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U.S. Department of Health and Human Services

Safety

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Enforcement Report for October 7, 2009

October 7, 2009
09-40

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I

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PRODUCT 
Bad Byron's Butt Rub Barbeque Seasoning Roasted Peanuts Net WT. 12 oz (340g). Packaged in a resealable can w/12 cans per case. All Natural Made in the USA with Domestic Peanuts, UPC 44923 58599. (Can with a PR on the bottom is not subject to recall). Recall # F-1244-9    
CODE
Cans with PR imprinted on the bottom are not subject to recall.
RECALLING FIRM/MANUFACTURER
Bad Byron's Specialty Food Products, Inc., Santa Rosa Beach, FL, by email, letter, and recall notice posted on website on February 13, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,487 cases
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
1) Bliss Brothers Dairy Witch's Brew Ice Cream packaged in half gallon and 3 gallon containers. Recall # F-1245-9;

2) JJ Lawson Brand Snickers Ice Cream packaged in 3 gallon. Recall # F-1246-9
CODE
1) Lot #: 8252 & 8273;
2) Lot #’s: 8109, 8147 & 8218
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bliss Bros Dairy, Inc., Attleboro, MA, by telephone on January 30, 2009 and press release on February 23, 2009.
Manufacturer: Star Kay White, Inc., Congers, NY. Firm initiated recall is complete.
REASON
Product was manufactured using peanut products recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
977 -1/2 gallon; 41 units 3-gallon Witches Brew; 165 -3 gallon Snickers
DISTRIBUTION
MA, RI, CT, NH, and ME
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PRODUCT 
Snack bar. Roman Meal Whole Grain & Fruit Dark Chocolate Peanut Butter Snack Bars, packaged in plastic wrapper. Paperboard Retail caddy case contains 12 bars. Individual bar UPC Code 41511 16002. Individual Wrapper front reads in part: "Whole grain & fruit, Roman Meal, dark chocolate peanut butter snack bars, net wt 2 oz (57 g)" Wrapper back reads in part: "INGREDIENTS: WHOLE GRAIN OATS, SEMI-SWEET CHOCOLATE CHIPS, RAISINS, DATES, PEANUT BUTTER...NATURAL FLAVOR, For information about Whole Grain Rewards visit www.romanmeal.com, ". 12 bar caddy top of box reads in part: "Whole grain & fruit, Roman Meal, dark chocolate peanut butter snack bars, 12 - 2 oz (57 g) bars net wt 24 oz (684 g)." Caddy case UPC Code 41511 16102. Recall # F-1247-9
CODE
Best Before 22JUN09A. "Best Before" date is printed on back of individual wrapper and on the right side panel of the display caddy
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roman Meal Co Inc., Tacoma, WA, by e-mail and telephone on February 27, 2009 and March 3, 2009 and by press release and letter dated March 3, 2009 and letter dated March 4, 2009. 
Manufacturer: Bloomfield Bakers, Los Alamitos, CA. Firm initiated recall is complete.
REASON
Product was manufactured using peanut products recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
20,304/2 oz bars
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) The Jewel Date Company 100% Organic Peanut Date Roll, 12 oz. consumer packaged in a plastic produce style clamshell (12) containers per case. Refrigerate after opening. 2) The Jewel Date Company 100% Organic Peanut Date Roll, 15 lb bulk, stored in a 2 piece cardboard container. Refrigerate after opening. Recall # F-1248-9
CODE
1) Lot #’s: JE3257, JE0148, JE0158, JE2628, JE2988, JE3018, JE0079, JE0089; 2) Lot #’s: JE0158, JE2618, JE2668, JE0079
RECALLING FIRM/MANUFACTURER
Jewel Date Co. Inc., Thermal, CA, by e-mail and telephone on February 13, 2009 and by e-mail on February 24, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
2655 lbs/281 cases total
DISTRIBUTION
CA, DE, IL, & MN
___________________________________
PRODUCT 
1) Ultimate Nut & Candy Co. Sugar Free & Low Carb Milk Peanut Butter Cups, 5oz bags. Recall # F-1249-9;

2) Ultimate Confections Peanut Butter Crisp (A Chocolate Bark), 16 oz. Recall # F-1250-9;

3) Ultimate Nut & Candy Co. Peanut Butter Jars, 16 oz. Recall # F-1251-9
CODE
Products were sold between Jan 1 2007 and Feb 13 2009; Coded 7001 to 7365, 8001 to 8365 and 9001 to 9044
RECALLING FIRM/MANUFACTURER
The Ultimate Nut Company, Inc. dba Ultimate Nut & Candy Co., Burbank, CA, by press release on March 17, 2009 and posted on the firm's website & in their retail store.  Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Peanut butter cups (77 lbs); peanut butter crisps (26 lbs); peanut butter 16oz jars (545 lbs)
DISTRIBUTION
CA
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PRODUCT 
1) Caramel corn Bars. Label reads (in part): "Wrights ...CARAMEL CORN BAR WITH PEANUTS...WRIGHT POPCORN AND NUT CO." Packaged in 2.25 oz. First five ingredients are popcorn sugar, corn syrup, coconut oil, peanuts. UPC 0 4840 04120 8. Recall # F-1252-9;

2) Small chopped peanuts. Label reads (in part): "SMALL CHOP ITEM #541000-541005 ...net wt 30 lbs (13.61 kg)". Packaged in bulk cartons. Ingredient is peanuts. 30 pound bulk containers. Recall # F-1253-9
CODE
1) Sell by 5/30/07, 6/30/07, 7/30/07, 8/30/07, 9/30/07, 10/30/07, 11/30/07, 5/30/08, 6/30/08, 7/30/08, 8/30/08, 9/30/08, 10/30/08, 11/30/08, 12/30/08, 2/28/09, 3/30/09, 4/30/09;

2) Lot # T7004, T7134, T7171, T8032/1827, T8025/1825, T8067/1849, T8223/1981, and one lot identified as "T"
RECALLING FIRM/MANUFACTURER
Wright Popcorn & Nut Co., San Francisco, CA, by telephone on March 18, 2009 and press release on March 27, 2009. Firm initiated recall is ongoing.
REASON
The products were manufactured using peanuts or state peanut products] recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
26,186 units
DISTRIBUTION
CA, UT, AZ, NV, OR, WA, and ID
___________________________________
PRODUCT 
1) Raw Blanched Peanuts, Net Wt. 5 lbs., Product of USA. 2) Raw Blanched Peanuts, Net Wt. 25 lbs., Recall # F-1254-9
CODE
1) Item # 340-235 (5lb), 340-245 (25lb); Item # 2678 and 2748 (25lb only) Date Sold: September 22, 2008 thru November 1, 2008.
RECALLING FIRM/MANUFACTURER
Torn & Glasser Inc., East Rancho Dominguez, CA. by letter on February 20, 2009 and by press release on March 23, 2009.Firm initiated recall is ongoing.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
154/ 5 lb containers; 425/ 25 lb containers
DISTRIBUTION
AZ, CA, CO, HI, LA, NV, TX
___________________________________
PRODUCT 
1) Argires Salted Deluxe Mixed Nuts; packaged in : Item 60-MIX-WH-DXS14, 14 oz. plastic tubs, UPC 0 79003-74305 4; Item 60-MIX-WH-DXS16, 16 oz. plastic tubs, UPC 0 79003-74306 1; Item 50-MIX-WH-DXS16, 16 oz. polypropylene bags/24 per case, UPC 0 79003-30241 1. Recall # F-1290-9;

2) Argires Roasted Deluxe Mixed Nuts; packaged in: Item 60-MIX-WH-DXR14, 14 oz. plastic tubs, UPC 0 79003-74331 1; Item 60-MIX-WH-DXR16, 16 oz. plastic tubs, UPC 0 79003-74307 6. Recall # F-1291-9;

3) Argires Salted Pistachio Kernels; Item 60-PIS-WH-MS13,13 oz. plastic tub, UPC 0 79003 73611 7. Recall # F-1292-9;

4) Argires Natural Pistachios In Shell Salted; packaged in: Item 50-PIS-WH-IS16, 24/16 oz bags, UPC 0 79003-30131 5; Item 50-PIS-WH-IS12, 24/12 oz bags, UPC 0 79003-30132 2; Item 50-PIS-WH-IS8, 18/8 oz bags, UPC 0 79003-30130 8; Item 50-199-WH-PIS, 4 oz $1.99 bags, UPC 0 79003-53604 5; Item 50-PIS-RT-IS16, 16 oz tubs, UPC 0 79003-30121 6; Item 60-PIS-WH-NAT12, 12 oz tubs, UPC 0 79003-73604 9; Item 50-PIS-RT-1.5, 12/1.5 oz bags; Recall # F-1293-9;

5) Argires Chili Limon Pistachios; Item 60-PIS-WH-CH12, 12 oz tubs, UPC 0 78993-73602 5. Recall # F-1294-9;

6) Argires Habanero Pistachios; Item 60-PIS-WH-HAB12, 12 oz tubs, UPC 0 79003-73603 2. Recall # F-1295-9;

7) Argires Red Pistachios In Shell Salted; Item 50-PIR-WH-IS16, 24/16 oz bags, UPC 0 79003-30221 3. Recall # F-1296-9
CODE
1), 4) Tub pack dates 2702008 thru 0892009, where the first three digits are the Julian date followed by the year; bag pack dates 08270 thru 09089, where the first two digits indicate the year followed by the Julian date;
 
2), 3), 5), 6) Tub pack dates 2702008 thru 0892009, where the first three digits are the Julian date followed by the year;

7) Bag pack dates 08270 thru 09089, where the first two digits indicate the year followed by the Julian date
RECALLING FIRM/MANUFACTURER
Anton Argires Co., Alsip, IL, by telephone and posted on their website on March 31, 2009, and a press release on April 2, 2009, and April 7, 2009. Firm initiated recall is complete.  
REASON
The products contain pistachio nuts recalled by Setton because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
11,062 lbs
DISTRIBUTION
IL, FL
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PRODUCT 
1) Small clear cylinders containing 5 oz of pistachios. Sold to one hotel chain in Southern California for use in room mini bars. Recall # F-1297-9;

2) Gold Gift Towers of 5 boxes, the top one containing 2 oz. of pistachios. Sold to one hotel/resort customer in Nevada. Recall # F-1298-9;

