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U.S. Department of Health and Human Services

Safety

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Enforcement Report for September 29, 2010

September 29, 2010                                                                                        10-38

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I
___________________________________
PRODUCT
1) Black Bean Summer Corn in 7 lb. Package. Recall # F- F-2841-2010;
2) Broccoli Salad in 7 lb. Package. Recall # F-2842-2010;
3) Butternut Squash in 7 lb. Package. Recall # F-2843-2010;
4) Carribean Salad in 7 lb. Package. Recall # F-2844-2010;
5) Couscous in 5 lb. Package. Recall # F-2845-2010;
6) Curried Veggie Salad in 7 lb. Package. Recall # F-2846-2010;
7) Krab & Bay Shrimp Pasta Salad in 7 lb. Package. Recall # F-2847-2010;
8) Krab & Shrimp Louie Salad in 10 lb. Package. Recall # F-2848-2010;
9) Mediterranean Edamame Salad in 7 lb. Package. Recall # F-2849-2010;
10) Moroccan Eggplant in 7 lb. Package. Recall # F-2850-2010;
11) Orzo Sun Dried Tomato Salad in 7 lb. Package. Recall # F-2851-201;
12) Pasta Italia in 7 lb. Package. Recall # F-2852-2010;
13) Quinoa Inca Mint Salad in 7 lb. Package. Recall # F-2853-2010;
14) Salami & Smoked Gouda in 7 lb. Package. Recall # F-2854-2010;
15) Tabuli in 5 lb. Package. Recall # F-2855-2010;
16) Tortilla Slaw in 7 lb. Package. Recall # F-2856-2010;
17) Bacon Potato Salad Bar Salad in 5 lb. Package. Recall # F-2857-2010;
18) Broccoli Pasta Salad Bar Salad in 5 lb. Package. Recall # F-2858-2010;
19) Red Bean Cabbage Salad Bar Salad in 5 lb. Package. Recall # F-2859-2010;
20) Barley Broccoli with Raisins Salad Bar Salad in 5 lb. Package. Recall # F-2860-2010;
21) Tomato Feta Barley Salad Bar Salad in 5 lb. Package. Recall # F-2861-2010;
22) Wildrice Corn Blackbean Salad Bar Salad in 5 lb. Package. Recall # F-2862-2010;
23) Roasted Eggplant Barley Salad Bar Salad in 5 lb. Package. Recall # F-2863-2010;
24) Curried Tofu Value Added Salad in 8 oz. Package. Recall # F-2864-2010;
25) Thai Peanut Medley Value Added Salad in 8 oz. Package. Recall # F-2865-2010;
26) Garden Salad in 10 oz. Package. Recall # F-2866-2010;
27) Greek Salad in 13 oz. Package. Recall # F-2867-2010;
28) Caesar Salad in 13 oz. Package. Recall # F-2868-2010;
29) Chinese Mandarin Salad in 13 oz. Package. Recall # F-2869-2010;
30) Shrimp Caesar Salad in 13 oz. Package. Recall # F-2870-2010;
31) Cobb Meatless Salad in 13 oz. Package. Recall # F-2871-2010;
32) Baked Tofu Sandwich in 7.5 oz. Package. Recall # F-2872-2010;
33) Chicken Salad Sandwich in 7.5 oz. Package. Recall # F-2873-2010;
34) Egg Salad Sandwich in 7.5 oz. Package. Recall # F-2874-2010;
35) Ham & Cheese Sandwich in 7.5 oz. Package Recall # F-2875-2010;
36) Peanut Butter and Jelly Sandwich in 6 oz. Package. Recall # F-2876-2010;
37) Roast Vegetable Sandwich in 7.5 oz. Package. Recall # F-2877-2010;
38) Roast Beef and Cheese Sandwich in 7.5 oz. Package. Recall # F-2878-2010;
39) Tuna Salad Sandwich in 7.5 oz. Package. Recall # F-2879-2010;
40) Turkey & Cranberry Cream Cheese Sandwich in 7.5 oz. Package. Recall # 2880-2010;
41) Turkey & Jack Cheese Sandwich in 7.5 oz. Package. Recall # F-2881-2010;
42) Ham & Cheese Wrap in 12 oz. Package. Recall # F-2882-2010;
43) Roast Beef & Cheese Wrap in 12 oz. Package. Recall # F-2883-2010;
44) Turkey & Cheese Wrap in 12 oz. Package. Recall # F-2884-2010
45) Falafel Wrap in 11 oz. Package. Recall # F-2885-2010;
46) Greek Wrap in 10 oz. Package. Recall # F-2886-2010;
47) Falafel Burger 4 oz. Package. Recall # F-2887-2010;
48) Sandwich Falafel 6oz. Package. Recall # F-2888-2010;
49) Burrito- Azteca Whole Wheat 16oz. Package. Recall # F-2889-2010;
50) Hummus Regular in 8 oz. Package. Recall # F-2890-2010;
51) Spicy Hummus in 8 oz. Package. Recall # F-2891-2010;
52) Baba Ghannouj Hummus in 8 oz. Package. Recall # F-2892-2010;
53) Sun Dried Tomato Hummus in 8 oz. Package. Recall # F-2893-2010;
54) Roasted Red Pepper Hummus in 8 oz. Package. Recall # F-2894-2010;
55) Ginger Noodle Salad in 8 oz. Package. Recall # F-2895-2010
CODE
None
RECALLING FIRM/MANUFACTURER
Quong Hop & Co, South San Francisco, CA, issued a press release on and a notification to its customers on July 22, 2010. California Initiated recall is ongoing.
REASON
Products may be contaminated with Listeria Monocytogenes
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
AK, AZ, WA, CA, OR, NV
___________________________________
PRODUCT
Kroger "Meals Made Simple Shrimp Linguini"- Linguini Pasta, Shrimp, Garlic Butter Sauce, Broccoli & Tomatoes - packaged in 24 oz (1 lb 8 oz). Recall # F-2838-2010
CODE
DATE CODES: SEP10201111 AUG20201111 JUL06201121 JUN17201111 JUN04201111 MAY03201121 APR14201121 MAR08201121 FEB23201121 FEB10201121 JAN14201111 DEC18201011 NOV19201021 OCT22201011 SEP23201011 AUG22201011 JUL07201011 LOT NUMBERS: SO33175 SO33083 SO32805 SO32675 SO32560 SO32367 SO32233 SO32049 SO31991 SO31929 SO31754 SO31656 SO31496 SO31280 SO-31134 SO-30915 SO-30632
RECALLING FIRM/MANUFACTURER
Recalling Firm: Contessa Premium Foods, Inc., San Pedro, CA, by email on August 13, 2010 and press release on August 14, 2010.
Manufacturer: Contessa Food Products, Inc., Commerce, CA. Firm initiated recall is ongoing.
REASON
Kroger (product distributor) and Contessa Premium Foods, Inc. (product manufacturer) are recalling 24 ounce bags of Kroger brand Meals Made Simple Shrimp Linguini, because it may contain undeclared milk product.
VOLUME OF PRODUCT IN COMMERCE
369,570 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Queso Fresco Cheese: Wrapped in plastic or in a plastic container with a sell by date attached. Labeled with the following brand names: Queserio Chipilo, Chipilo and Aztlan. Package configuration: 14 oz. UPC 89007300115. Recall # F-2839-2010
CODE
All date codes up to and including September 26, 2010
RECALLING FIRM/MANUFACTURER
Queseria Chipilo, Inc., Passaic, NJ, by press on August 27, 2010 and August 31, 2010. FDA initiated recall is ongoing.
REASON
FDA Sampling had positive results for Listeria in finished product and facility.
VOLUME OF PRODUCT IN COMMERCE
Approx. 52, 0000 lbs.
DISTRIBUTION
NY, NJ, VA, MD, DE, CT
___________________________________
PRODUCT
1) Chocolate Truffles shaped like ice cream cones, malted. Recall #F-2834-2010;
2) Chocolate Truffles shaped like ice cream cones, four flavors in a box. Recall #F-2835-2010
CODE
Best if enjoyed by 11/2/2010 through 11/15/2010
RECALLING FIRM/MANUFACTURER
Moonstruck Chocolate Company, Portland, OR, by sending recall letter to their own Moonstruck cafe stores on August 17, 2010. Firm initiated recall is ongoing.
REASON
Undeclared allergen. Product's label fails to declare peanut butter.
VOLUME OF PRODUCT IN COMMERCE
180/12 pc. boxes and 369/4 pc. boxes
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II
___________________________________
PRODUCT
1) Hot Smoked Salmon, vacuum packaged, approximately 5 lbs. Recall # F-2836-2010;
2) Hot Smoked Sturgeon, vacuum packaged, approximately 5 lbs. Recall # F-2837-2010
CODE
NONE
RECALLING FIRM/MANUFACTURER
Newman's Fish Markets, Inc., Portland, OR, by telephone on August 20, 2010 and letter on August 21, 2010. FDA initiated recall is ongoing.
REASON
Potential of pathogen contamination of smoked salmon and sturgeon because the products were undercooked.
VOLUME OF PRODUCT IN COMMERCE
142.1 lbs. Hot Smoked Salmon and 1.76 lbs Hot Smoked Sturgeon
DISTRIBUTION
OR

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II
___________________________________
PRODUCT
DOPamine HCl Injection, USP; 400 mg/5 mL (80 mg/mL), 25 x 5 mL single dose vials per package; Rx Only; NDC 0517-1905-25. Recall # D-892-2010
CODE
Lot # 0170
RECALLING FIRM/MANUFACTURER
Luitpold Pharmaceuticals, Inc., Shirley, NY, by letter dated August 5, 2010. Firm initiated recall is ongoing.
REASON
Labeling: The label lacks warning or Rx legend. The vial label was missing the red printing "DOP" and "WARNING: NOT FOR DIRECT IV INJECTION. MUST BE DILUTED BEFORE USE. IV INFUSION ONLY." statement.
VOLUME OF PRODUCT IN COMMERCE
38,125 vials
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
Diovan HCT(R) valsartan and hydrochlorothiazide, USP, 320 mg/12.5 mg 90 tablets, NDC 0078-0471-34, Rx only, Novartis label. Tablet description: pink, ovaloid with beveled edge, debossed NVR on one side and HIL on the other side. Recall # D-893-2010
CODE
Lot F0130 (exp. APR 2012)
RECALLING FIRM/MANUFACTURER
Novartis Pharmaceuticals Corp., Suffern, NY, by letter dated September 9, 2010.  Firm initiated recall is ongoing.
REASON
Labeling mix-up. The firm received complaints that bottles labeled to contain Diovan HCT 320/12.5mg tablets actually contained Diovan HCT 320/25mg.
VOLUME OF PRODUCT IN COMMERCE
15,835 bottles
DISTRIBUTION
Nationwide, PR

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III
___________________________________
PRODUCT
Azathioprine Tablets, USP, 50 mg, Rx only, 100 Tablets. NDC 0781-5075-01. Recall # D-891-2010
CODE
Lot numbers: 177865, 177866, 177915, 177916, 178311, 178312, 179641, 179642, 179643, 181161, 181162, 181163, 181164, 181165, 181397, 181398, 181399, 181400, 181401, 181840, 181841, 182923, 182924, 182925, 182926, 183500, 183501, 183502, 183633, 183634, 183635, 183636, 186121, 186122, 186123, 186690, 186691, 186692, 186693, 187513, 187514, 187515, 187516, 188521, 188522, 188523, 189025, 189026, 189027, 189028, 189456, 189457, 189458, 189459, 189905, 189906, 189907, 189908, 191703, 191704, 191705, 191706, 192808, 192809, 192810, 192811, 192812
RECALLING FIRM/MANUFACTURER
Sandoz Inc., Broomfield, CO, by letter on June 10, 2010. Firm initiated recall is ongoing.
REASON
CGMP Deviations; failure to fully investigate dissolution failures prior to releasing product.
VOLUME OF PRODUCT IN COMMERCE
647,057 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Benazepril Hydrochloride Tablets, 5 mg, 100-count bottles, Rx only, NDC 60505-0265-1. Recall # D-894-2010;

2) Citalopram HBr Tablets, 40 mg, 100-count bottles, Rx only, NDC 60505-2520-1. Recall # D-895-2010;

3) DILT-XR (Diltiazem Hydrochloride) Extended-Release Capsules USP (Once-a-day dosage), 240 mg, a) 100-count, NDC 60505-0016-6, b) 500-count, NDC 60505-0016-8; Rx only. Recall # D-896-2010;

4) DILT-XR (Diltiazem Hydrochloride) Extended-Release Capsules, USP (Once-a-day dosage), 180 mg, 100-count bottle, Rx only, NDC 60505-0015-6. Recall # D-897-2010;

5) Gemfibrozil Tablets USP, 600 mg, 500-count bottles, Rx only, NDC 60505-0034-8. Recall # D-898-2010;

6) Loratadine Tablets USP, 10 mg, Antihistamine, a) 100-count bottle, NDC 60505-0147-1, b) 1000-count bottle, NDC 60505-0147-8, OTC. Recall # D-899-2010;

7) Lovastatin Tablets USP, 10 mg, 60-count bottle, Rx only, NDC 60505-0177-0. Recall # D-900-2010;

8) Lovastatin Tablets USP, 20 mg, 60-count bottle, Rx only, NDC 60505-0178-0. Recall # D-901-2010;

9) Lovastatin Tablets USP, 40 mg, 60-count bottle, Rx only, NDC 60505-0179-0. Recall # D-902-2010;

10) Nizatidine Capsules USP, 150 mg, 60-count bottle, Rx only, NDC 60505-0230-4. Recall # D-903-2010;

11) Nizatidine Capsules USP, 300 mg, 30-count bottle, Rx only, NDC 60505-0231-1. Recall # D-904-2010;

