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U.S. Department of Health and Human Services

Safety

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Enforcement Report for April 7, 2010

April 7, 2010                                                                                        10-13

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I
___________________________________
PRODUCT
Tone's Imitacion Tocino En Trocitos (Imitation Bacon Bits), packaged in 425 g (15-oz.) plastic jars, 12/case. Recall # F-1557-2010
CODE
Lot #728481, Exp Date 26.01.12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ach Food Companies Inc., Cordov, TN, by press release, letter and e-mail on March 4, 2010.
Manufacturer: Ach Food Companies, Inc., Ankeny, IA. Firm initiated recall is ongoing.
REASON
The product was manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
2.244/426 gal bottles
DISTRIBUTION
Mexico
___________________________________
PRODUCT
RFT 1679 Brown Gravy Dry Mix, Net Wt 25.00 lbs. Recall # F-1558-2010
CODE
Lot #1000501C1; Lot #1003301C1
RECALLING FIRM/MANUFACTURER
Reed Food Technology, Pearl, MS, by e-mails on February 26, 2010 and March 2, 2010. Firm initiated recall is ongoing.
REASON
Possible salmonella contamination.
VOLUME OF PRODUCT IN COMMERCE
151 bags
DISTRIBUTION
MS                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               
___________________________________
PRODUCT
1) HK Anderson Honey Mustard Pretzel Bites in a) 3.5 oz bags, UPC Code 0-70271-00131; b) 9.0 oz bags, UPC Code 0-70271-00130-0; c) 18.0 oz bags, UPC Code 0-70271-00128-0. Recall # F-1559-2010;

2)  CVS Honey Mustard Pretzel Bites in 18.0 oz bags. UPC Code 0-50428-12015-6. Recall # F-1560-2010; 

3) President's Choice Honey Mustard Onion Pretzel Bite in 300 gr bags. UPC Code 0-60383-99222-4.  Recall F-1561-2010;

4) Safeway Honey Mustard Onion Nugget in 10 oz bags. UPC Code 0-21130-29039-0. Recall # F-1562-2010;

5) Sunflower Markets Honey Mustard Nugget. UPC Code 8-59393-00041-4. Recall # F-1563-2010;

6) Honey Mustard Onion Pretzel Pieces sold in bulk. Recall # F-1564-2010;

7) Honey Mustard Onion Pretzel Bites sold in bulk. Recall # F-1565-2010;

8) Whole Grain Honey Mustard Nuggets sold in bulk. Recall # F-1566-2010
CODE
a) Use by dates: JUN 11 10 G6, JUN 11 10 I3, JUN 11 10 I5, JUL 01 10 G6, and JUL 22 10 I3; b) Use by dates: MAY 14 10 G5, MAY 14 2010 I4, JUN 11 10 G4, and JUL 01 10 I5, Lot number: 35139CP; c) Use by dates: MAY 14 2010 H4, MAY 14 2010 I4, JUN 11 2010 G6, JUN 11 2010 H5, JUL 01 2010 G6, JUL 22 2010 G4, and JUL 22 2010 I3;

2) Use by dates: SEP 15 2010 G5, SEP 15 2010 G6, SEP 15 2010 G7, SEP 15 2010 H4, SEP 15 2010 H5, SEP 15 2010 H6, SEP 15 2010 H7, SEP 15 2010 I4, SEP 15 2010 I5, and SEP 15 2010 I6;

3) Use by dates: 2010 MA 14 I2, 2010 MA 28 I2, 2010 MA 28 I2, and 2010 JL 15 H7;

4) Use by dates: MAY 11 10 I5, JUN 25 10 I3, and JUL 01 10 I5;

5) Use by date: MAY 14 10 H4;

6) Use by dates: MAR 21 10 I3, APR 11 10 H3, APR 11 10 H5, MAY 01 10 G6, and MAY 22 10 G4;

7) Use by dates: 05 FEB 2010 I, APR 11 10 I5, and APR 25 10 I3, MAY 0110 I5, Lot number: 012710I and 0127I3;

8) Use by dates: APR 11 10 G6 and APR 11 10 H6
RECALLING FIRM/MANUFACTURER
Recalling Firm: National Pretzel Co., Lancaster, PA, by e-mails on March 4, 2010 and by press release on March 5, 2010.
Manufacturer: California Pretzel Co., Visalia, CA. Firm initiated recall is ongoing.
REASON
The product was manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors In because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
9711 cases
DISTRIBUTION
Nationwide, Canada and Australia

___________________________________
PRODUCT
Golden Chick Bean Seasoning Mix, Item No. 94001 (T745GF), packaged in 4.5-oz. pouches, 30/case.  Recall # F-1567-2010
CODE
Lot numbers: 9334, 9413, 9825, 9826, and 9827
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bay State Milling Co., Quincy, MA, by telephone on March 8, 2010 and by letter dated March 9, 2010.
Manufacturer: Bay State Blending, Wichita, KS. Firm initiated recall is ongoing.
REASON
The product was manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors In because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
180/30/4.5 oz. pouch cases

DISTRIBUTION
TX
___________________________________
PRODUCT
Bacon Onion Dip T2537, Ingredients***Pack Size 30 lb bags, Case Size: 1 bag per case. Recall # F-1568-2010
CODE
Lot # 00338, Date: February 15, 2010
RECALLING FIRM/MANUFACTURER
All American Seasoning, Inc., Denver, CO, by telephone on March 3, 2010. Firm initiated recall is complete.
REASON
The product was manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors In because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,800 lbs (packed in 60-30 lb boxes)
DISTRIBUTION
NE
___________________________________
PRODUCT
1) Kroger Onion Soup & Dip Mix sold in 2 ounce packages with UPC code 0001111073293. Recall # F-1569-2010;

2) Kroger Beefy Onion Soup & Dip Mix sold in 2.2 ounce packages with UPC code: 0001111073929. Recall # F-1570-2010
CODE
1) Sell by JAN 06 11 PB1 to FEB 17 11 PB1;
2) Sell by DEC 28 10 PB1 to FEB 23 11 PB1
RECALLING FIRM/MANUFACTURER
Kroger, Co., Cincinnati, OH, by e-mail, telephone and press release on February 27, 2010. Firm initiated recall is ongoing.
REASON
The product was manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors In because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
15,999 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Healthwise Cream of Mushroom Soup, 15g bags. Recall # F-1571-2010
CODE
Lot # 22267
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nutritional Resources, Inc., Grovetown, GA, by telephone on March 3, 2010 and by letters on March 4, 2010.
Manufacturer: Blendco, Inc., Hattiesburg, MS. Firm initiated recall is ongoing.
REASON
The product was manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors In because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
11,172 boxes containing 7/15 gram packages per box
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
Concord Foods Vegetable Dip Seasoning Mix - Homestyle. Net weight 1.5 oz (43 g) UPC Code: 041409002066. Recall # F-1572-2010
CODE
Best By: 07/27/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Concord Foods, Inc., Brockton, MA, by press release and letter on March 5, 2010.
Manufacturer: Basic Food Flavors, Inc., North Las Vegas, NV. Firm initiated recall is ongoing.
REASON
The product was manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors In because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
527 cases (18 pouches/case)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Agilex Natural Flavor Chicken Type. Recall # F-1573-2010
CODE
Lot # 57200AA, Date of Production: 12-7-2009
RECALLING FIRM/MANUFACTURER
Key Essentials, Inc. dba Agilex Flavors, Rancho Santa Margarita, CA, by letter dated February 26, 2010. Firm initiated recall is ongoing.
REASON
The product was manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors In because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
5 containers of 20KG each
DISTRIBUTION
Canada
___________________________________
PRODUCT
1) Spinach Dip sold under the following brand names: Delicioso , 12/12oz (UPC 29358 10031); De la Casa, 6/32oz (UPC 29358 11273); Fresh Food Concepts, 12/12oz, UPC 47502-48151; Rojo's Garden Fresh, 12/14oz, UPC 475002-48003. Recall # F-1574-2010

2) Fresh Food Concepts Spinach Dip with Real Yogurt, 12/12 oz; UPC 47502-48151. Recall # F-1575-2010
CODE
Use by date 04/30/10 and before
RECALLING FIRM/MANUFACTURER
Fresh Food Concepts, Inc., Buena Park, CA, by letter on March 4, 2010 and press release on March 5, 2010. Firm initiated recall is ongoing.
REASON
The product was manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors In because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
15,520 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Illes Seasonings & Flavors AU JUS Seasoning 6390 Net Contents: 20 pounds 9.07 Kilograms For Manufacturing Use Only. Recall # F-1576-2010;

2) Illes Seasonings & Flavors Spanish Rice with Cheese & Jalapeno 5704 6 x 35 pound Bags/Drum Net Contents: 210 pounds 95.256 Kilograms For Manufacturing Use Only. Recall # F-1577-2010;

3) Illes Seasonings & Flavors Smoky Bacon Peppercorn Rub 6517 Per Net Contents: 50 pounds 22.7 Kilograms For Manufacturing Use Only. Recall # F-1578-2010;

4) Illes Seasonings & Flavors Chicken Base W/O MSG 4361 Net Contents: 35 pounds 15.88 Kilograms For Manufacturing Use Only. Recall # F-1579-2010;

5) Illes Seasonings & Flavors French Onion Dip Seasoning 6399 Net Contents: 36.8 pounds 16.69 Kilograms For Manufacturing Use Only. Recall # F-1580-2010;

6) Illes Seasonings & Flavors Rockbottom Italian Seasoning 6405 Net Contents: 50 pounds 22.7 Kilograms For Manufacturing Use Only. Recall F-1581-2010;

7) Illes Seasonings & Flavors Heb Mesquite BBQ Marinade 6081 Net Contents: 50 pounds 22.7 Kilograms For Manufacturing Use Only. Recall # F-1582-2010;

8) Illes Seasonings & Flavors Flavor Enhancer 4666 Net Contents: 50 pounds 22.68 Kilograms For Manufacturing Use Only. Recall # F-1583-2010;