3) Holiday Delight Chocolate Bark, swirled with White Chocolate and Pistachios, fig and apricots in 4.5 oz plastic bag. Recall $ F-1299-9;

4) Holiday Gift Towers packed in 4 or 5 tiers with gold boxes, each containing 2 oz of pistachios in the second box. Recall # 1300-9
CODE
No codes
RECALLING FIRM/MANUFACTURER
Astor Chocolate Corp., Lakewood, NJ, by press release and letters on April 8, 2009. Firm initiated recall is ongoing.
REASON
Products manufactured and/or distributed using pistachios from Setton Farms, Terra Bella, CA, which were recalled due to possible salmonella contamination.
VOLUME OF PRODUCT IN COMMERCE
71 cases holiday Slab, 1,050 gift towers, 198 mini tubes, 9,348 gold towers
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Salted Pistachios: Nuts About Florida Pistachios, Lightly Salted packaged in 3.5 oz plastic bags UPC 0002910105 and 8 oz plastic bags UPC 0002910112, all lots with expiration prior to October 15, 2009. "Barnardo "Quality Products Si nice 1942". La Botana De Don Pepe, Pistachios, Salados packaged in 3.5 oz plastic bags UPC 6629710702, all lots with expiration prior to October 15, 2009. Recall # F-1301-9;

2) Pistachios, No Salt: Nuts About Florida, Pistachios, No Salt Added packaged in 8 oz plastic bags UPC 0002910111. All lots with expiration prior to October 15, 2009. "Barnardo "Quality Products Since 1942". Recall # F-1302-9
 CODE
All lot codes
RECALLING FIRM/MANUFACTURER
Barnard Nut Co., Inc., Miami, FL, by e-mail on March 31, 2009 and press release on April 10, 2009. Firm initiated recall is complete.
REASON
The products were manufactured using pistachios recalled by Setton Pistachio of Terra Bella, because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
281,213 bags
DISTRIBUTION
FL
___________________________________
PRODUCT 
1) Albanese Confectionery Group Shelled Pistachios R/S, Net Wt 25 lbs, No UPC. Recall # F-1303-9

2) Albanese Confectionery Group Shelled Pistachios R/NS, Net Wt 25 lbs, No UPC. Recall # F-1304-9;

3) Albanese Confectionery Deluxe Mix Nuts, Salt, Net Wt 30 lb, No UPC. Recall # F-1305-9;

4) Albanese Confectionery Deluxe Mix Nuts, R&NS, Net Wt 30 lb, No UPC. Recall # F-1306-9
CODE
Lots 8246 through 9098
RECALLING FIRM/MANUFACTURER
Albanese Confectionery Group, Merrillville, IN, by letter dated April 7, 2009 and press release on April 10, 2009. Firm initiated recall is complete.
REASON
The products were manufactured using pistachios recalled by Setton Pistachio of Terra Bella, because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide and Bermuda
___________________________________
PRODUCT 
brand names
Raw, Shelled Pistachios under the brand names: a) Katy’s Kitchen (3/2 lb packages; Item #14237; UPC #22486 14237), b) Sysco Classic (3/2 lb packages; Item # 5685888; UPC # 74865 75872), c) Azar (3/2 lb packages; Item # 7116996; UPC #76500 71169) and d) Baker Select (5 lb package; Item # 9619896). Recall # F-1307-9
CODE
Lot numbers: a) 8280, 8328, 9034, and 9082; b) 8287, 8294, 8309, 8328, 9012, 9034, 9054, 9061, 9077, and 9085; c) 8280, 8310, 9020, 9034, and 9064; d) 8328, 8344, 8358, 9007, 9026, and 9068
RECALLING FIRM/MANUFACTURER
Franklin Connections LP, El Paso, TX, by press release, letter and telephone beginning April 8, 2009. Firm initiated recall is complete.
REASON
The products were manufactured using pistachios recalled by Setton Pistachio of Terra Bella, because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
55,799 lbs
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Pistachio Meat Raw (No Shell) 9 oz plastic cup UPC 65585200132 Private Label: Whole Foods Market,  Adams Fairacre Farms, Bethel Market, Boiceville Market, Caraluzzi’s Old World Market, Clement’s Market, Ernest Klein & Co, International Supermarket, Friend’s Marketplace, Gourmet Garage, Graul’s Market, Harvest Co-Op Market, Hurley Ridge, Highland Park, Jubilee Market Place, Lee’s Palmer’s Market, Walter Stewart Wild by Nature. Recall # F-1308-9;

2) Pistachio Meat, Roasted Salted (No Shell) 9 oz plastic cup UPC 65585200129 Pistachio Meat, Roasted Salted (No Shell), Bulk No UPC, Private Label: Adams Fairacre Farms Belmont Market Brand Whole Foods Market Adams Fairacre Farms Bethel Market Boiceville Market Caraluzzi’s Old World Market Clement’s Market County Markets (C-Town) Ernest Klein & Co International Supermarket Fresh Pond Market  Friend’s Marketplace Graul’s Market Harvest Co-Op Market Hurley Ridge, Highland Park Jubilee Market Place Lee’s McQuades Market Place Morton Williams Supermarket  Palmer’s Market Robert’s Fresh Market The Kosher Marketplace Walter Stewart Windfall Market. Recall # F-1309-9;

3)  Pistachio Meat, Roasted No Salt (No Shell) 9 oz plastic cup UPC 65585200473, Private Label: Adams Fairacre Farms Bethel Market Ernest Klein & Co International Supermarket Friend’s Marketplace Graul’s Market Harvest Co-Op Jubilee Market Place McQuads Market Place Palmer’s Market Walter Stewart. Recall # F-1310-9;

4) Pistachio Roasted Salted (In Shell), 2.5 oz Plastic Cup UPC:65585200499 Pistachio Roasted Salted (In Shell), 4 oz Bag UPC:65585200257 Pistachio Roasted Salted (In Shell) , 4.25oz Bag UPC: 65585200257 Pistachio Roasted Salted (In Shell),8 oz Plastic Cup UPC: 65585200093 Pistachio Roasted Salted (In Shell) , 17 oz Tub UPC: 65585200339 Pistachio Roasted Salted (In Shell) , Bulk No UPC Private Labels: Adams Fairacre Farms Belmont Market Brand Caraluzzi's Old World Market Brand Food Emporium Brand Bethel Market Boiceville Market Clement's market Country Market (C-Town) Ernest Klein & Company International Supermarkets Fresh Pond Market Friend's Marketplace Gourmet Garage Grauls's Market Harvest Co-Op Market Haddon House Highland Park Omni Foods Jubilee Market Place Lee's McQuads Markeplace Morton Williams Supermarket Robert's Fresh Market The Kosher Market Walter Stewart windfall Market Wild by Nature Ruma Fruit and Produce. Recall # F-1311-9;

5) 4 Section Nut Tray, 13 oz Plastic tray UPC: 65585200141 6 Section Nut Tray, 26 oz Plastic tray UPC: 65585200396 Private Label: Food Emporium Brand Boiceville Market Brand Country Market (C-Town) Ernest Klein & Co International Supermarket Gourmet Garage Wild by Nature. Recall # F-1312-9;

6) ZARBS Gift Box (contains 7.5 oz Pistachio Shell) 24.5 oz Paperboard, No UPC. Recall # F-1313-9
CODE
1) Use by Date: 8/09/09 to 12/31/09;
2) Use by Date: 7/23/09 to 12/31/09;
3) Best by Date: 7/15/09 to 12/31/09;
4), 5), 6) Best if Used By Date: 7/7/09 to 12/31/09;
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aurora Products, Inc., Stratford, CT, by e-mail and telephone on April 13, 2009.
Manufacturer: Setton Pistachio of Terra Bella, Inc., Terra Bella, CA. Firm initiated recall is ongoing.
REASON
Products manufactured with pistachios from Setton Farms may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
42,295 lbs
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Raw shelled pistachios in heat sealed poly bags. Label includes date of packaging “Pistachios 2 lbs (908 g) Net Wt Contains: Pistachio Nuts Merlino Foods. Recall # F-1314-9
CODE
Product is coded with the date of packaging only.
RECALLING FIRM/MANUFACTURER
A A Merlino & Associates, Seattle, WA, by telephone on April 8-10, 2009. Firm initiated recall is complete.
REASON
The products were manufactured using pistachios recalled by Setton Pistachio of Terra Bella, because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
2,208- 2 lb packages
DISTRIBUTION
WA, OR, CA
___________________________________
PRODUCT 
1) Austinuts Pistachio Kernels, Raw and Dry Roasted Salted, Net Wt 25 lbs, Net Wt 8 oz, and Net Wt 4 oz. Recall # F-1315-9;

2) Austinuts Deluxe Nut Mix Dry Roasted Salted, Net Wt 8 oz (227 g). Recall # F-1316-9;

3) Austinuts Gourmet Nut Mix Dry Roasted Salted, Net Wt 8 oz (227 g). Recall # F-1317-9
CODE
1) Only Lot numbers ending in “SE” with packing codes of P3598 through P04999;

2) Only Lot numbers: P008913201AW through P026913201AW;

3) Only Lot numbers: P364814401AW through P026914401AW
RECALLING FIRM/MANUFACTURER
Recalling Firm: Austinuts Wholesale, Inc., Manor, TX, by press release and e-mail on April 27, 2009.
Manufacturer: Setton Pistachio of Terra Bella, Inc., Terra Bella, CA. Firm initiated recall is complete.
REASON
The products were manufactured using pistachios recalled by Setton Pistachio of Terra Bella, because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,413 lbs
DISTRIBUTION
TX
___________________________________
PRODUCT 
1) Peanut Butter Gelato; Net Wt 1.08 gallon white plastic tub. Recall # F-1318-9;

2) Dream Bomba; Net Wt 7.48 lbs; 20 monoportions individually packed in a white cardboard box. Recall # F-1319-9;

3) Peanut Butter Cheesecake, Net Wt 5.07 lbs. White cardboard box. Recall # F-1320-9
CODE
1) Lot number 7155, Exp. 5/2009; Lot number 7183, Exp. 6/2009 Lot number 7211, Exp. 7/2009;

2) Lot number 8116, exp. 10/2009; Lot number 8121, exp. 10/2009; Lot number 8220, exp. 2/2010; Lot number 8297, exp. 4/2010; Lot number 8353, exp. 6/2010;