12) Terazosin Hydrochloride Capsules, 1 mg, a) 100-count bottle, NDC 60505-0115-0, b) 500-count bottle, NDC 60505-0115-5, Rx only. Recall # D-905-2010
CODE
1) Batch HX5819, Exp 07/10;
2) Batch JH2204, Exp 07/11;
3) a) Batch HW4437, HY3540, Exp 09/10; b) Batch HW4435, HY3541, Exp 09/10;
4) Batch HY3576, Exp 09/10;
5) Batch JD4444, JD4448, Exp 04/11;
6) a) Batch HX8178, Exp 07/10; JA9708, Exp 11/10; b) Batch HY3556, Exp 07/10; JA9709, Exp 11/10;
7) Batch JF0662, Exp 05/11;
8) Batch JF0660, Exp 05/11;
9) Batch JF0664, Exp 05/11;
10) Batch JC8097, Exp 02/11;
11) Batch JC8098, Exp 02/11;
12) a) Batch JE0404, Exp 04/11; b) Batch JE0403, Exp 04/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Apotex Corp., Weston, FL, by letter and e-mail on May 11, 2010.
Manufacturer: Apotex Inc., Toronto Ontario, Canada. Firm initiated recall is ongoing.
REASON
CGMP Deviations: Apotex Corporation, Weston, FL is recalling multiple products in the US market manufactured prior to August 2009 using API and raw materials that had passed the vendor's suggested expiry.
VOLUME OF PRODUCT IN COMMERCE
218,071 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Anastrozole tablets, 1 mg, 30 Tablets per HDPE Bottle, Rx only; NDC #63323-129-30; Product Code: 129030. Recall # D-906-2010
CODE
Lot numbers 870AF0010, Exp. date: 05/2012; Lot number: 870AF00201; Exp. date: 05/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: APP Pharmaceuticals LLC, Schaumburg, IL, by letters dated September 1, 2010.
Manufacturer: Fresensius Kabi Oncology Limited (Baddi), Baddi, India. Firm initiated recall is ongoing.
REASON
Cross Contamination w/Other Products: A potential for some foreign tablets to be in bottles of anastrozole tablets 1 mg.
VOLUME OF PRODUCT IN COMMERCE
7,192 bottles
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
Stomach Relief Tablets, Bismuth Subsalicylate 262 mg, 30 chewable tablets, OTC, packaged under the following labels: GoodSense Stomach Relief Tablets Chewables, NDC 0113-0469-65; Kroger Chewables Stomach Relief, NDC 30142-469-65; TopCare Stomach Relief Chewables; Equaline Chewables Stomach Relief, NDC 41163-469-65; Stomach Relief, NDC 38045-469-65; HEB Stomach Relief, NDC 37808-469-65; Meijer Stomach Relief Tabs, NDC 41250-469-65; Chewable Tablets Stomach Relief, NDC 21130-469-65; Leader Chewables Pink Bismuth, NDC 37205-720-65; Hannaford Chewables Stomach Relief, NDC 41268-469-65; Sunmark Stomach Relief Tablets, NDC 49348-177-44; Hy-Vee Chewables Stomach Relief Tablets, NDC 42507-469-65; Giant Eagle Chewable Stomach Relief Tablets, NDC 56194-469-65; Longs Wellness Chewable Tablets Stomach Relief, NDC 12333-9319-1; Publix Stomach Relief Chewable, NDC 56062-469-65; CareOne Stomach Relief,  NDC 41250-469-65. Recall # D-907-2010
CODE
Units: 0AE2097, 0AE2719, 0AV0701, 0AV0702, 0AV0703, 0AV0704, 0AV0705, 0AV0706, 0AV0731, 0AV0732, 0AV0733, 0AV0734, 0AV0738, 0AV0741, 0BE1947, 0BV0552, 0BV0553, 0BV0554, 0BV0568, 0BV0569, 0BV0597, 0BV0598, 0BV0599, 0BV0600, 0CV0486, 0CV0487, 0CV0488, 0CV0503, 0CV0504, 0CV0510, 0CV0511, 0CV0512, 0CV0517, 0CV0518, 0CV0519, 0CV0522, 0CV0523, 0CV0524, 0CV0525, 0CV0526, 0DV0478, 0DV0479, 0DV0489, 0DV0490, 0DV0491, 0DV0492, 0DV0521, 0DV0522, 0DV0523, 0DV0537, 0DV0538, 0DV0539, 0DV0540, 0DV0731, 0EE1891, 0EE2573, 0EV0527, 0EV0536, 0EV0537, 0EV0538, 0EV0539, 0EV0559, 0FV0511, 0FV0515, 0FV0516, 0FV0607, 8AV0066, 8AV0067, 8AV0068, 8AV0228, 8AV0229, 8AV0230, 8AV0231, 8AV0765, 8BV0033, 8BV0072, 8BV0183, 8BV0184, 8BV0185, 8BV0186, 8CV0049, 8CV0051, 8CV0052, 8CV0083, 8CV0084, 8CV0092, 8CV0093, 8CV0094, 8CV0095, 8CV0209, 8CV0210, 8DV0053, 8DV0054, 8DV0064, 8DV0078, 8DV0150, 8DV0151, 8DV0195, 8DV0202, 8DV0203, 8DV0204, 8EV0045, 8EV0046, 8EV0078, 8EV0100, 8EV0102, 8EV0103, 8EV0104, 8EV0174, 8EV0176, 8EV0177, 8EV0192, 8EV0226, 8EV0227, 8EV0353, 8EV0405, 8FV0049, 8FV0050, 8FV0088, 8FV0181, 8FV0276, 8GE1257, 8GV0042, 8GV0043, 8GV0044, 8GV0046, 8GV0047, 8GV0062, 8GV0083, 8GV0084, 8GV0098, 8GV0099, 8GV0367, 8GV0458, 8HV0052, 8HV0067, 8HV0083, 8HV0084, 8HV0096, 8HV0097, 8HV0114, 8HV0154, 8HV0155, 8HV0236, 8JV0077, 8JV0087, 8JV0136, 8KV0782, 8KV0783, 8KV0784, 8KV0803, 8KV1003, 8KV1004, 8KV1005, 8KV1006, 8KV1007, 8KV1009, 8LE1740, 8LE1741, 8LV0585, 8LV0586, 8LV0602, 8LV0603, 8LV0604, 8LV0605, 8LV0672, 8LV0687, 8LV0688, 8LV0923, 8LV1267, 8MV0843, 8MV0851, 8MV0852, 8MV0853, 8MV0935, 8MV1140, 8MV1287, 9AV0970, 9AV0971, 9AV0989, 9AV0990, 9AV0991, 9AV0992, 9AV1005, 9AV1006, 9AV1135, 9AV1136, 9BE1775, 9BE1776, 9BE2513, 9BV0711, 9BV0712, 9BV0713, 9BV0714, 9BV0729, 9BV0856, 9BV0857, 9BV0858, 9BV0950, 9BV1029, 9BV1030, 9BV1031, 9BV1032, 9CE2300, 9CE2701, 9CV0712, 9CV0713, 9CV0714, 9CV0715, 9CV0716, 9CV0736, 9CV0737, 9CV0738, 9CV0739, 9CV0774, 9CV0775, 9CV1046, 9DV0583, 9DV0584, 9DV0642, 9DV0692, 9DV0693, 9DV0694, 9DV0695, 9DV0696, 9DV0697, 9EE1781, 9EV0545, 9EV0561, 9EV0580, 9EV0581, 9EV0612, 9EV0628, 9EV0629, 9FV0505, 9FV0506, 9FV0507, 9FV0508, 9FV0509, 9FV0524, 9FV0536, 9FV0537, 9FV0594, 9GE1981, 9GE2548, 9GV0679, 9GV0698, 9GV0707, 9GV0713, 9GV0714, 9GV0761, 9GV0858, 9GV0859, 9GV0860, 9HE2310, 9HV0617, 9HV0618, 9HV0619, 9HV0620, 9HV0633, 9HV0634, 9HV0635, 9HV0650, 9HV0686, 9HV0687, 9JV0806, 9JV0807, 9JV0808, 9JV0809, 9JV0829, 9JV0830, 9JV0831, 9JV0878, 9JV0879, 9JV0880, 9JV0899, 9JV0900, 9JV0901, 9JV0902, 9JV0903, 9JV0904, 9JV0905, 9JV1324, 9KE2531, 9KV0634, 9KV0635, 9KV0636, 9KV0637, 9KV0638, 9KV0639, 9KV0640, 9KV0695, 9KV0696, 9KV0717, 9KV0718, 9KV0719, 9KV0720, 9KV0820, 9KV0905, 9LV0737, 9LV0738, 9LV0739, 9LV0753, 9LV0754, 9LV0766, 9MV0870, 9MV0871, 9MV0872, 9MV0873, 9MV0874, 9MV0881, 9MV0882, 9MV0883, 9MV0902, 9MV0906, 9MV0907, 9MV0908, 9MV0911, 9MV1234 and 9ME2322
RECALLING FIRM/MANUFACTURER
L. Perrigo Co., Allegan, MI, by letter on July 12, 2010. Firm initiated recall is ongoing.
REASON
Label lacks warning; the label does not include the required calcium content warning statements.
VOLUME OF PRODUCT IN COMMERCE
1,431,887
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
DermOtic Oil (fluocinolone acetonide) 0.01%, Ear Drops, For Otic Use Only, Not for Ophthalmic Use, Net Wt. 20 mL, bottle, Rx only; NDC 28105-160-20. Recall # D-908-2010
CODE
Lot Numbers: B090039, Exp: 08/2010; D090076, Exp: 10/2010
RECALLING FIRM/MANUFACTURER
Hill Dermaceuticals, Inc., Sanford, FL, by letter dated August 9, 2010. Firm initiated recall is ongoing.
REASON
Subpotent: The product is sub-potent prior to the expiration date.
VOLUME OF PRODUCT IN COMMERCE
51,384 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Adderall XR (Mixed Salts of a Single-Entity Amphetamine) Extended Release Capsules, 5 mg, 100 count bottle; Rx only; NDC 54092-381-01. Recall # D-909-2010;

2) Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of a Single Entity Amphetamine Product); Extended Release Capsules, 5 mg, 100 count bottle; Rx only; NDC 0555-0790-02. Recall # D-910-2010;

3) Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of a Single Entity Amphetamine Product); Extended Release Capsules, 10 mg, 100 count bottle; Rx only; NDC 0555-0787-02. Recall # D-911-2010;

4) Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of a Single Entity Amphetamine Product) Extended Release Capsules, 5 mg, 100 count bottle; Rx only; NDC 0115-1328-01. Recall # D-912-2010
CODE
1) Lot # A56222A, Exp 09/13, Lot # A57502A, Exp 11/13;
2) Lot # A55700A, Exp 4/13 Lot A55701A, Exp 7/13 Lot # A57636A, Exp 11/13;
3) Lot # A56189A, Exp 11/13;
4) Lot # A55529B, Exp 3/13 Lot # A57635B, Exp 11/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Shire Pharmaceuticals, Inc., Wayne, PA, by letters on June 9, 2010.
Manufacturer: DSM Pharmaceuticals Inc., Greenville, NC. Firm initiated recall is ongoing.
REASON
Subpotency (under-filled capsules).
VOLUME OF PRODUCT IN COMMERCE
85,359 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Potassium Citrate Extended-Release Tablets USP, 10 mEq (1080 mg per tablet), 100-count bottle, Rx only; NDC 64980-138-01; UPC 3 64980 13801 7. Recall # D-913-2010
CODE
Lot # 104238, Exp 04/12
RECALLING FIRM/MANUFACTURER
Corepharma LLC, Middlesex, NJ, letters on September 16, 2010. Firm initiated recall is ongoing.
REASON
Failed USP Dissolution Test Requirements: Out of Specification value for dissolution at the 3 month stability test interval.
VOLUME OF PRODUCT IN COMMERCE
3,514 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0509-10
CODE
Unit: W038309124191 and W038309124191
RECALLING FIRM/MANUFACTURER
Mississippi Valley Regional Building Center, Davenport, IA, by facsimile and telephone on January 15, 2010. Firm initiated recall is complete.
REASON
Blood products, which did not meet the acceptable product specifications for release, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
D.C.
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B- 1831-10
CODE
Units: W142809408642, W142809408639
RECALLING FIRM/MANUFACTURER
Tri-counties Blood Bank, San Luis Obispo, CA, by telephone on January 15, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability determination was inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1988-10
CODE
Unit: 72M913611
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on April 22, 2010. Firm initiated recall is complete.
REASON
Blood product, which yielded a platelet count that was below the acceptable limit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1989-10
CODE
Unit: 72M913334
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on April 3, 2010. Firm initiated recall is complete.
REASON
Blood product, which yielded a platelet count that was below the acceptable limit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1990-10
CODE
Unit: 72N495098
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc. – Birmingham Region, Birmingham, AL, by facsimile on April 13, 2010. Firm initiated recall is complete.
REASON
Blood product, which yielded a platelet count that was below the acceptable limit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1991-10
CODE
Units: W127809131444, W127809132353, W127810130161
RECALLING FIRM/MANUFACTURER
Tacoma Pierce County Blood Bank, Tacoma, WA, by electronic delivery note on March 25, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Switzerland, WA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1999-10
CODE
Unit: 72N602880
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc. – Birmingham Region, Birmingham, AL, by facsimile on April 28, 2010. Firm initiated recall is complete.
REASON
Blood product, with a low platelet, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-2001-10
CODE
Units: W117009134536, W117009134536
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific – Irwin Center, San Francisco, CA, by telephone on March 29, 2010, and by letter dated March 30, 2010. Firm initiated recall is complete.
REASON
Blood products, which were collected from donors in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA

___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-2142-10;
2) Recovered Plasma. Recall # B-2143-10
CODE
1) and 2) Unit: 6385482
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by telephone on January 26, 2010 and by facsimile on February 2, 2010. Firm initiated recall is complete.
REASON
Blood products which were collected from a donor whose suitability pertaining to risk factors for Creutzfeldt-Jakob Disease (vCJD) was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria, TX
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-2145-10;
2) Cryoprecipitated AHF. Recall # B-2146-10
CODE
1) and 2) Units: W149510305432, W149508300782
RECALLING FIRM/MANUFACTURER
Northern California Community Blood Bank, Eureka, Ca, by email and facsimile on April 27, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
Austria, TX, CA
___________________________________
PRODUCT
1) Platelets. Recall # B-2252-10;
2) Platelets Irradiated. Recall # B-2253-10  
CODE
1) Units: W053309701516; W053309503549; W053309503560; W053309503561; W053309503565; W053309604057; W053309604080; W053309303649; W053309303651;

2) Units: W053309303628; W053309603730; W053309303400; W053309603840; W053309503205; W053309603703; W053309303394; W053309503320; W053309402000, W053309503688, W053309503691, W053309701515, W053309604252, W053309604267, W053309604268
RECALLING FIRM/MANUFACTURER
Community Blood Center, Inc., Appleton, WI, by letter dated June 16, 2009. Firm initiated recall is complete.  
REASON
Blood products, with a low platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
24 units
DISTRIBUTION
WI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2311-10
CODE
Unit: 24KJ94805
RECALLING FIRM/MANUFACTURER
The American National Red Cross, River Valley Region, Louisville, KY, by letter dated July 7, 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
KY, CA
___________________________________
PRODUCT
Source Plasma. Recall # B-2312-10
CODE
Unit: 2030113717
RECALLING FIRM/MANUFACTURER
PlasmaCare, Inc., Columbus, OH, by letter dated November 28, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was previously deferred for high risk behavior, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelet PGD Test System, 100 Test pouches per box; an in vitro diagnostic bacterial detection system for platelet transfusion products; 510(k) BK090028. Recall # B-2376-10
CODE
Box Lot Number L06184, Pouch Lot Number 09345-001, Exp January 17, 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fenwal, Inc., Lake Zurich, IL, by telephone on July 21, 2010 and by letter dated July 27, 2010.
Manufacturer: British Biocell International, Cardiff, UK. Firm initiated recall is ongoing.
REASON
Platelet PGD Test System, with a defect preventing the detection of gram negative bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
48 boxes
DISTRIBUTION
CA, IL, MA, MI, MN, NH, OH, PA, SD, TX, WA, WI
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-2377-10
CODE
Unit: W044410105525
RECALLING FIRM/MANUFACTURER
Northern Illinois  Blood Bank dba Rock River Valley BC, Rockford, IL, by telephone on June 3, 2010. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-2379-10
CODE
Unit: W117009335310
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific – Irwin Center, San Francisco, CA, by telephone on September 9, 2009 and by letter dated September 14, 2009. Firm initiated recall is complete.
REASON
Blood product, collected using automated equipment that was not validated for use, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-2380-10
CODE
Unit: W036510052520 (split unit)
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Baton Rouge, LA, by visit on April 27, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-2381-10
CODE
Unit: W-039709102638A
RECALLING FIRM/MANUFACTURER
Aurora Area Blood Bank dba – Heartland Blood Centers, Aurora, IL, by on line notification on June 14, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (VCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2382-10
CODE
Units: W038110004836; 9595408; W038110050489
RECALLING FIRM/MANUFACTURER
Florida’s Blood Center, Inc., Orlando, FL, by letter and telephone on May 25, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT
1) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-2385-10;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-2386-10
CODE
1) Unit: W035810382058;
2) Units: W035810382058 (split unit), W035810382048
RECALLING FIRM/MANUFACTURER
BloodSource, Inc., Mather, CA, by telephone and facsimile on May 19, 2010. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NY, CA