9) Illes Seasonings & Flavors Rice Seasoning 4820 200 X 1.293 oz Bags Net Contents: 16.1625 Pounds 7.33 Kilograms For Manufacturing Use Only. Recall # F-1584-2010;

10) Illes Seasonings & Flavors Chicken Noodle Seasoning 5858 Net Contents:  27.50 pounds 12.47 Kilograms For Manufacturing Use Only. Recall # F-1585-2010;

11) Illes Seasonings & Flavors Italian Chicken Marinade 6421 Net Contents: 50 pounds 22.7 Kilograms For Manufacturing Use Only. Recall # F-1586-2010;

12) Illes Seasonings & Flavors Italian Marinade 6071 Net Contents: 50 pounds 22.7 Kilograms For Manufacturing Use Only. Recall # F-1587-2010;

13) Illes Seasonings & Flavors Fajita Marinade 6392 Net Contents: 54.5 pounds 24.72 Kilograms For Manufacturing Use Only. Recall # F-1588-2010

14) Illes Seasonings & Flavors Italian Seasoning 6175 Net Contents: 50 pounds 22.7 Kilograms. For Manufacturing Use Only. Recall # F-1589-2010;

15) Illes Seasonings & Flavors Chili's Southwestern Spice 6283 30 X 4.3 oz Bags Net Contents: 8.0625 pounds 3.66 Kilograms. Recall # F-1590-2010
CODE
1) Lot code: 0203100010;

2) Lot codes: 0209100039 and 0114100054;

3) Lot code: 0211100004;

4) Lot code # 0210100010;

5) Lot Code #'s: 0208100023, 1230090007, 1230090006, 1027090098, and 0210100018;

6) Lot codes: 0204100002, 0217100048, and 0111100007;

7) Lot code #'s: 0209100020, 0209100021, 0209100022, 0128100023, 0128100024, 1230090005, 1230090004, 0128100023, 0106100077, 1230090005, 0106100078, and 0114100023;

8) Lot code #: 0114100033;

9) Lot code #'s: 0106100118 and 0107100001;

10) Lot code #'s: 1014090017 and 1008090012;

11) Lot code #'s: 0917090015 and 1001090003;

12) Lot code #: 1014090039;

13) Lot code #: 1106090012;

14) Lot code #'s: 0917090116, 1014090040, 1008090066, 1008090067, 1008090068, 1008090069, and 0917090117;

15) Lot #: 1027090098                                                                                                                                                                                                                                       
RECALLING FIRM/MANUFACTURER
Illes Food Ingredient Ltd., dba Illes Seasonings & Flavors, Carrollton, TX, by e-mail on March 1, 2010. Firm initiated recall is ongoing.
REASON
The product was manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors In because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
2,320 total
DISTRIBUTION
TX, SC, GA, AR, AL, MS, OK, NC                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             
___________________________________
PRODUCT
1) Chicken Base without MSG # 2118 Net Wt. 50 lbs. Recall # F-1591-2010;

2) LA Hcienda / Mariano's Spanish Rice Seasoning # 1547 Net Wt. 4.25 oz (120.5 GMS) Packed: 24 / 4.25 OZS (BAGS/CASE). Recall # F-1592-2010;

3) LA Hcienda / Mariano's  Chicken Enchilada Spice Mix # 1548 Net Wt. 5 oz (141.8 GMS) Packed: 24 / 5 oz (Bags / Case). Recall # F-1593-2010;

4) LA Hcienda / Mariano's Tortilla Soup Spice # 1549 Net Wt. 2.25 oz (63.8 GMS) Packed: 24 / 2.25 oz (Bags / Case). Recall # F-1594-2010
CODE
1) Lot Code # 2-9-100272 and Lot # 2-16-100371;
2) Lot # 2-10-100323;
3) Lot # 2-10-100325;
4) Lot # 2-10-100324
RECALLING FIRM/MANUFACTURER
The Valdez, Corp., Carrollton, TX, by telephone and fax on February 26, 2010. Firm initiated recall is ongoing.
REASON
The product was manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors In because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
172 cases
DISTRIBUTION
TX
___________________________________
PRODUCT
Barcel Tostachos Chili & Cheese Corn Chips, Net Wt 3.17 oz (90g); UPC Code 074323 043587. Recall # F-1595-2010
CODE
Lot numbers: AuG1110, AUG1810, AUG2510, and SEP0110; manufactured between February 11, 2010 and March 3, 2010
RECALLING FIRM/MANUFACTURER
Barcel USA LLC, Irving, TX, by press release and e-mail on March 16, 2010 and by letter on March 17, 2010. Firm initiated recall is ongoing.
REASON
The product was manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors In because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
2,700 cases
DISTRIBUTION
CA, TN, IL, FL, NJ, TX, NC
___________________________________
PRODUCT
1) Natural & Artificial Bacon Type Flavor, 50 lb. poly-lined bags; Made in U.S.A.; product code QK19397. Recall # F-1596-2010;

2) Natural Bacon Type Flavor, 50 lb. poly-lined bags; Made in U.S.A.; product code QK20854. Recall # F-1597-2010;

3) Tomato-Basil Seasoning, 50 lb. (22.68 kg.) poly-lined cartons; Made in U.S.A.; product code QL37875. Recall # F-1598-201. Recall # F-1598-2010
CODE
1) Lot #: MO60211;
2) and 3) Lot #’s: M060061 and M060062;
RECALLING FIRM/MANUFACTURER
Givaudan, Itasca, IL, by letters dated March 1, 2010. Firm initiated recall is ongoing.
REASON
The product was manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors In because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
10,150 lbs
DISTRIBUTION
IL, MO, NV
___________________________________
PRODUCT
1) Spicy Black Bean Corn Sticks, Net Wt. 12 lbs; a round, thin, stick-like products, 1-2" long, with a dusty seasoning coating, packed in two 6-lb. foil bags per case, a bulk snack product for repackaging or further manufacturing; item code 10070F26. Recall # F-1599-2010;

2) Chili Cheese Corn Twists, Net Wt. 15 lbs; a round spiral, about 2" long, with a dusty seasoning coating, packed in poly-lined cardboard box, a bulk snack product for repackaging or further manufacturing. Recall # F-1600-2010
CODE
1) Lot code 0340A;
2) Lot code 0110C, 0120A and 0220A
RECALLING FIRM/MANUFACTURER
TH Foods Inc., Loves Park, IL, by telephone and letters on March 2, 2010. Firm initiated recall is ongoing.
REASON
The product was manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors In because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
801 cases
DISTRIBUTION
CA, IN, MD, MA, NJ, OR, PA, TX

___________________________________
PRODUCT
Natural Bacon Flavor #1201105 in 50 lb containers. Recall # F-1602-2010
CODE
Lot numbers 213884, 213867, and 215861
RECALLING FIRM/MANUFACTURER
Recalling Firm: The Food Source, Inc., Frazer, PA, by telephone on March 9, 2010 and by letter on March 8, 2010.
Manufacturer: Mother Murphys Laboratory, Greensboro, NC. Firm initiated recall is ongoing. 
REASON
The products were manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors In because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
500 lbs
DISTRIBUTION
KS
___________________________________
PRODUCT
1) Boyds Brown Gravy Mix in plastic bag with paper stick on label Net Wt 16 oz Boyd Coffee Company. Product is also packaged in 1 lb. plastic bag with a paper stick on label stating 1664 Brown Gravy Mix,  Boyd Coffee Company. BCC Product Code: 1665 (and the remainder is in Chinese). Recall # F-1603-2010;

2) Seasoning mix - Boyds E-3 Seasoning in 35 pound plastic package with paper stick on label Boyd Coffee Company, BCC Product Code: 1690. Recall # F-1604-2010;

3) Cream of Mushroom Soup in 1.1 pound plastic bag with paper stick on label Net Wt 17.6 oz Boyd Coffee Company; BCC Product Code: 5801. Recall # F-1605-2010;

4) Beef Barley Vegetable Soup a Complete Soup Mix in 13,2 oz. plastic bag with paper stick on label stating Boyd Coffee Company; BCC Product Code: 5816. Recall # F-1606-2010;

5) French Onion Soup complete soup mix in 14 oz plastic bag (no brand name on the label); BCC Product Code: 5828. Recall # F-1607-2010;

6) DEMI - GLACE Brown Sauce Mix in 16 oz. plastic bag with paper stick on label. (No other brand or responsible firm on label). BCC Product Code: 5956. Recall # F-1608-2010;

7) MANDARIN CITRUS VEGETABLES Net Wt.: 50 in tote with label affixed NORPAC: Lot # BCC Product code: BCC Production Order: (No other brand name of responsible firm on label). BCC Product Code: 5746. Recall # F-1609-2010;

8) Aztec Black Bean - SS (black bean soup flavoring) distributed in 50 lb. totes with paper label affixed NORPAC: Lot # BCC BCC Product Code: BCC Production Order: (No brand name or contact information on label). BCC Product Code: 5853. Recall # F-1610-2010;

9) Vegetable Beef Supreme in 50 lb. tote with affixed paper label stating Production Date: NORPAC: Lot # BCC Product Code: BCC Production Order: (No brand name or contact information on the label). BCC Product Code: 5859. Recall # F-1611-2010;

10) Tomato Florentine - SS in 50 lb. tote with affixed paper label stating Production Date: NORPAC: Lot # BCC Product Code: BCC Production Order: (No brand name or contact information on the label). BCC Product Code: 5879. Recall # F-1612-2010;

11) Harvest Vegetable in 50 lb. tote with affixed paper label stating Production Date: NORPAC: Lot # BCC Product Code: BCC Production Order: (No brand name or contact information on the label); BCC Product Code: 5893. Recall # F-1613-2010;

12) Japanese Jakitori - JA in 50 lb. tote with affixed paper label stating Production Date: NORPAC: Lot # BCC Product Code: BCC Production Order: (No brand name or contact information on the label); BCC Product Code: 5897. Recall # F-1614-2010;