3) Lot number 8189, Exp. 6/2009; Lot number 8228, Exp. 8/2009; Lot number 8351, Exp. 12/2009
RECALLING FIRM/MANUFACTURER
Bindi North America, Belleville, NJ, by letters on January 30, 2009 and press release on February 2, 2009. Firm initiated recall is complete.
REASON
Products were manufactured using peanut butter product recalled by Peanut Corporation of America, because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
592 tub of gelato; 4,770 cases dream bamba; 2,548 cheesecakes
DISTRIBUTION
CA, CT, MA, NJ
___________________________________
PRODUCT 
Peanut Butter. Dry Roasted Runner Peanuts fresh ground for self serve in store peanut butter grinders. Customers fill self serve fresh ground peanut butter into 8 oz or 16 oz clear round plastic containers. No codes, however bins have Bulk Bin number 2039. Recall # F-1321-9
CODE
No codes
RECALLING FIRM/MANUFACTURER
Winco Perishables Dist., Woodburn, OR, by e-mail on January 30, 2009 and by press release on February 26, 2009. Firm initiated recall is complete.
REASON
Product was manufactured using peanut butter product recalled by Peanut Corporation of America, because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Approximately 27,125/25 lb cases
DISTRIBUTION
ID, OR, WA
___________________________________
PRODUCT 
Peanut Butter Dessert Bar (No Brand, still in R&D Phase) in 40 gram plastic foil package. Recall # F-1322-9
CODE
Manufactured on 09/18/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Challenge Dairy Products, Inc., Dublin, CA, by telephone and e-mail on January 22, 2009.  
Manufacturer: Alexius International, Inc., Fresno, CA. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
114 bars
DISTRIBUTION
CA, MA, SC, PA
___________________________________
PRODUCT 
1) Durey Libby Honey Roasted Peanuts, 10 lb. and 30 lb. boxes Distributed by 07072; Also packaged in 10 oz. round plastic containers with snap off lid: No UPC numbers on bulk boxes. 10 oz UPC 081641251464. Recall # F-1323-9;

2) Snack Shack Peanuts Honey Roasted, sold in 10 oz., 14 oz., and 1 lb. clear plastic containers. UPC 10 oz: 081641251464; UPC 14 oz: 081641151467; UPC 1 lb: 081641351461. Recall # F-1324-9   
CODE
Lot codes: 7001 through 9029; Expiration Dates: 01/01/07 through 07/01/09
RECALLING FIRM/MANUFACTURER
Durey Libby Edible Nuts Inc., Carlstadt, NJ, by letters on January 29, 2009 and a press release on February 6, 2009. Firm initiated recall is complete.
REASON
Products were manufactured using peanuts recalled by the Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Approximately 135 cases
DISTRIBUTION
NY, NJ, MA, VA

___________________________________
PRODUCT 
1) JJ Kelly Snacks Mountain Mix, UPC 007626863630, 8.5 oz packages. Recall # F-1325-9;

2) JJ Kelly Snacks Oriental Mix, UPC 007626863631, 8 oz packages. Recall # F-1326-9;

3) JJ Kelly Snacks Yogurt Trail Mix, UPC 007626863632, 8 oz packages. Recall # F-1327-9;

4) JJ Kelly Snacks Raisin Nut Mix, UPC 007626863634, 8.5 oz packages. Recall # F-1328-9;

5) JJ Kelly Snacks Banana Sesame Crunch, UPC 007626863638, 9 oz packages. Recall # F-1329-9
CODE
Expiration dates between 02/2008 to 02/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Shapiro Produce, Everett, MA, by press release, letter, e-mail, fax or telephone on February 6, 2009. 
Manufacturer: Mister Snacks, Inc., Amherst, NY. Firm initiated recall is complete.  
REASON
Product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
315 cases
DISTRIBUTION
NH, CT, RI, MA
___________________________________
PRODUCT 
Raw Jumbo Spanish peanuts packaged in the following sizes: 14 oz (400g), 2 lbs, 5 lbs, 10 lbs, 25 lbs, 50 lbs and original packaging of 110.23 lbs. Recall # F-1330-9
CODE
All lots sold since January 1, 2007.
RECALLING FIRM/MANUFACTURER
Atlantic Food & Spices, Inc., Dallas, TX, by telephone starting March 5, 2009. Firm initiated recall is ongoing. 
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
22 bags, 110.23 lbs each
DISTRIBUTION
TX
___________________________________
PRODUCT 
1) Bulk peanut butter made from peanut splits, dry roasted, no salt. Bin # 2101 in plastic containers up to 2 lbs. Bin #3000 in plastic containers up to 1 lb. Recall # F-1331-9

2) Bulk peanut butter made from peanut splits, dry roasted, no salt and peanuts, granulated, dry roasted, medium; Bin # 900 in plastic containers up to 1 lb. Recall # F-1332-9;

3)  Bulk peanut butter made from organic peanut splits, dry roasted, no salt; Bin # 3001 in plastic containers up to 2 lbs. Recall # F-1333-9    
CODE
None
RECALLING FIRM/MANUFACTURER
Sherm's Thunderbird Market, Medford, OR, by press release on March 9, 2009. Firm initiated recall is complete.
REASON
The products were manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
OR
___________________________________
PRODUCT 
Texas Star Nut & Food Company Raw Peanuts a) Net Wt 12 oz (340g), UPC 8-32112-00410-8; Also packages in 5 lb and 45 lb cardboard boxes. Recall # F-1334-9
CODE
Sell By January 11, 2009 through August 31, 2009
RECALLING FIRM/MANUFACTURER
Texas Start Nut & Food Co, Boerne TX , by letter on February 16, 2009 and February 24, 2009 and by press release on March 16, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
4,205 pounds
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Funway Brand Caramel and Chocolate Apples with Peanuts sold as: Funway Red Caramel Apples 24ct/4oz. each packaged in plastic containers or wrapped in plastic bags. Mfg. Item No: 01111/UPC: 7-40743-01101-6; Funway Red Caramel Apples 4pk/12 per case 16oz., each packaged in plastic containers or wrapped in plastic bags. Mfg. Item No: 01114/UPC:7-40743-01104-7; Funway Brown Caramel Apples 24ct/4oz. each packaged in plastic containers or wrapped in plastic bags. Mfg. Item No: 01211/UPC:7-40743-01201-3; Funway Brown Caramel Apples 4pk/12 per case 16oz., each packaged in plastic containers or wrapped in plastic bags. Mfg. Item No: 01214/UPC:7-40743-01204-4; Funway Gourmet Chocolate Apple 14oz./12 per case, each packaged in plastic containers or wrapped in plastic bags. Mfg. Item No: 01688/UPC:7-40743-01601-1; Funway V-Day Chocolate/Carmel Apples 12oz./12 per case, each packaged in plastic containers or wrapped in plastic bags. Mfg. Item No: 01788/UPC:7-40743-01501-4. Product Codes: 30209028, 17509033, 30209033, 30209035, 30209037, 30209040, 19909042, 30209042, 30209044, 30209047, 19909049, 30209049, and 30209054. Recall # F-1335-9
CODE
Best by dates: 2/19/09, 2/20/09, 02/21/09, 2/24/09, 2/26/09, 2/28/09, 3/3/09, 3/4/09 and 3/5/09
RECALLING FIRM/MANUFACTURER
JNR Confection Specialty Corp. dba Funway Snack Foods, Maywood, CA, by letter and press release on March 17, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
45,456 units
DISTRIBUTION
CA
___________________________________
PRODUCT 
Granulated Peanuts. Cases are packaged in cardboard cartons. Cases are identified as: a) Item number 83928 a 10 lb case with 4/2.5lb bags; b) Item number 13060-5 a 5 lb case with 2/2.5 lb bags; c) Item number 13060-10 a 10 lb bag; d) Item number 99PRD012087 a 10 lb bag. Recall # F-1336-9
CODE
a) Lot numbers: 011608, 081108, and 091508; b) Lot numbers: 122808, 012508, 042508, 051308, 061608, 063008, 071408, 072808, 082508, 091508; c) Lot numbers: 010908, 041608, 041708, 042408, 042508, 061708, 070208, 070308, 070808, 071008, 071408, 072108, 072208, 080408, 080708; d) Lot numbers: 042408, 042508, 070308, and 070808
RECALLING FIRM/MANUFACTURER
Tropical Nut & Fruit Co., Inc., Orlando, FL, by telephone, fax, letter, e-mail and press release on January 29, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
21,790 pounds
DISTRIBUTION
FL, MI, TN, NC
___________________________________
PRODUCT 
1) Can Do Kid brand Cookies & Cream bar, UPC 8-54260-00102-0, 40 gram bar. Recall # F-1337-9;

2) Can Do Kid brand Chocolate Crunch bar, UPC 8-54260-0101-3, 40 gram bar. Recall # F-1338-9;

3) Isagenix IsaLean brand Choc. Dipped Honey Peanut bar, Recall # F-1339-9;

4) Nestle brand Optifast Honey Nut 'n Oat bar. Recall # F-1340-9;

5) Zone brand 3 Carb Chocolate Brownie bar. Recall # F-1341-9;

6) Think Thin brand Chocolate Mudslide bar. Recall # F-1342-9;

7) Think Thin brand Dark Chocolate bar. Recall # F-1343-9;

8) Promax 70 brand Double Fudge Brownie bar. Recall # F-1344-9;

9) Promax 70 brand Cookies and Cream bar. Recall # F-1345-9;

10) Promax brand Chocolate Chip Cookie Dough bar. Recall # F-1346-9;

11) Shaklee brand Cinch Lemon Cranberry bar. Recall # F-1347-9;

12) Shaklee brand Cinch Peanut Butter Crunch bar. Recall # F-1348-9;

13) Shaklee brand Cinch Chocolate Decadence bar. Recall # F-1349-9
CODE
1) Best By/Sell By Dates: 102109, 062608, 080208, 082808, 100808, 011709, 050809, 081409;

2) Best By/Sell By Dates: 102109, 062608, 080208, 082808, 100808, 011709, 050809, 081409;

3) Lot/Best By Date: 0037, 0547, 0557, 0727, 0737, 1797, 1927, 2287, 2297, 3137, 3147, 3607, 3617, 0188, 0218, 0298, 0298A, 0308, 0498, 0509, 04390408, 04390508, 05390108, 06390408, 06390508, 06390608, 07390108, 08390108, 08390208, 09390308, 11390108, 11390208, 12390308, 12390808;