___________________________________
PRODUCT
1) Platelets Pheresis Leukocytes Reduced. Recall # B-2387-10;
2) Fresh Frozen Plasma. Recall # B-2388-10 
CODE
1) Unit: W117010232658 (Split unit)
2) Unit: W117010232658
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific – Irwin Center, San Francisco, CA, by telephone on May 21, 2010 and by letter on May 24, 2010.
Manufacturer: Blood Centers of the Pacific – Shasta Blood Center, Redding, CA. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-2401-10;
2) Platelets Leukocytes Reduced. Recall # B-2402-10
CODE
1) and 2) Unit: W037709013625
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH, by letter dated May 19, 2009. Firm initiated recall is complete.
REASON
Blood products collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH
___________________________________
PRODUCT
Red Blood Cells. Recall # B-2403-10
CODE
Unit: W001607001819
RECALLING FIRM/MANUFACTURER
Recalling Firm: Department of the Air Force, Wright Patterson AFB, OH, by letter on October 16, 2007.
Manufacturer: Department of Air Force 88th Medical Group SGQC WPAFB, Wright Patterson AFB, OH. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2437-10
CODE
Unit: 026KN68256
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by telephone and email on September 10, 2008 and by follow-up letter on September 11, 2008.
Manufacturer: The American National Red Cross, Mobile, AL. 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
AL, CA
___________________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-2439-10
CODE
Unit: 9144312
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on November 6, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-2453-10;
2) Cryoprecipitated AHF, Pooled. Recall # B-2454-10;
3) Platelets Leukocytes Reduced. Recall # B-2455-10
CODE
1) Units: 2913897, 1075621;
2) Unit: 2913897;  
3) Unit: 1075621
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH, by letter dated January 2, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
OH
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2457-10
CODE
Unit: FT36461
RECALLING FIRM/MANUFACTURER
BloodCenter of Wisconsin, Inc., Milwaukee, WI, by fax on July 29, 2008. 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
WI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2459-10
CODE
Units: W036308300027, LY28181
RECALLING FIRM/MANUFACTURER
Recalling Firm: BloodCenter of Wisconsin, Inc., Milwaukee, WI, by fax on September 16, 2008.
Manufacturer: BloodCenter of Wisconsin, Inc., La Crosse, WI.  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
WI
___________________________________
PRODUCT
Platelets. Recall # B-2460-10
CODE
Unit: W035209196530S
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on November 18, 2008. 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
TX
___________________________________
PRODUCT
Platelets. Recall # B-2461-10
CODE
Unit: W0352081552159
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated October 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
TX
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-2464-10
CODE
Unit: 4055163; 4055163 (double Pheresis product)
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated December 4, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel through a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2465-10
CODE
Unit: GN47381
RECALLING FIRM/MANUFACTURER
Recalling Firm: BloodCenter of Wisconsin, Inc., Milwaukee, WI, by fax on November 19, 2008.
Manufacturer: BloodCenter of Wisconsin, Inc., Sheboygan, WI.  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
WI
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-2469-10
CODE
Unit: LV19994
RECALLING FIRM/MANUFACTURER
BloodCenter of Wisconsin, Inc., Milwaukee, WI, by fax on May 2, 2006. 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
WI
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-2470-10;
2) Platelets. Recall # B-2471-10
CODE
1) and 2) Unit: W0352081064003
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on September 10, 2008 and by letter on September 23, 2008. 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
TX
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-2473-10;
2) Platelets. Recall # B-2474-10
CODE
1) and 2) Unit: W0352081738894
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone and fax on October 24, 2008 and by follow-up letter on November 17, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-2475-10;
2) Cryoprecipitated AHF. Recall # B-2476-10;
3) Platelets. Recall # B-2477-10
CODE
1), 2) and 3) Unit: W0352081384580
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on October 22, 2008 and by letter on November 6, 2008 and January 22, 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
3 units
DISTRIBUTION
TX

___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-2478-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-2479-10;
3) Cryoprecipitated AHF. Recall # B-2480-10
CODE
1) Units: 2928261, 2924085;
2) Units: 2928261, 2924085, 2988139, 2914839;
3) Unit: 2988139
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH, by letter dated August 21, 2008. Firm initiated recall is complete.
REASON
Blood products, not tested for viral markers using an FDA approved donor screening test, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
OH, KY, IN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2482-10
CODE
Unit: 026FH22167
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by email and telephone on September 6, 2008 and by follow-up letter on September 8, 2008.
Manufacturer: The American National Red Cross, Mobile, AL. 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
AL, CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-2485-10
CODE
Unit: W0416100209481 (split unit)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc/dba United Blood Services, Meridian, MS, by telephone on June 4, 2010.
Manufacturer: Blood Systems, Inc/dba United Blood Services, Tupelo, MS. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MS

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1998-10
CODE
Unit: W120610201988
RECALLING FIRM/MANUFACTURER
Michigan Blood, Saginaw, MI, by facsimile on April 9, 2010. Firm initiated recall is complete.
REASON
Blood product, lacking a verified platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2000-10
CODE
Units: 007FN75711, 007FN75722, 007FN75732, 007FY91185, 007FY91192
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Tucson, AZ, by telephone on March 20, 2010. Firm initiated recall is complete.
REASON
Blood products, possibly out of controlled storage for more than 30 minutes, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
AZ
___________________________________
PRODUCT
Recovered Plasma. Recall # B-2144-10
CODE
Unit: W149510305432
RECALLING FIRM/MANUFACTURER
Northern California Community Blood Bank, Eureka, Ca, by email and facsimile on April 27, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria, TX, CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-2310-10
CODE
Unit: 24KJ94805
RECALLING FIRM/MANUFACTURER
The American National Red Cross, River Valley Region, Louisville, KY, by letter dated July 7, 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
KY, CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-2330-10
CODE
Unit: W001605004129
RECALLING FIRM/MANUFACTURER
Recalling Firm: Department of the Air Force, Wright Patterson AFB, OH, by letter dated September 23, 2008.
Manufacturer: Department of Air Force 88th Medical Group SGQC WPAFB, Wright Patterson AFB, OH. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who resided in a HIV Group O risk area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-2435-10
CODE
Units: 24FX07368 (part 1 and 2), 24FX07369 (part 1 and 2), 24FX07370 (part 1, 2 and 3)
RECALLING FIRM/MANUFACTURER
The American National Red Cross, River Valley Region, Louisville, KY, by telephone on August 29, 2007. Firm initiated recall is complete.
REASON
Blood products, possibly exposed to unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
KY
___________________________________
PRODUCT
Recovered Plasma. Recall # B-2438-10
CODE
Unit: 026KN68256
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by telephone and email on September 10, 2008 and by follow-up letter on September 11, 2008.
Manufacturer: The American National Red Cross, Mobile, AL. 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
AL, CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-2456-10
CODE
Units: W001607703690, W001607702745
RECALLING FIRM/MANUFACTURER
Recalling Firm: Department of the Air Force, Wright Patterson AFB, OH, by letter dated April 30, 2008.
Manufacturer: Department of Air Force 88th Medical Group SGQC WPAFB, Wright Patterson AFB, OH. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2458-10
CODE
Unit: W036308501722V
RECALLING FIRM/MANUFACTURER
BloodCenter of Wisconsin, Inc., Milwaukee, WI, by fax on August 3, 2008. Firm initiated recall is complete.
REASON
Blood product, with insufficient red cell preservative solution added, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets. Recall # B-2462-10
CODE
Unit: W0352081143864
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone and follow-up letter on October 23, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Recovered Plasma. Recall # B-2483-10
CODE
Unit: 026FH22167
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by email and telephone on September 6, 2008 and by follow-up letter on September 8, 2008.
Manufacturer: The American National Red Cross, Mobile, AL. 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
AL, CA

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II
___________________________________
PRODUCT   
1) Infinity Delta/Gamma X XL Patient Monitor. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications. Catalog Number: MS18597. Recall # Z-2283-2010

2) Infinity Delta/Gamma X XL Patient Monitor. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications. Catalog Number: MS18852. Recall # Z-2284-2010
CODE
None
RECALLING FIRM/MANUFACTURER
Draeger Medical Systems, Inc., Telford, PA, by letters on June 4, 2010. Firm initiated recall is ongoing.
REASON
Monitor keys may become inoperative or activate spontaneously. This may cause a membrane switch panel malfunction, which could result in the monitor discharging a patient automatically.
VOLUME OF PRODUCT IN COMMERCE
9,475 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT   
1) Deknatel Bondek Plus Polyglycolic Absorbable Surgical Sutures, Bon+BG BR 3-0 DSL 19 1N (45cm), Teleflex Medical. Bondek and Bondek Plus Synthetic Absorbable Surgical Sutures intended uses are in general surgical procedures where general soft tissue approximation and/or ligation are performed, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures. Catalog Number: EP4084N. Recall # Z-2286-2010;

2) Deknatel Bondek Plus Polyglycolic Absorbable Surgical Sutures, Bon+VI R 0 HRX27 1N (70 cm), Teleflex Medical. Catalog Number: EP1081P. Recall # Z-2287-2010
CODE
1) Lot number: 02A0801449;
2) Lot number: 02A0801448, 02A0802800, 020A802802 and 02A0801433
RECALLING FIRM/MANUFACTURER
Recalling Firm: Telefelx Medical, Durham, NC, by letter dated February 1, 2010.
Manufacturer: Teleflex Medical, Nueva Laredo, Mexico. Firm initiated recall is ongoing.
REASON
Labeling error; The Bondek Suture product inside the box are of a different catalog number than labeled on the outer box.
VOLUME OF PRODUCT IN COMMERCE
17 sales units (24 packs per sales unit/408 units)
DISTRIBUTION
Nationwide and Germany
___________________________________
PRODUCT   
ReliaMed Deluxe Portable Adjusting Table. Product is a medical table used on patients for massage and chiropractic treatment. Recall # Z-2288-2010
CODE
The tables do not bear lot or serial numbers; however there are two device identification numbers representative of two different colors. ZZRNT100BL (blue) ZZRMT100BLK (black)
RECALLING FIRM/MANUFACTURER
Recalling Firm: MDC Acquisition Co., Rancho Cucamonga, CA, by letters in April 2010.
Manufacturer: Huangshan City Shexian Comfort Massanage Applia, Huangshan, China. Firm initiated recall is ongoing.
REASON
Two complaints were received of the vinyl-covered, padded, plywood table surface breaking near the foot end.
VOLUME OF PRODUCT IN COMMERCE
265 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT   
Zimmer ITST" Intertrochanteric/Subtrochanteric Fixation Locking Bolt Extractor - Nonsterile. The ITST Intertrochanteric/Subtrochanteric Fixation Locking Bolt Extractor instrument is a reusable surgical instrument used to separate the femoral nail from the locking bolt after nail implantation/fixation in trauma surgeries. Catalog No. 00-2258-051-01. Recall # Z-2289-2010
CODE
Lot No. 53951300; Manufactured 8/8/2002
RECALLING FIRM/MANUFACTURER
Zimmer Inc., Warsaw, IN, by letters dated July 8, 2010. Firm initiated recall is ongoing.
REASON
Instruments were manufactured with the incorrect grade of steel, increasing the potential for fracture during use.
VOLUME OF PRODUCT IN COMMERCE
20 units
DISTRIBUTION
Nationwide, Canada, Spain, Germany, and Great Britain
___________________________________
PRODUCT   
3M Red Dot Monitoring Electrode, Catalog #2560 & Novaplus Universal Monitoring Electrode #V2560, used for ECG monitoring. Recall # Z-2383-2010
CODE
2560 LOT #'S: 2012-06 CX, 2012-06 CY, 2012-06 CZ, 2012-06 DA, 2012-06 DB, 2012-05 CN, 2012-05 CM, 2012-05 CK, 2012-05 CJ, 2012-05 CI, 2012-05 CH,2012-05 CG, 2012-05 CF, 2012-05 CE, 2012-05 CD, and 2012-05 CC. V2560 NOVATION PRIVATE LABEL LOT: 2012-05 CL
RECALLING FIRM/MANUFACTURER
Recalling Firm: 3M Company, Medical Division, Saint Paul, MN, by letters dated July 29, 2010.
Manufacturer: 3M Canada Co., Morden Manitoba, Canada. Firm initiated recall is ongoing
REASON
The sensing element of the 3M Red Dot Monitoring Electrode, Catalog # 2560 and Novaplus Universal Monitoring Electrode #V2560 may have corrosion. In an emergency situation where defibrillation is necessary and electrodes are already in use, the electrodes may malfunction and provide a delayed or no trace response.
VOLUME OF PRODUCT IN COMMERCE
11,063 units
DISTRIBUTION
CA, FL, IL, KS, KY, MI, MO, NE, NJ, NY, OH, PA, RI, SD, TN, VA, WI ___________________________________
PRODUCT   
ONLINE TDM N-acetylprocainamide, Part number 04642520190 N- acetylprocainamide reagent. Recall # Z-2386-2010
CODE
Lot number: 14456200
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Operations, Inc., Indianapolis, IN, by letter dated February 2010. Firm initiated recall is ongoing.
REASON
The N-acetylprocainamide reagent lot 14456200 shows an incorrect expiration date of 7/31/2011. The correct expiration date for the lot is 1/31/2011.
VOLUME OF PRODUCT IN COMMERCE
40 kits
DISTRIBUTION
AL, CT, NY, PA, TX
___________________________________
PRODUCT   
GLUCm used on Synchron LX and UniCel DxC Synchron Clinical Systems, Part Number: 472500 ( ynchron LX20, LX20 PRO, LXI 725, UniCel DxC 600, UniCel DxC 600 PRO, UniCel DxC 600i, UniCel DxC 800, UniCel DxC 800 PRO, UniCel DxC 880i, UniCel DxC 680i, UniCel DxC 660i, and UniCel DxC860i ). Recall # Z-2388-2010
CODE
All non-expired lots are affected by the recall.
RECALLING FIRM/MANUFACTURER
Beckman Coulter Inc., Brea, CA, by letter dated April 2010.  Firm initiated recall is ongoing.
REASON
UniCel DxC and Synchron LX instruments produced inaccurate (low) GLUCm results. False low results could affect or delay diagnosis or treatment.
VOLUME OF PRODUCT IN COMMERCE
84, 186 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT   
1) Hospira brand Symbiq One-Channel Infuser LIST No. 16026 Symbiq One-Channel Infuser, List Number Configurations: 16026-04-01/03/04, 51/52, 53/54, 79/80, 81/82, 83/84, 87/88 and 89/90, 16026-13-25/26, 53/54. Recall # Z-2390-2010;

2) Hospira brand Symbiq Two-Channel Infuser, LIST No. 16027 Symbiq Two-Channel Infuser, List Number Configurations: 16027-04-01/03/04, 51/52, 53/54, 79/80,81/82,83/84,87/88 and 89/90 16026-27-89/90, 16027-27-89/90, 16027-13-25/26,53/54. Recall # Z-2391-2010
CODE
All units of these List Numbers.
RECALLING FIRM/MANUFACTURER
Hospira, Inc. Morgan Hill, CA, by letter dated February 22, 2010. Firm initiated recall is ongoing.
REASON
The clamp may not secure to the IV pole and the pump may slip or fall off. The pump may fall on a person or pull the tubing out of the IV container.
VOLUME OF PRODUCT IN COMMERCE
6,793 units
DISTRIBUTION
Nationwide, Australia, Canada, Colombia, Costa Rica, Malaysia, Mexico, Singapore. and the UAE
___________________________________
PRODUCT   
BIOMET MICROFIXATION REF: 02-0461 Rees Insulated Forceps, 21CM, (8.25") (L), Stainless steel, nylon, ***Non-Sterile Product***. The Rees Insulated Forceps are used during surgery to grasp, dissect and coagulate selected tissue. Recall # Z-2392-2010
CODE
Lot Numbers: 042308D08, 112108K08, 031309C09, 041009D09, 042310B10, 021910B10, 092707I07, 102607J07, 032607C07, 041607D07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biomet Microfixation, Inc., Jacksonville, FL, by letter dated July 2010.
Manufacturer: Egon Faulhaber Pinzetten, Frittlingen, Germany. Firm initiated recall is ongoing
REASON
The forceps insulation may have cracks or breaks in the insulation that may cause burns to patients when used.
VOLUME OF PRODUCT IN COMMERCE
130 units
DISTRIBUTION
Nationwide, Norway, Canada, and Mexico
___________________________________
PRODUCT   
Clinical Chemistry Phosphorus assay. Recall # Z-2398-2010
CODE
Lot number: 81040HW00; expires July 15, 2010, 85009HW00; expires December 15th, 2010. (All Lots of Clincal Phosphorous LN 7D71-21)
RECALLING FIRM/MANUFACTURER
Abbott Laboratories Inc., South Pasadena, CA, by letter dated May 4, 2010. Firm initiated recall is ongoing.
REASON
Product may give inaccurate results and aspiration errors with reagent configuration, including results outside of linear range & calibration failure.
VOLUME OF PRODUCT IN COMMERCE
3,136 units
DISTRIBUTION
Nationwide, Germany, New Zealand, Trinidad/Tobago, Cayman Island, Hong Kong, Chile, Curacao, Jamaica, Australia, and Bahamas
___________________________________
PRODUCT   
The Gyrus ACMI Pleatman Sac Tissue Removal System facilitates removal of specimens while minimizing contamination of the abdominal cavity or wound tract. The system contains one (1) Sac and one (1) obturator in a sterile, ready -to -use, single- use procedure tray. Recall # Z-2436-2010
CODE
Lot number: 186540FC
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gyrus Acmi, Inc., Southborough, MA, by telephone on August 3, 2010.
Manufacturer: Gyrus Medical, Inc., Osseo, MN. Firm initiated recall is ongoing.
REASON
A manufacturing error in the production of the trays used in this lot, it is possible that a crack could form that would compromise the package integrity, and possibly the sterility of the packaged device.
VOLUME OF PRODUCT IN COMMERCE
2 cases (20 devices)
DISTRIBUTION
UT, PA, Canada
___________________________________
PRODUCT   
1) Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 5 mm (3/16"), Length: 1.8 m (6 ft.); Sterile, for single use only, 50 tubes per case; Made in Mexico; catalog N56A and NEX56A (European label). Recall # Z-2450-2010;

2) Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 5 mm (3/16"), Length: 3.0 m (10 ft.); Sterile, for single use only, 50 tubes per case; Made in Mexico; catalog N510 and NEX510 (European label).  Recall # Z-2451-2010;

3) Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 5 mm (3/16"), Length: 3.6 m (12 ft.); Sterile, for single use only, 50 tubes per case; Made in Mexico; catalog N512 and NEX512 (European label). Recall # Z-2452-2010

4) Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 6 mm (1/4"), Length: 1.8 m (6 ft.); Sterile, for single use only, 50 tubes per case; Made in Mexico; catalog CN6 and NEX (European label). Recall # Z-2453-2010;

5) Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 6 mm (1/4"), Length: 3.0 m (10 ft.); Sterile, for single use only, 50 tubes per case; Made in Mexico; catalog N610 and NEX610 (European label). Recall # Z-2454-2010;

6) Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 6 mm (1/4"), Length: 3.6 m (12 ft.); Sterile, for single use only, 50 tubes per case; Made in Mexico; catalog N612 and NEX612 (European label). Recall # Z-2455-2010;

7) Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 7 mm (9/32"), Length: 1.8 m (6 ft.); Sterile, for single use only, 50 tubes per case; Made in Mexico; catalog N76A and NEX76A (European label). Recall # Z-2456-2010;

8) Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 7 mm (9/32"), Length: 3.0 m (10 ft.); Sterile, for single use only, 50 tubes per case; Made in Mexico; catalog N710 and NEX710 (European label). Recall # Z-2457-2010;

9) Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 7 mm (9/32"), Length: 3.6 m (12 ft.); Sterile, for single use only; Made in Mexico; catalog N712 and NEX712 (European label). Recall # Z-2458-2010

10) All Presource Kits that contain Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors; Sterile, for single use only; Presource Kits are custom packaged kits that contain various products as requested by specific hospital it’s made for. All work orders manufactured with the affected Medi-Vac Non-Conductive Tubing (all lots prior to Y10K) of the following Presource Kit Catalog numbers: AD4410346A, ADPVT0137A, AN1440132G, AN1BC8765K, AN1HD00401, AN1HD00402, AN1HD00403, AN1HD0040A, AN1HD0040D, AN1HD0040E, AN1HD0040F, AN1VB8550A, AN1W11505D, AN2BC87651, AN2BC8765G, ANE228891D, ANE336899B, ANE336899C, ANE337178H, ANE411105A, ANE445297A, ANE451348E, ANE451348F, ANECG3266B, ANEHD0040B, ANEHD0040D, ANEHD0040E, ANEHD0040F, ANEVF0839B, ANEVM0722I, ANEVM0722J, ANEVM0722K, ANEVP6706A, ANEVP6706B, BA1BC87651, BA1BC87652, BA1BC8765P, BA1BC8765Q, BA1BC8765T, BA1VT3436K, BA1VT3436M, BA1VT3436N, BA1VT3436P, BA1VT3436R, BABV85615A, BABV85615B, CA1732289D, CA1734322B, CAN10-I962, CAN213585A, CAN410130A, CAN410130B, CAN481521B, CAN482677A, CAN485373A, CAN733718D, CANOC3718A, ENTVP6706A, MA1MH5297A, MAT955327B, MAT955327C, MATCG0045A, MATV16666C, MATV16666D, OM4410346A, OMSCG3091A, OMSOC0110A, OR1CN0084A, OR1CN0084B, OR1CN0084C, ORCHF5342A, OREVM0726A, OREVM0726B, OREVM0726C, ORP593693A, ORPCN0084A, ORPCN0084B, ORPCN0084C, ORPCN0084D, ORPHF5342A, ORPHF5342B, ORPHF5342E, ORPHF5342G, ORPVM0726F, ORPVM0726G, ORPVM0726H, OUTHF5342A, OVC241104I, OVC241104J, OVC241104K, OVC241104L, OVC241104M, OVC336813A, OVCHF1259A, OVCHF1259B, OVCHF1259C, OVCHF1259D, OVCHF1259E, PAJVGAME1, PAJVGAMEO, PAJVGAMEP, PAJVPAMMJ, PAMHAAFBC, PAMHAAFBD, PAMHGAMCF, PAMHGAMCG, PB12ABWCJ, PB12ABWCK, PB12ABWCL, PB12DCWCG, PB12DCWCH, PB12PEWCJ, PB12PEWCK, PB23LASMD, PB23LASMF, PB23LASMG, PB23LASMH, PB23LASMI, PB23MGWOE, PB23TASAA, PB23TASAB, PB23TASAC, PB23TASAD, PB23TASAE, PB23VHGMA, PB24GLGMG, PB24HYGMH, PB24LIGML, PB24LISMC, PB24LISMD, PB24LISME, PB24LISMF, PB24LISMG, PB24LSSMD, PB24LSSME, PB24LSSMF, PB24MLSMC, PB24MLSMD, PB24MLSME, PB24MLSMG, PB2GLSPHC, PB2GOTPHB, PB30GYPRA, PB30GYPRB, PB30GYPRC, PB30MGPR1, PB30MGPRA, PB30MGPRB, PB33OTMWA, PB35DCSTA, PB35LSPH1, PB35LSPHA, PB35LSPHB, PB35OTPHA, PB41LSCNA, PB41MJCN1, PB41MJCNA, PB41THNRH, PB46CSSHC, PB46CSSHD, PB46CSSHF, PB46CSSHG, PB46CSSHH, PB46CSSHJ, PB54JVREE, PB54LSREC, PB60DCLHJ, PB60LSLH5, PB60LSLHV, PB60LSLHW, PB69ABEHB, PB69CSEHC, PB69CSEHD, PB69MAEHB, PB69VGEHD, PB73GLSJN, PB73GLSJO, PB73LSUHR, PB73LTUHS, PB73MJSBK, PB73MJSBL, PB73MJSBM, PB73MJSBN, PB73MJSBO, PB73MJSBP, PB73MJSBQ, PB7CDCYNA, PB7CDCYNB, PB7CDCYND, PB7CLVAS1, PB7CLVASA, PB7CLVASB, PBCGCSCD3, PBCGCSCD4, PBCGCSCDL, PBCGCSCDN, PBCGCSCDO, PBCGCSCDP, PBCGCSCDR, PBCGDCMJH, PBCGDCMJI, PBCGDCMJJ, PBCGGAMRB, PBCGGAMRC, PBCGGAMRD, PBCGGAMRE, PBCGHYMRB, PBCGHYMRC, PBCGHYMRD, PBCGLSMJL, PBCGLSMJM, PBCGLSMJN, PBCGLSMJO, PBCGLSMJP, PBCGLVMHC, PBCGLVMHF, PBCGLVMHG, PBCGLVMHH, PBCGLVMHI, PBCGMJMRB, PBCGMJMRC, PBCGMJMRD, PBCGMJMRE, PBCGMLMRB, PBCGMLMRC, PBCGMLMRD, PBCGMLMRE, PBHDHSCHB, PBHDHSCHC, PBHDJVSUI, PBHDMAWAF, PBHFCSLR5, PBHFCSLRG, PBHFCSLRH, PBHFCSLRI, PBHFCSLRJ, PBHFCSLRK, PBJVAD001, PBJVAD00J, PBMHAHESG, PBMHCSESF, PBMHCSESG, PBMHCSESH, PBMHCSESI, PBMHCSESJ, PBMHCSESK, PBMHCSESL, PBMHCSESN, PBMHCSWD1, PBMHCSWDF, PBMHCSWN3, PBMHCSWN4, PBMHCSWND, PBMHCSWNE, PBMHCSWNG, PBMHCSWNH, PBMHCSWNI, PBMHDCFBF, PBMHHSBHD, PBMHVDESB, PBMHVDESC, PBMHVDESE, PBMHVDESF, PBMHVDESG, PBMHVDFBE, PBMHVDMH1, PBMHVDMHD, PBMHVDMHE, PBMHVDMHF, PBMHVDMHG, PBOCCSVBH, PBOCCSVBI, PBOCCSVBJ, PBOCCSVBK, PBOCCSVBM, PBOCCSVBL, PBOCCSVBN, PBOCCSVBO, PBOCCSVBP, PBOCCSVBQ, PBOCLSSNM, PBOCLSSNN, PBOCLSSNO, PBOCOTANS1, PBOCOTANSH, PBOCOTHOQ, PBOCOTHOR, PBOCOTHOS, PBOCOTHOU, PBV1ABFSS, PBV1DCFSJ, PBV1VHFSH, PBV8DCVAT, PBV8DCVAU, PBV8LSVAT, PBV8LSVAU, PBV8LSVAV, PBVBSCNMD, PBVBSCNME, PBVBSCNMF, PBVBSCNMG, PBVBSCNMH, PBVBSCNMI, PBVBSCNMJ, PBVZOTMBH, PBW1LSOMS, PC12MCWCK, PC12MCWCL, PC12OHWCP, PC12OHWCQ, PC12OHWCR, PC12OHWCS, PC12OHWCT, PC12OHWCU, PC12OHWCV, PC12OVWCQ, PC12OVWCS, PC12OVWCT, PC12OVWCU, PC12OVWCV, PC12VAWCL, PC12VAWCM, PC13OH60B, PC13OHCA1, PC13OHCAC, PC13OHCAD, PC13OHCAE, PC13OHEM6, PC13OHEMS, PC13OHEMU, PC13OHEMX, PC13OHEMY, PC13OHEMZ, PC13OPEME, PC13OPEMF, PC13OPEMG, PC13OPEMJ, PC13OPEMK, PC21AOUHA, PC21CGUHA, PC22HEMCH, PC22HTHCC, PC22HTHCD, PC22HTHCE, PC22HTHCG, PC22HTHCH, PC22HTHCI, PC23CACVG, PC23HSSM1, PC23HSSMG, PC23HSSMH, PC23HSSMI, PC23HSSMJ, PC23HSSMK, PC23HSSML, PC23HSSMM, PC23HSSMN, PC23OHCV1, PC23OHCVB, PC23OHCVF, PC23OHCVG, PC23OHCVH, PC23OHCVI, PC23OHCVJ, PC23OHCVK, PC23OHCVL, PC23OHCVM, PC23OHCVN, PC23VSCV1, PC23VSCV2, PC23VSCVJ, PC24FPBP2, PC24FPBPK, PC24FPBPL, PC24FPBPN, PC24FPBPP, PC24FPBPQ, PC24FPBPR, PC24MVWRN, PC24OHBPT, PC24OHBPW, PC2GOHPH1, PC2GOHPHD, PC35OHPHA, PC35OHPHB, PC35OHPHC, PC36MVCRB, PC36MVCRC, PC36MVCRD, PC36MVCRE, PC36MVCRF, PC36OHCRB, PC36OHCRC, PC36OHCRD, PC13OPEMH, PC36OHCRE, PC36OHCRF, PC36OHCRG, PC36OHRH1, PC36OHRHA, PC36OHRHB, PC36OHRHC, PC41CBTQ1, PC41CBTQB, PC41CBTQC, PC41CBTQD, PC41CBTQE, PC41CG117, PC41CG118, PC41CG119, PC41CG16L, PC41CG16M, PC41CG16N, PC41CG16O, PC41CG16P, PC41CG16Q, PC41CG16R, PC41CSTCB, PC41CSTCC, PC41CSTCD, PC41CVHCS, PC41CVHCT, PC41CVHCU, PC41CVHCV, PC41CVHCW, PC41CVHCX, PC41CVHCY, PC41CVHCZ, PC41OHCN1, PC41OHCNA, PC41OHCNC, PC41OHCND, PC41OHCNF, PC43CGNOH, PC43CGNOI, PC43CGNOJ, PC43CGSPS, PC43OTLGH, PC43OTLGI, PC43OTLGJ, PC48OH04A, PC48OH04B, PC48OH04C, PC48OHNB5, PC48OHNB6, PC48OHNB7, PC48OHNBP, PC48OHNBQ, PC48OHNBR, PC48OHNBU, PC48OHNBV, PC48OHNBW, PC48OHNBZ, PC48PBNBG, PC48PBNBI, PC48PBNBJ, PC48PBNBK, PC48PBNBL, PC48PBNBM, PC48TYNBI, PC48TYNBJ, PC48TYNBK, PC48TYNBL, PC48TYNBM, PC48TYNBN, PC48TYNBO, PC48TYNBP, PC55OHSCO, PC55OHSCP, PC55OHSCQ, PC55OHSCR, PC55OHSCS, PC55OHSCT, PC55OHSCU, PC55OHSCV, PC55OHSCW, PC57CG80H, PC57CG80I, PC57CG80J, PC57CG80K, PC57CG80L, PC57OHLGA, PC57OHLGB, PC57OHLGC, PC57OHLGD, PC57VLSHJ, PC57VLSHK, PC57VLSHL, PC57VLSHM, PC57VLSHN, PC5FCGGSB, PC5FCGGSC, PC60OHANBE, PC60OHANBF, PC60OHANBG, PC60OHANBH, PC60OHANBI, PC63ODHAC, PC63ODHAD, PC69OHKSC, PC69OHKSD, PC69OHKSE, PC69OHKSF, PC69OHRMA, PC69OHRMB, PC69OHRMC, PC69OHRMD, PC73AOUHV, PC73MJ816, PC73MJ817, PC73MJ818, PC73MJ81F, PC73OH81L, PC73OHCM1, PC73OHCM2, PC73OHCM3, PC73OHCM4, PC73OHCMB, PC73OHCMC, PC73OHCMD, PC73OHCME, PC73OHCMF, PC73OHLUQ, PC73OHLUR, PC73OHLUS, PC73OHLUT, PC73OHLUU, PC73OHLUW, PCCGAAMJL, PCCGAAMJM, PCCGAAMJN, PCCGAAMJP, PCCGAAMJQ, PCCGAAMJR, PCCGLVMJ1, PCCGLVMJG, PCCGLVMJI, PCCGLVMJK, PCCGOHABK, PCCGOHABS, PCCGOHMJ5, PCCGOHMJ6, PCCGOHMJ7, PCCGOHMJ8, PCCGOHMJ9, PCCGOHMJJ, PCCGOHMJL, PCCGOHMJN, PCCGOHMJO, PCCGOHMJP, PCCGOHMJQ, PCCGOHMJR, PCCGOHMJT, PCCGOHMJU, PCCGOHMJV, PCCGOTMJM, PCCGOTMJN, PCCGOTMJO, PCCGOTMJP, PCCGOTMJQ, PCCGOTMJS, PCCNOHLTF, PCCNOHLTG, PCCZABFLH, PCHBH2BRH, PCHBMJVAG, PCHDOHACHB, PCHDOHACHC, PCHDOHACHD, PCHDOHACHE, PCHDOHACHF, PCHFBCBFA, PCMHPMBHA, PCMHPMBHB, PCOCMJSNS, PCOCOTSNN, PCOCOTSNP, PCOCPMSNN, PCRMOTAMUG, PCRMOTAMUH, PCRMOTMUI, PCRMOTMUJ, PCRMOTMUK, PCV1MVUMF, PCV2CCCPS, PCVAHCSJA, PCVAHCSJB, PCVMAOBJ2, PCVMAOBJQ, PCVMAOBJR, PCVMAOBJS, PCVMAOBJU, PCVMAOBJV, PCVMAOBJW, PCVMAOBJX, PCVMOTACRM, PCVMOTACRN, PCVNCG50N, PCVNCGASJU, PCVNOH09A, PCVNOH09D, PCVTAASWT, PCVTCGNM2, PCVTCGNMR, PCVTCGNMS, PCVTCGNMT, PDHDKTWCG, PDHDKTWCH, PDHDKTWCI, PDHFLVLUH, PE12BTAKDM, PE12CLLOM, PE12EA33D, PE12EAKDN, PE12EAKDO, PE12EAWCP, PE12EAWCQ, PE12HN33B, PE12HNWCI, PE12HNWCJ, PE12MIWCI, PE12MIWCJ, PE12MJWCJ, PE12MJWCK, PE12NSWCH, PE12NSWCI, PE12TPWCK, PE12TPWCL,