13) 5648 Market Cafe Cream of Mushroom Soup Base in 2 lb. plastic bag with a stik-on label. Boyd Coffee Company. (The remainder of the verbiage is in Chinese). BCC Product Code: 5648 BCC. Recall # F-1615-2010;
CODE
1) Lots: 69876, 70644, 72213, 72872, 72873, 72874;

2) Lots: 68913, 72680;

3) Lots: 70321, 72456

4) Lot: 70323;

5) Lots: 73637, 73966;

6) Lot: 70403;

7) Norpac Lot: 5522 BCC Lots 72143, 74009;

8) Norpac Lot: 4207 BCC Lot: 72426;

9) Norpac Lot: 4214 BCC Lots: 69543, 71816, 74306, 74518

10) Norpac Lot: 4236 BCC Lots: 69531, 70764;

11) Norpac Lot: 5573 BCC Lot: 73562;

12) Norpac Lot: 4209 BCC Lots: 69545, 70099, 70100, 70101, 70102, 70771, 71457, 71458, 72427, 72951, 72952, 72953, 72954, 7295;

13) Lots: 70637, 708322, 71429
RECALLING FIRM/MANUFACTURER
Boyd Coffee Co., Portland, OR, by telephone and e-mail on February 26, 2010 and by visit on March 1, 2010. Firm initiated recall is complete.
REASON
The products were manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors In because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
AZ, CA, CO, ID, MN, MT, OR TX, UT, WA, Canada, Taiwan
___________________________________
PRODUCT
1) Chicken Flavor Rice Seasoning #2481. Recall # F- 1616-2010;
2) Fried Rice Seasoning #2485. Recall # F- 1617-2010;
3) Spanish Rice Seasoning #2495. Recall # F- 1618-2010
CODE
1) Lots: 0912601, 0912562, 0911553;
2) Lots: 0912600, 0911555, 0910597;
3) Lot: 0912597
RECALLING FIRM/MANUFACTURER
Bds Natural Products, Carson, CA, by letters on February 26, 2010. Firm initiated recall is ongoing.
REASON
The products were manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors In because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
8,656 lbs
DISTRIBUTION
CA
___________________________________
PRODUCT
Herr's Cracked Pepper and Sea Salt Flavored Kettle Style Potato Chips in a) 1.875 oz and b) 8.5 oz bags, UPC 072600014909. Recall # F-1619-2010
CODE
a) Dates codes FEB 27 2010 up to and including JUNE 12 2010; and b) dates codes FEB 27 2010 up to and including MAY 15 2010
RECALLING FIRM/MANUFACTURER
Herrs Foods, Inc., Nottingham, PA, by press release on March 8, 2010. Firm initiated recall is ongoing.
REASON
The products were manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors In because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
9,198 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Mrs. Gerry's Old Fashioned Spinach Dip packaged in 12 oz. (340 g) 12/case & 5 lbs (2.26 kg) 2/case packaged in plastic round tubs w/ lid, UPC 1783979005 (5 lb.) & UPC 1783979075 (12 oz.). Old Home Spinach Dip in 8 oz. packaged in plastic round tub w/ lid, UPC 070322004925. Recall # F-1620-2010;

2) Mrs. Gerry's Crab Creole Spread packaged in 7 oz. (198g) plastic round tub w/ snap off lid, 6/ case, UPC 017839784445. Recall # F-1621-2010
CODE
1) Use by Date: 12 oz. size - 1/27 - 4/22/10 5 lb. size - 1/27 - 4/14/10 8 oz. size - 1/27 - 4/22/10 Old Home;

2) Use by Date: 4/20/10 and 5/24/10
RECALLING FIRM/MANUFACTURER
Recalling: Mrs Gerry's Kitchen, Inc., Albert Lea, MN, by press release and telephone on March 5, 2010 and by press release on March 9, 2010. Firm initiated recall is ongoing.
REASON
The products were manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
38,691 lbs
DISTRIBUTION
IA, SD, MN, ND, NE, KS, CO, WI, MI, IL, MO
___________________________________
PRODUCT
Dean's Creamy Taco Dip in 8 oz. plastic tubs, 12 tubs per case; UPC 0 26700 12910 0. Plant 17-536. Recall # F-1632-2010;

CODE
Sell by dates: MAR 27 10, APR 29 10 and JUN 02 10;

RECALLING FIRM/MANUFACTURER
Ventura Foods, LLC, Thornton, IL, by press release on March 5, 2010. FDA initiated recall is ongoing.
REASON
The products were manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,126 cases
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II
___________________________________
PRODUCT
Knorr Fish Flavor Boullion Mix; Net Wt. 32 oz., 907 grams. Product is only sold to Food Service. UPC 4800191244. Recall # F-1601-2010
CODE
Lot Codes: VA3569 and VA3579
RECALLING FIRM/MANUFACTURER
Recalling Firm: Unilever Foodsolutions,
Lisle, IL, by telephone and letter on March 12, 2010. 
Manufacturer: Vanee Foods Dba Joseph's Foods, Broadview, IL. Firm initiated recall is ongoing.
REASON
The products were manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
257 cases of 6 x 2 lb containers         
DISTRIBUTION
FL, IK, TX, GA, IL, AR, OR
___________________________________
PRODUCT
Savannah Classics, Broccoli Rice & Cheese Casserole, Net Wt. 32 oz, 2 lbs. 908g, UPC 07512836005; Net Wt. 16 lb., Contains 8-2 lb. trays, UPC 075128360053; Net Wt. 4.5 lbs. 2.04 kg UPC 075128360084; Net Wt. 18 lbs. 8.16 kg Contains 4 - 4.5 lb. trays, UPC 075128360084, and Classic SYSCO, Broccoli Rice & Cheese Casserole, Net Wt. 4.5 lbs. 72 oz. 2.04 kg, UPC 074865719643. Recall # F-1622-2010
CODE
Lots: 0106101865 / Use By 01 / 2011 0112101865 / Use By 01 / 2011 0119101865 / Use By 01 / 2011 0126101865 / Use By 01 / 2011 0202101865 / Use By 02 / 2011 0216101865 / Use By 02 / 2011 0223101865 / Use By 02 / 2011
RECALLING FIRM/MANUFACTURER
Savannah Food Company, Inc., Savannah, TN, by telephone on March 2, 2010 and by letter dated March 3, 2010. Firm initiated recall is ongoing.
REASON
The products were manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
7,095 cases
DISTRIBUTION
AL, LA, TN, IN, AR, KY, OK, MS, SC, TX                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      
___________________________________
PRODUCT
1) Jalapeno Dip Mix, 50 pound paper bag, Storage in 70-85 degrees F. Recall # F-1623-2010;

2) White Queso Sauce Mix, 50 pound paper bag, Store70-85 degrees F. Recall # F-1624-2010;

3) BBQ Pork Rind Seasoning 50 pound paper bag, Store 70-85 degrees F. Recall # F-1625-2010;

4) Meat Seasoning 20 pound corrugated case, Store 70-85 degrees F. Recall # F-1626-2010;

5) Seasoned Hoagie Seasoning 50 pound paper bag, Store 70-85 degrees F. Recall # F-1627-2010;

6) Dill Dip Seasoning 46.5 pound corrugated case, Store 70-85 degrees F. Recall # F-1628-2010;

7) Mesquite Smoked Bacon, 50 pound paper bag, Store 70-85 degrees F. Recall # F-1629-2010;

8) Spinach Dip Spice 50 pound corrugated case, Store 70-85 degrees F. Recall # F-1630-2010;

9) Creamy Garlic Sauce Mix, 50 pound paper bag, Store 70-85 degrees F. Recall # F-1631-2010
CODE
1) Lot 552161 02/24/2010, S050560;
2) Lot #550431 1/12/2010 S051172;
3) Lot #550551 1/20/2010 S-1946-8;
4) Lot 548329 11/17/2009 & Lot 548328 11/17/2009, S-2876-3;
5) Lot 549548 12/17/2009 & Lot 549549 12/17/2009, S-4486-2;
6) Lot 548781 11/24/2009 & Lot 549538 12/16/2009, S-3183-1;
7) Lot 550393 01/11/2010, S049734;
8) Lot 548996 12/01/2009, S48631;
9) Lot 548997 12/02/2009, Lot 548998 12/02/2009, Lot 549532 12/15/2009, Lot 549794 12/18/2009, Lot 549795 12/18/2009, Lot 549963 01/05/2010, Lot 550550 01/19/2010, Lot 550840 01/20/2010, Lot 551112 02/01/2010, Lot 551113 02/01/2010 & Lot 551392 02/11/2010, S050563
RECALLING FIRM/MANUFACTURER
Maine, Inc., Milford, OH, by letters on March 1, 2010. Firm initiated recall is ongoing.
REASON
The products were manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
35,787 Kg
DISTRIBUTION
AR, AZ, CA, CO, GA, KS, KY, LA, MI, MN, MS, NC, OH, OK, PA, VA
___________________________________
PRODUCT
1) Sweet Art Black Food Decorating Cartridge, 1.217 fl. oz., exclusively for use in Sweet Art Jet Decorating System, packaged 1 cartridge per clam shell container. The cartridge is labeled as Sweet Art Food Jet Cartridge. Recall # F-1641-2010;

2) Sweet Art Color Food Decorating Cartridge, .913 fl. oz. exclusively for use in Sweet Art Jet Decorating System, packaged 1 cartridge per clam shell container. The cartridge is labeled as Sweet Art Food Jet Cartridge. Recall # F-1642-2010
CODE
1) All cartridges sold between 2/5/09-2/4/10, serial numbers 8986-9999 and 1000-1324;
2) All cartridges sold between 2/5/09-2/4/10, serial numbers 2727-5208
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sweet Art Co., Lenexa, KS, by letters dated February 8, 2010.
Manufacturer: Midwest Technology Connection, Kansas City, MO. Firm initiated recall is ongoing.
REASON
Some product samples were found to contain Volatile Organic Chemicals.
VOLUME OF PRODUCT IN COMMERCE
3,818 cartridges
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Flavor for Chicken Pot Pie WS560002D. Recall # F-1643-2010;