4)  83375007CA;

5) Best By Date: 111109;

6) Best By Dates:  122809, 020410;

7) Best By Dates: 122909, 020510;

8) Best By Date: 30DEC09;

9) Best By Date: 5JAN10;

10) Best By Dates: 20DEC09, 20JAN10;

11) Lot #’s: CE8296, CE8353;

12) Lot #: CE8295;

13) Lot #’s: CE8294, CE8296
RECALLING FIRM/MANUFACTURER
Creative Energy Foods LLC, Oakland, CA, by press release, letters, telephone, and e-mails on January 21, 2009. Firm initiated recall is ongoing.
REASON
The products were manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
CA, OH, IN, AZ and Canada
___________________________________
PRODUCT 
1) Isagenix Chocolate Dipped Honey Peanut IsaLean Bar, Net Wt 2.29oz (68 g), (UPC # 602410), wrapped in a foiled lined cellophane package. Recall # F-1350-9;

2) Isagenix IsaLean Bar Peanut Crunch, Net Wt. 2.22 oz, (UPC # 602421), wrapped in a foiled-lined cellophane package. Recall # F-1351-9
CODE
1) Lot Numbers: 11390108, 11390208, 12390308, 12390808., 0037, 0547, 0557, 0727, 0737, 1797, 1927, 2287, 3137, 3147, 3607, 3617, 0188, 0218, 0298, 0298A, 0308, 0498, 0508, 04390408, 04390508, 05390108, 06390408, 06390508, 06390608, 07390108, 08390108, 08390208, 09390308;

2) Lot Number: 1017, 1027, 1627, 1637, 1997, 2647, 0368, 0608, 04390208, 06390108, 07390408, 09390208
RECALLING FIRM/MANUFACTURER
Recalling Firm: Isagenix International, Chandler, AZ, by letters on January 24, 2009.
Manufacturer: Creative Energy Foods LLC, Oakland, CA. Firm initiated recall is complete.
REASON
The product was manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
2,561,274 Units
DISTRIBUTION
 Nationwide
___________________________________
PRODUCT 
1) Garber's brand Tin Roof Sundae Ice Cream, packed in Gallon paper carton, UPC 028387-000239. Recall # F-1352-9;

2) Frederick Farms brand Nutty Buddy Ice Cream, packaged as individual 4oz cones with UPC 028387-300001 and in cartons of 8/6 pack, UPC 028387-303705. Recall # F-1353-9
CODE
All date codes before January 29, 2009
RECALLING FIRM/MANUFACTURER
Garber Ice Cream Co., Inc., Winchester, VA, by telephone, letter, fax and e-mail on January 30, 2009 and February 2, 2009 and by press release on February 11, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
3,546 units
DISTRIBUTION
VA, WV, PA, MD, DC, NJ, FL

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS I

___________________________________
PRODUCT 
1) Herbal Disiac Capsules, 250 mg All Natural Herbal Extract, 40 capsule bottle, UPC 8 80907 67733 4. Recall # D-1979-2009;

2) LIBIEXtreme Capsules, 1000 mg Natural Herbal Extract, single capsule packet, UPC 6 20186 60211 1. Recall # D-1980-2009;

3) Y-4ever Capsules, 800 mg All Natural Herbal Extract, single capsule packet, UPC 8 80907 67739 6. Recall # D-1981-2009;

4) POWERMANIA Liquid, 1780 mg Energy & Herbal Blend, 1 fluid ounce packet, UPC 8 80907 67710 5. Recall # D-1982-2009;

5) LIBIMAX X Liquid, 1580 mg Energy & Herbal Blend, 1 fluid ounce packet, UPC 8 80907 67736 5. Recall # D-1983-2009;

6) POWERMANIA Capsules, 1000 mg All Natural Herbal Extract, 1 capsule packet, UPC 8 80907 67711 2. Recall # D-1984-2009
CODE
All lots
RECALLING FIRM/MANUFACTURER
Nature & Health Co., Brea, CA, by press release on July 15, 2009. Firm initiated recall is ongoing.
REASON
Unapproved Drug; Product contains tadalafil, an ingredient used in an FDA approved product for erectile dysfunction
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Sodium Chromate Cr 51 Injection, Diagnostic, Sterile, Non-Pyrogenic Solution, 250 uCi/vial, 100 uCi/mL, For Intravenous Administration, Rx Only. Recall # D-1985-2009
CODE
Lot # 370-9004, exp. 7/24/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mallinckrodt, Inc., Hazelwood, MO, by letters dated June 23, 2009.
Manufacturer: Mallinckrodt, Inc., Maryland Heights, MO. Firm initiated recall is complete.
REASON
Subpotent; sodium chromate
VOLUME OF PRODUCT IN COMMERCE
96 vials
DISTRIBUTION
Nationwide, Canada, Mexico
___________________________________
PRODUCT 
1) STEAM capsules, 5 capsule bottle, UPC 8 52263 30033 1. Recall # D-1986-2009;

2) STEAM capsules, 5 capsule bottle, UPC 8 52263 30033 1. Recall # D-1987-2009
CODE
1) Lot # 80214, Exp 06/11;
2) Lot # 90260, Exp 06/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nutracoastal Trading, LLC, Freeport, NY, by telephone on July 27, 2009, press release on July 28, 2009 and August 21, 2009, and on August 24, 2009 by e-mail, fax, letter and telephone.
Manufacturer: Eniran Manufacturing, Farmingdale, NY. Firm initiated recall is ongoing.
REASON
Marketed Without an Approved NDA/ANDA: Private laboratory analysis of STEAM, Lot # 90260 found that the product contains tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction (ED), making STEAM capsules an unapproved new drug.
VOLUME OF PRODUCT IN COMMERCE
9,435 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________
PRODUCT 
Naproxen Tablets, USP, 500 mg tablets, 1000 tablets per bottle, Rx only, NDC 53746-190-10. Recall # D-1973-2009
CODE
Lot # HC06109, Exp 03/13
RECALLING FIRM/MANUFACTURER
Amneal Pharmaceuticals, Hauppauge, NY, by letter dated August 10, 2009. Firm initiated recall is ongoing.
REASON
Superpotent (Single Ingredient Drug). Tablet Thickness. This product is being recalled because of a report of one oversized (thick) tablet.
VOLUME OF PRODUCT IN COMMERCE
986 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III

___________________________________
PRODUCT 
1) Lac-Hydrin (ammonium lactate) Lotion, 12%, 400 g bottle, NDC 10631-098-14; 225 g bottle. Physician Sample Not For Sale. Not for individual sale. Rx only. Recall # D-1897-2009;

2) Lac-Hydrin (ammonium lactate) Cream, 12%, 385 g bottle, Rx only, NDC 0072-5730-38. Recall # D-1898-2009
CODE
1) Lot # RB704301, Exp 08/11 (400 g); Lot # RB710701, Exp 06/11 (225 g Physician's Sample);

2) Lot # RB692601, Exp 06/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ranbaxy Pharmaceuticals, Inc., Jacksonville, FL, by letters on September 3, 2009. 
Manufacturer: Contract Pharmaceuticals Limited, Buffalo, NY. Firm initiated recall is ongoing.
REASON
Crystallization: Lac-Hydrin Cream and Lotion are being recalled because they have the potential to undergo crystal formation.
VOLUME OF PRODUCT IN COMMERCE
19,871 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Oxycodone and Acetaminophen Tablets, USP, 5 mg/325 mg, 100 tablets per bottle, Rx only, NDC 53746-0203-01. Recall # D-1976-2009
CODE
The subject bottle was shipped together with the identical product Lot # BC00609, Exp 02/11
RECALLING FIRM/MANUFACTURER
Amneal Pharmaceuticals, Brookhaven, NY, by letter dated June 23, 2009. Firm initiated recall is ongoing.
REASON
Labeling: Incorrect/Missing Lot No. (s): One bottle of Oxycodone and Acetaminophen 5 mg/325 mg tablets, 100 count bottle was found without a lot number and expiration date.
VOLUME OF PRODUCT IN COMMERCE
6,931 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1586-09
CODE
Unit: W141608139761
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program, Seattle, WA, by letter on February 3, 2009. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1587-09
CODE
Unit: W14160817536
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by letter on February 5, 2009.
Manufacturer: Puget Sound Blood Center and Program, Bellevue, WA. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT 
1) Platelets Leukocytes Reduced. Recall # B-1588-09;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1590-09
CODE
1) and 2) Unit: 22GG37361
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by telephone on March 11, 2009 and March 19, 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
PA
___________________________________
PRODUCT 
Source Plasma. Recall # B-1596-09
CODE
Units: GA1249461; GA1249858; GA1250732; GA1251137
RECALLING FIRM/MANUFACTURER
DCI Biologicals LLC, Gallup, NM, by facsimile on February 18, 2009 and February 20, 2009. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor with a history of high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
United Kingdom

