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U.S. Department of Health and Human Services

Safety

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Enforcement Report for January 12, 2011

January 12, 2011                                                                                        11-02

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II
___________________________________
PRODUCT
Perishable 6 lbs. Nacho Chips. Restaurant Style Chips Family Owned Since 1930. 6 # Chip, Cardboard box with three (3) two (2) pound bags inside. Fragile. Ingredients: Stone Ground Corn, Vegetable Oil (contains one or more of the following: Cottonseed Oil, Corn Oil and/or Palm Olein), Water, Trace of Lime, Salt. Recall # F-0317-2011
CODE
Lot # 111710
RECALLING FIRM/MANUFACTURER
Cardona Foods, Inc., Fort Worth, TX, by telephone on December 1, 2010. Firm initiated recall is ongoing
REASON
Yellow #5 is not declared on the label.
VOLUME OF PRODUCT IN COMMERCE
58 Cases (174 Bags)
DISTRIBUTION
TX
___________________________________
PRODUCT
Case Labeling: "***SEA BEST * AHI TUNA LOINS Thunnus albacares) * KEEP FROZEN 0 F OR BELOW * SIZE: 5/7 LOINS, * PRODUCT OF VIETNAM * (Wild Caught at Pacific FAO 71) * PACK 1/20 LB * Net Wt. 20 lbs (9.07 kg) * Ingredients: Tuna, Carbon-monoxide (used to preserve natural color) ***." "*** Product Code printed on case above bar code "#6217408". UPC 10075391967918. FDA No.: 17012326708. Recall # F-0318-2011   
CODE
Lot Code 928378, Best By: 07/06/12, S//N: 43910 
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beaver Street Fisheries, Inc., Jacksonville, FL, by letter on October 29, 2010.
Manufacturer: Great Ocean Choice LTD, Co., Nha Trang, Vietnam. Firm initiated recall is ongoing.
REASON
Laboratory analysis of Ahi Loins has confirmed presence of histamines.  
VOLUME OF PRODUCT IN COMMERCE
3,920 pounds
DISTRIBUTION
AL, FL, TN, TX, St. Johns, Antigua, and Grand Cayman, Cayman Islands
___________________________________
PRODUCT
1) Gourmet Cheddar Popcorn packed in 12 oz clear plastic bags, 24 oz clear plastic bags, and 3.5 lb clear plastic bags. Each bag is closed with a colored twist-tie. Recall # F-0321-2011;

2) Chicago Triple Mix packed in 12 oz. clear plastic bags, closed with a colored twist tie. Recall # F-0322-2011;

3) Caramel corn packed in 9 ounce clear plastic tubs, 2.5 and 4 pound clear plastic bags. Recall # F-0323-2011
CODE
The codes for the bagged popcorn are assigned by color of twist-tie. Each twist-tie represents a certain week of manufacturing. There are only four colors of twist-ties, which only count for four weeks. This is because when the twist-tie color is encountered again in four weeks, it is time to pull the products and discard them for quality purposes. The twist-tie colors and corresponding dates related to the recall are as follows: Yellow-10/25/2010 to 10/29/2010, Red-11/08/2010 to 11/12/2010, Blue- 11/15/2010 to 11/19/2010, and Yellow- 11/22/2010 to 11/26/2010
RECALLING FIRM/MANUFACTURER
V Lobby Shoppes Inc., Springfield, OH, by telephone and visit beginning November 22, 2010 and November 23, 2010, by press release on November 24, 2010 and letters faxed on November 29, 2010.  Firm initiated recall is ongoing.
REASON
The products are being recalled because of undisclosed products (milk and soy) on the label.
VOLUME OF PRODUCT IN COMMERCE
1) 310 units; 2) 72 units; 3) 36 units
DISTRIBUTION
OH
___________________________________
PRODUCT
De Boles Kids Only! Gluten Free Tubettini Corn Pasta, Net Wt 8.5 oz (240 g). Recall # F-0324-2011
CODE
Best by 22JUL11D1, 10NOV11D1, and 09JAN12D1
RECALLING FIRM/MANUFACTURER
Deboles Nutritional Foods Inc., DBA Shreveport Macaroni Mfg Co., Shreveport, LA, by email on December 17, 2010. Firm initiated recall is ongoing.
REASON
Product may contain undeclared whole wheat alphabet pasta.
VOLUME OF PRODUCT IN COMMERCE
2193 cases of 12 units
DISTRIBUTION
FL, CA, TX, IN, GA, NH, WA, PA, CT, IL, NY, MN, NJ, MD, OH, IA, CO,
___________________________________
PRODUCT
Royal Rice Blend 5 lb package In a plastic film cryovac bag. Recall # F-0325-2011
CODE
Julian dates printed on the bag 0273 & 280
RECALLING FIRM/MANUFACTURER
Culinary Standards Corp., Louisville, KY, by email on December 1, 2010. Firm initiated recall is ongoing.   
REASON
A supplier of Low Sodium Chicken Base sent the recalling firm an updated specification sheet. Once received, it was noticed that the new sheet now shows soy as a declared allergen. This is a change from the previous spec sheet. A review of the recalling firm's finished product label showed that Soybean Oil and Hydrolyzed Soy Protein were not declared in the allergen statement. The supplier failed to notify the recalling company of the change.
VOLUME OF PRODUCT IN COMMERCE
264 cs/4/5 lb bags
DISTRIBUTION
MD

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II
___________________________________
PRODUCT
Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx only; NDC 0172-3758-80. Recall # D-157-2011
CODE
Lot # TE03074, Exp 03/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter dated November 3, 2010.
Manufacturer: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India. Firm initiated recall is ongoing.
REASON
CGMP Deviations: some of the white tablets exhibit a blue discoloration.
VOLUME OF PRODUCT IN COMMERCE
2,376 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Lipitor (atorvastatin calcium) tablets, 40 mg, 90 count bottle, Rx only, NDC 0071-0157-23. Recall # D-161-2011  
CODE
Lot # 0836050, Exp 04/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer Inc., New York, NY, by letter and press release on December 17, 2010.
Manufacturers: Pfizer Ireland Pharmaceuticals, Cork, Ireland;
Pfizer Manufacturing Deutschland Gmbh, Freiburg, Germany;
Rexam, Las Piedras, PR. Firm initiated recall is ongoing.
REASON
Chemical Contamination: complaints of an uncharacteristic odor identified as 2,4,6 tribromoanisole.
VOLUME OF PRODUCT IN COMMERCE
19,182 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Metoprolol Tartrate Tablets, USP, 50 mg, a) 100 count bottles (NDC 0781-1223-01), b) 1000 count bottles (NDC 0781-1223-10), Rx only. Recall # D-162-2011;