2) Vegetarian Beef Type Flavor WS699198. Recall # F-1644-2010;

3) Beef Extract Flavor, WS067007A. Recall # F-1645-2010
CODE
1) Lot: 932719;
2) Lots: 932806 and 934801; 
3) Lots: 934803, 001323, and 004811
RECALLING FIRM/MANUFACTURER
Wynn Starr Foods of Kentucky, Inc., Louisville, KY, by telephone and e-mail on March 1, 2010. Firm initiated recall is ongoing.
REASON
The products were manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
6,750.5 pounds
DISTRIBUTION
AR, KS, OR, MS, TX. Canada

___________________________________
PRODUCT
Roast Beef Flavor (083-00670) in 100 lb drums. Recall # F-1646-2010
CODE
Batch 1000594357
RECALLING FIRM/MANUFACTURER
Cargill Flavor Systems, Cincinnati, OH, by telephone on February 26, 2010. Firm initiated recall is ongoing.
REASON
The products were manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
500 pounds – 5/100 pound drums
DISTRIBUTION
IN

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS III
___________________________________
PRODUCT
1) Distillata brand 5 gallon plastic bottles of Spring Water. Recall # F-1639-2010

2) Distillata 5 gallon plastic bottles of Drinking Water. Recall # F-1640-2010
CODE
1) and 2) 11/13/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: The Distillata Co., Cleveland, OH, by telephone and letters on March 3, 2010.
Manufacturer: The Distillata Co., Akron, OH. Firm initiated recall is ongoing.
REASON
Unsafe water analysis. Bottles tested positive for coliform 9 (parts per million) spring water; and coliform 4 (parts per million) drinking water FDA regulations require water to contain less than 3 parts per million.
VOLUME OF PRODUCT IN COMMERCE
3,345 units
DISTRIBUTION
OH

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS I
___________________________________
PRODUCT
1) Yi Shou capsules, 400 mg, (3 x 10-count blister packs) 30 capsules per box. Recall # D-388-2010;

2) Yi Shou Capsules, 650 mg, Extra Strength, (3 x 10-count blister packs) 30 capsules per box. Recall # D-389-2010  
CODE
All lots
RECALLING FIRM/MANUFACTURER
Healthy Body Forero, Bayamon, PR, by fax on November 5, 2009 and press release on November 24, 2009. Firm initiated recall is ongoing. 
REASON
Marketed Without Approved NDA/ANDA: FDA analysis found that these products contains sibutramine, the active ingredient in an FDA-approved drug indicated for use as an appetite suppressant for weight loss, making it an unapproved new drug.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
PR

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II
___________________________________
PRODUCT
Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 400 mg/5 mL; Rx only; NDC 63304-979-01. Recall # D-383-2010
CODE
Lot numbers# 1910779 and 1910782 of 400mg/57mg (base) per 5mL; Exp 5/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ranbaxy Pharmaceuticals, Inc., Princeton, NJ, by letters on March 2, 2010. 
Manufacturer: Ranbaxy Laboratories, Ltd., Dewas, India. Firm initiated recall is ongoing.  
REASON
Complaints received of 2 lots of Amoxicillin & Clavulanate Potassium for Oral Suspension turning brown upon reconstitution. The product should be white.
VOLUME OF PRODUCT IN COMMERCE
a) 23,544; b) 11,400
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Vial label: MethylPREDNISolone Acetate Injectable Suspension, USP, 40 mg/mL Sterile, For IM, Intrasynovial and Soft Tissue Use. Not For Intravenous Use. Shake Well. Rx only, 1mL Single Dose Vial; NDC 0781-3131-71 Box label: MethylPREDNISolone Acetate Injectable Suspension, USP 40 mg/mL Sterile for intramuscular, intrasynovial and soft tissue injection only. Not For Intravenous Use, Rx only, One 1 mL Single Dose Vial, Case label: SANDOZ; MethylPREDNISolone Ac 40 mg/mL SD 1 mLV US, Qty: 120 x (1 x 1 mL), Store between 20-25 'C; Exp: 2010-11. Recall # D-384-2010;

2) 2) Vial label: MethylPREDNISolone Acetate Injectable Suspension, USP 40 mg/mL Sterile, For IM, Intrasynovial and Soft Tissue Use. Not For Intravenous Use. NDC 0781-3131-71 Box label: MethylPREDNISolone Acetate Injectable Suspension, USP 40 mg/mL Sterile for intramuscular, intrasynovial and soft tissue injection only, Not For Intravenous Use, Sterile Rx only, 10x1 mL Single Dose Vials. Case label: SANDOZ; METHYLPREDNI Ac 40 mg/mL SD 10 x 1mLV US, Qty96 x (10 x 1 mL) Store between 20-25 'C. Recall # D-385-2010;

3) Vial label: MethylPREDNISolone Acetate Injectable Suspension, USP, 80 mg/mL, Sterile, For IM, Intrasynovial and Soft Tissue Use, Not For Intravenous Use, Shake Well, Rx only, 1mL Single Dose Vial, NDC 0781-3132-71 Box label: MethylPREDNISolone Acetate Injectable Suspension, USP, 40 mg/mL, Sterile, For intramuscular, intrasynovial and soft tissue injection only, Not For Intravenous Use,  Rx only, One 1 mL Single Dose Vial, Case label: SANDOZ; METHYLPREDNI Ac 80 mg/mL SA IMV US, Qty: 120 x (1 x 1 mL), Store between 20-25 'C. Recall # D-386-2010;

4) Vial label: MethylPREDNISolone Acetate Injectable Suspension, USP, 80 mg/mL, Sterile, For IM, Intrasynovial and Soft Tissue Use, Not For Intravenous Use, Shake Wwll, Rx only, 1mL Single Dose Vial, NDC 0781-3132-71 Box label: MethylPREDNISolone Acetate Injectable Suspension, USP, 80 mg/mL, Sterile, For intramuscular, intrasynovial and soft tissue injection only, Not For Intravenous Use, Rx only, 10 x 1 mL Single Dose Vials, Case label: SANDOZ; METHYLPREDNI Ac 80 mg/mL SA IMV US, Qty: 96 x (10 x 1 mL), Store between 20-25 'C. Recall # D-387-2010
CODE
1 Lot numbers: 150692, exp 11/30/2010; 150693, exp. 11/30/2010 and 155905, exp. 7/31/2011;

2) Lot numbers: 149633, exp. 10/31/2010; 152864, exp. 3/31/2011; 155904, exp. 7/31/2011;

3) Lot numbers: 149332, exp. 8/31/2010 and 155797, exp. 8/31/2010; 

4) Lot numbers: 150568, exp. 11/30/2010; 153048, exp. 3/31/2011; 158623, exp. 11/30/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sandoz, Inc., Princeton, NJ, by letter on March 5, 2010. 
Manufacturer: Sandoz Canada Inc., Boucherville, Canada. Firm initiated recall is ongoing.
REASON
Methylprednisolone Acetate in the 40 and 80 mg, single dose lots were mistakenly labeled with a 24 month expiration date instead of 18 months.
VOLUME OF PRODUCT IN COMMERCE
35,235 vials
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Temodar (temozolomide) for Injection, 100 mg/vial, for Intravenous Use Only, Single-Use Vial, Discard after use, Rx only, NDC 0085-1381-01. Recall D-397-2010
CODE
Batch # E-KAS- and E-KAS-3
RECALLING FIRM/MANUFACTURER
Recalling Firm: Schering Corp., Miami Lakes, FL, by letter on March 18, 2010.
Manufacturer: Baxter Oncology GmbH, Halle/Westfalen, Germany. Firm initiated recall is ongoing.
REASON
There is potential for defects to exist in the glass vials that may, in rare cases, result in damage to the vials that may compromise the integrity of the vials. Use of these vials which are damaged may present a risk of infection to patients, particularly those who are immunocompromised.
VOLUME OF PRODUCT IN COMMERCE
6,792 vials
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III
___________________________________
PRODUCT
Fluocinonide Cream USP, 0.05%, Net Wt 30 grams, Rx only; NDC 0168-0139-30. Recall # D-369-2010
CODE
Lot 872A (exp 9/11)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nycomed US Inc., Melville, NY, by letter dated March 5, 2010.
Manufacturer: Nycomed Us Inc., Hicksville, NY. Firm initiated recall is ongoing.
REASON
Firm received one complaint of leakage from tube crimp.
VOLUME OF PRODUCT IN COMMERCE
30,358 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Rosaderm Cleanser (Sodium Sulfacetamide 10%/Sulfur 5%), packaged in 6 oz (NDC 68032-104-06) and 12 oz  tubes, NDC 68032-104-12, Rx only. Recall # D-390-2010
CODE
6 oz (NDC 68032-104-06) Lot #s: 15400, Exp 3/31/2010; 15600, Exp 4/30/2010; 88100, Exp 5/31/2010; 88200, Exp 5/31/2010; F08A056, Exp 10/31/2009; F08A060, Exp 10/31/2009; F08C064, Exp 12/31/2009; 12 oz (NDC 68032-104-12) Lot #s: 88000, Exp 5/31/2010; F07K075, Exp 8/31/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: River's Edge Pharmaceuticals, LLC, Suwannee, GA, by E-mail on August 28, 2009.  
Manufacturer: Harmony Labs, Inc., Landis, NC. Firm initiated recall is ongoing.
REASON
Manufacturing Validation: Packaging validation was conducted after product distribution.
VOLUME OF PRODUCT IN COMMERCE
43,655 tubes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Benzoyl Peroxide Cleanser, Topical Acne Therapy, 4.5%, 400 mL bottle, Rx Only, NDC 68032-114-40. Recall # D-391-2010;

2) Benzoyl Peroxide Cream, Topical Acne Therapy, 6.5%, 125 mL tube, Rx Only, NDC 68032-118-12. Recall # D-392-2010;