___________________________________
PRODUCT 
Source Plasma. Recall # B-1598-09
CODE
Units: 0200008011, 0200008116, 0200008414, 0200011782, 0200011931, 0200012546, 0200012713, 0200012914, 0200013077, 0200013300, 0200013462, 0200014077, 0200014214, 0200014579, 0200014821, 0200015065, 0200015305, 0200015737, 0200016634, 0200016734, 0200016986, 0200017195, 0200017420, 0200017664, 0200017929, 0200018150, 0200018409, 0200018734, 0200019204, 0200019305, 0200019731. 0200020245, 0200020344, 0200020696, 0200021104, 0200021560, 0200021928, 0200022294, 0200022482, 0200022715, 0200022924, 0200023174, 0200023710, 0200024030, 0200024325, 0200024658
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biomat USA, Inc., Los Angeles, CA, by letter on December 30, 2004.  
Manufacturer: Biomat USA, Inc., Macon, GA. Firm initiated recall is complete. 
REASON
Blood products, collected from a donor whose physical examination was overdue, were distributed.
VOLUME OF PRODUCT IN COMMERCE
46 units
DISTRIBUTION
Spain
___________________________________
PRODUCT 
Source Plasma. Recall # B-1599-09
CODE
Units: 0200037197, 0200037654, 0200037722, 0200046739, 0200046983, 0200047315, 0200047855, 0200048069, 0200048396, 0200048578, 0200048890, 0200049323, 0200049490, 0200049795, 0200050121, 0200050461, 0200050723, 0200051121, 0200051320, 0200053821, 0200054007, 0200054422, 0200054665, 0200054850, 0200055046, 0200055236, 0200055660, 0200055881, 0200056386
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Macon, GA, by letter on June 1, 2006. Firm initiated recall is complete. 
REASON
Blood products, collected from a donor who received tattoos within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
29 units
DISTRIBUTION
Spain
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1601-09
2) Red Blood Cells Leukocytes Reduced. Recall # B-1602-09
CODE
1) Unit: 12GE85971;
2) Units: 12KE02270; 12LV43994
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Charlotte, NC, by telephone on November 10, 2007 and letter on November 13, 2007.
Manufacturer: Whole Blood Collections-Mobiles-Carolinas Region, Wilmington, Wilmington, NC. 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
3 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
1) Red Blood Cells. Recall # B-1608-09;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1609-09
CODE
1) Unit: 007FX24319;
2) Units: 007FH52656, 007FR34317, 007FR34321, 007FR34323, and 007FY80264    
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Arizona Region, Tucson, AZ, by facsimile on January 7, 2009 and letter on January 15, 2009. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may compromise the sterility of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
AZ
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-1613-09;
2) Plasma Frozen. Recall # B-1614-09
CODE
1) and 2) Unit: 12KQ60542
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Charlotte, NC, by letter and telephone on March 14, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1653-09   
CODE
Unit: W047009259584
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc., New Brunswick, NJ, by letter dated June 2, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1656-09   
CODE
Unit: W036509005829
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Alexandria, LA, by letter dated July 21, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT 
Red Blood Cells. Recall # B-1658-09
CODE
Unit: 5034562
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Piedmont, SC, by telephone on April 24, 2009 and by letter dated April 28, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC
___________________________________
PRODUCT 
1) Plasma Frozen. Recall # B-1659-09;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1660-09   
CODE
1) Unit: W087608022985;
2) Units: W087608820904, W087608022985, W087609020660
RECALLING FIRM/MANUFACTURER
Virginia Blood Service, Inc., Richmond, VA, by telephone or e-mail on May 6, 2009 and by letter dated May 26, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for testing positive for the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
VA
___________________________________
PRODUCT 
Source Plasma. Recall # B-1662-09
CODE
Units: 4590020140, 4590019964, 4590019490, 4590019270, 4590018818, 4590018608, 4590018131, 4590017894, 4590022205, 4590021525, 4590021310, 4590020785, 4590020587
RECALLING FIRM/MANUFACTURER
Life Sera, Jacksonville, FL, by e-mail on March 31, 2009. 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
13 units
DISTRIBUTION
Austria
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1687-09   
CODE
Unit: W044608570561 (2 units)
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on May 21, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT 
1) Fresh Frozen Plasma (Apheresis), Recall # B-1689-09;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-1690-09     
CODE
1) Unit: W087609047378;
2) Unit: W087609047848
RECALLING FIRM/MANUFACTURER
Virginia Blood Service Inc., Richmond, VA, by telephone on May 7, 2009 and by letter dated June 3, 2009. Firm initiated recall is complete.
REASON
Blood products, for which the sterility may have been compromised, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-1691-09;
2) Plasma, Frozen. Recall # B-1692-09
CODE
1) Units: 20M50010, 20M56364, 20M56368;
2) Unit: 20M56364
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Salt Lake City, UT, by telephone on December 4, 2007, by letter dated December 20, 2007, or by electronic notification on December 20, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
ID, UT
___________________________________
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1696-09
CODE
Unit: 35S71537 (double collection)
RECALLING FIRM/MANUFACTURER
American National Red Cross, Roanoke, VA, by telephone and letter on July 14, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WV, VA
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-1697-09;
2) Fresh Frozen Plasma. Recall # B-1698-09;
3) Platelets. Recall # B-1699-09
CODE
1), 2), and 3) Unit: W0352090905379
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on April 21, 2009 and by letter dated May 21, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had received a piercing within one year of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

___________________________________
PRODUCT 
1) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1454-09   
2) Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated. Recall # B-1455-09
CODE
1) and 2) Unit: W041009035604L
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc. dba United Blood Services, Scottsdale, AZ, by telephone and facsimile on March 5, 2009 and by letter dated April 14, 2009. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly tested for red blood cell antigens, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AZ
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-1589-09
CODE
Unit: 22GG37361
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by telephone on March 11, 2009 and March 19, 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
CA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1597-09   
CODE
Unit: 12GY10762
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Charlotte, NC, by telephone on March 3, 2008 and by follow-up letter on April 14, 2008.
Manufacturer: American Red Cross Carolinas Blood Services Region, Charlotte, NC. Firm initiated recall is complete.
REASON
Blood product, manufactured without additive solution, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-1600-09
CODE
Units: 12GE85971, 12KE02270; 12LV43994
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Charlotte, NC, by telephone on November 10, 2007 and letter on November 13, 2007.
Manufacturer: Whole Blood Collections-Mobiles-Carolinas Region, Wilmington, Wilmington, NC. 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
3 units
DISTRIBUTION
CA
___________________________________
PRODUCT 
Source Plasma. Recall # B-1603-09
CODE
Unit: AQ030601
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Asheville, NC, by facsimile on October 2, 2007. 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
NC
___________________________________
PRODUCT 
1) Red Blood Cells. Recall # B-1654-09;
2) Platelets. Recall # B-1655-09
CODE
1) and 2) Unit: W120608420429
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Traverse City, MI, by facsimile on May 22, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for Chagas disease, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-1661-09   
CODE
Unit: W087609020660
RECALLING FIRM/MANUFACTURER
Virginia Blood Service, Inc., Richmond, VA, by telephone or e-mail on May 6, 2009 and by letter dated May 26, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was previously deferred for testing positive for the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT 
Source Plasma. Recall # B-1684-09
CODE
Units: LZ112629, LP063784
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank Inc., Mo, Saint Louis, MO, by facsimile on April 30, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria, Germany
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1688-09
CODE
Units: 3505086, 3505084
RECALLING FIRM/MANUFACTURER
Community Blood Bank of Erie County, Buffalo, NY, by telephone on May 26, 2009 and by letter dated May 29, 2009. Firm initiated recall is complete.
REASON
Blood products, collected using scales for which the quality control testing was not performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY
___________________________________
PRODUCT 
1) Recovered Plasma. Recall # B-1693-09
CODE
Units: 20M50010, 20M56368
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Salt Lake City, UT, by telephone on December 4, 2007, by letter dated December 20, 2007, or by electronic notification on December 20, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-1701-09;
2) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1702-09
CODE
1) Units: W035208179231T, W035208207452A, W0352082099820;
2) Unit: W035209001156B (2 units)  
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated June 8, 2009. Firm initiated recall is complete.
REASON
Blood products, which did not meet the requirement for red blood cell recovery, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
TX

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

___________________________________
PRODUCT 
Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems. Recall # Z-0005-2009
CODE
Software version 3.40 or higher
RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Medical Systems Inc., Tustin, CA, by letter on September 30, 2008. 
Manufacturer: Toshiba Medical Systems Co., Tochigi-Ken, Japan. Firm initiated recall is ongoing.  
REASON
Audible signal is not available at all times when using the HLC fluoroscopy mode. Special means of activation are not designed in for selection of High Level Controls, as required by regulation.
VOLUME OF PRODUCT IN COMMERCE
129 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Hologic Discovery series Bone Densitometer System Software versions 12.6, 2.3., or 2.4. Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics. Recall # Z-1725-2009;

2) Hologic Explorer series Bone Densitometer System Software versions 12.6, 2.3., or 2.4. Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics. Recall # Z-1726-2009;

3) Hologic QDR 4500 series Bone Densitometer Software versions 12.6, 2.3., or 2.4 Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics. Recall # Z-1727-2009;