2) Metoprolol Tartrate Tablets, USP, 100 mg, a) 100 count bottle (NDC 0781-1228-01), b) 1000 count bottles (NDC 0781-1228-10), Rx only. Recall # D-163-2011
CODE
1) a) Lot # 170048, Exp 11/10; 170900, Exp 01/11; 173554, Exp 02/11; 176221, Exp 06/11; 176225, Exp 04/11; 184025, Exp 04/12; 188709, Exp 08/12; 191185, Exp 10/12; 192071, Exp 01/13; 192692, Exp 02/13; 196857, Exp 06/13; V09014, Exp 02/12; V09018, Exp 06/12;
b) Lot # 169335, Exp 10/10; 169336, Exp 10/10; 170045, Exp 09/10; 170608, Exp 12/10; 170609, Exp 12/10; 170896, Exp 01/11; 170897, Exp 01/11; 170898, Exp 01/11; 170899, Exp 01/11; 170901, Exp 01/11; 170902, Exp 02/11; 170903, Exp 02/11; 170904, Exp 02/11; 171021, Exp 10/10; 171023, Exp 12/10; 172801, Exp 12/10; 172802, Exp 12/10; 172803, Exp 12/10; 173553, Exp 02/11; 173554, Exp 02/11; 173555, Exp 03/11; 173556, Exp 03/11; 173557, Exp 04/11; 173558, Exp 04/11; 173559, Exp 05/11; 173560, Exp 06/11; 173570, Exp 05/11; 173721, Exp 02/11; 173722, Exp 05/11; 175127, Exp 03/11; 176218, Exp 05/11; 176219, Exp 04/11; 176220, Exp 06/11; 176221, Exp 06/11; 176222, Exp 06/11; 176223, Exp 07/11; 176224, Exp 07/11; 176225, Exp 04/11; 176367, Exp 07/11; 176368, Exp 04/11; 176369, Exp 04/11; 177270, Exp 07/11; 177273, Exp 08/11; 177371, Exp 08/11; 179061, Exp 08/11; 179062, Exp 09/11; 179063, Exp 09/11; 179064, Exp 09/11; 179065, Exp 09/11; 179066, Exp 09/11; 179067, Exp 09/11; 179068, Exp 09/11; 179069, Exp 08/11; 179071, Exp 07/11; 179768, Exp 08/11; 179769, Exp 08/11; 180034, Exp 10/11; 180035, Exp 10/11; 180036, Exp 10/11; 180520, Exp 11/11; 180521, Exp 11/11; 180538, Exp 09/11; 181703, Exp 12/11; 181704, Exp 12/11; 181705, Exp 12/11; 181706, Exp 01/12; 182792, Exp 01/12; 183338, Exp 01/12; 184025, Exp 04/12; 186109, Exp 04/12; 186141, Exp 04/12; 187299, Exp 06/12; 187300, Exp 06/12; 188707, Exp 07/12; 188708, Exp 07/12; 188709, Exp 08/12; 188988, Exp 08/12; 188989, Exp 09/12; 188991, Exp 06/12; 190235, Exp 08/12; 190236, Exp 09/12; 190237, Exp 11/12; 191185, Exp 10/12; 192068, Exp 11/12; 192069, Exp 12/12; 192070, Exp 12/12; 192071, Exp 01/13; 192072, Exp 01/13; 192073, Exp 02/13; 192074, Exp 01/13; 192075, Exp 01/13; 192692, Exp 02/13; 192693, Exp 03/13; 193923, Exp 03/13; 194782, Exp 02/13; 195270, Exp 04/13; 195271, Exp 04/13; 196317, Exp 06/13; 196856, Exp 06/13; 196858, Exp 06/13; 197460, Exp 06/13; V07059, Exp 10/10; V09012, Exp 02/12; V09013, Exp 02/12; V09014, Exp 02/12; V09017, Exp 06/12; V09018, Exp 06/12; V09019, Exp 05/12;

2) a) Lot # 169343, Exp 10/10; 169344, Exp 10/10; 169475, Exp 11/10; 170615, Exp 12/10; 170616, Exp 12/10; 170618, Exp 01/11; 170620, Exp 01/11; 170908, Exp 02/11; 171439, Exp 03/11; 171440, Exp 03/11; 171443, Exp 03/11; 172147, Exp 04/11; 172149, Exp 04/11; 172150, Exp 04/11; 172151, Exp04/11; 172152, Exp 04/11; 172861, Exp 12/10; 172862, Exp 01/11; 172863, Exp 01/11; 175128, Exp 05/11; 175129, Exp 04/11; 176227, Exp 06/11; 176228, Exp 06/11; 176230, Exp 04/11; 176236, Exp 05/11; 176373, Exp 05/11; 177274, Exp 07/11; 177276, Exp 07/11; 177644, Exp 06/11; 177645, Exp 05/11; 178448, Exp 06/11; 178449, Exp 06/11; 179075, Exp 08/11; 179076, Exp 08/11; 179077, Exp 09/11; 179078, Exp 09/11; 179080, Exp 09/11; 179082, Exp 10/11; 179638, Exp 10/11; 179639, Exp 10/11; 179640, Exp 10/11; 180038, Exp 10/11; 180039, Exp 10/11; 180061, Exp 11/11; 180762, Exp 09/11; 180763, Exp 09/11; 181708, Exp 12/11; 181710, Exp 01/12; 181711, Exp 01/12; 181712, Exp 12/11; 181713, Exp 12/11; 182785, Exp 01/12; 182786, Exp 01/12; 182788, Exp 01/12; 182790, Exp 01/12; 184754, Exp 02/12; 187305, Exp 06/12; 187307, Exp 07/12; 187781, Exp 07/12; 188711, Exp 08/12; 190238, Exp 09/12; 191513, Exp 01/13; 192076, Exp 11/12; 192079, Exp 12/12; 192694, Exp 02/13; 192695, Exp 02/13; 193928, Exp 03/13; 194785, Exp 03/12; 195276, Exp 05/13; 195277, Exp 05/13; 196321, Exp 06/13; V07075, Exp 12/10; V07076, Exp 12/10;
b) Lot # 169474, Exp 11/10; 170613, Exp 12/10; 170614, Exp 12/10; 170617, Exp 12/10; 170619, Exp 01/11; 170907, Exp 02/11; 170909, Exp 02/11; 171438, Exp 02/11; 171442, Exp 03/11; 172145, Exp 10/10; 172148, Exp 04/11; 172152, Exp 04/11; 173723, Exp 02/11; 175130, Exp 05/11; 176004, Exp 05/11; 176229, Exp 04/11; 176234, Exp 06/11; 176236, Exp 05/11; 177275, Exp 07/11; 177277, Exp 07/11; 177279, Exp 06/11; 177281, Exp 05/11; 177643, Exp 05/11; 179073, Exp 08/11; 179074, Exp 08/11; 179079, Exp 09/11; 179637, Exp 10/11; 180040, Exp 11/11; 180062, Exp 11/11; 180524, Exp 11/11; 180526, Exp 12/11; 180812, Exp 09/11; 181707, Exp 12/11; 181709, Exp 01/12; 182784, Exp 01/12; 182787, Exp 01/12; 182789, Exp 01/12; 183025, Exp 01/12; 183341, Exp 02/12; 183342, Exp 02/12; 183343, Exp 03/12; 183344, Exp 03/12; 183345, Exp 03/12; 184071, Exp 03/12; 184072, Exp 03/12; 184751, Exp 03/12; 184755, Exp 02/12; 185508, Exp 05/12; 185510, Exp 04/12; 186110, Exp 05/12; 187301, Exp 05/12; 187302, Exp 05/12; 187303, Exp 05/12; 187304, Exp 06/12; 187306, Exp 06/12; 187637, Exp 07/12; 187638, Exp 07/12; 187782, Exp 07/12; 188710, Exp 07/12; 188712, Exp 08/12; 188713, Exp 08/12; 188992, Exp 08/12; 188993, Exp 09/12; 188994, Exp 09/12; 188995, Exp 09/12; 189276, Exp 07/12; 189487, Exp 07/12; 190239, Exp 09/12; 190240, Exp 09/12; 191188, Exp 10/12; 191189, Exp 10/12; 191514, Exp 11/12; 191515, Exp 11/12; 192077, Exp 12/12; 192078, Exp 12/12; 192080, Exp 01/13; 192081, Exp 01/13; 192084, Exp 01/13; 192085, Exp 01/13; 192088, Exp 01/13; 192089, Exp 02/13; 193924, Exp 02/13; 193925, Exp 02/13; 193926, Exp 03/13; 193927, Exp 03/13; 194786, Exp 03/13; 194787, Exp 03/13; 195273, Exp 04/13; 195274, Exp 04/13; 195275, Exp 05/13; 196319, Exp 06/13; 196320, Exp 06/13; 196322, Exp 07/13; V07077, Exp 12/10
RECALLING FIRM/MANUFACTURER
Sandoz Inc., Broomfield, CO, by letters on November 18, 2010 and January 5, 2011. Firm initiated recall is ongoing.
REASON
Failed USP Content Uniformity Requirements: Metoprolol batches may exhibit non-homogenous granulation.
VOLUME OF PRODUCT IN COMMERCE
100 count: 2,043,192 bottles; 1000 count 724,482 bottles
DISTRIBUTION
Nationwide and PR