3) Benzoyl Peroxide Gel, Topical Acne Therapy, 4.5%, 125 mL tube, Rx Only, NDC 68032-113-12. Recall # D-393-2010;

4) Benzoyl Peroxide Pad, 4.5%, box containing 30 foil pouches each with a single-use medicated pad (6 mL each), Rx Only, NDC 68032-143-75. Recall # D-394-2010;  

5) Benzoyl Peroxide Cleanser, Topical Acne Therapy, 6.5%, 400 mL bottle, Rx Only, NDC 68032-120-40. Recall # Recall # D-395-2010;

6) Benzoyl Peroxide Cleanser, Topical Acne Therapy, 8.5%, 400 mL bottle, Rx Only, NDC 68032-117-40. Recall # D-396-010 
CODE
1) Lot #s: F07L048, Exp 05/31/2009; F2800, Exp 10/31/2009;

2) Lot # F5900, Exp 10/31/2009;

3) Lot # F07G025, Exp 06/30/2009;

4) Lot # 5318, Exp 8/31/2009;

5) Lot #s: F07K015, Exp 4/30/2009; F08C063, Exp 9/30/2009;

6) Lot #s: 15300, Exp 11/30/2009; F07K016, Exp 04/30/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: River's Edge Pharmaceuticals, LLC, Suwanee, GA, by e-mail on/about April 22, 2009.
Manufacturer: Harmony Labs, Inc., Landis, NC. Firm initiated recall is complete.
REASON
Product lacks stability: documents indicated potential problems with assay.
VOLUME OF PRODUCT IN COMMERCE
23,597 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II 
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0182-10
CODE
Unit: 36FG40440
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross, Columbia, SC, by facsimile on January 30, 2009 or by letter dated March 13, 2009.
Manufacturer: The American National Red Cross, South Carolina Region, Charleston, SC. 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
GA
___________________________________
PRODUCT
Source Plasma. Recall # B-0313-10
CODE
Units: 382041903, 382041942
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Tuscaloosa, AL, by facsimile on September 8, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who may have received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0567-10
CODE
Unit: W037909559785 (Parts 1 and 2)
RECALLING FIRM/MANUFACTURER
Blood Center of Iowa, Des Moines, IA, by letter dated September 18, 2009. Firm initiated recall is complete.
REASON
Blood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0626-10
CODE
Unit: 21LV36056
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Portland, OR, by fax on April 23, 2008 and follow-up letter on April 27, 2008. 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
OR                               
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0757-10;
2) Red Blood Cells Leukocytes Reduced, Irradiated. Recall # B-0758-10;
3) Plasma frozen. Recall # B-0759-10
CODE
1) Units: 18FG29623, 18GT37198, 18FG29638, 18FG29644, 18FJ94637, 18FJ94645, 18GG91189, 18GM34439, 18GT37234, 18FG29877, 18FG29881, 18FG29885, 18FG29660, 18FG29661, 18FG29663, 18FG29666, 18GG90970, 18GG91139, 18GG91156, 18GG91164, 18GG91200, 18GG91296, 18GG91359, 18GM34276, 18GM34280, 18GM34305, 18GT37214, 18GT37230, 18GW20665, 18GW20666, 18GW20670, 18GW20672, 18GW20689, 18GW20691, 18GW20700, 18GW20701, 18GW20702, 18GW20704, 18GW20707, 18GL65968, 18GL65986, 18GL65988, 18GL66007, 18GM34424, 18GM34425, 18FG29868, 18FG29883, 18GM34428, 18FJ94647, 18GG91007, 18GM34297, 18FJ94623, 18FJ94625, 18FJ94639, 18GM34260, 18GM34262, 18GM34282, 18GM34433, 18GM34440, 18GM34441, 18FJ94627, 18GG90977, 18GL65970, 18GM34277, 18GT37202, 18GT37214, 18GT37215, 18GG90945, 18GM34293, 18FJ94948, 18GM34442, 18FG29616, 18FG29861, 18GG90939, 18GG91126, 18FG29613, 18GL65971, 18FG29871, 18FJ94938, 18GT37200, 18FG28618, 18FG29636, 18FG29642, 18GM34257, 18FG29879, 18GR30919,18GM34284, 18FG29640, 18GM34427, 18GG91321;

2) Units: 18FG29870, 18FG29860;

3) Units: 18FG29879, 18GT37214, 18FG28993, 18GM34257, 18FG29881     
RECALLING FIRM/MANUFACTURER
The American National Red Cross – Great Lakes Region, Lansing, MI, by telephone on October 9, 2008 and October 10, 2008 and by follow-up letter dated October 10, 2008, October 11, 2008 and October 14, 2008. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
97 units
DISTRIBUTION
DC, MD, MI, PA, VA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0763-10 
CODE
Unit: 003FM13452
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red, Douglasville, GA, by letter on October 25, 2007.
Manufacturer: The American National Red Cross - Southern Region, Douglasville, GA. Firm initiated recall is complete.
REASON
Blood product, which tested negative for hepatitis, but were collected from a donor who was previously deferred for a history of hepatitis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0765-10; 
2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0766-10
CODE
1) Units: 003KK43886, 003KK42563;
2) Units: 003KZ19914, 003KZ19702, 003KZ19431
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA, by facsimile and letter on October 12, 2005. 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
5 units
DISTRIBUTION
GA                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         
___________________________________
PRODUCT
Platelets Pheresis – 7d Leukocytes Reduced. Recall # B-0883-10 
CODE
Unit: 9681450 (part 1 and 2)
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone and letter on February 18, 2008. Firm initiated recall is complete.
REASON
Blood products, possible contaminated with Propionibacterium sp., were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL

___________________________________
PRODUCT
Apheresis Platelets 7-d Irradiated Leukocytes Reduced. Recall # B-0884-10
CODE
Unit: 4777714  
RECALLING FIRM/MANUFACTURER
Florida’s Blood Services, Inc., St Petersburg, FL, by fax on July 30, 2007. Firm initiated recall is complete.
REASON
Blood product, found to have possible bacteria contamination using the BacT ALERT System, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis 7-d Leukocytes Reduced. Recall # B-0885-10
CODE
Unit: 9912716 (part 1, 2 and 3)
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on December 4, 2007, fax on December 5, 2007 and by letter on January 14, 2008. Firm initiated recall is complete.
REASON
Blood products, possible contaminated with Propionibacterium sp., were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0886-10
CODE
Unit: 4776183 (part 1 and 2)
RECALLING FIRM/MANUFACTURER
Florida’s Blood Services, Inc., St Petersburg, FL, by fax on August 5, 2007. Firm initiated recall is complete.
REASON
Blood products, found to have possible bacteria contamination using the BacT ALERT System, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0898-10
CODE
Unit: W290609010233
RECALLING FIRM/MANUFACTURER
Penrose-St Franc Health Services Blood Bank, Colorado Springs, CO, by telephone on November 24, 2009. 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
CO
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0899-10
CODE
Unit: 72M22250X
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Huntsville, AL, by fax on November 17, 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
Platelets Pheresis Leukocytes Reduced. Recall # B-0900-10
CODE
Unit: 72L953543
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Huntsville, AL, by fax on November 16, 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
Platelets Pheresis Leukocytes Reduced. Recall # B-0901-10
CODE
Unit: 72L953660
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Huntsville, AL, by fax on November 16, 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
Platelets Pheresis Leukocytes Reduced. Recall # B-0902-10
CODE
Unit: 72M044880
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Montgomery Region, Montgomery, AL, by fax on November 9, 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
Platelets Pheresis Leukocytes Reduced. Recall # B-0903-10
CODE
Unit: 72L885880
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by fax on September 29, 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
GA

___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0904-10
CODE
Unit: 72L648966
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Birmingham Region, Birmingham, AL, by fax on September 2, 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
Platelets Pheresis Leukocytes Reduced. Recall # B-0905-10
CODE
Unit: 72L896901
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Mobile, 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-0906-10
CODE
Unit: 72L952884
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Birmingham Region, Birmingham, AL, by fax on November 2, 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
Platelets Pheresis Leukocytes Reduced. Recall # B-0907-10
CODE
Unit: 72M134455
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Mobile, AL, by fax on October 29, 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
Platelets Pheresis Leukocytes Reduced. Recall # B-0908-10
CODE
Unit: 72L952780
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by fax on October 28, 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
Platelets Pheresis Leukocytes Reduced. Recall # B-0909-10
CODE
Unit: 72L796176
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Huntsville, AL, by fax on October 23, 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
Platelets Pheresis Leukocytes Reduced. Recall # B-0910-10
CODE
Unit: 72L688675
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Birmingham Region, Birmingham, AL, by fax on September 15, 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
Platelets Pheresis Leukocytes Reduced. Recall # B-0911-10
CODE
Unit: 72L324738
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Birmingham Region, Birmingham, AL, by fax on September 15,  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
Platelets Pheresis Leukocytes Reduced. Recall # B-0912-10
CODE
Unit: 72M196107
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Birmingham Region, Birmingham, AL, by fax on December 3,  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
Platelets Pheresis Leukocytes Reduced. Recall # B-0913-10
CODE
Unit: 72M435436
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by fax on November 19, 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
GA

