 23, 2009 and verbal communication beginning January 21, 2009. Firm initiated recall is ongoing.
REASON
During QC post release monitoring, the firm determined that the monolayer culture of rabbit kidney cells previously distributed by the firm, appeared to contain another type of cells (monkey kidney cells).
VOLUME OF PRODUCT IN COMMERCE
1,127 units
DISTRIBUTION
CA, FL, GA, MA, MO, NY, NJ, TN, TX, VA, and Ontario Canada and Manitoba Canada.
___________________________________
PRODUCT 
Aplicare Advantage Dressing Change System, Central Line Dressing Change, Sterile Part number: A3402. The product is used for Central Line Dressing Change. Recall # Z-1310-10
CODE
Lot number: 35397
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aplicare, Inc., Meriden, CT, by telephone and letter on March 3, 2010.
Manufacturer: Aplicare, Inc., Prichard, WV. Firm initiated recall is complete.
REASON
Incorrect expiration date on outer kit label-extended.
VOLUME OF PRODUCT IN COMMERCE
103 cases (20 each)
DISTRIBUTION
CT, RI, NJ, OH
___________________________________
PRODUCT 
1) KODAK T-MAT L/RA Film, Catalog/REF # 181 4631, 35x43 cm 5-100 Sheet Boxes Folhas/Hojas, Device Listing # E420904 Intended use: Imaging film. Recall # Z-1314-2010;

2) KODAK T-MAT G/RA Film, Catalog/REF # 151 0023, 24x30 cm, 5-100 Sheet Boxes FOLHAS/Hojas, Device Listing # E420904 Intended use: Imaging film. Recall # Z-1315-2010
CODE
1) Lot 533 012;
2) Lot 835 021
RECALLING FIRM/MANUFACTURER
Recalling Firm: Carestream Health, Inc., Rochester, NY, by letters dated March 12, 2010 and by email beginning on March 12, 2010.
Manufacturer: Carestream Health, Inc., White City, OR. Firm initiated recall is ongoing.
REASON
Product mix-up. The firm received a customer complaint indicating that the customer had opened a box of film and although it was supposed to be T-MAT L/RA, it was performing like T-MAT G/RA.
VOLUME OF PRODUCT IN COMMERCE
1,435 units
DISTRIBUTION
Nationwide, Australia, Canada, Chile, El Salvador, Honduras, and New Zealand

  RECALLS AND FIELD CORRECTIONS: VETERINARY – CLASS II
___________________________________
PRODUCT 
Estrumate Solution for Injection (Cloprostenol sodium equivalent to 250 ug/mL) An Analogue of Prostaglandin F2 for Intramuscular Injection in Beef and Dairy Cattle. NDC: 0061-1266-05. Recall # V-187-2010 
CODE
Lot number 7571101, Exp. 5/20/2010; 7580101, Exp 5/20/2010; 7625101, Exp 7/20/2010, 7626101, Exp 7/20/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Intervet Schering-Plough Animal Health, Roseland, NJ, by letters on May 26, 2010.   
Manufacturer: Essex Animal Health Friesoythe, Friesoythe, Germany. Firm initiated recall is ongoing.
REASON
Presence of particles in specific lots of Estrumate (cloprostenol sodium ) Injection.
VOLUME OF PRODUCT IN COMMERCE
28,205 vials
DISTRIBUTION
OH, MO, AR, CO, TX. MN, ID, SD, OK, PA, NE, FL, KS, IA, CA, MA

END OF ENFORCEMENT REPORT FOR JUNE 16, 2010

#