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III
___________________________________
PRODUCT
Equaline� Maximum Strength Heartburn Relief Ranitidine tablets USP 150 mg acid reducer, OTC, 1) 50 tablets (doses), NDC 41163-404-50, 2) 65 tablets (65 doses), NDC 41163-404-61. Recall # D-156-2011
CODE
Lot number: 7945253B, Exp 07/12; 7945253C, Exp 07/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dr Reddy's Laboratories Inc., Bridgewater, NJ, by letter on November 15, 2010.   
Manufacturer: Dr. Reddy's Laboratories Louisiana LLC. Shreveport, LA. Firm initiated recall is ongoing.
REASON
Label Error on Declared Strength: Ranitidine tablets carton states 'Compare to Zantac 75' whereas it should state "Compare to Zantac 150'.  
VOLUME OF PRODUCT IN COMMERCE
14,160 cartons
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Se-Natal 19 Chewable Tablets; Vitamins and Minerals with Folic Acid; 100 tablets; Rx only; NDC #13925-01-1701. Recall # Recall # D-158-2011;

2) Seton ET-EC Tablets, NDC # 13925-10-1060; this product is package in bulk containers. Firm states they do not have a label available for this product since it is in bulk. It is a Prenatal Multivitamin and Minerals with Iron and Folic Acid. Recall # D-159-2011;

3) Se-Natal 90 Prenatal Multivitamin/Mineral Tablets; 100 tablets; Rx only; NDC # 13925-102-01. Recall # D-160-2011
CODE
1) Lot # 906020, Exp 04/11;
2) Lot # 903021, Exp 04/11;
3) Lot # 904083, Exp 04/11
RECALLING FIRM/MANUFACTURER
Rasi Laboratories, Inc., Somerset, NJ, by letters on September 23, 2010 and October 21, 2010. Firm initiated recall is ongoing.
REASON
Superpotent Multiple Ingredient Drug: Prescription prenatal vitamins do not meet the product specifications for iron due to its high content and ascorbic acid due to its low content.
VOLUME OF PRODUCT IN COMMERCE
1) 5045 bottles; 2) 5300 bottles; 3) 3960 bottles
DISTRIBUTION
NJ

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS II
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0256-11;
2) Platelets. Recall # B-0257-11
CODE
1) and 2) Unit: 4819762
RECALLING FIRM/MANUFACTURER
Recalling Firm: Oklahoma Blood Institute, Oklahoma City, OK, by facsimile on October 16, 2008.
Manufacturer: East Central Oklahoma Blood Institute, East Central Oklahoma Blood Institute, Ada, OK. 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
OK, NY, and Switzerland
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0431-11
CODE
Unit: W045010064826
RECALLING FIRM/MANUFACTURER
Recalling Firm: Community Blood Center Of Greater Kansas City, Kansas City, MO, by fax on September 21, 2010. 
Manufacturer: Community Blood Center of Greater Kansas City, Overland Park, KS. 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
MO
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0432-11;
2) Plasma Frozen. Recall # B-0433-11;
3) Platelets. Recall # B-0434-11
CODE
1), 2)), and 3) Unit: 3132337
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on October 4, 2010.  Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo or body piercing within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
GA
___________________________________
PRODUCT
1) Cryoprecipitated AHF. Recall # B-0435-11;
2) Plasma. Recall # B-0436-11;
3) Red Blood Cells. Recall # B-0437-11
CODE
1), 2), and 3) Unit: 3200335
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on September 2, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
GA, Israel
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0449-11
CODE
Unit: 7238501
RECALLING FIRM/MANUFACTURER
Lane Memorial Blood Bank, Eugene, OR, by letter dated April 12, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.  
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OR
___________________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0464-11
CODE
Unit # 9480884
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc. Orlando, FL, by fax on June 16, 2008. Firm initiated recall is complete.
REASON
Blood product, which contained an antibody but was labeled negative for unexpected antibodies, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells (Apheresis). Recall # B-0466-11
CODE
Units: W065610031253 Part 1; W065610031253 Part 2
RECALLING FIRM/MANUFACTURER
Bergen Community Reg Blood Center, Paramus, NJ, by telephone on August 11, 2010. Firm initiated recall is complete.
REASON
Blood products, which did not meet the acceptable product specifications, were distributed
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ
___________________________________
PRODUCT
Source Plasma. Recall # B-0484-11
CODE
Units: 4570088858;4570089896;4570089107;4570093780; 4570093342;4570092603;4570092208;4570091402; 4570091049;4570090301;4570094584
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Inc.. Charlotte, NC, by electronic mail on September 22, 2010 and September 23, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
Austria