PE12TPWCM, PE21HNUHA, PE21TAHAK, PE23ETWMB, PE23NAXFD, PE23THSM1, PE23THSMB, PE23THSMC, PE23THSMD, PE24MJSMC, PE24MJSMD, PE24MJSME, PE24MJSMF, PE24TAAACB, PE24TABMJ, PE24TABMK, PE24TASMB, PE36DNCRB, PE36DNCRC, PE36TACRA, PE36TACRB, PE36TACRC, PE36TMCH2, PE36TMCHM, PE36TMCHN, PE36TMCHO, PE43NSNOL, PE46TASPD, PE46TASPE, PE46TAUHJ, PE4ETMCHP, PE54HNYRK, PE54HNYRL, PE54HNYRM, PE54HNYRN, PE63EMGHA, PE69EAKSA, PE69EAKSB, PE69EAKSC, PE73NSUH6, PE73NSUHU, PE82EATC2, PE82EATCR, PECGDRMRB, PECGDRMRC, PECGDRMRD, PECGDRMRE, PECGHNMRB, PECGHNMRC, PECGHNMRD, PECGHNMRE, PECGNSMRB, PECGNSMRC, PECGNSMRD, PECGNSMRE, PECGTAMRB, PECGTAMRC, PECGTAMRD, PEHBHNVAH, PEHDETCHA, PEHDETCHB, PEHDNSSUJ, PEOCNSSHG, PEOCNSSNN, PEOCNSSNP, PERMHNMUQ, PEV1HNFSJ, PEV1NSHHF, PEV1TAFSJ, PEV1TAFSK, PEV8HNVAA, PEV8HNVAB, PEV8HNVAT, PEV8HNVAU, PEV8TAVAQ, PEVMNABWB, PEVNSDBGA, PEVZTAMBE, PEW1HNMC1, PEW1HNMCF, PEW1HNMCG, PEW1HNMCH, PG11GUTMC, PG12BRWCJ, PG12BRWCK, PG12CBWCJ, PG12CBWCK, PG12COLOC, PG12EGLOD, PG12LGWCA, PG12LGWCB, PG12LGWCC, PG12LSWCK, PG12LSWCL, PG12LSWCM, PG12MAWCK, PG12MAWCL, PG12MDWCI, PG12MNWCK, PG12MNWCL, PG12OBSHD, PG12OMWCJ, PG12OMWCK, PG12RCWCJ, PG12RCWCK, PG15GSFCF, PG15GSFCG, PG15GSFCH, PG15GSFCI, PG15GSFCK, PG15GSFCL, PG15GSFCM, PG15GSFCN, PG21BBUHA, PG21LBUHA, PG21LGUHA, PG21MJUHA, PG21OTAUHA, PG21RCHAI, PG23LBSM1, PG23LBSM2, PG23LBSMD, PG23LBSME, PG23LBSMF, PG23LBSMG, PG23LBSMH, PG23LGSM1, PG23LGSM2, PG23LGSM3, PG23LGSM4, PG23LGSME, PG23LGSMF, PG23LGSMH, PG23LGSMI, PG23LGSMJ, PG23LPSME, PG23LPSMG, PG23LPSMH, PG23LPSMI, PG23LPSMJ, PG23MAGMB, PG23MAGMD, PG23MASAF, PG23MASAH, PG23MBGMB, PG23MBTUL, PG23MNMPM, PG23MNSMF, PG23MNSMG, PG23MNSMH, PG23MNSMI, PG23MNSMJ, PG23MNSMK, PG23MNSML, PG23MNSMM, PG23MNSMN, PG24LCBPQ, PG24LGSMD, PG24LGSME, PG24MAWRR, PG24MNJMP, PG24MNJMT, PG24MPSMD, PG24MPSME, PG24MPSMF, PG2GLBPHC, PG2GLPPHC, PG30MAPR1, PG30MAPR2, PG30MAPR3, PG30MAPR4, PG30MAPRA, PG30MAPRB, PG30MAPRC, PG30MJPR1, PG30MJPR2, PG30MJPR3, PG30MJPRA, PG30MJPRB, PG33LCRVI, PG35LBPHA, PG35LBPHB, PG35LPPHA, PG35LPPHB, PG40MFDOF, PG41ABHCN, PG41BACN1, PG41BACNA, PG41ENHMH, PG41ENHMI, PG41ENHMJ, PG41LCHC6, PG41LCHC7, PG41LCHC8, PG41LCHCR, PG41LCHCS, PG41LCHCT, PG41LCHCU, PG41LCHCV, PG41MANRF, PG41MNHCB, PG41OTIRA, PG45HNPHK, PG46LBSRH, PG46MASPG, PG46MASPH, PG46MASPI, PG46MBSPG, PG46MBSPH, PG46MBSPI, PG46MNSPF, PG46MNSPG, PG46MNSPH, PG46OTSPF, PG46OTSPG, PG46OTUHO, PG47ENSFJ, PG47ENSFK, PG47ENSFL, PG47ENSFM, PG48AMMIH, PG48BRLSD, PG48BRLSF, PG48LPLSC, PG4FGSCFB, PG54BKWB2, PG54HNDSD, PG54HNDSE, PG54LCREH, PG54MAREE, PG54MNDSE, PG54MNRED, PG55LCACMK, PG55LCACML, PG55LCACMM, PG55LCACMN, PG55LCACMO,PG60MJSMK, PG63BRRV1, PG63BRRVA, PG63BRRVC, G63BRRVD, PG63BRRVE, PG63GBRVG, PG63LPGHA, PG63MJDHH, PG69LYVCP, PG73BJLUI, PG73BJLUL, PG73BJLUN, PG73BJLUO, PG73BNLU1, PG73BNLUI, PG73BNLUK, PG73BNLUL, PG73BNLUM, PG73BNLUN, PG73BNLUO, PG73BNLUP, PG73LPUHU, PG73MAAUHQ, PG73MASB1, PG73MASBJ, PG73MASBK, PG73MASBL, PG73MASBN, PG73MASBO, PG73MASBP, PG73MASJT, PG73MNUHR, PG73MPLUE, PG73MPLUF, PG73MPLUG, PG73MPLUH, PG73MPLUI, PG73OTALU1, PG73OTALUI, PG73OTALUJ, PG73OTALUK, PG73OTALUL, PG73OTAUHR, PG73PCLUH, PG73PCLUJ, PG73PCLUL, PG73PCLUN, PG73TGUHT, PG92KDHRA, PG92KDHRB, PG92KDHRC, PGCGBDABD, PGCGBRMRB, PGCGBRMRC, PGCGBRMRD, PGCGGAMR1, PGCGGAMR2, PGCGGAMR3, PGCGGAMR4, PGCGGAMR5, PGCGGAMR6, PGCGGAMRB, PGCGGAMRC, PGCGGAMRD, PGCGGAMRE, PGCGGLMR1, PGCGGLMRB, PGCGGLMRC, PGCGGLMRD, PGCGLBAUC, PGCGLBMJJ, PGCGLBMJK, PGCGLBMJL, PGCGLBMJM, PGCGLBMJN, PGCGLBMJO, PGCGLBMJP, PGCGLBMJQ, PGCGLCMRB, PGCGLCMRC, PGCGMAABL, PGCGMAMJI, PGCGMAMJJ, PGCGMAMJK, PGCGMAMJL, PGCGMAMJM, PGCGMAMJN, PGCGMIMRB, PGCGMIMRC, PGCGMIMRD, PGCGMJMRB, PGCGMJMRC, PGCGMJMRD, PGCGMNMJJ, PGCGMNMJL, PGCGMNMJM, PGCGMNMJN, PGCGMNMJO, PGCGMNMJP, PGCGMNMJQ, PGCGMNMJR, PGCGOTMJJ, PGCGOTMJK, PGCGOTMJL, PGCGOTMJM, PGCGOTMJN, PGCGOTMJO, PGCGOTMJP, PGCGOTUIB, PGCGOTUIC, PGCGOTUID, PGCGOTUIF, PGCGOTUIG, PGCGOTUIH, PGCGRLMJA, PGCGRLMJC, PGCNENPAB, PGCNOTPAB, PGHBMAVAM, PGHBMNVAI, PGHDMASUI, PGHDMASUJ, PGHDMAWAH, PGHDMJCHA, PGHDMJCHB, PGHDMJCHC, PGHDMJCHD, PGHDMNCHA, PGHDMNCHB, PGHDMNCHC, PGMHMAESI, PGMHSUWNF, PGOCLSSNP, PGOCLSSNR, PGOCMASNQ, PGOCMJJOB, PGSVGSHMA, PGSVGSHMB, PGSVGSHMC, PGSVGSHMD, PGSVGSHME, PGSVGSHMF, PGV1MPFSL, PGV8BCVC1, PGV8BCVC2, PGV8BCVCC, PGV8BCVCE, PGV8BCVCG, PGV8EN17A, PGV8EN17B, PGV8EN17C, PGV8EN17D, PGV8MAVCT, PGV8MAVCU, PGV8MAVCW, PGV8OTZNM, PGV8OTZNN, PGVFNLAGG, PGVFNLAGH, PGVHENHHH, PGVMTOBLK, PGVNBPBGA, PGVNGL09M, PGVNMN09I, PGVTMNSWU, PGVZAHMBB, PGVZMNMBF, PGVZOTMBG, PH12TCGUX, PH21BRUHA, PH21BRUHB, PH21BRUHC, PH21TCUHA, PH22TCMH1, PH22TCMH2, PH22TCMHD, PH22TCMHE, PH22TCMHF, PH22TCMHG, PH22TCMHI, PH22TCMHJ, PH22TCMHL, PH2GTCPHC, PH35TCPHA, PH35TCPHB, PH41TCCN1, PH41TCCNA, PH41TCCNB, PH41TCCNC, PH41TCCND, PH41TCCNE, PH41TCCNF, PH41TCCNG, PH44TCSEJ, PH6ETHRVA, PH6ETHRVB, PH76TCMDP, PH76TSMDP, PH76TSMDQ, PH76TSMDR, PH95BRSEC, PHCGTHAUB, PHCGTHAUC, PHCGTTMRB, PHCGTTMRC, PHCGTTMRD, PHCGTTMRE, PHHDTCCHE, PHHDTCCHF, PHJVBRMMA, PHJVBRMMB, PHJVBRMMC, PHMHTCMHG, PHOCTCMMD, PHOCTCMME, PHOCTCMMF, PHOCTCNSP, PHOCTSMMF, PHOCTSMMH, PHOCTSMMI, PHOCTSMML, PJ12BDWCG, PJ12BDWCH, PJ12BDWCI, PL08CSDWD, PL08CSDWE, PL08CSDWF, PL08CSDWG, PL08CSDWH, PL23CPSAE, PL23CSMPM, PL23CSWMH, PL23CSWOD, PL24CSBMW, PL24CSBMX, PL24CSBMY, PL24CSBMZ, PL29CSAHC4, PL29CSAHC5, PL29CSAHCM, PL29CSAHCN, PL29CSAHCO, PL29CSLW1, PL29CSLWF, PL29CSLWG, PL29CSLWH, PL29CSLWI, PL29CSLWJ, PL29CSLWK, PL29CSLWL, PL29VDAHC3, PL29VDAHCQ,PL29VDAHCR, PL33CSLMA, PL33CSLMB, PL33VALM1, PL33VALMA, PL33VALMC, PL33VALMD, PL41CSCCM, PL41CSCCN, PL41CSTQB, PL41CSTQC, PL41CSTQD, PL41CSTQE, PL41CSTQG, PL41VDTQB, PL42CSOMY, PL44CSSEK, PL44SESJ6, PL44SESJE, PL45CS581, PL45CS58A, PL45CS58B, PL45CS58C, PL45CSDHW, PL45CSDHX, PL45CSDHY, PL45CSDHZ, PL46SHVD1, PL46SHVD2, PL46SHVDD, PL46SHVDG, PL46SHVDH, PL46SHVDI, PL54CSSVM, PL54CSSVO, PL54CSSVP, PL54CSSVQ, PL54VDASV1, PL54VDASV2, PL54VDASVF, PL54VDASVG, PL54VDASVI, PL54VDASVJ, PL54VDASVK, PL60LR07G, PL60LR07H, PL60LR07I, PL60LR07J, PL73BPNVA, PL73BPNVB, PL82CS173, PL82CS174, PL82CS175, PL82CS176, PL82CS17R, PLCGCSMJO, PLHDCSAGI, PLHDCSCHA, PLHDCSCHB, PLHDCSCHC, PLHDCSCHE, PLHDCSCHF, PLHDCSHC1, PLHDCSHC2, PLHDCSHC3, PLHDCSHCK, PLHDCSHCL, PLHDCSHCM, PLHDCSHCO, PLHDCSWAG, PLHDCSWAH, PLHDCSWAI, PLHDCSWAJ, PLHDVDHC1, PLHDVDHC2, PLHDVDHC3, PLHDVDHCL, PLHDVDHCM, PLHDVDHCN, PLHDVDHCO, PLHDVDHCQ, PLMHCSMHD, PLMHCSMHE, PLMHCSMHG, PLMHCSMHH, PLMHCSMHI, PLMHCSMHJ, PLMHCSMHK, PLMHCSMHL, PLOCLRNS3, PLOCLRNSF, PLOCLRNSG, PLOCLRNSH, PLOCLRNSI, PLOCOTNSG, PLRLLTMMV, PLV8VDVCV, PLV8VDVCW, PLV8VDVCX, PLVHCSSMA, PLVMCSBJJ, PLVMCSBJK, PLVMCSBJL, PLVMCSBJM, PLVTCSMMV, PLW1CSBL1, PLW1CSBL2, PLW1CSBL3, PLW1CSBL4, PLW1CSBLM, PLW1CSBLN, PLW1CSBLO, PLW1CSBLP, PLW1CSBLQ, PLW1CSBLR, PLW1CSBLS, PLW1CSBLT, PLW1CSBLU, PLW1CSBLV, PLW1CSBLW, PLW1CSBLX, PLW1CSBLY, PMRMMM05I, PN12ACGUM, PN12ACWCJ, PN12ACWCK, PN12CYWCO, PN12CYWCP, PN12CYWCQ, PN12OTGUZ, PN12SHGUO, PN12SPDPG, PN12VPWCN, PN12VPWCO, PN12VPWCP, PN21CRUH1, PN21CRUH2, PN21CRUH3, PN21CRUHB, PN21CRUHC, PN23CRGMB, PN23CRSMF, PN23CRSMG, PN23CRSMH, PN23CRSMI, PN23CRSMJ, PN23LMGMA, PN23LMSMH, PN23LMSMI, PN23LMSMJ, PN23LMSMK, PN23LMSML, PN23LMSMM, PN23LMSMN, PN23PSXFE, PN23SPMCM, PN23SPROE, PN24CRACA, PN24CRACB, PN24CRACC, PN24CRACD, PN24CYBP1, PN24CYBP2, PN24CYBPO, PN24CYBPP, PN24CYBPS, PN24CYBPT, PN24LMJML, PN24LMWR6, PN24LMWR7, PN24LMWR8, PN24LMWR9, PN24LMWRO, PN24LMWRP, PN24LMWRQ, PN24NSASC, PN24SPBPQ, PN24SPBPR, PN24SPBPS, PN24SPBPT, PN24SPBPV, PN24SPBPW, PN29CYHCN, PN29CYHCO, PN29CYHCP, PN29CYHCQ, PN41CRCNA,PN41ND79A, PN41NDHC6, PN41NDHCU, PN41NDHCV, PN41NDHCW, PN41NDHCX, PN41NDHCY, PN41NDHCZ, PN41NJCNA, PN41OT791, PN41OT792, PN41OT79A, PN41OTHCW, PN41OTHCX, PN41OTHCY, PN41OTHCZ, PN41SPCNA, PN47CY79A, PN47CYHMW, PN47CYHMX, PN47CYHMY, PN47CYHMZ, PN54CRRED, PN60SPLHI, PN60SPLHJ, PN60SPLHK, PN60SPLHL, PN69CRKSA, PN69CRKSB, PN69NJKSA, PN73CR111, PN73CR112, PN73CR113, PN73CR11A, PN73CR11B, PN73CR11C, PN73CRLU2, PN73CRLUT, PN73CRLUW, PN73CRLUX, PN73CRLUY, PN73CRLUZ, PN73CRUHY, PN73CRUHZ, PN73CYSBW, PN73LMSB1, PN73LMSB3, PN73LMSB4, PN73LMSBP, PN73LMSBQ, PN73LMSBR, PN73LMSBS, PN73LMSBT, PN73LMSBU, PN73LMSBV, PN73NDSJU, PN73NDSJV, PN73NNUHS, PN73NNUHT, PN73OTSB2, PN73OTSBM, PN73OTSBN, PN73OTSBO, PN73OTSBP, PN73SPLU2, PN73SPLU3, PN73SPLUL, PN73SPLUN, PN73SPLUO, PN73SPLUP, PN73SPLUQ, PN73VPLUL, PN73VPLUO, PN73VPLUP, PN73VPLUQ, PN73VPLUR, PN73VPLUS, PNCGCNAUB, PNCGCNAUC, PNCGCRABT, PNCGCRMJ7, PNCGCRMJM, PNCGCRMJN, PNCGCRMJQ, PNCGCRMJR, PNCGCRMRB, PNCGCRMRC, PNCGCRMRD, PNCGNJMJ2, PNCGNJMJ3, PNCGNJMJ4, PNCGNJMJL, PNCGNJMJM, PNCGNJMJN, PNCGNJMJO, PNCGNJMJP, PNCGNLMRB, PNCGNLMRC, PNCGNLMRD, PNCGNSMRB, PNCGSPMR1, PNCGSPMRB, PNCGSPMRC, PNCGSPMRD, PNCGSPMRE, PNHDNDAGC, PNHDNDAGG, PNHDNNCHC, PNOCCYORS, PNOCCYORT, PNOCCYORU, PNOCCYORV, PNOCCYSNS, PNOCNUJOG, PNOCSPSCA, PNOCSPSCB, PNOCSPSNU, PNV1CSFSG, PNV1CSFSH, PNV1CSFSI, PNV1CSFSJ, PNV1CSFSK, PNV1CSFSL, PNV1CSFSM, PNV1CSFSN, PNV1LSFSG, PNV1LSFSH, PNV1LSFSJ, PNV1MNFSI, PNV1MNFSJ, PNV1MNFSK, PNV1MNFSL, PNV1MNFSN, PNV1MNFSO, PNV1SPGSF, PNV8LMVCT, PNV8LMVCU, PNV8LMVCV, PNV8LMVCX, PNVMSPBWR, PNVNAS09N, PNVNVP09L, PNVPNDSJO, PNVTLLSWV, PNVTOTNMP, PO12AKSUF, PO12AR33A, PO12AR33B, PO12AR33C, PO12ARGUY, PO12ARGUZ, PO12EXWCN, PO12EXWCO, PO12EXWCP, PO12FTWCP, PO12FTWCQ, PO12FTWCR, PO12HFWCL, PO12HFWCM, PO12KNWCJ, PO12KNWCK, PO12LELOO, PO12MEWCL, PO12MEWCM, PO12MEWCN, PO12SHSUF, PO12SHWCM, PO12SHWCN, PO12SHWCO, PO12SPWCM, PO12SPWCN, PO12SPWCO, PO12SPWCP, PO12THWCP, PO12THWCR, PO12THWCS, PO12TK33F, PO12TKWC1, PO12TKWCQ, PO12TKWCR, PO12TKWCS, PO12TKWCT, PO12TRWCK, PO12TRWCL, PO12TRWCM, PO18TKNDD, PO1DAKUNA, PO1DAKUNB, PO1DKRUNA, PO1DKRUNB, PO1DKRUNC, PO1DKRUND, PO21AKUHA, PO21APUH1, PO21APUH2, PO21APUH3, PO21APUHA, PO21APUHB, PO21EXUHA, PO21LEHAN, PO21LMUHA, PO21TJUHA, PO23ARSMA, PO23ARSMC, PO23ARSMD, PO23ARSME, PO23ARSMF, PO23ARWML, PO23ARWMM, PO23BOGMD, PO23FAGMB, PO23GHGMA, PO23GOWOD, PO23HPMPI, PO23KDSFH, PO23LEAMT, PO23SHAHCE, PO23SHAML, PO23SSSM1, PO23SSSMI, PO23THAFE, PO23THAWMJ, PO23TKAEG, PO23UDSFG, PO23UEMPI, PO24AASM3, PO24AASM4, PO24AASM5, PO24AASM6, PO24AASMD, PO24AASME, PO24AASMF, PO24AASMG, PO24AASMH, PO24AASMI, PO24ARBMO, PO24HPSMF, PO24LESMB, PO24LESMC, PO24LESMD, PO24LESME, PO24LESMF, PO24LESMG, PO24OTJMK, PO24SHASD, PO24SHBMF, PO24SHBMG, PO24SHBMH, PO24SHBMI, PO24SHSMC, PO24SHSMD, PO24SHSMF, PO24SHSMG, PO24SHSMH, PO24SHSMI, PO24TH041, PO24TH042, PO24TH043, PO24TH044, PO24TH04A, PO24TH04B, PO24TH04C, PO24THBPW, PO24THBPX, PO24THBPZ, PO24THGMD, PO24THGMF, PO24THSM2, PO24THSM3, PO24THSM4, PO24THSME, PO24THSMF, PO24THSMG, PO24THSMH, PO24THSMI, PO24THWRK, PO24TKB04A, PO24TKB04B, PO24TKBP3, PO24TKBP4, PO24TKBPU, PO24TKBPV, PO24TKBPW, PO24TKBPX, PO24TKBPY, PO24TKBPZ, PO24TKGMD, PO24TKGMF, PO24TKSM1, PO24TKSM2, PO24TKSM3, PO24TKSME, PO24TKSMF, PO24TKSMG, PO24TKSMH, PO24TKSMI, PO24TKWRN, PO24UEBMP, PO24UEBMT, PO29EXFGG, PO29EXFGH, PO29EXFGI, PO29EXFGJ, PO29EXFGL, PO29KASUB, PO29KASUC, PO29KASUD, PO29KASUE, PO29KASUF, PO29KASUG, PO29KASUH, PO29SHSUAB, PO29SHSUC, PO29SHSUD, PO29SHSUE, PO29SHSUF, PO29SHSUG, PO29SSMHK, PO29SSMHL, PO2GHPPHC, PO2GTHPH1, PO2GTHPH2, PO2GTHPH3, PO2GTHPH4, PO2GTHPH5, PO2GTHPH6, PO2GTHPH7, PO2GTHPH8, PO2GTHPHD, PO2GTHPHE, PO2GTHPHF, PO2GTKPH1, PO2GTKPH2, PO2GTKPH3, PO2GTKPH4, PO2GTKPH5, PO2GTKPHD, PO2GTKPHE, PO30AYPR1, PO30AYPRA, PO30AYPRB, PO30AYPRC, PO30AYPRE, PO30AYPRF, PO30KAPRA, PO30KAPRB, PO30KAPRC, PO30KEPRA, PO30KEPRB, PO30KEPRC, PO30THHRA, PO30THHRB, PO30THHRC, PO30THHRD, PO35HPPHA, PO35HPPHB, PO35THPH1, PO35THPHA, PO35THPHB, PO35THPHC, PO35TKPH1, PO35TKPHA, PO35TKPHB, PO35TKPHC, PO36LXSMD, PO36TKSMD, PO36TKSME, PO41ANVAD, PO41ARHCT, PO41HPHBH, PO41HPHBK, PO41LEVAC, PO41OTHBJ, PO41SHHBI, PO41THCNA, PO41TK10A, PO41TKCNA, PO41TKHBO, PO41TKMTZ, PO45ARPHI, PO46ARSPF, PO46ARSPG, PO46ARSPH, PO46ARSPI, PO46ARSPJ, PO46HFSPE, PO46HFSPF, PO46HFSPG, PO46HFSPH, PO46LESPH, PO46LESPI, PO46SHSPD, PO46SHSPE, PO46SHSPF, PO46SHSPG, PO46SHSPH, PO46TKSRJ, PO48ARLSC, PO48LELSC, PO48OSLSC, PO48OSLSD, PO48SALSC, PO48SALSD, PO48SPLSD, PO48SPLSE, PO48THLSC, PO48TJWMA, PO48TJWMB, PO48TKLSC, PO4ATKHCA, PO54BKRED, PO54KAWBE, PO54LXRED, PO54OTREE, PO54SAWBC, PO54SAWBD, PO54SAWBE, PO54TKRE2, PO54UERED, PO55ARTAB, PO60LXSMH, PO60UESMH, PO63LMGHA, PO69THEHE, PO69TKEHE, PO73AKUHQ, PO73AKUHR, PO73ARSJN, PO73ARSJO, PO73HNUHS, PO73HPSBU, PO73LSSB1, PO73LSSBR, PO73LSSBS, PO73LSSBT, PO73LSSBV, PO73LSSBW, PO73LSSBX, PO73LSSBY, PO73LSSBZ, PO73LXUHT, PO73LXUHU, PO73MJSBT, PO73OTSBM, PO73OTSBN, PO73OTSBO, PO73OTSBP, PO73OTSBQ, PO73OTSBR, PO73OTSJP, PO73OTSJQ, PO73OTSJR, PO73THSJK, PO73THSJL, PO73TJUHT, PO73TJUHU, PO92OPDRC, PO94TJSET, POCGACABI, POCGAKABH, POCGFTMRB, POCGFTMRC, POCGFTMRD, POCGHPABH, POCGHPABL, POCGKAMRB, POCGKAMRC, POCGKAMRD, POCGLXABK, POCGLXMRB, POCGLXMRC, POCGLXMRD, POCGSHMRB, POCGSSMJH, POCGSSMJI, POCGSSMJJ, POCGSSMJK, POCGSSMJL, POCGSSMJM, POCGSSMJN, POCGTHABP, POCGTHMR1, POCGTHMRB, POCGTHMRC, POCGTHMRD, POCGTHMRE, POCGTKABQ, POCGTKMRB, POCGTKMRC, POCGTKMRD, POCGTKMRE, POCGTKUCL, POHBAAVAD, POHBTHVAF, POHDAKCHA, POHDAKCHB, POHDAKCHC, POHDEXCHA, POHDEXCHC, POHDEXCHD, POHDEXCHE, POHDSHCHA, POHDSHCHB, POHDSHCHC, POHDSHCHD, POHDTHSUJ, POHDTKCHA, POHDTKCHB, POHDTKCHD, POHDTKCHE, POHDTKCHF, POHDTKSUI, POHDTKSUK, POHFASLUF, POHFEXLUE, POHFTHBFB, POMHINBHG, POMHKAESI, POMHTHMHH, POMHTKBHF, POMHTKWDE, POOCARSNL, POOCARSNM, POOCARSNN, POOCARSNO, POOCEXSNM, POOCFSVBH, POOCFTSCI, POOCFTSCJ, POOCSHSNO, POOCSHSNP, POOCSHSNQ, POOCSHSNR, POOCSLPUD, POOCSLPUE, POOCSLPUF, POOCSLPUG, POOCSLPUJ, POOCSLPUK, POOCSLPUL, POOCSLPUM, POOCTHSNR, PORMFTOHD, POV1AKFSM, POV1ASGSG, POV2HNWCH, POV2HNWCI, POV2HNWCJ, POV2HNWCK, POV2MJWCH, POV2SHWC1, POV2SHWCB, POV2SHWCC, POV2SHWCE, POV2SHWCF, POV8AHVCA, POV8AHVCC, POV8ARVAT, POV8ARVAU, POV8HPVCN, POV8LEVCR, POV8LEVCS, POV8LEVCT, POV8SH17A, POV8SH17B, POV8SH17C, POV8SUVAA, POV8SUVAB, POV8THVCX, POV8THVCY, POV8TK17A, POV8TKVCY, POV8TKVCZ, POV8UEVAU, POV8UEVAV, POVAOHSJA, POVAOHSJB, POVAOHSJC, POVAOHSJD, POVAOHSJE, POVMARBJL, POVMEXBJC, POVMHNBJK, POVMHNBJL, POVMHNBJM, POVMHNBJN, POVMSH22A, POVMTK22H, POVNAABGN, POVNEXBGK, POVNTH92A, POVTEXSWH, POVTOTNMR, POVTTKSAP, POW1ARCCJ, POW1ARCCK, POW1ARCCL, POW1ARCCM, POW1ARCCN, POW1ARCCO, POW1ARMC1, POW1ARMCM, POW1ARMCN, POW1ARMCO, POW1ARMCP, POW1ARMCQ, POW1ARMCR, POW1ARMCS, POW1AROCF, POW1AROCG, POW1AROCH, POW1AROCI, POW1AROCJ, POW1FTOM2, POW1FTOMT, POW1FTOMU, POW1FTOMW, POW1FTOMX, POW1SHAMGI, POW1SHOMR, POW1SHOMS, POW1SHOMT, POW1SHOMU, POW1SHOMV, POW1SHOMW, POW1SHSPD, POW1SHWSH, POW1SSOLE, POW1SSOLF, POW1SSOLG, POW1SSOLH, POW1THOMP, POW1THOMQ, POW1THOMS, POW1THOMT, POW1THOMU, POW1THOMV, POW1TKOMR, POW1TKOMS, POW1TKOMT, POW1TKOMU, PP82OTWMT, PPVTOHSW2, PPVTOHSWT, PPVTOHSWU, PPVTOHSWX, PPVTOHSWY, PQ18OPSJA, PQ18OPSJB, PQ18OPSJC, PQ73EYLU1, PQ73EYLU2, PQ73EYLUH, PQ73EYLUI, PQ73EYLUJ, PQ73EYLUK, PQ73EYLUL, PQ73OTLUI, PQ73OTLUJ, PQ73OTLUK, PQ73OTLUL, PQHBBEVAF, PQMHEEESI, PQMHEEESJ, PSDKOTAOB, PSDKOTAOC, PU12OTKDC, PU12OTKDF, PU24CCBLR, PU41PYCNA, PU73CYSJM, PU73OTSB4, PU73OTSBP, PU92BCHRD, PU92BCHRE, PU92RDHRD, PU92RDHRE, PU92RDHRF, PU92RDHRG, PU92RDHRH, PUCGCYMRB, PUCGCYMRC, PUCGRPAUC, PUCGRPAUD, PUCGRPAUE, PUW1RPMMQ, PUW1RPMMR, PUW1RPMMS, PUW1RPMMT, PUW1RPMMU, PUW1RPMMW, PUW1RPMMX, PUW1RPMMY, PV08CDGHH, PV08CDGHI, PV08CDGHJ, PV08CDGHK, PV08CDGHL, PV08CDGHM, PV08VLGHI, PV08VLGHJ, PV08VLGHK, PV08VLGHL, PV08VLGHM, PV08VLGHN, PV12CAGUV, PV12CVUMT, PV12OTGUX, PV13AVXEK, PV21CAUHA, PV21CAUHB, PV21MJUHA, PV21PVUHA, PV21PVUHB, PV23AVSMH, PV23AVSMI, PV23CASMM, PV24AABP1, PV24AABPN, PV24AABPP, PV24AABPQ, PV24AABPR, PV24AABPS, PV24AABPT, PV24CABP1, PV24CABP2, PV24CABPH, PV24CABPI, PV24CABPJ, PV24CABPM, PV24CABPN, PV24CABPO, PV26PVSAB, PV2GAAPHC, PV35AAPHA, PV35AAPHB, PV41LVCNA, PV4FOYCFC, PV60MNSMI, PV73AVLUG, PV73AVLUI, PV73AVLUJ, PV73AVLUK, PV73AVLUL, PV73AVSB1, PV73AVSBK, PV73AVSBL, PV73AVSBN, PV73AVSBP, PV73AVSBQ, PV73AVSBR, PV73AVUHS, PV73OTBSN, PV73OTBSO, PV73OTBSQ, PV73OTBSS, PV73OTBST, PV73OTBSU, PV73OTBSV, PV73VUSJP, PVCGAVMRB, PVCGCVMRB, PVCGCVMRD, PVCGMJABJ, PVCGVAMRB, PVCGVAMRC, PVCGVAMRD, PVCGVAMRE, PVCGVLMRB, PVCGVLMRC, PVCGVLMRD, PVCGVLMRE, PVHDPVSUH, PVMHAVMHK, PVMHPKESA, PVSVAVTME, PVV1CEFSI, PVVAVS60E, PVVNVABGK, PVVNVLBSJR, PW12BSGUW, PW12BSGUX, PW23BJXFG, PW23HETUA, PW23OSWOF, PW30PSPRA, PW30PSPRB, PW67BSMDN, PW73PLUHV, PWCGPLMJF, PWCGPLMJG, PWCGPLMJH, PWCGPLMJJ, PWCGPLMJK, PWCGPLMJL, PWCGPLMJM, PWHDPLSUH, PWOCOTMHJ, PWVNHN09K, PWVTFLSWE, PZ12ADUMA, PZ12ADUME, PZ12ADUMF, PZ12ADUMG, PZ23ANAMUG, PZ23ANBUB, PZ23ANBUC, PZ33ADHRI, PZ33ADHRJ, PZ33ADHRK, PZ35ANPHA, PZ36ANAVC, PZ36ANAVD, PZ36ANAVE, PZ36ANAVF, PZ41ESTNA, PZ41FCHCJ, PZ41FCHCK, PZ41FCHCL, PZ41GSHMF, PZ41GSHMG, PZ41GSHMH, PZ45OTNCF, PZ45OTNCG, PZ45OTNCH, PZ54FCSMD, PZ55ENSF2, PZ55ENSFF, PZ55ENSFG, PZ55ENSFH, PZ55ENSFI, PZ55OTSFB, PZ55OTSFC, PZ63OTMCG, PZ73MNCRB, PZ73OTCRA, PZCGTHAGEG, PZMHADFB1, PZMHADFB2, PZMHADFBA, PZMHADFBB, PZMHADFBC, PZMHADFBD, PZMHADFBE, PZMHADFBF, PZMHLAWN2, PZMHLAWN3, PZMHLAWN4, PZMHLAWNC, PZMHLAWND, PZMHLAWNE, PZMHLAWNF, PZRMANBMUI, PZRMANMUK, PZV8ANVAL, PZVBOTANM2, PZVBOTANM3, PZVBOTANMK, PZVBOTANML, PZVBOTANMM, PZVBOTANMN, PZVBOTANMO, PZVBOTANMP, PZVBOTANMQ, PZVBOTANMR, PZVBOTANMS, PZVMANBLH, PZVMANBLI, PZVMANBLJ, PZVMANJWH, PZVMANJWI, PZVMANJWJ, PZVMANJWK, PZVMANJWL, PZVMOTCHG, RE7363573A, RESVM0726A, RESW11505C, RESW1505B, RPD239008A, SP1411105C, SP1421926B, SP1421926C, SP1691807A, SP1CG7271C, SP1CG7271D, SP1CG7271E, SP1CG7317K, SP1CG7317L, SP1HF5342E, SP1HF5342F, SP1HF5342G, SP1HF5342H, SP2534859G, SP2534859I, SP2534859J, SP2HF5342C, SP2HF5342D, SP5HF5342D, SP5HF5342E, SP5HF5342F, SP5HF5342G, SP5HF5342H, SPK224490A, SPK224716C, SPK224716D, SPK224716E, SPK370130A, SPK422677B, SPK483772A, SPK6918071, SPK691807A, SPK691807B, SPK691807C, SPK691807D, SPK765210C, SPK765210D, SPK765210E, SPKCN5570C, SPKCN5570D, SPKCN5570E, SPKCN5570F, SPKCN5570G, SPKDH9501A, SPKHD8398B, SPKOC0110A, SPKOC7731F, SPKOC7731H, SPKRM2105A, SPKVB0149N, SPKVM0726B, SPKVM0726C, SPKVM0726D, SRIET0513L, UCV69OHK11, UEN69TMKSD, UNE69SPKSD, UOP30KAPRB, UOP30KAPRE, UOP30KAPRF, UOP30OGPRB, UOP30OGPRC, UOP30OGPRD and UOP63BKGSF. Recall # Z-2459-2010
CODE
All lots prior to Y10Kxxxx
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cardinal Health, Mc Gaw Park, IL, by letter dated August 16, 2010. Manufacturer: Productos Urologos De Mexico S.A, Mercurio Mexicali, Mexico. Firm initiated recall is ongoing.
REASON
The packaging seals may not be intact, resulting in compromised sterility for the listed Medi-Vac Non-Conductive Tubing.
VOLUME OF PRODUCT IN COMMERCE
78,605,894 packages
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT   
Nuclear Magnetic Resonance Imaging System (MRI). Trace item 9896-030-14351 -1.5T Sense XL Torso coil 12nc on coil: 4535-671-4188x. Recall # Z-2461-2010
CODE
Site numbers: 544006, 537871, 534961, 544704, 545154, 545236, 545219, 545943, 546637, 545879, 545914, 543286, 547585, 548729, 550876, 553379, 550044, 554797, 41443789, 555412, 41444993, 41445232, 556803, 557348, 557344, 557513, 557179, 557644, 557560, 551656, 558845, 41446147, 552550, 552516, 555787, 41445636, 41455922, 83325, 558369, 86968, 101408, 101877, 102110, 102353, 102004, 104343, and 41455948
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letter dated September 30, 2008.
Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is complete.
REASON
The cables of the coil may become too hot and cause burns when placed too close to the patient. While using the 1.5T Sense XL Torso coil, unwanted radiofrequencies (RF) interaction with the patient can occur. Especially in combination with high SAR levels and when the RF cables of the coil are too close to the patient, this RF interaction has resulted in RF burns to patients.
VOLUME OF PRODUCT IN COMMERCE
47 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT   
Philips BV Pulsera Mobile X-Ray system with the extended rotation option. Recall #
Z-2463-2010;