4) Hologic Delphi series Bone Densitometer Software versions 12.6, 2.3., or 2.4 Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics. Recall # Z-1728-2009
CODE
1) S/N: 80348 80652 81530 82238 82256 82386 82437 82620 82632 82708 82793 82794 82796 82798 82799 82806 82808 82810 82811 82812 82813 82814 82815 82818 82824 82825 82826 82827 82828 82832 82833 82834 82835 82836 82837 82838 82839 82840 82842 82843 82844 82845 82846 82847 82851 82853 82854 82855 82856 82857 82859 82860 82862 82865 82866 82867 82872 82875 82876 82877 82879 82880 82881 82883 82887 82889 82891 82892 82895 82896 82897 82898 82900 82901 82902 82903 82904 82906 82909 82910 82911 82912 82916 82917 82918 82920 82921 82922 82924 82926 82927 82928 82929 82932 82933 82935 82936 82939 82941 82944 82945 82947 82949 82950 82956 82957 82958 82959 82960 82963 82964 82967 82968 82969 82970 82972 82976 82977 82978 82979 82981 82982 82983 82986 82988 82989 82990 82991 82992 82993 82996 83000 83001 83002 83003 83004 83005 83007 83008 83009 83010 83011 83013 83014 83015 83017 83018 83019 83020 83021 83022 83023 83025 83027 83028 83029 83032 83034 83035 83038 83039 83040 83041 83043 83044 83045 83046 83047 83049 83050 83051 83055 83057 83059 83062 83064 83065 83072 83074 83075 83076 83077 83080 83081 83082 83083 83084 83085 83086 83087 83088 83090 83091 83092 83093 83094 83096 83098 83100 83105 83107 83109 83111 83112 83114 83115 83116 83118 83120 83121 83122 83126 83131 83133 83134 83139 83141 83142 83144 83148 83149 83150 83154 83155 83156 83157 83159 83160 83161 83163 83164 83165 83169 83170 83171 83173 83174 83175 83176 83177 83178 83181 83182 83185 83186 83190 83191 83194 83195 83197 83199 83201 83202 83203 83205 83206 83207 83209 83210 83211 83213 83216 83218 83219 83220 83221 83223 83225 83227 83229 83231 83233 83235 83240 83241 83243 83245 83246 83249 83252 83254 83255 83256 83260 83261 83263 83264 83267 83268 83269 83271 83272 83273 83276 83277 83279 83280 83281 83282 83285 83287 83290 83291 83292 83293 83294 83300 83301 83302 83305 83306 83308 83309 83310 83311 83312 83313 83314 83316 83317 83321 83322 83323 83324 83326 83328 83329 83332 83334 83337 83338 83342 83343 83346 83348 83350 83351 83352 83353 83356 83357 83360 83362 83363 83365 83366 83367 83369 83370 83371 83373 83376 83377 83378 83384 83385 83386 83387 83388 83390 83395 83397 83398 83399 83400 83402 83406 83411 83412 83413 83414 83415 83417 83418 83419 83420 83421 83422 83425 83426 83427 83428 83429 83430 83431 83432 83435 83436 83438 83439 83440 83441 83442 83445 83447 83448 83450 83451 83452 83454 83455 83456 83457 83458 83459 83460 83464 83467 83468 83469 83470 83472 83474 83475 83478 83480 83483 83484 83485 83489 83491 83492 83493 83494 83495 83496 83497 83499 83500 83502 83503 83506 83509 83510 83511 83512 83514 83515 83516 83517 83519 83520 83521 83522 83523 83524 83525 83526 83527 83529 83530 83531 83532 83534 83535 83536 83537 83538 83541 83542 83543 83544 83545 83547 83548 83549 83550 83555 83556 83557 83558 83560 83561 83562 83563 83566 83568 83569 83574 83575 83577 83578 83579 83580 83581 83583 83584 83585 83586 83590 83591 83596 83597 83598 83599 83600 83602 83603 83606 83607 83608 83609 83616 83617 83618 83619 83620 83622 83626 83627 83628 83629 83631 83632 83633 83634 83635 83637 83639 83640 83642 83643 83645 83647 83648 83649 83651 83652 83657 83658 83659 83660 83662 83667 83668 83669 83670 83673 83674 83675 83676 83677 83680 83682 83683 83686 83688 83689 83690 83691 83693 83694 83699 83700 83701 83702 83703 83704 83705 83708 83710 83711 83712 83714 83715 83716 83717 83719 83721 83722 83723 83726 83727 83728 83729 83730 83731 83733 83734 83735 83736 83738 83739 83740 83741 83743 83744 83746 83747 83748 83749 83755 83757 83759 83761 83764 83765 83767 83768 83769 83770 83773 83774 83775 83776 83777 83778 83780 83781 83786 83788 83789 83790 83791 83794 83796 83800 83801 83804 83807 83810 83811 83812 83814 83816 83819 83821 83822 83823 83824 83825 83826 83827 83828 83829 83830 83831 83833 83834 83835 83836 83838 83839 83840 83842 83844 83845 83847 83848 83849 83851 83852 83853 83854 83855 83856 83857 83861 83862 83863 83864 83866 83869 83870 83871 83872 83873 83876 83877 83878 83880 83881 83883 83887 83888 83890 83892 83893 83895 83896 83898 83899 83900 83902 83904 83912 83913 83916 83920 83921 83922 83926 83931 80121C 80158C 80390A 82791 82792 82797 82800 82801 82802 82803 82805 82807 82816 82817 82819 82820 82821 82822 82823 82829 82830 82831 82841 82848 82849 82852 82858 82861 82864 82868 82870 82871 82873 82874 82878 82882 82884 82885 82886 82888 82890 82894 82899 82905 82907 82908 82913 82914 82915 82919 82923 82925 82930 82931 82934 82937 82938 82940 82942 82946 82948 82951 82952 82953 82954 82955 82961 82962 82965 82966 82971 82973 82974 82975 82980 82984 82985 82994 82995 82997 82998 83006 83012 83016 83024 83026 83030 83031 83033 83036 83037 83042 83048 83052 83053 83054 83056 83058 83060 83061 83063 83066 83067 83068 83069 83070 83071 83073 83078 83079 83089 83095 83097 83099 83101 83102 83103 83104 83106 83108 83110 83113 83117 83119 83123 83124 83125 83127 83128 83129 83130 83132 83135 83136 83137 83138 83140 83143 83145 83146 83147 83151 83152 83153 83158 83162 83166 83167 83168 83172 83179 83180 83183 83184 83187 83188 83189 83192 83193 83196 83198 83200 83204 83208 83212 83214 83215 83217 83222 83224 83226 83228 83230 83232 83234 83236 83237 83239 83242 83244 83247 83248 83250 83251 83253 83257 83258 83259 83262 83265 83266 83270 83274 83275 83283 83284 83286 83288 83289 83295 83296 83297 83298 83299 83303 83304 83307 83315 83318 83319 83320 83325 83327 83330 83331 83333 83335 83336 83339 83340 83341 83344 83345 83347 83349 83354 83355 83358 83359 83361 83364 83368 83372 83374 83375 83379 83380 83381 83382 83383 83389 83391 83392 83393 83394 83396 83401 83403 83404 83405 83407 83408 83409 83410 83416 83423 83424 83433 83434 83437 83443 83444 83446 83449 83453 83461 83462 83463 83465 83466 83471 83473 83476 83477 83479 83481 83486 83487 83488 83490 83498 83501 83504 83505 83508 83513 83518 83528 83533 83539 83540 83546 83551 83552 83553 83554 83559 83564 83565 83567 83570 83571 83572 83573 83576 83582 83587 83588 83589 83592 83593 83594 83595 83601 83604 83605 83610 83611 83612 83613 83614 83615 83621 83623 83624 83625 83630 83636 83638 83641 83644 83646 83650 83653 83654 83655 83656 83661 83663 83664 83665 83666 83671 83672 83678 83679 83681 83684 83685 83687 83692 83695 83696 83697 83698 83706 83707 83709 83713 83718 83720 83724 83725 83732 83737 83742 83745 83750 83751 83752 83753 83754 83756 83758 83760 83762 83763 83766 83771 83772 83779 83782 83783 83784 83785 83787 83792 83793 83795 83797 83798 83799 83802 83803 83805 83806 83808 83809 83813 83815 83817 83818 83820 83832 83841 83843 83846 83850 83858 83859 83860 83865 83867 83868 83874 83879 83882 83884 83885 83891 83897 83901 83903 83905 83909 83910 83911 83929, and 83935;

2) S/N: 90877 90968 91005 91165 91206 90139 90941 90944 91327 90865 90936 90952 91032 91126 91127 91193 91228 90921 91022 91308 91328 90859 90860 90899 90885 90969 90970 91057 91070 91107 91141 91222 91296 91434 91065 90843 90846 90929 90930 90931 90932 90933 90935 90948 90950 90951 90961 90962 90963 90964 90965 91013 91014 91015 91016 91017 91018 91019 91020 91043 91044 91045 91046 91047 91048 91049 91050 91151 91152 91153 91154 91155 91213 91214 91215 91218 91238 91239 91240 91241 91242 91243 91253 91254 91256 91257 91262 91263 91265 91266 91268 91269 91310 91311 91312 91313 91314 91315 91351 91352 91355 91356 91357 91358 91359 91360 91382 91383 91384 91385 91386 91387 91426 91129 90849 90867 91051 90889 91012 91039 91054 91099 91100 91143 91345 91361 91411 91457 91459 91076 91258 90866 90875 90879 90916 90917 90918 90945 90939 90942 90953 90971 90972 90976 90995 90996 91009 91033 91036 91059 91060 91068 91069 91071 91072 91105 91106 91111 91118 91123 91124 91133 91137 91138 91181 91182 91202 91211 91221 91223 91225 91259 91283 91284 91285 91287 91299 91300 91301 91316 91317 91322 91324 91331 91337 91350 91367 91368 91370 91409 91415 91416 91420 91437 91438 91444 91429 90912 90913 91224 91260 91261 91330 91446 91108 91294 90946 91343 90861 90862 90882 90940 90980 90983 91035 91115 91144 91231 91290 91291 91346 91377 91381 91425 91430 91431 91465 91471 91480 91481 90844 90847 90848 90850 90863 90864 90890 90892 90893 90894 90898 90920 90923 90924 90934 90938 91026 91028 91029 91030 91031 91113 91114 91128 91180 91183 91186 91187 91208 91210 91212 91226 91227 91229 91252 91286 91307 91319 91342 91378 91412 91413 91440 91441 91442 91443 91449 91452 91453 91454 91455 91456 91458 91460 91461 91466 91467 91470 91473 90854 90911 90978 90994 91066 91103 91104 91125 91250 91298 91379 91380 91400 91424 91435 91451 91064 91075 91428 91178 91282 91297 91403 91365 91174 91271 91094 91318 90914 90988 91395 91482 90907 90910 91109 91110 91132 91135 91184 91288 91292 91293 91306 91320 91326 91372 91404 90871 90872 90873 90874 90876 90954 90955 90956 90957 90958 91097 91098 91101 91102 91136 91147 91148 91149 91150 91375 91390 91391 91393 91394 91414 91418 91432 91472 91486 91487 91488 91489 91207 90855 90858 90887 90888 90896 90901 90902 90926 90927 90928 90959 90960 90966 90967 90977 90984 90985 90986 90987 90997 90998 90999 91001 91002 91003 91007 91008 91052 91053 91055 91077 91078 91079 91080 91085 91086 91087 91093 91157 91158 91159 91167 91168 91169 91170 91171 91172 91173 91176 91177 91179 91198 91199 91234 91235 91236 91237 91244 91245 91264 91275 91276 91277 91278 91279 91332 91333 91334 91335 91336 91338 91339 91340 91344 91347 91363 91364 91369 91396 91406 91407 91417 91421 91436 91439 91462 91463 91468 91469 91474 91476 91477 91485 91499 91501 90884 90891 90895 90919 90992 91006 91063 91084 91119 91161 91232 91246 91255 91302 91309 91323 91329 91402 91422 91493 90851 91142 90982 90897 91185 91190 90993 90869 90870 90903 90908 90949 90973 90974 90975 91062 91083 91120 91121 91122 91130 91145 91160 91162 91163 91164 91196 91247 91248 91273 91274 91353 91354 91362 91366 91427 91475 91479 91027 91156 91280 91399 91447 91203 90868 90947 91042 91081 91082 91131 91233 91373 91495 91496 91498 91500 91502 91504 91397 91398 90880 90881 91061 90845 90878 91000 91004 91267 91021 91304 91341 91445 90852 91067 91037 91038 91450 90856 90990 91034 91205 91281 91289 91374 91401 91478 90937 91140 91197 91303 91423 91175 90981 91117 91209 91251 91325 91483 90900 91091 91371 91410 90943 91270 91272 91408 91010 91011 91405 90853 90883 90886 90915 90922 90925 90979 90989 90991 91025 91056 91058 91088 91089 91090 91095 91096 91112 91116 91139 91188 91189 91191 91192 91194 91195 91204 91230 91321 91348 91349 91376 91392 91433 91448 91484 91490 91491 91492 91092 91249 91295 91419 90904 90905 90906 90909 91023 91024 91040 91041 91073 91074 91200 91201 91216 91217 91219 91220 90857 91166 91305 91388 91389 91464 91134 91494 91497 82791 82792 82797 82800 82801 82802 82803 82805 82807 82816 82817 82819 82820 82821 82822 82823 82829 82830 82831 82841 82848 82849 82852 82858 82861 82864 82868 82870 82871 82873 82874 82878 82882 82884 82885 82886 82888 82890 82894 82899 82905 82907 82908 82913 82914 82915 82919 82923 82925 82930 82931 82934 82937 82938 82940 82942 82946 82948 82951 82952 82953 82954 82955 82961 82962 82965 82966 82971 82973 82974 82975 82980 82984 82985 82994 82995 82997 82998 83006 83012 83016 83024 83026 83030 83031 83033 83036 83037 83042 83048 83052 83053 83054 83056 83058 83060 83061 83063 83066 83067 83068 83069 83070 83071 83073 83078 83079 83089 83095 83097 83099 83101 83102 83103 83104 83106 83108 83110 83113 83117 83119 83123 83124 83125 83127 83128 83129 83130 83132 83135 83136 83137 83138 83140 83143 83145 83146 83147 83151 83152 83153 83158 83162 83166 83167 83168 83172 83179 83180 83183 83184 83187 83188 83189 83192 83193 83196 83198 83200 83204 83208 83212 83214 83215 83217 83222 83224 83226 83228 83230 83232 83234 83236 83237 83239 83242 83244 83247 83248 83250 83251 83253 83257 83258 83259 83262 83265 83266 83270 83274 83275 83283 83284 83286 83288 83289 83295 83296 83297 83298 83299 83303 83304 83307 83315 83318 83319 83320 83325 83327 83330 83331 83333 83335 83336 83339 83340 83341 83344 83345 83347 83349 83354 83355 83358 83359 83361 83364 83368 83372 83374 83375 83379 83380 83381 83382 83383 83389 83391 83392 83393 83394 83396 83401 83403 83404 83405 83407 83408 83409 83410 83416 83423 83424 83433 83434 83437 83443 83444 83446 83449 83453 83461 83462 83463 83465 83466 83471 83473 83476 83477 83479 83481 83486 83487 83488 83490 83498 83501 83504 83505 83508 83513 83518 83528 83533 83539 83540 83546 83551 83552 83553 83554 83559 83564 83565 83567 83570 83571 83572 83573 83576 83582 83587 83588 83589 83592 83593 83594 83595 83601 83604 83605 83610 83611 83612 83613 83614 83615 83621 83623 83624 83625 83630 83636 83638 83641 83644 83646 83650 83653 83654 83655 83656 83661 83663 83664 83665 83666 83671 83672 83678 83679 83681 83684 83685 83687 83692 83695 83696 83697 83698 83706 83707 83709 83713 83718 83720 83724 83725 83732 83737 83742 83745 83750 83751 83752 83753 83754 83756 83758 83760 83762 83763 83766 83771 83772 83779 83782 83783 83784 83785 83787 83792 83793 83795 83797 83798 83799 83802 83803 83805 83806 83808 83809 83813 83815 83817 83818 83820 83832 83841 83843 83846 83850 83858 83859 83860 83865 83867 83868 83874 83879 83882 83884 83885 83891 83897 83901 83903 83905 83909 83910 83911 83929, and 83935;