___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0485-11
CODE
Unit: W035210275466J
RECALLING FIRM/MANUFACTURER
Carter BloodCare/ WE & Lela I Stewart Blood Center, Inc., Tyler, TX, by telephone on October 18, 2010. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a potential malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Source Plasma. Recall # B-0509-11
CODE
Units: 4030441472, 4030439607, 4030437732, 4030436641, 4030435822, 4030434584, 4030434032, 4030432753, 4030432047, 4030430891, 4030430231, 4030429083, 4030428471, 4030427094, 4030426429, 4030425037, 4030424501, 4030423312, 4030422518, 4030420867, 4030420334, 4030418773, 4030418109, 4030416672, 4030416101, 4030414612, 4030414103, 4030412561, 4030412307, 4030410710, 4030410046, 4030408464, 4030407757, 4030406047, 4030405261, 4030403656, 4030402815, 4030401219, 4030400468, 4030398711, 4030397811, 4030395564, 4030394951, 4030392088, 4030390838, 4030389495, 4030388173, 4030386896, 4030385591, 4030384068, 4030382997, 4030381493, 4030380365, 4030378937, 4030377927, 4030376478, 4030375160, 4030373814, 4030372631, 4030371284, 4030370128, 4030368860, 4030293064, 4030294401, 4030367340, 4030366445, 4030364977, 4030364045, 4030362451, 4030361689, 4030360360, 4030359525, 4030358179, 4030357456, 4030356071, 4030355318, 4030353913, 4030353120, 4030351409, 4030351114, 4030349674, 4030349088, 4030347152, 4030346314, 4030344486, 4030343685, 4030341835, 4030341136, 4030339326, 4030338941, 4030337115, 4030336826, 4030335022, 4030334137, 4030332312, 4030331561, 4030329996, 4030328628, 4030326998, 4030326241, 4030324664, 4030323702, 4030322132, 4030319877, 4030319093, 4030316679, 4030314331, 4030312960, 4030311622, 4030310310, 4030309192, 4030308098, 4030306397, 4030305682, 4030303936, 4030303105, 4030301413, 4030300654, 4030299236, 4030298237, 4030296740, 4030295923, 4030286574, 4030285203, 4030283797, 4030282646, 4030280922, 4030279995, 4030278295, 4030277500, 4030276122, 4030274885, 4030274050, 4030272674, 4030271474, 4030270427, 4030269248, 4030268057, 4030266989, 4030265716, 4030264779, 4030263296, 4030262680, 4030261339, 4030258537, 4030257435, 4030256274, 4030254683, 4030253977, 4030252300, 4030251513, 4030250062, 4030249249, 4030247369, 4030245669, 4030244958, 4030243534, 4030242791, 4030241434, 4030240654, 4030239296, 4030238667, 4030237496, 4030236960, 4030235651, 4030235114, 4030233714, 4030233110, 4030231970, 4030231354, 4030230465, 4030229875, 4030228739, 4030228047, 4030226030, 4030224606, 4030223955, 4030222719, 4030222070, 4030220840, 4030220182, 4030218991, 4030218360, 4030217243, 4030216239, 4030215027, 4030213960, 4030213004, 4030211877, 4030210429, 4030209831, 4030208036, 4030207440, 4030206020, 4030205354, 4030203887, 4030203248, 4030201950, 4030201273, 4030199884, 4030199146, 4030197751, 4030197191, 4030195741, 4030195192, 4030194016, 4030193365, 4030191737, 4030190983, 4030189243, 4030188503, 4030178899, 4030178328, 4030177213, 4030176725, 4030175363, 4030174007, 4030173331, 4030172088, 4030171505, 4030170267, 4030169650, 4030168275, 4030167805, 4030166377, 4030165712, 4030164448, 4030163812, 4030162528, 4030162037, 4030160836, 4030160233, 4030158950, 4030158370, 4030157063, 4030156489, 4030155286, 4030154958, 4030148640, 4030147811, 4030147063, 4030146234, 4030145407, 4030144588, 4030143674, 4030142870, 4030142058, 4030141252, 4030140424, 4030139768, 4030139016, 4030138453, 4030137607, 4030137073, 4030135905, 4030135315, 4030134258, 4030133663, 4030132989, 4030131993, 4030131469, 4030130494, 4030129912, 4030128259, 4030123115, 4030122316, 4030121555, 4030120796, 4030120039, 4030119295, 4030118422, 4030117892, 4030117064, 4030116412, 4030115442, 4030114956, 4030114060, 4030113631, 4030112599, 4030112077, 4030111105, 4030110542, 4030109556, 4030109014, 4030108026, 4030107561, 4030106631, 4030106112, 4030105078, 4030104599, 4030103548, 4030102995, 4030102044, 4030101591, 4030100511, 4030099730, 4030098920, 4030098047, 4030097342, 4030096504, 4030095796, 4030095061, 4030094299, 4030093472, 4030092485, 4030091550, 4030091017, 4030089874, 4030089380, 4030088443, 4030087187, 4030086677, 4030085014, 4030084312, 4030083591, 4030082924, 4030082251, 4030081668, 4030080426, 4030079770, 4030079124, 4030078447, 4030077757, 4030077085, 4030076508, 4030075925, 4030052486, 4030052088, 4030051371, 4030050927, 4030049849, 4030049095, 4030048522, 4030047323, 4030046638, 4030046209, 4030045389, 4030045079, 4030044043, 4030043611, 4030042763, 4030042292, 4030041573, 4030041197, 4030040554, 4030039211, 4030038771, 4030037977, 4030037624, 4030036787, 4030036344, 4030035733, 4030035253, 4030034457, 4030033986, 4030033187, 4030032753, 4030031982, 4030031548, 4030030856, 4030030471, 4030029792, 4030029367, 4030028667, 4030028282, 4030027624, 4030027222, 4030026554, 4030026194, 4030025619, 4030025226, 4030024522, 4030024156, 4030023477, 4030023091, 4030022420, 4030022080, 4030021511, 4030021207, 4030020623, 4030020246, 4030019595, 4030019288, 4030447010, 4030446368, 4030441956, 4030440810, 4030440007, 4030438238, 4030437042, 4030436440, 4030434919, 4030434369, 4030433123, 4030432487, 4030431176, 4030430589, 4030429210, 4030428315, 4030427180, 4030425671, 4030425203, 4030423583, 4030422952, 4030421773, 4030421220, 4030419176, 4030417752, 4030416761, 4030415374, 4030414666, 4030410798, 4030409325, 4030408527, 4030407021, 4030406260, 4030404550, 4030403735, 4030402117, 4030401302, 4030399524, 4030398598, 4030396869, 4030395611, 4030394238, 4030392871, 4030391672, 4030390313, 4030387494, 4030385943, 4030384291, 4030383314, 4030380696, 4030379843, 4030378306, 4030377335, 4030375575, 4030374752, 4030372895, 4030371995, 4030370472, 4030369724, 4030368086, 4030367322, 4030365659, 4030364917, 4030362876, 4030361420, 4030360646, 4030359284, 4030358507, 4030356026, 4030354970, 4030353529, 4030350889, 4030349548, 4030346889, 4030345991, 4030343696, 4030340234, 4030339231, 4030338064, 4030335117, 4030332931, 4030331589, 4030329037, 4030327950, 4030324815, 4030322911, 4030321711, 4030320226, 4030317731, 4030316681, 4030314976, 4030313879, 4030312352, 4030311297, 4030309273, 4030308072, 4030306061, 4030305065, 4030302009, 4030300907, 4030299270, 4030297733, 4030296769, 4030295496, 4030294429, 4030292952, 4030291815, 4030289544, 4030287681, 4030286607, 4030284909, 4030283569, 4030282026, 4030280946, 4030278866, 4030277166, 4030273853, 4030273095, 4030271825, 4030269926, 4030268297, 4030267273, 4030266188, 4030261030, 4030256248, 4030291822, 4030290457, 4030289030, 4030287700, 4030367813, 4030350000, 4030254912, 4030253386, 4030252539, 4030250944, 4030250160, 4030248795, 4030246837, 4030245361, 4030243984, 4030236015, 4030234953, 4030234163, 4030232910, 4030231891, 4030231233, 4030229863, 4030229219, 4030227963, 4030225907, 4030224856, 4030223922, 4030219122, 4030217739, 4030216575, 4030214066, 4030211887, 4030209828, 4030171928, 4030170805, 4030440720, 4030440235, 4030438694, 4030438103, 4030435937, 4030435323, 4030417758, 4030417094, 4030413129, 4030409315, 4030407314, 4030405352, 4030396575, 4030392251, 4030391578, 4030389738, 4030389008, 4030387131, 4030386525, 4030383398, 4030382422, 4030380812, 4030379565, 4030377830, 4030376341, 4030375241, 4030373711, 4030372552, 4030370943, 4030370235, 4030345920, 4030344756, 4030343413, 4030342058, 4030340378, 4030339441, 4030337301, 4030336060, 4030334620, 4030332849, 4030331696, 4030329792, 4030329031, 4030327176, 4030325539, 4030216955, 4030111481, 4030108622, 4030106184, 4030105298, 4030104125, 4030099244, 4030098209, 4030093362, 4030086546, 4030085576, 4030084854, 4030080771, 4030080252, 4030073506, 4030069145, 4030068076, 4030065046, 4030064376, 4030060098, 4030054560, 4030033439, 4030025110, 4030013691, 4030013083, 4030368457, 4030347250, 03HKJRHG, 03HKHTHZ, 03HKHKNX, 03HKGZHT, 03HKGZBP, 03HKGYTP, 03HKGYMZ, 03HKGXXT, 03HKDDRD, 03HKDDLY, 03HKDCKQ, 03HKDBZM, 03HKBHWQ, 03HKBFSF, 03HKBFRC, 03HKBFMW, 03HKBFHT, 03HKBFBN, 03HKBFBG, 03HKBDWR, 03HKBDWK, 03HKBDLG, 03HKBDJF, 03HKBDGP, 03HKBDDQ, 03HKBCZF, 03CQXSLP, 03CQXRWK, 03CQXRHJ, 03CQXQYC, 03CQXPSM, 03CQXPLL, 03CQWZNV, 03CQWXFS, 03CQWWQQ, 03CQWWHX, 03CQWWBV, 03CQWTVS, 03CQWDZP, 03CQXSVV, 03CQWZJH, 03CQWYTJ, 03CQWYLX
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Louisville, KY, by facsimile and electronic notification on February 10, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from donors who were previously deferred for a history of high risk behavior, were distributed
VOLUME OF PRODUCT IN COMMERCE
658 units
DISTRIBUTION
Germany, Switzerland, IL, MD