2) Philips BV Endura Mobile X-Ray system with the extended rotation option. Recall # Z-2464-2010
CODE
1) Devices are identified with Site Numbers: 557506, 549822, 41986793, 541557, 542427, 542854, 543458, 543461, 543465, 544411, 544459, 544460, 544464, 544467, 544473, 544475, 544476, 544562, 545102, 545397, 545922, 545996, 546516, 546788, 547746, 549060, 549071, 549112, 549113, 549114, 549115, 549116, 549117, 549118, 549120, 549121, 549130, 549133, 549137, 549140, 549272, 549273, 549274, 549275, 549706, 550189, 550190, 550524, 550808, 551034, 551142, 551190, 551191, 551262, 551292, 551329, 551369, 551400, 551422, 551524, 551548, 552226, 552229, 552230, 552235, 552236, 552240, 552241, 552243, 552246, 552250, 552251, 553205, 553693, 557062, 41490308, 41490309, 41490311, 41490312, 41490314, 41490316, 41490318, 549136, 546531, 41796150, 542769, 543460, 41490306, 41490307, 41490315, 558453, 558455, 554812, 556052, 557184, 556854, 41445794, 556920, 555646, 548992, 556125, 553640, 41445436, 549262, 553177, 552327, 553296, 553694, 555645, 556518, 557564, 41446009, 41446185, 41750637, 41765919, 41783704, 41794417, 41832433, 549260, 553274, 549235, 559963, 553855, 558862, 551605, 41446396, 41645797, 556382, 41446310, 553211, 553219, 551039, 41710489, 41446060, 550379, 553016, 557195, 555379, 41647329, 546687, 41445895, 559003, 553730, 553596, 555783, 549218, 553772, 552912, 41445657, 559877, 550649, 557711, 553958, 550450, 41727262, 549142, 548385, 555727, 558611, 556529, 553990, 554005, 554014, 41443764, 557617, 555181, 555185, 551478, 41445815, 549878, 552233, 556645, 552724, 549855, 555168, 555168, 41796152, 557445, 552292, 41445423, 549694, 552401, 552402, 552403, 545492, 552621, 556501, 551688, 41446272, 551820, 555002, 554849, 41445741, 41445911, 553327, 553959, 41445894, 551592, 559322, 556006, 556889, 557914, 557915, 41953816, 549128, 549139, 550971, 549006, 557058, 552239, 552015, 553851, 558638, 545103, 558444, 543463, 559584, 41792689, 547643, 41620994, 549125, 549127, 549132, 550183, 550184, 550186, 558387, 558388, 558389, 558390, 558391, 558392, 558393, 558394, 41445356, 41445740, 559679, 556481, 549059, 549064, 41987951, 550252, 550252, 559101, 556045, 552017, 557521, 558633, 558634, 41987067, 552386, 552336, 556942, 552262, 41833197, 552265, 552964, 553564, 555353, 555354, 558004, 41566346, 552334, 553642, 544457, 549528, 551388, 542684, 550128, 41443746, 41701188, 553898, 41445476, 552452, 554093, 555793, 41443616, 548653, 556075, 552014, 557019, 557020, 544533, 559331, 41443605, 41443668, 41445453, 41455878, 551580, 555326, 553307, 551992, 552573, 41445504, 554432, 556239, 542426, 41445509, 556818, 547299, 549964, 42028669, 41443563, 555301, 555692, 558531, 551507, 556461, 551723, 552232, 550056, 544470, 549241, 553903, 555151, 554859, 558260, 550416, 555532, 555533, 547171, 549126, 554272, 559068, 41757225, 41980509, 41446770, 549070, 41445506, 552510, 552511, 554381, 559533, 557149, 42053457, 551813, 553503, 555054, 557487, 554817, 555704, 541556, 41833714, 554012, 552249, 556702, 543462, 555400, 555658, 41445599, 41657683, 546851, 553071, 559924, 549968, 553360, 552234, 41446285, 554543, 554372, 553880, 551840, 547172, 550925, 551366, 553310, 556998, 549403, 549404, 549405, 549406, 549407, 553562, 553591, 549221, 556623, 553289, 549061, 554472, 41446088, 551952, 552291, 552569, 556022, 556023, 556162, 554570, 551822, 555682, 555682, 556130, 554336, 546680, 41780151, 559658, 41445441, 554430, 551381, 41780384, 558386, 553218, 555169, 553874, 545924, 558250, 41445487, 553600, 559026, 553972, 553973, 550819, 550820, 552459, 552460, 544191, 557499, 41445728, 553192, 553292, 554214, 556614, 556615, 550541, 552561, 549122, 553916, 551427, 552308, 552715, 552716, 544469, 41446183, 41446186, 559448, 41445415, 554799, 41938323, 545085, 548743, 42182142, 41445922, 550523, 545284, 41781423, 556546, 42056714, 556199, 556220, 556221, 556222, 556223, 549727, 554661, 559045, 552578, 552581, 553442, 553443, 554505, 553988, 556160, 551445, 551128, 553286, 554883, 553072, 554891, 554892, 554893, 554894, 554895, 556024, 41621991, 41783605, 41796073, 556137, 556887, 554501, 554502, 556777, 41616194, 41616195, 551133, 551134, 551135, 551136, 551137, 556182, 556183, 41757995, 41757996, 556542, 544463, 548781, 548782, 558654, 557593, 41620935, 41620966, 548569, 551024, 549063, 549519, 549520, 41566245, 550200, 552161, 558698, 555573, 41445528, 557596, 42000523, 555134, 555135, 554340, 555133, 554219, 544984, 555172, 550865, 557528, 557530, 557531, 551797, 554473, 554474, 554475, 554476, 555005, 557463, 556802, 556809, 551685, 558632, 554379, 556713, 557255, 553150, 553879, 554378, 554428, 554429, 556138, 549993, 542423, 552840, 551594, 552103, 552525, 549732, 550427, 552297, 557210, 41725527, 552237, 41443601, 41444618, 547684, 555735, 557146, 549540, 541547, 557408, 550562, 554315, 554837, 554838, 554839, 555342, 544456, 542584, 552547, 552642, 559563, 547082, 554347, 41768050, 41768058, 41768059, 546999, 547000, 551384, 552868, 552869, 557708, 544471, 558452, 554688, 557690, 558500, 41445717, 557455, 557712, 552670, 546579, 543219, 543220, 543222, 41445521, 545751, 554949, 551518, 549563, 552310, 41793882, 551300, 556193, 555009, 557443, 557444, 41576092, 558867, 41446789, 551532, 551531, 551533, 551534, 545961, 552122, 555443, 555606, 41701158, 554724, 550113, 550121, 556865, 558228, 549596, 557229, 41444449, 41443673, 549728, 549733, 552182, 555734, 555824, 558232, 544466, 558395, 549287, 42182154, 555604, 557587, 549752, 554736, 553768, 559880, 41446095, 42057341, 558247, 557199, 42037365, 558790, 548702, 551882, 550879, 41630562, 553875, 556958, 559690, 556544, 556545, 41898013, 559537, 556588, 41587498, 548397, 41939336, 544462, 544474, 544972, 547602, 547603, 548398, 549119, 552365, 41577782, 548853, 41658562, 41658563, 41658564, 41658565, 558567, 559655, 547805, 550426, 550428, 41725782, 557592, 555156, 554552, 554553, 548972, 548975, 552542, 552618, 554864, 554870, 554871, 547288, 556083, 550844, 541558, 549301, 557017, 553162, 554199, 554200, 558246, 549143, 551686, 551687, 555023, 555024, 555025, 41443831, 552565, 552566, 41443590, 552462, 558427, 551539, 41765927, 552018, 41445933, 554345, 554663, 556997, 554679, 554889, 550762, 557250, 557252, 552244, 41556812, 554353, 552335, 544461, 558231, 551712, 551713, 553057, 553058, 556067, 41443872, 552439, 558248, 555113, 551023, 554761, 553535, 556015, 41658375, 551506, 41701180, 555693, 558635, 41585081, 553015, 41712352, 41712375, 557642, 558647, 558523, 552405, 552406, 551139, 41445304, 556100, 548004, 551428, 554273, 553163, 41446454, 41611719, 41611720, 549021, 549025, 549027, 551591, 551264, 549129, 548354, 554407, 557440, 557441, 557442, 41446243, 550123, 550125, 550131, 556985, 558966, 558967, 41980506, 548308, 550651, 551020, 554681, 41953942, 558925, 556935, 41443721, 41444577, 544458, 552070, 559363, 551013, 556825, 551885, 554303, 558844, 558847, 554274, 556051, 556845, 556853, 548602, 556462, 551473, 42182158, 551528, 551529, 551530, 551536, 551537, 551538, 551487, 544396, 552445, 552242, 550856, 558861, 543862, 547169, 41936644, 551764, 551547, 552247, 41445553, 41445802, 559294, 550923, 555142, 553565, 557489, 557490, 551546, 553861, 557709, 554025, 555746, 557614, 557615, 543059, 41748088, 41748089, 551368, 555500, 555494, 555499, 555495, 555157, 552688, 552689, 552690, 556838, 556841, 552157, 555319, 554195, 41446667, 556536, 544622, 556950, 553473, 553474, 551646, 553449, 551132, 551212, 549005, 547221, 556578, 549049, 559423, 551373, 555275, 41622664, 553181, 559364, 555967, 42182116, 552483, 558843, 553882, 558418, 41416302, 41885442, 41885443, 558693, 554611, 545822, 554420, 554421, 41445718, 557047, 552245, 556165, 552034, 556510, 550372, 548104, 41986353, 41795593, 552632, 552643, 554235, 551331, 551332, 551333, 557273, 557274, 557635, 557636, 557637, 41986345, 41986348, 558924, 552722, 552723, 554034, 551293, 557282, 558522, 559251, 41781354, 555695, 555696, 552075, 559415, 559417, 551967, 557220, 41416329, 556646, 556660, 556081, 556082, 41585198, 559254, 548929, 557591, 546508, 42182150, 553161, 41445921, 554742, 556849, 554778, 552740, 556204, 556205, 555217, 557665, 557242, 556866, 556320, 551854, 552921, 556473, 556474, 550066, 547975, 552471, 553654, 553221, 557565, 557566, 554621, 551444, 551277, 552248, 548733, 551549, 544465, 551425, 554217, 554218, 547656, 550136, 41632199, 41632201, 553359, 557254, 547284, 558699, 549674, 558229, 558230, 558235, 41443611, 552016, 555148, 556206, 556207, 557570, 559319, 545139, 545140, 41957602, 557582, 41445915, 41555898, 553500, 555601, 555602, 556126, 41713383, 555410, 555411, 546145, 41726634, 556255, 551729, 548700, 553589, 557284, 552739, 548731, 549171, 552231, 556057, 557035, 557036, 552678, 41446086, 554248, 41445775, 556265, 556266, 558419, 546086, 551624, 555036, 550603, 552638, 547790, 547791, 553587, 554500, 547839, 41443675, 551513, 548984, 552298, 552299, 553967, 555003, 548790, 553364, 554636, 554637, 554638, 549065, 554959, 41446424, 549144, 41793821, 41757081, 41757083, 545631, 551367, 551621, 552228, 556145, 556180, 550264, 550022, 550023, 553832, 553833, 559495, 41443748, 41445791, 41445484, 558697, 558249, 546461, 547375, 555479, 555501, 555502, 559775, 42442866, 556563, 556564, 556570, 41443603, 552312, 550298, 557281, 558835, 547710, 553182, 551033, 558440, 558441, 553683, 552225, 556628, 556254, 543464, 42084783, 552841, 552842, 555648, 556026, 554667, 555132, 549749, 549072, 41445534, 555469, 558236, 555391, 557589, 554032, 556335, 43120974, 42677713, 42678207, 42678208, 42917176, 42861819, 42879778, 42879779, 42877739, 42877741, 42877743, 42877745, 42877747, 42877749, 42877750, 42877752, 42825111, 42573106, 42673598, 42474590, 42455282, 42455439, 42624941, 42861834, 42865440, 42865605, 43246451, 42879230, 42878368, 42573399, 42602299, 42635590, 42636398, 42636399, 42474574, 42474575, 43338394, 42573203, 42891050, 42473457, 42474563, 42573165, 42917289, 42573192, 42865606, 42553919, 42635567, 42880965, 42869153, 42625869, 43043495, 43056780, 42892002, 42683563, 42453911, 42892363, 42627942, 42917166, 42968938, 42627935, 42573118, 42861808, 42878153, 43083516, 42566165, 42566168, 42736788, 42869214, 42573189, 42573191, 42892402, 42495270, 42869019, 42616997, 42639032, 42877781, 42877789, 42877790, 42877794, 42877795, 42877796, 42877799, 42877803, 42877813, 42877814, 42573428, 42573429, 42879774, 42879776, 42879777, 42879775, 42878126, 42608333, 42608337, 42474568, 42869138, 42607825, 42727418, 42826877, 42792818, 42792938, 42878380, 42453900, 42880753, 42724008, 42573195, 43326065, 42573110, 42917171, 42865948, 42865949, 42865656, 42916268, 42673153, 42967767, 42879240, 42916328, 42638526, 42453921, 42916313, 42865645, 42799382, 42622640, 42878386, 42878440, 42866193, 42678370, 42677649, 42869087, 42692086, 42624734, 42454149, 42723370, 42723386, 42723388, 42879172, 42879170, 42917165, 42878374, 42669138, 42878225, 42470770, 42440473, 42678321, 42879150, 42879151, 42892422, 42791443, 42879078, 42573112, 42672347, 42678333, 42879169, 42598765, 42473479, 42878367, 42551935, 42861795, 42708001, 42708002, 42878253, 42601652, 42891052, 42891959, 42865969, 42866916, 42677402, 42678347, 42672459, 42454796, 42626199, 42878264, 42916162, 42673554, 42673588, 42673589, 42673591, 42673595, 42573198, 42879218, 42608271, 42878231, 43057942, 42451806, 42573107, 42917278, 42943097, and 42657622;