3) S/N: 45264A 45260A 45214A 45241A 45036A 47585C 49124C/CE 47513C 47758C 48342C/NCE 48337C/NCE 49781C/CE 48137C/NCE 47262C 45425SL/CE 45251SL 45751SL/CE 45815SL/CE, and 49521W/CE;

4) S/N: 70638A 70756 70387C 71202W, and 70089W
RECALLING FIRM/MANUFACTURER
Hologic, Inc., Bedford, MA, by letter dated April 17, 2009. Firm initiated recall is ongoing.
REASON
System may not turn off at the end of the x-ray and cause additional x-ray exposure.
VOLUME OF PRODUCT IN COMMERCE
1914 units
DISTRIBUTION
Nationwide, Canada, Europe, Austria, Belgium, Bulgaria, Czech Republic, Denmark, France, Germany, Great Britain, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Macedonia, Netherlands, Norway, Poland, Portugal, Romania, Russia, Serbia, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine, Uzbekistan, Algeria, Arab Emirates, Argentina, Australia, Bahrain, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, Hong Kong, Indonesia, India, Iran, Iraq, Israel, Japan, Jordan, Kenya, Korea, Kuwait, Lebanon, Malaysia, Morocco, Mexico, Pakistan, Peru, Puerto Rico, South Africa, Saudi Arabia, Singapore, Syria, Taiwan, Thailand, Tunisia, Venezuela, and Vietnam
___________________________________
PRODUCT 
1) Dall Miles Cable Grip System; Catalog number 6704-0-210; The Dall-Miles Recon and Trauma Cable System provides the surgeon with a variety of methods for achieving trochanteric reattachment and for cerclage fixation. Recall # Z-1821-2009;

2) V 40 Femoral Head, Sterile, 22 mm; Catalog number 6260-4-122, Catalog number 6260-5-226; Intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty. Recall # Z-1822-2009
CODE
1) Lot # 29233201; Exp. 2/3/2014;

2) Lot # 29213701; Exp. 1/28/2014 and lot # 29228301; Exp 1/28/2014
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on June 18, 2009.
Manufacturer: Stryker Ireland, Ltd., Orthopedics, Carrigtohill, County Cork, Ireland. Firm initiated recall is ongoing.
REASON
Sterilization issue: During post-sterilization inspection of the outer blister packaging of the affected lots, it was determined that the outer blister did not meet the required minimum seal width.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
NX 2008 Central Monitoring System (CMS). Product code: E2FB6 Agfa's Computed Radiography Systems with NX Workstations are intended for use in providing diagnostic quality images to aid the physician with diagnosis. Recall # Z-1889-2009
CODE
NX Software versions: 2.0. 7000, 3.0.7000, 2.0.8000 and 3.0.8000
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp., Greenville, SC, by letter on/about June 22, 2009.
Manufacturer: Agfa HealthCare GMBH, Peissenberg, Germany. Firm initiated recall is ongoing.
REASON
After opening and closing a study on a Central Monitoring System while a study is still open on an in-room NX system, a problem of image mix-up can occur on the in-room NX system.
VOLUME OF PRODUCT IN COMMERCE
97 units
DISTRIBUTION
IL, PA, TX, Canada, Europe, Asia Pacific and Latin America
___________________________________
PRODUCT 
1) Sheridan Preformed Cuffed Tracheal Tube, Nasal 6.5, Catalog Number: 5-22313. Used for oral or nasal intubation for airway management. Recall # Z-1890-2009;

2) Sheridan Preformed Cuffed Tracheal Tube, Nasal 7.0, Catalog Number: 5-22314. Used for oral or nasal intubation for airway management. Recall # Z-1891-2009
CODE
1) Lot number 01A0900364;
2) Lot number 01A0900365
RECALLING FIRM/MANUFACTURER
Teleflex Medical, Durham, NC, by letters on or about July 6, 2009. Firm initiated recall is ongoing.
REASON
The Nasal Preformed Tracheal Tubes were found to have incorrect insertion depth mark printings.
VOLUME OF PRODUCT IN COMMERCE
1,160 units
DISTRIBUTION
Nationwide and countries of France and Japan
___________________________________
PRODUCT 
1) Boston Scientific Clipping Device, Resolution Clip, working length 155 cm, working channel 2.8 mm; Product codes M00522600 (1 clip) and M00522602 (20 clips). The Resolution Clip Device is a pre-loaded single-use clip on a flexible delivery system. It is placed into the gastrointestinal tract for the purpose of endoscopic marking, hemostasis, anchoring jejunal tubes and closure of lumenal perforations. Recall # Z-1895-2009;

2) Boston Scientific Clipping Device, Resolution Clip, working length 235 cm, working channel 2.8 mm; a) Product codes M00522610 (1 clip) and b) M00522612 (20 clips). The Resolution Clip Device is a pre-loaded single-use clip on a flexible delivery system. It is placed into the gastrointestinal tract for the purpose of endoscopic marking, hemostasis, anchoring jejunal tubes and closure of lumenal perforations. Recall # Z-1896-2009
CODE
1) Lot #: 0ML9042402 and Lot #: 0ML9042701;

2) a) Lot #s: 0ML9042004, 0ML9042101, 0ML9042102, 0ML9042702, 0ML9050401 and 0ML9051201;  b) Lot #s 0ML9042005, 0ML9042006, 0ML9042204, 0ML9042705, 0ML9042706, 0ML9050402, 0ML9050403, 0ML9051205 and 0ML9051206
RECALLING FIRM/MANUFACTURER
Recall Firm: Boston Scientific Corp., Quincy, MA, by letter dated June 17, 2009.  
Manufacturer: Medventure Technology Corp., Jeffersonville, IN. Firm initiated recall is ongoing.
REASON
The clip may not deploy or, if deployed, the clip may not release from the tissue.
VOLUME OF PRODUCT IN COMMERCE
4,486 units
DISTRIBUTION
Nationwide, France, Germany, Great Britain, Italy, Netherlands, Spain and Sweden
___________________________________
PRODUCT 
SmartPort CT Port Access System, Catalog number CT80STPD, AngioDynamics Incorporated The SmartPort CT Port Access System is indicated for any patient requiring repeated access of the vascular system or other selected body site, for delivery of medications, nutritional supplementation, fluids, blood products, and sampling of blood. Recall # Z-1898-2009
CODE
Lot number: 983533
RECALLING FIRM/MANUFACTURER
Angiodynamics, Inc., Manchester, GA, by letters on July 16, 2009. Firm initiated recall is ongoing.
REASON
The product may contain an incorrect size catheter and introducer.
VOLUME OF PRODUCT IN COMMERCE
150 kits
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Triathlon AR 4:1 Cutting Blocks - Size 1-8; Catalog Numbers: 6541-0-701, 6541-0-702, 6541-0-703, 6541-0-704, 6541-0-705, 6541-0-706, 6541-0-707, & 6541-0-708; Triathlon MIS Instruments; Non Sterile. The Triathlon AR 4:1 Cutting Blocks and the Triathlon MIS 4:1 Cutting Blocks are used to prepare the Femur (bone cuts) for the Triathlon femoral component. Recall # Z-1916-2009;