___________________________________
PRODUCT
Source Plasma. Recall # B-0539-11
CODE
Units: 5020142087; 5020140902; 5020137403; 5020134169; 5020133482; 5020132354; 5020131366; 5020130627; 5020129100; 5020128479; 5020121435; 5020143056; 5020115206; 5020113103; 5020112185
RECALLING FIRM/MANUFACTURER
Octapharma Plasma Inc., Omaha, NB, by email on October 13, 2010.  Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
Australia
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0540-11
CODE
Unit: N53105
RECALLING FIRM/MANUFACTURER
Virginia Blood Service Inc., Richmond, VA, by telephone on September 10, 2010 and follow up letter dated October 5, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0541-11
CODE
Units: W1151100273966; W1151100273966; W1151100273966
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by fax on November 2, 2010. Firm initiated recall is complete
REASON
Blood products, labeled leukoreduced which did not meet the requirements for leukoreduced products, were distributed.  
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL, AL
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0543-11
2) Platelets. Recall # B-0545-11
CODE
1) Units: W043210026177; W043210011493; W043209043002;
2) Unit: W043209043002
RECALLING FIRM/MANUFACTURER
Blood Assurance Inc., Chattanooga, TN, by fax on October 18 and 23, 2010. Firm initiated recall is complete
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NY, TN
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0546-11
CODE
Unit: W0416100398366
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc/dba United Blood Services, Meridian, MS, by telephone and fax on September 13, 2010. 
Manufacturer: Blood Systems Inc/dba United Blood Services, Tupelo, MS. 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
MS
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0547-11
CODE
Unit: W043210077070
RECALLING FIRM/MANUFACTURER
Blood Assurance Inc., Chattanooga, TN, by telephone on October 8, 2010. Firm initiated recall is complete.
REASON
Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0548-11  
CODE
Unit: W038110208934
RECALLING FIRM/MANUFACTURER
Recalling Firm: Florida's Blood Centers - Lake Park, Lake Park, FL, by telephone on September 1, 2010. 
Manufacturer: Florida's Blood Centers, Inc. - Pt. St. Lucie, Port St Lucie, FL. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated Washed. Recall # B-0549-11
CODE
Unit: W066510602216
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK, by telephone and fax on October 19, 2010. Firm initiated recall is complete.
REASON
Blood product, incorrectly labeled as negative for the Jka antigen, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Alaska
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0551-11
CODE
Unit: 20KK60908
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Salt Lake City, UT, by the LOGICS system, fax and letters on September 17, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, UT
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0552-11
CODE
Unit: W071210043675
RECALLING FIRM/MANUFACTURER
Medic Inc., Knoxville, TN, by letter dated September 10, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0553-11  
CODE
Units: W038110202002; W038110139902; W038110073054
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Melbourne, FL, by telephone and follow-up letter on September 9, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0554-11
CODE
Unit: W115110002338M
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Mobile, AL, by fax on October 12, 2010. Firm initiated recall is complete.
REASON
Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
 1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0557-11;
2) Cryoprecipitated AHF. Recall # B-0559-11
CODE
1) Unit: 84FT28669;
2) Unit: POOLID4204
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Oakland, CA, by Observation Report on August 18, 2010 and fax on August 19, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
 Red Blood Cells Leukocytes Reduced. Recall # B-0573-11
CODE
Unit: 003GQ15420
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA, by telephone and email on March 27, 2007 and follow-up letter on March 29, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, GA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0576-11
CODE
Unit: 49FS00859
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross. Tulsa, OK, by telephone on November 29, 2007.
Manufacturer: American National Red Cross SW Region – HT, Tulsa, OK.  Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL, CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0578-11
CODE
Unit: 49LG91238
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Tulsa, OK, by telephone on November 1, 2007.
Manufacturer: American Red Cross, Waco, TX. Firm initiated recall is complete. 
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK, CA

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS III
___________________________________
PRODUCT
Source Leukocytes. Recall # B-0542-11  
CODE
Recall # W066210032525
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ, by fax on October 13, 2010. Firm initiated recall is complete
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.  
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0544-11
CODE
Units: W043210026177; W043210011493; W043209043002
RECALLING FIRM/MANUFACTURER
Blood Assurance Inc., Chattanooga, TN, by fax on October 18 and 23, 2010. Firm initiated recall is complete
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NY, TN
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0550-11
CODE
Unit: 20KK60908
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Salt Lake City, UT, by the LOGICS system, fax and letters on September 17, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, UT
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0555-11
CODE
Units: W038110143893; W038110143893; W038110181719; W038110181719; W038110206041; W038110206041
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by letters dated August 27, 2010, August 31, 2010 and September 22, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to an area endemic for leishmaniasis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0556-11
CODE
Units: 011KT16695; 011KT16695 (split product)
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Saint Louis, MO, by letter dated August 20, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
France, CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0558-11
CODE
Unit: 84FT28669
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Oakland, CA, by Observation Report on August 18, 2010 and fax on August 19, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
____________________________________
PRODUCT
Plasma. Recall # B-0570-11
CODE
Unit: 7686286
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc., Long Island City, NY, by telephone on February 1, 2008 and by letter dated February 7, 2008. Firm initiated recall is complete.
REASON
Blood product, labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
Plasma Frozen. Recall # B-0574-11
CODE
Unit: 003GQ15420
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA, by telephone and email on March 27, 2007 and follow-up letter on March 29, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, GA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0575-11
CODE
Unit: 49FS00859
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross. Tulsa, OK, by telephone on November 29, 2007.
Manufacturer: American National Red Cross SW Region – HT, Tulsa, OK.  Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL, CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0577-11
CODE
Unit: 49LG91238
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Tulsa, OK, by telephone on November 1, 2007.
Manufacturer: American Red Cross, Waco, TX. Firm initiated recall is complete. 
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK, CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0579-11
CODE
Units: 49FP27237 Part 1; 49FP27237 Part 2; 49FP27237 Part 3; 49FP27238 Part 1; 49FP27238 Part 2; 49FP27238 Part 3; 49FP27264 Part 1; 49FP27264 Part 2; 49FP27264 Part 3; 49FP27291 Part 1; 49FP27291 Part 2; 49FP27291 Part 3; 49FP27297 Part 1; 49FP27297 Part 2; 49FP27297 Part 3; 49FP27357 Part 1; 49FP27357 Part 2; 49FP27357 Part 3
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Tulsa, OK, by telephone on June 26, 2008.
Manufacturer: American National Red Cross SW Region – HT, Tulsa, OK. Firm initiated recall is complete
REASON
Blood products, for which the quality control testing was incomplete, were distributed
VOLUME OF PRODUCT IN COMMERCE
18 units
DISTRIBUTION
OK, TX, MA

RECALLS AND FIELD CORRECTIONS:  DEVICES – CLASS I     
___________________________________
PRODUCT
1) AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm, 4.0 mm x 20 mm balloon size. Part (REF) number: 2076-4020. Recall # Z-0838-2011;

2) AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm, 5.0 mm x 20 mm balloon size, Part (REF) number: 2076-5020. Recall # Z-0839-2011;

3) AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm, 6.0 mm x 20 mm balloon size, Part (REF) number: 2076-6020. Recall # Z-0840-2011;

4) AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 90 cm, 6.0mm x 20 mm balloon size, Part (REF) number: 2092-6020. Recall # Z-0841-2011;

5) AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 50 cm, 6.0mm x 20 mm balloon size, Part (REF) number: 2105-6020. Recall # Z-0842-2011  
CODE
All lot codes
RECALLING FIRM/MANUFACTURER
AngioScore Inc., Fremont, CA, by letter on November 10, 2010 and November 16, 2010. Firm initiated recall is ongoing.
REASON
Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. May result in vessel injury or embolism.
VOLUME OF PRODUCT IN COMMERCE
16,132 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II
___________________________________
PRODUCT
Access Immunoassay Systems, Part Number: 81600 ; Access 2 Immunoassay Systems, Part Number: 81600N; Synchron LXi 725; UniCel DxI 800 Access Immunoassay Systems, Part Number: 973100; UniCel DxI 600 Access Immunoassay Systems, Part Number A30260; UniCel DxC 600i, Part Number: A25656; UniCel DxC 660i, Part Number: A64871; UniCel DxC 860i, Part Number: A64935; UniCel DxC 880i, Part Number: A59102; SYNCHRON Access Clinical Systems The Access/DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentration found in human body fluids. Function of the Peristaltic Pump: to aspirate unbound material from reaction vessels and to move waste from vacuum jar into waste bottle through associated tubing within the Access Immunoassay System. Recall # Z-0607-2011
CODE
All versions
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letters dated August 13, 2010.
Manufacturer: Beckman Coulter, Inc., Chaska, MN. Firm initiated recall is ongoing.
REASON
This recall was initiated because Beckman Coulter has received reports of erroneous test results being reported as a result of assay reagent packs being transferred between systems. Erroneous results will be generated as a result of missing or incorrect assay reagents. In these cases both false positive and false negative results are possible, depending upon the assay configuration.
VOLUME OF PRODUCT IN COMMERCE
9571 instruments
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
The PercuNav MP008R-B Button Probe is designed to be used with Philips (formerly Traxtal) PercuNav Image Guided Intervention System. Some of the clinical applications of the Button Probe require sterility and others may not. However, it is possible that patient contamination could occur if a non-sterile Button Probe is used in clinical applications where aseptic technique is required. The device's labeled in part: " TRAXTAL PERCUNAV...(1) Button Probe Right hand version, 25mm... STERILE...For use with Traxtal's PercuNav system only. Do not use if package is opened or damaged. Dispose of safely after single use to avoid risk of infection...Rx only...Use immediately after opening unit package. Store at room temperature". Recall # Z-0617-2011
CODE
Lot codes and Expiry Date: I280903 (09-2012); C151005 (03-2013); E111003 (05-2013); and E251002 (05-2013)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Healthcare Inc., Andover, MA, letters dated November 10, 2010. 
Manufacturer: Traxtal,A Philips Healthcare Co., Toronto, Canada. Firm initiated recall is ongoing.
REASON
The protective cover over the tip of the MP008R-B Button Probe may fall off, causing the probe tip to damage the packaging and compromise the sterility of the probe.  
VOLUME OF PRODUCT IN COMMERCE
25 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Stryker Titanium Intraline Anchor, Model Numbers 3910400050, 3910400055, 3910400060, 3910400065, Soft Eyelet Anchor. Recall # Z-0618-2011
CODE
Serial numbers: 09049AE2, 09050AE2, 09051AE2, 09052AE2, 09054AE4
RECALLING FIRM/MANUFACTURER
Stryker Endoscopy, San Jose, CA, letter dated August 21, 2009. Firm initiated recall is ongoing. 
REASON
Potential breakage -- product may break while inserting it into the bone during surgery. This may prolong surgery, or, if undetected during surgery, result in retained fragments that may cause metal sensitization or immune response, or necessitate further intervention to retrieve the titanium fragments.
VOLUME OF PRODUCT IN COMMERCE
447 units
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
Inter-Op Acetabular System Hooded Trial Insert size 32mm/57mm, non-sterile, REF 9363-32-057. Recall # Z-0619-2011
CODE
Unit: 61438482
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer Inc., Warsaw, IN, by telephone on November 15, 2010. 
Manufacturer: Accellent Orthopaedics, Houston, PA. Firm initiated recall is ongoing.
REASON
Mislabeled - Device packages labeled as hooded trial inserts contain standard trial inserts.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
KS, UT and Canada
___________________________________
PRODUCT
Cmax Surgical Tables, Model #'s: Cmax110, Cmax 220. Recall # Z-0624-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Steris Corp., Mentor, OH, letters dated August 26, 2010. 
Manufacturer: Steris Corp., Montgomery, AL. Firm initiated recall is ongoing.
REASON
Cmax Surgical Tables may lose calibration if the table is operated only on battery power and if the table is in a low battery charge condition. This could result in the table moving into an unexpected tilt position when the Level button is depressed on the hand control keypad.
VOLUME OF PRODUCT IN COMMERCE
1,635 tables
DISTRIBUTION
Nationwide and countries of Australia, Canada, China, Columbia, Dominican Republic, India, Israel, Mexico, New Zealand, Saudi Arabia, Singapore, South Korea and Taiwan
___________________________________
PRODUCT
Model 4000 Monitor component of the LifeVest Wearable Defibrillator. Product number 10A0988-A01. Recall # Z-0625-2011
CODE