2) Devices are identified with Site Numbers: 556612, 557063, 42975222, 557590, 41955473, 42291865, 41416327, 556862, 558237, 42880805, 555243, 558975, 42639034, 556678, 42608281, 41445430, 42869163, 41938039, 41443860, 41445552, 41566246, 555517, 554350, 42869100, 556979, 559665, 558233, 556608, 556135, 559070, 42162893, 553976, 555395, 556977, 558613, 556171, 554497, 556587, 42966787, 559663, 42326711, 42045315, 553989, 42394051, 42373518, 555001, 553171, 557037, 41585083, 555463, 41445445, 553917, 41658558, 42824768, 42382482, 41905206, 41796621, 555021, 41445126, 556531, and 41765654
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems, North America Co. Phillips, Bothell, WA, by letter dated September 30, 2008.
Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing.  
REASON
The C-arm rotation brake does not always function properly, and may not hold the C-arm position if the C-arm is not positioned in its maximum rotation and if it is accidentally bumped by medical staff or patients. Unwanted C-arm movement may cause the C-arm to collide with a patient. The brakes function properly if the C-arm is rotated to its maximum positions.
VOLUME OF PRODUCT IN COMMERCE
1,378 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT   
Spider Flex Monopolar Hook (Spider Surgical Instruments), TransEnterix. Model number: 9000031. Recall # Z-2465-2010
CODE
Lot numbers: DSC077201001, DSC083201001, DSC043201001, DSC049201001, DSC079201001, DSC091201002      
RECALLING FIRM/MANUFACTURER
TransEnterix, Inc., Durham, NC, by letter dated June 22, 2010. Firm initiated recall is ongoing.
REASON
The hook end effecter from a monopolar device may become dislodged and fall into the patient when in use during laparoscopic surgery. Retrieval from the patient may involve extended anesthesia time.
VOLUME OF PRODUCT IN COMMERCE
46 boxes (6 units per box)
DISTRIBUTION
AZ, FL, GA, NC, NY, OH, OR, SC, TX
___________________________________
PRODUCT   
1) 1) Terumo Advanced Perfusion System 1, Catalog number 801763, 100/120V System 1 base. Recall # Z-2480-2010;