2) Triathlon MIS 4:1 Cutting Blocks - Size 1-8; Catalog Numbers: 6541-5-701, 6541-5-702, 6541-5-703, 6541-5-704, 6541-5-705, 6541-5-706, 6541-5-707, & 6541-5-708; Triathlon MIS Instruments; Non Sterile. The Triathlon AR 4:1 Cutting Blocks and the Triathlon MIS 4:1 Cutting Blocks are used to prepare the Femur (bone cuts) for the Triathlon femoral component. Recall # Z-1917-2009
CODE
All lot codes
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on February 12, 2008. Firm initiated recall is complete.
REASON
Triathlon Cutting Blocks did not assemble to the Triathlon Impactor/Extractor Handle.
VOLUME OF PRODUCT IN COMMERCE
690 units
DISTRIBUTION
Nationwide and Sweden, Spain, Italy, Portugal, United Kingdom, Hong Kong, Australia and New Zealand
___________________________________
PRODUCT 
Stratus OCT Model 3000 instruments distributed with version 6.0.0 software, product number 2660021119710 (new instrument) or 2660022119710 (refurbished instrument), and Stratus 6.0.0 Software Kit, product number 2660021133164. The Stratus OCT is a high resolution tomographic device for the viewing and axial cross sectional imaging of posterior ocular structures. It is used for in vivo imaging and measurement of the retina, retinal nerve fiber layer, macula, and optic disk. The Stratus OCT with Retinal Nerve Fiber Layer and Macula Normative Database is a quantitative tool for the comparison of retinal nerve fiber layer in the human retina to a database of known normal subjects. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases, including, but not limited to, macular edema, central serous retinopathy, and glaucoma. Recall # Z-2048-2009
CODE
Instrument serial numbers 3000-1366, 3000-1691, 3000-3058, 3000-3222, 3000-3660, 3000-3959, 3000-4641, 3000-4696, 3000-4802, 3000-5269, 3000-5304, 3000-5457, 3000-6070, 3000-6174, 3000-6258, 3000-6468, 3000-6517, 3000-6770, 3000-6894, 3000-7118, 3000-7157, 3000-7752, 3000-7834, 3000-7847, 3000-8226, 3000-8491, 3000-8534, 3000-8920, 3000-9441, 3000-9469, 3000-9530, 3000-9705, 3000-9791, 3000-9974, 3001-0156, 3001-0235, 3001-0324, 3001-0820, 3001-0842, 3001-0851, 3001-0854, 3001-1002, 3001-1028, 3001-1044, 3001-1046, 3001-1048, 3001-1049, 3001-1052, 3001-1054, 3001-1055, 3001-1056, 3001-1057, 3001-1067, 3001-1069, 3001-1070, 3001-1071, 3001-1072, 3001-1075, 3001-1076, 3001-1077, 3001-1078, 3001-1079, 3001-1083, 3001-1084, 3001-1085, 3001-1086, 3001-1088, 3001-1090, 3001-1093, 3001-1095, 3001-1096, 3001-1098, 3001-1116, 3001-1117, 3001-1119, 3001-1120, 3002-10267, 3002-6731, and 3002-7265. Software upgrade license numbers MSR-10000, MSR-10002, MSR-10003, MSR-10005, MSR-10008, MSR-10009, MSR-10010, MSR-10011, MSR-10012, MSR-10013, MSR-10014, MSR-10015, MSR-10016, MSR-10017, MSR-10019, MSR-10020, MSR-10021, MSR-10022, MSR-10023, MSR-10024, MSR-10025, MSR-10026, MSR-10028, MSR-10029, MSR-10030, MSR-10031, MSR-10032, MSR-10033, MSR-10035, MSR-10036, MSR-10037, MSR-10039, MSR-10040, MSR-10041, MSR-10045, MSR-10048, MSR-10049, MSR-10057, MSR-10058, MSR-10060, MSR-10065, MSR-10066, MSR-10067, MSR-10072, MSR-10073, MSR-10074, MSR-10075, MSR-10076, MSR-10077, MSR-10078, MSR-10079, MSR-10080, MSR-10081, MSR-10082, MSR-10083, MSR-10084, MSR-10086, MSR-10087, MSR-10088, MSR-10089, MSR-10090, MSR-10091, MSR-10092, MSR-10094, MSR-10096, MSR-10097, MSR-10099, MSR-10100, MSR-10101, MSR-10102, MSR-10103, MSR-10106, MSR-10108, MSR-10110, MSR-10111, MSR-10116, MSR-10120, MSR-10124, MSR-10125, MSR-10126, MSR-10127, MSR-10128, MSR-10129, MSR-10130, MSR-10131, MSR-10132, MSR-10133, MSR-10134, MSR-10135, MSR-10136, MSR-10137, MSR-10138, MSR-10139, MSR-10140, MSR-10141, MSR-10142, MSR-10143, MSR-10144, MSR-10148, MSR-10149, MSR-10150, MSR-10151, MSR-10157, MSR-10158, MSR-10160, MSR-10162, MSR-10168, MSR-10184, MSR-10198, and MSR-10199. Review software license numbers RVW6RMJM-00101, RVW6RMJM-00111, RVW6RMJM-00121, RVW6RMJM-00131, RVW6RMJM-00141, RVW6RMJM-00151, RVW6RMJM-00161, RVW6RMJM-00171, RVW6RMJM-00181, RVW6RMJM-00201, RVW6RMJM-00211, RVW6RMJM-00221, RVW6RMJM-00231, RVW6RMJM-00231, RVW6RMJM-00241, RVW6RMJM-00251, RVW6RMJM-00291, RVW6RMJM-00301, RVW6RMJM-00311, RVW6RMJM-00321, RVW6RMJM-00331, RVW6RMJM-00341, RVW6RMJM-00361, RVW6RMJM-00371, RVW6RMJM-00381, RVW6RMJM-00391, RVW6RMJM-00401, RVW6RMJM-00411, RVW6RMJM-00421, RVW6RMJM-00431, RVW6RMJM-00441, RVW6RMJM-00451, RVW6RMJM-00471, RVW6RMJM-00481, RVW6RMJM-00491, RVW6RMJM-00501, RVW6RMJM-00521, RVW6RMJM-00531, RVW6RMJM-00541, RVW6RMJM-00551, RVW6RMJM-00561, RVW6RMJM-00571, RVW6RMJM-00581, RVW6RMJM-00591, RVW6RMJM-00601, RVW6RMJM-00611, RVW6RMJM-00631, RVW6RMJM-00641, RVW6RMJM-00651, RVW6RMJM-00661, RVW6RMJM-00671, RVW6RMJM-00681, RVW6RMJM-00691, RVW6RMJM-00741, RVW6RMJM-00761, RVW6RMJM-00771, and RVW6RMJM-01341. Code RDCM1-00111
RECALLING FIRM/MANUFACTURER
Carl Zeiss Meditec Inc., Dublin, CA, by letter on July 2, 2009. Firm initiated recall is ongoing.
REASON
Mis-labeled image. A bug in version 6.0.0 software and 6.0.0 software kit used with Stratus OCT Model 3000 can produce a report that incorrectly labels OD or OS.
VOLUME OF PRODUCT IN COMMERCE
244 units
DISTRIBUTION
Nationwide, Austria, UK, Japan, Singapore, Argentina, France, Hong Kong, New Zealand, Canada, Colombia, Germany, Korea, Venezuela, India and China

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

___________________________________
PRODUCT 
Remel BactiSwab NPG Collection and Transport System, Sterile, 100 swab units/box, Catalog 12300. Collection and transportation of clinical specimens to the laboratory for microbiological examination when swab collection is appropriate. Recall # Z-1812-2009
CODE
Lot 725080, Exp. 2013.05.28
RECALLING FIRM/MANUFACTURER
Remel, Inc., Lenexa, Kansas, by letters dated May 7, 2009. Firm initiated recall is ongoing.
REASON
Incorrect expiration date on the product.
VOLUME OF PRODUCT IN COMMERCE
103 packages
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
T2 Ankle Arthrodesis Nail Surgical Protocol, Catalog Number LT2AA-OT, Stryker Orthopedics. The Surgical Protocol instructs surgeons on proper surgical technique for the T2 Ankle Arthrodesis Nail. Recall # Z-1818-2009
CODE
n/a
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters, dated November 17, 2006. Firm initiated recall is complete.
REASON
Operative Surgical Technique was found to have a typographical error where hyphens were inadvertently omitted in incision lengths (i.e. 1520 cm should be 15-20 cm).
VOLUME OF PRODUCT IN COMMERCE
1,270 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS III

___________________________________
PRODUCT 
1) Aviva Pre-Milking Udder Wash with Cocoa Butter and Chlorhexidine Gluconate, Net Contents One Gallon. The product is shipped 4 gallons per case. Recall # V-001-2010;

2) Chap Free Concentrated Teat Dip with Chlorhexidine and Glycerin, net contents one gallon. The product is shipped 4 gallons per case. Recall # V-002-2010;

3) Sani-T-Dip (teat dip), net contents one gallon. The product is shipped 4 gallons per case. Recall # V-003-2010
CODE
1) Lot numbers: 02019 exp 1/13/10, 03019 exp 2-19-10, 08029 exp 2-20-10, 18079 exp 7-8-10;

2) Lot numbers: 34128 exp 12-15-09, 05029 exp 2-4-10, 13059 exp 5-5-10, and 14059 exp 5-5-10;

3) Lot number 33118 exp 11-28-09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aviva Products, Sinking Spring, PA, by telephone and letter on August 28, 2009. 
Manufacturer: Pagoda Products Inc., Sinking Spring, PA. Firm initiated recall is complete.
REASON
Product was manufactured with expired chlorhexidine gluconate ingredients.
VOLUME OF PRODUCT IN COMMERCE
689 gallons
DISTRIBUTION
PA, MD, NY, MI

END OF ENFORCEMENT REPORT FOR OCTOBER 7, 2009

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