Serial numbers: 07000178, 07000196, 07000199, 07000202, 07000205, 07000211, 07000214, 07000223, 07000232, 07000241, 07000250, 07000265, 07000271, 07000289, 07000298, 07000301, 07000304, 07000307, 07000310, 07000313, 07000316, 07000325, 07000337, 07000343, 07000349, 07000355, 07000361, 07000373, 07000388, 07000397, 07000400, 07000409, 07000415, 07000427, 07000433, 07000436, 07000439, 07000448, 07000463, 07000466, 07000469, 07000472, 07000490, 07000496, 07000505, 07000511, 07000517, 07000520, 07000526, 07000529, 07000532, 07000538, 07000541, 07000574, 07000604, 07000628, 07000637, 07000646, 07000655, 07000658, 07000661, 07000697, 07000721, 07000730, 07000766, 07000769, 07000772, 07000784, 07000793, 07000796, 07000805, 07000808, 07000811, 07000820, 07000826, 07000838, 07000847, 07000853, 07000862, 07000877, 07000880, 07000883, 07000895, 07000898, 07000904, 07000913, 07000916, 07000919, 07000928, 07000937, 07000940, 07000943, 07000946, 07000955, 07000958, 07000976, 07000979, 07001006, 07001012, 07001018, 07001021, 07001024, 07001027, 07001030, 07001039, 07001042, 07001045, 07001066, 07001069, 07001072, 07001075, 07001081, 07001084, 07001087, 07001090, 07001105, 07001108, 07001111, 07001117, 07001120, 07001123, 07001126, 07001132, 07001138, 07001144, 07001147, 07001150, 07001153, 07001171, 07001174, 07001177, 07001180, 07001186, 07001195, 07001201, 07001204, 07001210, 07001216, 07001222, 07001225, 07001231, 07001234, 07001240, 07001243, 07001255, 07001270, 07001273, 07001285, 07001288, 07001291, 07001300, 07001303, 07001312, 07001315, 07001321, 07001324, 07001330, 07001333, 07001348, 07001360, 07001378, 07001381, 07001384, 07001387, 07001393, 07001396, 07001411, 07001414, 07001417, 07001423, 07001426, 07001432, 07001438, 07001441, 07001447, 07001450, 07001456, 07001462, 07001465, 07001483, 07001486, 07001492, 07001498, 07001510, 07001513, 07001525, 07001534, 07001543, 07001552, 07001564, 07001582, 07001594, 07001603, 07001606, 07001609, 07001615, 07001618, 07001624, 07001627, 07001630, 07001633, 07001636, 07001645, 07001648, 07001690, 07001696, 07001699, 07001702, 07001705, 07001708, 07001720, 07001723, 07001726, 07001735, 07001750, 07001753, 07001768, 07001780, 07001789, 07001804, 07001810, 07001813, 07001816, 07001828, 07001834, 07001837, 07001840, 07001843, 07001852, 07001855, 07001858, 07001861, 07001867, 07001870, 07001873, 07001879, 07001882, 07001885, 07001891, 07001897, 07001921, 07001924, 07001936, 07001942, 07001945, 07001951, 07001954, 07001957, 07001960, 07001963, 07001978, 07001981, 07001984, 07001999, 07002002, 07002008, 07002020, 07002032, 07002035, 07002047, 07002050, 07002071, 07002074, 07002077, 07002086, 07002089, 07002104, 07002110, 07002113, 07002119, 07002125, 07002134, 07002146, 07002149, 07002158, 07002167, 07002170, 07002173, 07002176, 07002179, 07002182, 07002185, 07002188, 07002191, 07002200, 07002212, 07002215, 07002227, 07002248, 07002251, 07002263, 07002266, 07002272, 07002278, 07002281, 07002287, 07002293, 07002299, 07002305, 07002308, 07002314, 07002317, 07002320, 07002329, 07002338, 07002344, 07002356, 07002365, 07002368, 07002380, 07002389, 07002392, 07002401, 07002413, 07002416, 07002428, 07002431, 07002437, 07002449, 07002455, 07002461, 07002467, 07002470, 07002473, 07002482, 07002488, 07002491, 07002494, 07002503, 07002512, 07002518, 07002524, 07002527, 07002530, 07002545, 07002548, 07002551, 07002554, 07002557, 07002563, 07002572, 07002575, 07002581, 07002593, 07002599, 07002602, 07002605, 07002611, 07002614, 07002623, 07002626, 07002629, 07002632, 07002650, 07002656, 07002659, 07002668, 07002671, 07002680, 07002683, 07002689, 07002692, 07002704, 07002707, 07002713, 07002722, 07002725, 07002728, 07002731, 07002752, 07002767, 07002776, 07002779, 07002785, 07002788, 07002791, 07002794, 07002800, 07002812, 07002815, 07002818, 07002821, 07002842, 07002845, 07002854, 07002857, 07002866, 07002869, 07002872, 07002875, 07002878, 07002881, 07002884, 07002899, 07002902, 07002905, 07002914, 07002929, 07002932, 07002935, 07002938, 07002941, 07002944, 07002950, 07002953, 07002962, 07002965, 07002968, 07002974, 07002983, 07002998, 07003004, 07003007, 07003010, 07003016, 07003022, 07003025, 07003028, 07003031, 07003043, 07003064, 07003070, 07003076, 07003079, 07003085, 07003088, 07003097, 07003106, 07003109, 07003112, 07003115, 07003118, 07003121, 07003133, 07003136, 07003142, 07003145, 07003151, 07003154, 07003157, 07003166, 07003169, 07003172, 07003175, 07003178, 07003184, 07003190, 07003193, 07003196, 07003199, 07003202, 07003205, 07003208, 07003211, 07003217, 07003220, 07003223, 07003238, 07003241, 07003253, 07003259, 07003268, 07003274, 07003280, 07003283, 07003292, 07003298, 07003301, 07003304, 07003310, 07003319, 07003322, 07003325, 07003328, 07003334, 07003337, 07003343, 07003352, 07003355, 07003361, 07003367, 07003370, 07003385, 07003391, 07003394, 07003400, 07003406, 07003409, 07003415, 07003424, 07003427, 07003430, 07003433, 07003460
RECALLING FIRM/MANUFACTURER
Zoll Lifecor Corp., Pittsburgh, PA, by letter and telephone beginning September 24, 2010. Firm initiated recall is ongoing.
REASON
The response button function may become intermittent. This can result in the device not progressing beyond the response button test during startup, which may prevent a conscious patient from delaying a treatment shock.  
VOLUME OF PRODUCT IN COMMERCE
494 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Prot�g� " GPS" Self-Expanding Biliary Stent System, Sterile EO, 14 mm 60mm 80 cm, REF SERB65-14-60-80, Rx only.  Prot�g� " GPS" Self-Expanding Biliary Stent System, Sterile EO, 12 mm 60mm 80 cm, REF SERB65-12-60-80, Rx only. Recall # Z-0626-2011
CODE
Lot 9199844 (REF SERB65-12-60-80) & 9199842 (REF SERB65-14-60-80)
RECALLING FIRM/MANUFACTURER
Ev3, Inc., Plymouth, MN, by letter dated September 29, 2010. Firm initiated recall is ongoing.
REASON
Mislabeled size: Specific Prot�g� GPS lots have product labeling that does not match the actual stent sizes contained in the packages. The affected product outer packaging is labeled as a 12 mm x 60 mm Prot�g� GPS stent but contains a 14 mm x 60 mm stent. This situation can potentially result in vessel damage. Conversely, a lot was labeled as a 14 mm x 60 mm Prot�g� GPS stent but actually contains 12 mm x 60 mm stent. This situation can lead to insufficient vessel apposition, and may result in stent migration.
VOLUME OF PRODUCT IN COMMERCE
30 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Wingspan Stent System, Model Number M003WE0300150, Indicated for use in improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy, in intracranial vessels with less than or equal to 50% stenosis that are accessible to the system. Recall # Z-0627-2011
CODE
Batch numbers 13215033 and 13192372
RECALLING FIRM/MANUFACTURER
Boston Scientific Corp., Fremont, CA, by letter dated 25 August 2010. Firm initiated recall is ongoing.
REASON
Products may not meet radial force specifications.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