2) Terumo Advanced Perfusion System 1, Catalog number 801764, 220/240V System 1 base. (This product is not distributed in the US). Recall # Z-2481-2010
CODE
1) Serial numbers 0001-1340;
2) Serial numbers 0001-1315
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letter dated September 10, 2010. Firm initiated recall is ongoing.
REASON
The design document states that the oxygen sensor would operate for 300,000 hours but the supplier of the oxygen sensor indicated that it has a 100,000 hour warranty. The oxygen sensor is a consumable part that slowly depletes over time. At the end of its service life, a depleted oxygen sensor results in a gas system calibration failure or a message to the user prompting service for the gas system. If the user does not recognize that the gas system has failed calibration, and attempts to use the system normally, the FiO2 readings may be inaccurate. The firm received seven complaints related to the oxygen sensor.
VOLUME OF PRODUCT IN COMMERCE
2,655 units
DISTRIBUTION
Nationwide, Canada, Indonesia, China, Chile, UAE, Japan, Singapore, UK, Malaysia, Taiwan, Belgium, Korea, Philippines and Thailand
___________________________________
PRODUCT   
1) Sterile double breast personal accessory convenience kit for the Symphony Breast pump; the kit connects to a hospital grade breast pump for the removal, collection, and storage of mother's breast milk; Article # 67099S. Recall # Z-2483-2010;

2) Sterile double breast personal accessory convenience kit for the Symphony or Lactina Breast pumps; the kit connects to a hospital grade breast pump for the removal, collection, and storage of mother's breast milk; Article # 67116S. Recall # Z-2484-2010;

3) Sterile single/double breast personal accessory convenience kit for single or double pumping with a Classic Breast pump; the kit connects to a hospital grade breast pump for the removal, collection, and storage of mother's breast milk; Article # 67093S. Recall # Z-2485-2010;

4) Sterile single/double breast personal accessory convenience kit for the Lactina Breast pump; the kit connects to a hospital grade breast pump for the removal, collection, and storage of mother's breast milk; Article # 67094S. Recall # Z-2486-2010
CODE
All lot numbers
RECALLING FIRM/MANUFACTURER
Medela Inc., McHenry, IL, by letters dated August 6, 2010. Firm initiated recall is ongoing.
REASON
The product sterility may be compromised due to possible pinholes in the rigid tray of the package.
VOLUME OF PRODUCT IN COMMERCE
6,824,825 kits
DISTRIBUTION
Nationwide, Guam, Barbados, Bermuda, British West Indies, Canada, Panama, Switzerland, Trinidad and Tobago, and Uganda
___________________________________
PRODUCT   
Sorin Paradym CRT-D Model 8750 and Sorin Group Paradym sonR CRT-D Model 8770. Recall # Z-2579-2010
CODE
Units: 001YH026 811YH056 824YH071 825YH049 825YH089 828YH052 835YH018 836YH016 836YH057 837YH041 851YH00B 903YH050 903YH05F 904YH018 904YH01B 904YH038 907YH017 907YI037 907YI041 909YI036 912YH049 912YH057 912YI009 912YI00A 912YI011 912YI025 912YI026 912YI028 912YI02B 912YI031 912YI048 914YI005 915YH012 915YH014 915YH041 916YH020 916YH028 916YH032 917YH002 917YH003 917YH024 917YH03F 918YH045 918YI029 918YI0A2 919YH02F 919YH03D 919YH044 919YH064 920YI085 920YI089 920YI092 922YH01C 923YH012 923YH023 923YH048 924YH01E 924YH02D 924YH046 925YH015 925YH032 926YH00D 926YH020 926YH037 926YH042 926YH05F 926YI012 926YI032 927YH01A 927YH030 928YH004 928YH01A 928YH033 928YH035 928YI024 928YI02C 928YI045 928YI070 929YH00B 929YH00D 929YH012 929YH019 929YH01C 929YH022 929YH023 929YH033 929YH055 929YI014 929YI030 931YH004 931YH018 931YH035 931YH037 931YH044 931YH04C 931YH052 931YH053 931YH057 931YH059 931YH05E 931YH061 931YH062 931YH063 931YH065 931YH068 931YH069 931YH06B 931YH06C 931YH070 931YH071 931YH072 931YH074 931YH075 931YH07A 931YH081 931YH084 931YI038 931YI066 932YH00B 932YH02E 932YH032 932YH039 932YH03B 932YH04D 932YH052 932YH065 932YH06B 932YH073 932YH0A3 932YH0AD 932YH0B4 932YH0BE 932YI011 932YI08C 933YH007 933YH009 933YH01F 933YH030 933YH060 933YH09D 933YH100 933YH103 933YH105 933YH111 934YH01A 934YH02A 934YH044 934YH04A 935YH005 935YH006 935YH007 935YH015 935YH01D 935YH045 935YH048 935YH058 936YH014 936YH01B 936YH01C 936YH01E 936YH021 936YH023 936YH03A 936YH041 936YH047 936YH062 936YH064 936YH06D 936YH06F 936YH071 936YH078 936YH082 936YH083 937YH01D 937YH022 937YH025 937YH02B 938YH005 938YH01A 938YH01D 938YH03F 939YH00A 939YH02D 940YH005 940YH041 940YH042 940YH057 940YH05A 940YH061 941YH043 942YH02C 943YH01E 943YH025 944YH032 945YH004 945YH00C 945YH01A 945YH053 947YH003 947YH017 947YH01B 947YH01E 947YH027 947YH036 947YH053 947YH057 947YH062 948YH031 948YH037 948YH03B 949YH064 949YH07F 949YH081 949YH084 949YH092
RECALLING FIRM/MANUFACTURER
Recalling Firm: ela Medical LLC, Plymouth, MN, by letter dated June 7, 2010.
Manufacturer: Sorin Biomedica C.R.M., S.r.l., Saluggia, VC, Italy. Firm initiated recall is ongoing.
REASON
The Paradym CRT 8750 and CRT sonR 8770 device models have a software anomaly, which will cause the device to lose the ability to sense/pace and to deliver further therapy. The software anomaly could only occur under a specific sequence of events.
VOLUME OF PRODUCT IN COMMERCE
215 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT   
1) Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device, Model Number 01-242208. Recall # Z-2580-2010;

2) Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device, Model Number 01-242208. Recall # Z-2581-2010
CODE
Model Numbers only
RECALLING FIRM/MANUFACTURER
Cardima Inc., Fremont, CA, by letter dated May 18, 2010. Firm initiated recall is ongoing.
REASON
Sterility compromised-- The sterile pouch in which the product is packaged may be compromised, which could result in patient infection.
VOLUME OF PRODUCT IN COMMERCE
28 units
DISTRIBUTION
PA, CA, OH, MI, MO, WA, Ireland, Belgium, the Netherlands

__________________________________
PRODUCT
Integra Suction Reservoir Kit for use with Integra NeuroSciences Subdural Drainage Catheter; Sterile, Rx only. This product is distributed by Integra NeuroSciences under, a) catalog number 910-500 and in Suction Valve Reservoir Kits under b) catalog number 31223 and c) 31253. Recall # Z-2588-2010
CODE
a) Lot codes 156618, 155186, 155817, 1561194, 156484, 157140, 157345, 157995, 158188, 158690, 158849, 159155; b) lot numbers 158817, 156484. 157140, 157345, 156618; c) lot numbers: 158817, 156484, 157345, 158690, 156618
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integra LifeSciences Corp., Plainsboro, NJ, by letters dated May 7, 2010.
Manufacturer: Integra Neurosciences Implants S.A., Sophia Antipolis, France. Firm initiated recall is ongoing.
REASON
The sterility of the product may be compromised. The product's sterility may be affected by a sterilization issue discovered by the supplier.
VOLUME OF PRODUCT IN COMMERCE
313 units
DISTRIBUTION
Nationwide, Australia, Chile, Costa Rica, Sri Lanka

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS III
___________________________________
PRODUCT   
Dimension IBCT Flex Reagent Cartridge. The total (IBCT) method used on the Dimension system is an in vitro diagnostic test intended to quantitatively measure Total Iron Binding capacity in human serum and plasma. Catalog number df84. Recall # Z-2385-2010
CODE
None
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Newark, DE, by letter dated December 2009. Firm initiated recall is complete.
REASON
Test produces falsely elevated IBCT results and Abnormal Reaction test report messages on heparinized plasma samples.
VOLUME OF PRODUCT IN COMMERCE
Unknown - all lots involved
DISTRIBUTION
Nationwide, Canada, Switzerland, New Zealand, Australia, Japan, South Korea
___________________________________
PRODUCT   
The Provent Nasal Cannula is a nasal appliance device placed in both nostrils intended to be used for transmission of respiratory airflow signals between the Provent Professional Sleep Apnea Therapy device and physiologic recorders. Catalog Number: MRS0208. Recall # Z-2435-2010
CODE
Lot Number: 1880783
RECALLING FIRM/MANUFACTURER
Ventus Medical, Inc., Belmont, CA, by letter on December 3, 2009. Firm initiated recall is complete.
REASON
The catalog number printed on two Nasal Cannula Diagnostic Kits (MRS0231) was different that the catalog number printed on the bulk pack shipper box and the other Nasal Cannula Kits in the same shipper (MRS0208). No devices were used on any patient.
VOLUME OF PRODUCT IN COMMERCE
40 units
DISTRIBUTION
Nationwide
____________________________________
PRODUCT   
Primary (inner) Package Label: Acuvue Oasys Brand Contact Lenses for Astigmatism with Hydraclear Plus (senofilcon A) Johnson & Johnson Vision Care, Inc. Rx Only, Sterile. Lot B006WBS1 -9.00D -1.25 CYL 80, 2013/05 AXIS. (Correct labeling) Mislabeled Outer (secondary) Label: Lot B006X641 D -8.50 CYL -1.25 AXIS 100, 2013/05 DO NO PAY Free Sample Not For Sale Consumer Note: This product has been provided free of charge to your Eye Care professional to aid in proper fitting. The sale of this product is prohibited. You should not have been charged money for this product. Contents: 1 lens (38% H2) in buffered saline with up to 0.005% methyl ether cellulose. Recall # Z-2445-2010
CODE
Lot # B006X641
RECALLING FIRM/MANUFACTURER
Vistakon, Jacksonville, FL, by letters dated July 28, 2010. Firm initiated recall is ongoing.
REASON
ACUVUE OASYS Brand Contact Lenses for Astigmatism may be mislabeled on the outer (secondary) packaging carton. The outer (secondary) cartons labeled as Lot B006X641 -8.50D -1.25cyl. 100 Axis may actually contain primary packages from Lot B006WBS1 -9.00D -1.25cyl. 80 Axis. The inner (primary) package labeling is correct. Product was only distributed to Eye Care Professionals for use in proper fitting of patients and labeled as "Not For Sale".
VOLUME OF PRODUCT IN COMMERCE
4,246 ea
DISTRIBUTION
Nationwide, Canada, Bahamas, Honduras, and United Arab Emirates

END OF ENFORCEMENT REPORT FOR SEPTEMBER 29, 2010

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