___________________________________
PRODUCT
Apheresis Platelets Leukocytes Reduced. Recall # B-0914-10
CODE
Unit: W039408516017
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., St Petersburg, FL, by fax on July 2, 2008. Firm initiated recall is complete.
REASON
Blood product, labeled leukoreduced without the assurance that it met the criteria for a leukoreduced product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis 7-d Leukocytes Reduced. Recall # B-0915-10
CODE
Unit: 9916723 (part 2 and 3)
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone December 7, 2007. Firm initiated recall is complete.
REASON
Blood products, with a pH lower than the acceptance criteria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis 7-d Leukocytes Reduced. Recall # B-0916-10
CODE
Unit: 9922570 (part 1, 2 and 3)
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone April 17, 2008. Firm initiated recall is complete.
REASON
Blood products with platelet count below the specified minimum requirement were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0917-10
CODE
Unit: 3259989 (part 1 and 2)
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone May 28, 2008. Firm initiated recall is complete.
REASON
Blood products, with platelet count below the specified minimum requirement, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0918-10;
2) Platelets. Recall # B-0919-10
CODE
1) and 2) Unit: 2018297
RECALLING FIRM/MANUFACTURER
Southeastern Community Blood Center, Inc., Tallahassee, FL, by letter on April 24, 2005 and fax on April 22, 2005. Firm initiated recall is complete.
REASON
Blood products collected from a donor taking the drug Evista, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL, GA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0935-10
CODE
Units: 003GZ99582, 003GZ99568, 003GZ99567, 003GZ99572
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Douglasville, GA, by telephone on February 12, 2008 and by letter on February 18, 2008 and March 25, 2008.
Manufacturer: The American National Red Cross – Southern Region, Douglasville, GA. Firm initiated recall is complete.
REASON
Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
GA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0955-10
CODE
Unit: 72M471263
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Huntsville, AL, by fax on December 9, 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
Platelets Pheresis Leukocytes Reduced. Recall # B-0956-10
CODE
Unit: 72M47642X
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Huntsville, AL, by fax on December 8, 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
Platelets Pheresis Leukocytes Reduced. Recall # B-0957-10
CODE
Unit: 72M404195
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Huntsville, AL, by fax on December 15, 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
Platelets Pheresis Leukocytes Reduced. Recall # B-0958-10
CODE
Unit: 72M476603
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Huntsville, AL, by fax on December 9, 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
Platelets Pheresis Leukocytes Reduced. Recall # B-0959-10
CODE
Unit: 72M472167
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Huntsville, AL, by fax on December 8, 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
Source Plasma. Recall # B-0960-10
CODE
Units: 13144500; 13138172; 13131296; 13125097; 13117382; 13112967; 13102548; 13096182; 13087913
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc, Tempe, AZ, by fax on January 12, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had been permanently deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0961-10;
2) Platelets Pooled Leukocytes Reduced. Recall # B-0962-10
CODE
1) and 2) Unit: 6824881
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by letter dated August 6, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Recovered Plasma. B-0964-10
CODE
Unit: 5583900
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by e-mail on March 18, 2009. Firm initiated recall is complete.
REASON
Blood products, 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
Austria
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0965-10
CODE
Unit: 72J331691
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Lecanto, FL, by fax on November 25, 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
FL

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III 
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0183-10
CODE
Unit: 36FG40440
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross, Columbia, SC, by facsimile on January 30, 2009 or by letter dated March 13, 2009.
Manufacturer: The American National Red Cross, South Carolina Region, Charleston, SC. 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-0627-10
CODE
Unit: 21LV36056
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Portland, OR, by fax on April 23, 2008 and follow-up letter on April 27, 2008. 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 Irradiated. Recall # B-0817-10
CODE
Units: W224309319294 (3 aliquots)
RECALLING FIRM/MANUFACTURER
Houchin Blood Services, Bakersfield, CA, by telephone on November 24, 22009. Firm initiated recall is complete.
REASON
Blood products, labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA

___________________________________
PRODUCT
Platelets Irradiated. Recall # B-0887-10
CODE
Unit: 5437970
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., St Petersburg, FL, by fax on January 11, 2008. 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
FL          
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0888-10
CODE
Unit: 4786527
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., St Petersburg, FL, by fax on October 8, 2007. Firm initiated recall is complete.
REASON
Blood product, found to have possible bacteria contamination using the BacT ALERT System, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0890-10 
CODE
Unit: 003GF28052
RECALLING FIRM/MANUFACTURER
The American National Red Cross – Southern Region, Douglasville, GA, by electronic (LOGIC) on April 2, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for which donor suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0920-10
CODE
Unit: 2018297
RECALLING FIRM/MANUFACTURER
Southeastern Community Blood Center, Inc., Tallahassee, FL, by letter on April 24, 2005 and fax on April 22, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor taking the drug Evista, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS I
___________________________________
PRODUCT
1) Medical Action Industries, IV Start Bundle Kit, using MPS Acacia with BD Q-Syte (BD #385151), Part number: 69946B. Recall # Z-1073-2010;

2) Medical Action Industries, Venous Access Tray, using BD Q-Syte Luer Access Split Septum (BD #385100)), Part number: 69498. Recall # Z-1074-2010;

3) Medical Action Industries, Dialysis Kit, using BD Q-Syte Luer Access Split Septum (BD #385100), Part number: 57977. Recall # Z-1075-2010
CODE
1) Lot numbers: 62295, 63591, 64197, 65175, 67162, 69906, 72113 and 73617;

2) Lot numbers: 62282, 69902, 70350, 70854 and 72108;

3) Lot numbers: 62394, 63042 and 64820
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medical Action Industries Inc., Arden, NC, by e-mail, letter on November 6, 2009.
Manufacturer: Becton Dickinson Medical Systems, Sandy, UT. Firm initiated recall is ongoing.
REASON
Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
VOLUME OF PRODUCT IN COMMERCE
18,800 kits
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Acacia Catalog # 385151 IV Extension Set 15cm Small Bore, Spin Nut w/BD Q-Syte. Recall # Z-1076-2010;

2) Acacia Catalog # 385151 IV Extension Set 15cm Small Bore, Spin Nut w/BD Q-Syte. Recall # Z-1077-2010;

3) Acacia Catalog # 385164 Tri-Extension IV Set 15cm Small Bore, Spin Nut w/BD Q-Syte. Recall # Z-1078-2010;

4) Acacia Catalog # 385165 "Y" IV Extension Set 20cm Macro Bore, Spin Nut w/BD Q-Syte. Recall # Z-1079-2010;

5) Acacia Catalog # 385166 Dual "Y" IV Extension Set 50cm Macro Bore, Spin Nut w/BD Q-Syte. Recall # Z-1080-2010
CODE
1) and 2) Lot A1950;
3) Lot A1951;
4) Lots A2100 and A2101;
5) Lots A2104
RECALLING FIRM/MANUFACTURER
Medical Product Specialist Inc dba MPS Acacia, Brea , CA, by letter dated December 18, 2009. Firm initiated recall is ongoing.
REASON
Some lots of IV Extension Sets with BD Q-Syte Luer Access Split Septum have a manufacturing deviation which could cause the product to not function properly, possibly resulting in an air embolism.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) IV Sets and Accessories, various configurations. An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, plasma or intravascular fluids from a container to a patient's vascular system. Recall # Z-1112-2010;

2) Y-Type Blood Pump Sets, with Detachable Polysulfone Stopcock. For Veterinary Use Only and with Two Luer Activated Y-Injection Sites, Y-Injection Site and 2 Gang 4-Way Polysulfone Stopcocks. An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, plasma or intravascular fluids from a container to a patient's vascular system. Recall # Z-1113-2010;

3) IV Extension Set with Spike and 2-Way Stopcock. An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, plasma or intravascular fluids from a container to a patient's vascular system. Recall # Z-1114-2010;

4) 15 Drop IV Sets, with Retractable Luer-Lock and with Smartsite(TM) Y-Injection sites and 4-Way Stopcock with Pressure Activated Valve Manifold. (Approx. 15 drops/ml). An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, plasma or intravascular fluids from a container to a patient's vascular system. Recall # Z-1115-2010;

5) Non-Vented IV Set with 2-Gang "Hi-Flo" Stopcocks with Luer Activated HEP Lock Valves and Luer Activated Y-Injection Sites. (Approx. 10 Drop/ML). An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, plasma or intravascular fluids from a container to a patient's vascular system. Recall # Z-1116-2010;

6) Positive Pressure Blood Pump Sets, with Stopcock and Smartsite(TM) Y-Injection Site and with 3-Gang 4-Way Stopcocks, Y-Injection Site and T-Connector. An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, plasma or intravascular fluids from a container to a patient's vascular system. Recall # Z-1117-2010;

7) 60 Drop IV Set with SmartSite(TM) Y-Injection Sites, 2-Gang Standard Bore Stopcocks and T-Connector. (Approx. 60 Drops/ML) SmartSite(TM) is a trademark of Alaris Medical Systems, Inc. An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, plasma or intravascular fluids from a container to a patient's vascular system. Recall # Z-1118-2010;

8) 150ML Burette IV Set with SmartSite(TM) Y-Injection Site, 2-Gang Standard Bore Stopcocks and T-Connector SmartSite(TM) is a trademark of Alaris Medical Systems, Inc. An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, plasma or intravascular fluids from a container to a patient's vascular system. Recall # Z-1119-2010;

9) 20 Drop IV Set with 3 SmartSite(TM) Y-Injection Sites, 2-Gang 4-Way Stopcock and Novex Stopcock. (Approx. 20 Drops/ML) SmartSite(TM) is a trademark of Alaris Medical Systems, Inc. An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, plasma or intravascular fluids from a container to a patient's vascular system. Recall # Z-1120-2010;

10) 8" Microbore Extension with Detachable SmartSite(TM) HEP-Lock and Retractable Spinning Luerlock. DEHP-Free SmartSite(TM) is a trademark of Alaris Medical Systems, Inc. An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, plasma or intravascular fluids from a container to a patient's vascular system. Recall # Z-1121-2010;

11) IV Set with Two SmartSite(TM) Y-Injection Sites, Stopcock and 3-Gang Pressure Activated Manifold Valve and Rotating Luer Lock End SmartSite(TM) is a trademark of Alaris Medical Systems, Inc. An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, plasma or intravascular fluids from a container to a patient's vascular system. Recall # Z-1122-2010;

12) 8" Extension Set with SmartSite(TM) HEP-Lock and Rotating Luer Lock. SmartSite(TM) is a trademark of Alaris Medical Systems, Inc. An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, plasma or intravascular fluids from a container to a patient's vascular system. Recall # Z-1123-2010;

13) 10 Drop IV Sets, with 3 Pre-Pierced Y-Injection Sites and 3-Gang Pressure Activated Manifold Valve. (Approx. 10 Drops/ML); with Two Y-Injection Sites and Rotating Luer Lock (Approx. 10 Drop/ML); with Positive Pressure Pump with 4-Way "Hi-Flo" Stopcock and 4 Pre-Pierced "Y" Injection Sites (approx. 10 Drop/mL). An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, plasma or intravascular fluids from a container to a patient's vascular system. Recall # Z-1124-2010;

14) Y-Type Positive Pressure Pump Set with 2-Gang 4-Way Stopcock and Detachable 4-Way Stopcock. An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, plasma or intravascular fluids from a container to a patient's vascular system. Recall # Z-1125-2010;

15) 7" Non-Kink Extension Set with Rotating Luer-Lock Connector. An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, plasma or intravascular fluids from a container to a patient's vascular system. Recall # Z-1126-2010;

16) Positive Pressure Blood Pumps, with Pre-Pierced Y-Injection Site; with Three SmartSite(TM)Injection Sites and Rotating Male Luer Lock. SmartSite(TM) is a trademark of Alaris Medical Systems, Inc; with 2""Hi-Flo" Stopcocks, Twin Y Injection Sites and Detachable 8" Extension with Retractable Luer-Lock; with Two SmartSite(TM) Y-injection Sites. SmartSite(TM) is a trademark of Alaris Medical Systems, Inc. An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, plasma or intravascular fluids from a container to a patient's vascular system. Recall # Z-1127-2010;

17) Y Type Blood Pump Sets, with 2 Vented Spikes and Double "Hi-Flo" Stopcock; with Luer Activated Y-Injection Sites, Y-Injection Site and 2 Gang 4-Way Stopcocks; with "Hi-Flo" Stopcocks and SmartSite(TM) Y Injection Site. SmartSite(TM) is a trademark of Alaris Medical Systems, Inc.; with Ball Pump 4-Way 3-Gang Stopcock Manifold and 4 SmartSite(TM) Y-Injection Sites SmartSite(TM) is a trademark of Alaris Medical Systems, Inc.; with 2 "Hi-Flo" Stopcocks, Two Y Injection Sites and Detachable 8" Extension with Option Lock; with 2 Vented Spikes and Double "Hi-Flo" Stopcock. An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, plasma or intravascular fluids from a container to a patient's vascular system. Recall # Z-1128-2010;

18) 4-Way "Hi-Flo" Extension Set with Two SmartSite(TM) Y-Injection Sites and Rotating Luer Lock SmartSite(TM). An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, plasma or intravascular fluids from a container to a patient's vascular system. Recall # Z-1129-2010;

19) Burette Set with SmartSite(TM) Y-Injection Site and SmartSite(TM) HEP-Lock on Burette SmartSite(TM) is a trademark of Alaris Medical Systems, Inc. An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, plasma or intravascular fluids from a container to a patient's vascular system. Recall # Z-1130-2010
CODE
1) All products with part number beginning with W followed by five numeric digits;

2) Product numbers IV-85001-AAMC and IV-85020-UW;

3) Product number MPI-17191;

4) Product numbers MPI-17224 and MPI-17272;

5) Product number MPI-17238;

6) Product numbers MPI-17243 and MPI-17259;

7) Product number MPI-17307;

8) Product number MPI-17308;

9) Product number MPI-17330;

10) Product number MPI-17517;

11) Product number MPI-17552.

12) Product number MPI-17635;

13) Product numbers MPI-17682, MPI-17708, and MPI-18020;

14) Product number MPI-17802;

15) Product number MPI-17848;

16) Product numbers: MPI-17893, MPI-17896, MPI-17898, and MPI-17900;

17) Product codes: MPI-17894, MPI-17895, MPI-17897, MPI-17899, MPI-17927, and MPI-18054;

18) Product code: MPI-17948;

19) Product code: MPI-17962
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arrow International Inc., Reading, PA, by letter dated February 19, 2010.
Manufacturer: Arrow International De Mexico, S.A.DE C.V., Camargo, Mexico. Firm initiated recall is ongoing.
REASON
Sterility may be compromised.
VOLUME OF PRODUCT IN COMMERCE
70,959,969 units
DISTRIBUTION
Nationwide, Canada, Columbia, South Africa, Turkey, Kazakhstan, Venezuela, Germany, Cuba, Panama, El Salvador, Costa Rica, Singapore, and United Kingdom

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II
___________________________________
PRODUCT
da Vinci S Surgical System IS2000 Endoscopic Instrument Control System, rev. A51_P7. Recall # Z-1161-2010
CODE
Code numbers between SG002 to SG836
RECALLING FIRM/MANUFACTURER
Intuitive Surgical, Inc., Sunnyvale, CA, by e-mail and visit on July 1, 2009 and July 7, 2009. Firm initiated recall is ongoing.
REASON
Gripper or Scissor jaws may close inadvertently, and will not open on command and various other reported modes of failure. Control by surgeon may fail and this failure may be difficult to detect.
VOLUME OF PRODUCT IN COMMERCE
782 units
DISTRIBUTION
Nationwide, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Norway,Qatar, Romania, Spain, Sweden, Switzerland, Turkey, the United Kingdom, Argentina, Australia, Brazil, Canada, China, India, Israel, Japan, Korea, Mexico, Russia, Saudi Arabia, Singapore and South Korea
___________________________________
PRODUCT
Olympus Trocar Spikes, Model numbers: A5821, A5948, A5949, WA58341L, and WA58343L Used in conjunction with a compatible trocar tube, trocar tubes are used for intraperitoneal access during laparoscopic access during laparoscopic applications, and enable the passage of endoscopes and other diagnostic and therapeutic tools through the abdominal wall. Recall # Z-1163-2010
CODE
Lot numbers: 075W, 076W, 077W, 078W, 081W, 083W, 084W, 07XW, and 07YW
RECALLING FIRM/MANUFACTURER
Recalling Firm: Olympus America Inc., Center Valley, PA, by letter dated February 8, 2010.
Manufacturer: Olympus Winter & Ibe Gmbh & Co., Hamburg, Germany. Firm initiated recall is ongoing.
REASON
Weak weld seams.
VOLUME OF PRODUCT IN COMMERCE
45 units
DISTRIBUTION
Nationwide: AL, AR, CA, FL, MI, MN, MO, NY, PA, OH, TX, WY, Canada
___________________________________
PRODUCT
UROLOGIX CTC Advance" Standard Microwave Catheter (3.0-5.0 cm), CTC Advance" Long Microwave Catheter (4.5+ cm), CTC Advance" Short Microwave Catheter (2.5 -3.5 cm), RTU Plus Balloon, and RTU Plus Handle, Sterile EO. The CTC Advance" catheters and RTU Plus are used as part of the Targis System. Each disposable device is packaged on a card inside a heat sealed pouch. Each Kit Box then hold 3 product pouches: 1 catheter, 1 coolant bag and 1 RTU Plus balloon. The RTU Plus Kit contains 3 RTU Plus Handles packaged in separate sterile pouches. Recall # Z-1174-2010
CODE
Kit Lot Number: ACP011610D, ACP011710E, ACP011810F, ACP011910G, AHP01810D, AHP011210A, AHP011310B, AHP012310C, AHP012510C, AHP012710C, ALP012510B, and RH00252 Catheter Lot Numbers: 091226MCA1, 091228MHA1, 091229MCA1, 091229MCA2, 091229MHA1, 09123MCA1, 091230MHA1, 100105MHA1, 100106MHA1, 100106MHA2, 100111MHA1, 100111MHA2, 100111MHA3, 100112MLA2, 100113MHA1, 100113MHA2, and 100114MHA1 RTU Plus Lot Numbers: Handle =RH00252, Balloon= RB0781 & RB0783
RECALLING FIRM/MANUFACTURER
Urologix, Inc., Minneapolis, MN, by letter dated February 18, 2010. Firm initiated recall is ongoing.
REASON
The reason for this Recall is a labeling error only; the issue involves a discrepancy in the "Use Before" date printed on the product label. In the affected lots, the "Use Before" date, commonly known as the expiration date, is printed as 2012-12 when it should read 2011-12. Only the individual product label contains the incorrect date; the Kit Box label is correct.
VOLUME OF PRODUCT IN COMMERCE
154 units
DISTRIBUTION
AL, AZ, CA, FL, IN, MI, MN, MS, NY, OK PA, TN, TX, WI
___________________________________
PRODUCT
1) Pelton & Crane Chairman 5000, Spirit 1500, Spirit 1800, Spirit 2000 and Spirit 3000 Dental Chairs with magnetic headrests. Intended for the properly positioning of patients to perform dental procedures. Chairman 5000-Agency Model #L5, Spirit 1500-Agency Model #SP15, Spirit 1800-Agency Model #SP18, Spirit 2000-Agency Model #SP20 and Spirit 3000-Agency Model #SP30. Recall # Z-1179-2010;

2) Pelton & Crane Chairman 5000, Spirit 1500, Spirit 1800, Spirit 2000 and Spirit 3000 Dental chairs with magnetic headrests. Intended for the properly positioning of patients to perform dental procedures. Chairman 5000-Agency Model #L5, Spirit 1500-Agency Model #SP15, Spirit 1800-Agency Model #SP18, Spirit 2000-Agency Model #SP20 and Spirit 3000-Agency Model #SP30. Recall # Z-1180-2010
CODE
Model numbers only.
RECALLING FIRM/MANUFACTURER
Pelton & Crane Co., Charlotte, NC, by letter dated February 9, 2010. Firm initiated recall is ongoing.
REASON
Magnetic headrests may affect patients with implantable pacemakers and defibrillators.
VOLUME OF PRODUCT IN COMMERCE
498 chairs and 619 replacement upholstery parts
DISTRIBUTION
Nationwide, Canada and Germany
___________________________________
PRODUCT
Advance Tibial Wedge Augment, REF KTAG-W315, Size 3/2+, Thickness 15 DEG, Surface Non-Porous, 1 Each, 2. The device is intended for use in total knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: 1) Noninflammatory degenerative joint disease, 2) inflammatory joint disease, 3) correction of functional deformity, 4) revision procedures where other treatments or devices have failed and 5) treatment of fractures that are unmanageable using other techniques. (For cement use only). Recall # Z-1215-2010
CODE
Lot numbers: 087441267 and 097441268
RECALLING FIRM/MANUFACTURER
Wright Medical Technology, Inc., Arlington, TN, by letter on February 19, 2010. Firm initiated recall is ongoing.
REASON
The product contained screws with the incorrect length (incorrectly contained 15 mm length screws instead of the correct 5 mm length screws).
VOLUME OF PRODUCT IN COMMERCE
47 devices
DISTRIBUTION
Nationwide, Canada, Netherlands, Germany, Japan, S. Korea, UK, Czech Republic, Turkey and Brazil
___________________________________
PRODUCT
AccuMax Quantum Complete (Model CU3/CU4), an alternating pressure with turn assist & on demand low air loss system. The device is intended to treat or prevent decubitus ulcers, extensive burns, urinary tract blockage and to aid circulation. Recall # Z-1216-2010
CODE
Serial No: 6101, 6170 and 6267-6613
RECALLING FIRM/MANUFACTURER
Recalling Firm: Encompass Therapeutic Support Systems dba BG North America, Glendale, CA, by letter dated March 5, 2010.
Manufacturer: KAP Medical, Corona, CA. and Leoch Battery Corp, Garden Grove, CA. Firm initiated recall is ongoing.
REASON
Potential out gasing of the battery and short term ignition of the gas within the control unit enclosure. This failure mode includes a risk for fire.
VOLUME OF PRODUCT IN COMMERCE
349 units
DISTRIBUTION
CA, TX, IN, OR, MO
___________________________________
PRODUCT
Live Better 1cc, 31 gauge x 5/16 inch U-100 Insulin Syringe short needle, 100 syringes. Used to draw a quantity of pharmaceutical from its container and allow administration of the pharmaceutical directly to the patient. As an alternative use the product will allow administration of the pharmaceutical to the patient via an intravenous port, heparin lock or saline lock. Recall # Z-1217-2010
CODE
Lot: 171124
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ulti Med, Inc., Saint Paul, MN, by letter dated February 3, 2010.
Manufacturer: Shinamerica Inc., De Smet, SD. Firm initiated recall is ongoing.
REASON
UltiMed, Inc. is recalling one lot of 1cc, 31 gauge x 5/16 inch U-100 Insulin Syringe Live Better because it is mislabeled and actually contains 1/2 cc, 30 gauge x 1/2 inch U-100 insulin Syringe.
VOLUME OF PRODUCT IN COMMERCE
25 units (each dispense and dispose sharps unit contains 100 syringes)
DISTRIBUTION
CT, NJ
___________________________________
PRODUCT
1) Harmony Lux Advantage LA Surgical Lighting and Visualization System, also known as the Harmony LA 500, B129382391. Designed to provide visible immunization of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. Intended to be used in a surgical setting. Recall # Z-1218-2010;

2) Harmony Lux Advantage LA Surgical Lighting and Visualization System, also known as the Harmony LA 700, B129382393. Designed to provide visible immunization of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. Intended to be used in a surgical setting. Recall # Z-1219-2010;

3) Harmony Lux Classic, Surgical Lighting System, also known as the Harmony LC 500, B129388085 and B12988086. Designed to provide visible immunization of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. Intended to be used in a surgical setting. Recall # Z-1220-2010
CODE
1) Serial Numbers: 0428102135-0428307020;
2) Serial Numbers: 0408504214-0417907007;
3) Serial Numbers: 0436005042-0430207104
RECALLING FIRM/MANUFACTURER
Recalling Firm: Steris Corp., Mentor, OH, by letter dated February 23, 2010.
Manufacturer: Steris Corp., Montgomery, AL. Firm initiated recall is ongoing.
REASON
Premature Bulb Failure
VOLUME OF PRODUCT IN COMMERCE
14,730 devices
DISTRIBUTION
Nationwide, Canada, Algeria, Australia, Bahrain, Bangladesh, Brazil, Chile, China, Costa Rica, Ecuador, El Salvador, France, Germany, Guam, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Malaysia, Mexico, New Zealand, Nigeria, Pakistan, Philippines, Poland, Qatar, Russia, Saudi Arabia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey, United Arab Emirates, United Arab Emirates, United Kingdom, Italy, Yemen and United Arab Emirates
___________________________________
PRODUCT
1) Publix Sterile Preserved Saline Solution 12oz, Product SKU#041415-003767. This product is supplied in 12 fl. oz. (355 mL) bottles for use in rinsing of soft (hydrophilic) contact lenses after heat (thermal) disinfection and rinsing of contact lenses following chemical disinfection. Recall # Z-1222-2010;

2) Top Care Sterile Preserved Saline Solution 12oz, Product SKU#0036800-16040. This product is supplied in 12 fl. oz. (355 mL) bottles for use in rinsing of soft (hydrophilic) contact lenses after heat (thermal) disinfection and rinsing of contact lenses following chemical disinfection. Recall # Z-1223-2010;

3) Safeway Sterile Preserved Saline Solution 12oz, Product SKU#321130-700707. This product is supplied in 12 fl. oz. (355 mL) bottles for use in rinsing of soft (hydrophilic) contact lenses after heat (thermal) disinfection and rinsing of contact lenses following chemical disinfection. Recall # Z-1224-2010;

4) Hannaford Sterile Preserved Saline Solution 12oz, Product SKU#041268-029297. This product is supplied in 12 fl. oz. (355 mL) bottles for use in rinsing of soft (hydrophilic) contact lenses after heat (thermal) disinfection and rinsing of contact lenses following chemical disinfection. Recall # Z-1225-2010;

5) Kroger Sterile Preserved Saline Solution 12oz, Product SKU#011110-385956. This product is supplied in 12 fl. oz. (355 mL) bottles for use in rinsing of soft (hydrophilic) contact lenses after heat (thermal) disinfection and rinsing of contact lenses following chemical disinfection. Recall # Z-1226-2010;

6) CVS Sterile Preserved Saline Solution 12oz, Product SKU#050428-253793. This product is supplied in 12 fl. oz. (355 mL) bottles for use in rinsing of soft (hydrophilic) contact lenses after heat (thermal) disinfection and rinsing of contact lenses following chemical disinfection. Recall # Z-1227-2010
CODE
1), 2), 3), 4) Lot # 9D524;
5) Lot # 9C523;
6) Lot #’s 9C523 and 9D524
RECALLING FIRM/MANUFACTURER
K C Pharmaceuticals, Inc., Pomona, CA, by letter dated February 17, 2010. Firm initiated recall is ongoing.
REASON
The recall was initiated because the affected lots were manufactured between two failed media fills; therefore the lots produced cannot be assured as being free of contamination and may not be sterile.
VOLUME OF PRODUCT IN COMMERCE
46,519 units
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
CADD-LEGACY 1 Model 6400, Ambulatory Infusion Pump, REF 21-6400-51, Rx Only. Recall # Z-1235-2010
CODE
Serial number: 370969
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc., Saint Paul, MN, by telephone on December 23, 2009. Firm initiated recall is ongoing.
REASON
The CADD-Legacy 1 Model 6400 Ambulatory Infusion Pump (Serial Number 370969) was shipped without documentation that the required accuracy testing had been performed during the manufacturing process. If the subject infusion pump did not go through the accuracy testing, and if it does not meet accuracy specifications, there is a potential for over or under-delivery.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS III
___________________________________
PRODUCT
PTS Panels CHOL+HDL Panel test strips for professional use with CardioChek P-A analyzer, Catalog # 1795. The product is used to measure total cholesterol, and HDL cholesterol, in whole blood. Recall # Z-0975-2010
CODE
Lot # G751
RECALLING FIRM/MANUFACTURER
Polymer Technology Systems, Inc., Indianapolis, IN, by letter dated February 20, 2009. Firm initiated recall is complete.
REASON
Extended expiration date; the product expired on February 12, 2009 but was labeled with a April 4, 2009 expiration date.
VOLUME OF PRODUCT IN COMMERCE
3,748 vials
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
ATEC 0909-12 Breast Biopsy and Excision System , 9 gauge, 9 centimeter handpiece, part number 0909-12, Rx, Sterile,. The handpiece is inserted into the breast to the site of the area of interest. When the proper location/position is achieved, the handpiece cuts and removes biopsy tissue. Recall # Z-1160-2010
CODE
Unit: 910058
RECALLING FIRM/MANUFACTURER
Hologic, Inc., Indianapolis, IN, by letters dated February 1, 2010. Firm initiated recall is ongoing.
REASON
The product is labeled as ATEC0909-12 but it actually contains 0909-20.
VOLUME OF PRODUCT IN COMMERCE
190 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  VETERINARY - CLASS II
___________________________________
PRODUCT
1) 312 PMB Pak 76A; Tylosyn 10.00g/lb, Sulfamethazine 10.00g/lb. Recall # V-067-2010;
2) 138 Tylosin-Sulfamethazine 10-10 Swine Premix Medicated. Recall # V-068-2010
CODE
1) Units: 06091680-1 exp. 06/11/2011; 07091937-1 exp. 07/28/2011;

2) Units: 10080653-1 exp.-10/29/2010; 12080849-1 exp.-12/17/2010; 12080890-1 exp.-12/29/2010; 05091548-1 exp.-05/15/2011;  
RECALLING FIRM/MANUFACTURER
ADM Alliance Nutrition of Puerto Rico, LLC, Barceloneta, PR, by telephone, letter, fax or e-mail beginning January 27, 2010.
REASON
Low Potency for Sulfamethazine as part of assay analysis.
VOLUME OF PRODUCT IN COMMERCE
101 bags
DISTRIBUTION
PR

END OF ENFORCEMENT REPORT FOR APRIL 7, 2010

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