China, Germany, Italy, the Philippines, Portugal and Turkey
________________________________________
PRODUCT
1) 1.5 mm Inion CPS Baby, 4 hole plate, REF PLT-1000, sterile. Recall # Z-0630-2011;
2)  1.5 mm Inion CPS Baby , 20 hole plate, REF PLT-1001, sterile. Recall # Z-0631-2011;
3) 1.5 mm Inion CPS Baby , C- plate 7 holes, REF PLT-1002, sterile. Recall # Z-0632-2011;
4) 1.5 mm Inion CPS Baby , X- plate 7 holes, REF PLT-1003, sterile. Recall # Z-0633-2011;
5) 1.5 mm Inion CPS Baby , 2 hole plate, REF PLT-1004, sterile. Recall # Z-0634-2011;
6) 1.5 mm Inion CPS, 4 hole plate, REF PLT-1005, sterile. Recall # Z-0635-2011;
7) 1.5 mm Inion CPS, 6 hole plate, REF PLT-1006, sterile. Recall # Z-0636-2011;
8) 1.5 mm Inion CPS, 20 hole plate, REF PLT-1007, sterile. Recall # Z-0637-2011;
9) 1.5 mm Inion CPS, C-plate, 7 holes, REF PLT-1008, sterile. Recall # Z-0638-2011;
10) 1.5 mm Inion CPS, L-plate right, 7 holes, REF PLT-1009, sterile.  Recall # Z-0639-2011;
11) 1.5 mm Inion CPS, L-plate left, 7 holes, REF PLT-1010, sterile. Recall # Z-0640-2011;
12) 1.5 mm Inion CPS, Burrhole plate, REF PLT-1011, sterile. Recall # Z-0641-2011;
13) 1.5 mm Inion CPS, X-plate, 7 holes, REF PLT-1012, sterile. Recall # Z-0642-2011;
14) 2.0 mm Inion CPS, 4 hole plate, REF PLT-1013, sterile. Recall # Z-0643-2011;
15) 2.0 mm Inion CPS, 4-hole plate, extended, REF PLT-1014, sterile. Recall # Z-0644-2011;
16) 2.0 mm Inion CPS, 10 hole plate, REF PLT-1016, sterile. Recall # Z-0645-2011
17) 2.0 mm Inion CPS, C-plate, 7 holes, REF PLT-1017, sterile. Recall # Z-0646-2011;
18) 2.5 mm Inion CPS, 4 hole plate, REF PLT-1023, sterile. Recall # Z-0647-2011;
19) 2.5 mm Inion CPS, 4 hole plate, extended, REF PLT-1024, sterile. Recall # Z-0648-2011;
20) 2.5 mm Inion CPS, 6 hole plate, REF PLT-1025, sterile. Recall # Z-0649-2011;
21) 2.5 mm Inion CPS, 6 hole plate,extended, REF PLT-1026, sterile, Recall # Z-0650-2011;
22) 2.5 mm Inion CPS, 8 hole plate, REF PLT-1027, sterile. Recall # Z-0651-2011;
23) 1.5 mm Inion CPS Baby, mesh plate 7 x 7 holes, REF PLT-1028, sterile. Recall # Z-0652-2011;
24) 1.5 mm Inion CPS Baby, Mesh plate 14 x 14 holes, REF PLT-1029, sterile. Recall # Z-0653-2011;
25) 1.5 mm Inion CPS, Mesh plate 7 x 7 10 holes, REF PLT-1030, sterile. Recall # Z-0654-2011;
26) 1.5 mm Inion CPS, Mesh plate 14 x 14 holes, REF PLT-1031, sterile. Recall # Z-0655-2011;
27) 2.0 mm Inion CPS, Mesh plate 7 x7 holes, REF PLT-1032, sterile. Recall # Z-0656-2011;
28) 2.0 mm Inion CPS, Mesh plate 14 x 14 holes, REF PLT-1033, sterile. Recall # Z-0657-2011;
29) 2.5 mm Inion CPS, Mesh plate 7 x 7 holes, REF PLT-1034, sterile. Recall # Z-0658-2011;
30) 2.5 mm Inion CPS, Mesh plate 14 x 14 holes, REF PLT-1035, sterile. Recall # Z-0659-2011;
31) 2.5 mm Inion CPS, 10 hole plate, REF PLT-1036, sterile. Recall # Z-0660-2011;
32) 2.0 mm Inion CPS, X-plate, 7 holes, REF PLT-1037, sterile. Recall # Z-0661-2011;
33) 2.0 mm Inion CPS, 6 hole plate, REF PLT-1038, sterile. Recall # Z-0662-2011;
34) 2.0 mm Inion CPS, L-plate right, 7 holes, REF PLT-1039, sterile. Recall # Z-0663-2011;
35) 2.0 mm Inion CPS, L-plate left, 7 holes, REF PLT-1040, sterile. Recall # Z-0664-2011;
36) 2.5 mm Inion CPS, 4 hole plate, extended long, REF PLT-1041, sterile. Recall # Z-0665-2011;
37) 1.5 mm Inion CPS Baby, 64 hole plate, REF PLT-1059, sterile. Recall # Z-0666-2011;
38) 1.5 mm Inion CPS Baby, X-plate, large, REF PLT-1062, sterile. Recall # Z-0667-2011;
39) 2.5 mm Inion CPS, 2.5 x 6 mm screw, REF SCR-1206, sterile. Recall # Z-0668-2011;
40) 2.5 mm Inion CPS, 2.5 x 8 mm screw, REF SCR-1207, sterile. Recall # Z-0669-2011;
41) 2.5 mm Inion CPS, 2.5 x 23 mm screw, REF SCR-1208, sterile. Recall # Z-0670-2011;
42) 2.8 mm Inion CPS, 2.8 x 23 mm screw, REF SCR-1209, sterile. Recall # Z-0671-2011;
43) 2.0 mm Inion CPS Baby, 2.0 x 5 mm screw, REF SCR-1210, sterile. Recall # Z-0672-2011;
44) 2.0 mm Inion CPS Baby, 2.0 x 7 mm screw, REF SCR-1211, sterile. Recall # Z-0673-2011;
45) 2.8 mm Inion CPS, 2.8 x 10 screw, REF SCR-1212, sterile. Recall # Z-0674-2011;
46) 2.8 mm Inion CPS, 2.8 x 12 mm screw, REF SCR-1213, sterile. Recall # Z-0675-2011;
47) 2.8 mm Inion CPS, 2.8 x 14 mm screw, REF SCR-1214, sterile. Recall # Z-0676-2011;
48) 2.8 mm Inion CPS, 2.8 x 16 mm screw, REF SCR-1215, sterile. Recall # Z-0677-2011
49) 2.8 mm Inion CPS, 2.8 x 18 mm screw, REF SCR-1216, sterile. Recall # Z-0678-2011;
50) 1.5 mm Inion CPS Baby, 1.5 x 4 mm screw, REF SCR-1220, sterile. Recall # Z-0679-2011;
51) 1.5 mm Inion CPS Baby, 1.5 x 6 mm screw, REF SCR-1221, sterile. Recall # Z-0680-2011;
52) 1.5 mm Inion CPS, 1.5 x 4 mm screw, REF SCR-1222, sterile. Recall # Z-0681-2011;
53) 1.5 mm Inion CPS, 1.5 x 6 mm screw, REF SCR-1223, sterile. Recall # Z-0682-2011;
54) 2.0 mm Inion CPS, 2.0 x 5 mm screw, REF SCR-1224, sterile. Recall # Z-0683-2011;
55) 2.0 mm Inion CPS, 2.0 x 7 mm screw, REF SCR-1225, sterile. Recall # Z-0684-2011;
56) 3.1 mm Inion CPS, 3.1 x 10 mm screw, REF SCR-1226, sterile. Recall # Z-0685-201;
57) 3.1 mm Inion CPS, 3.1 x 12 mm screw, REF SCR-1227, sterile. Recall # Z-0686-2011;
58) 3.1 mm Inion CPS, 3.1 x 14 mm screw, REF SCR-1228, sterile. Recall # Z-0687-2011;
59) 3.1 mm Inion CPS, 3.1 x 16 mm screw, REF SCR-1229, sterile. Recall # Z-0688-2011;
60) 3.1 mm Inion CPS, 3.1 x 18 mm screw, REF SCR-1230, sterile. Recall # Z-0689-2011;
61) 2.5 mm Inion CPS, 2.5 x 10 mm screw, REF SCR-1239, sterile. Recall # Z-0690-2011;
62) 2.5 mm Inion CPS, 2.5 x 12 mm screw, REF SCR-1240, sterile. Recall # Z-0691-2011;
63) 2.5 mm Inion CPS, 2.5 x 14 mm screw, REF SCR-1241, sterile. Recall # Z-0692-2011;
64) 2.5 mm Inion CPS, 2.5 x 16 mm screw, REF SCR-1242, sterile. Recall # Z-0693-2011;
65) 2.5 mm Inion CPS, 2.5 x 18 mm screw, REF SCR-1243, sterile. Recall # Z-0694-2011;
66) 2.0 mm Inion CPS, 2.0 x 9 mm screw, REF SCR-1284, sterile. Recall # Z-0695-2011;
67) 2.0 mm Inion CPS, 2.0 x 11 mm screw, REF SCR-1285, sterile. Recall # Z-0696-2011;
68) 2.0 mm Inion CPS, 2.0 x 13 mm screw, REF SCR-1286, sterile. Recall # Z-0697-2011;
69) 2.0 mm Inion CPS, 2.0 x 15 mm screw, REF SCR-1287, sterile. Recall # Z-0698-2011;
70) 2.0 mm Inion CPS, 2.0 x 17 mm screw, REF SCR-1288, sterile. Recall # Z-0699-2011
71) 2.0 mm Inion CPS, 2.0 x 20 mm screw, REF SCR-1289, sterile. Recall # Z-0700-2011;
72) 2.5 mm Inion CPS, 2.5 x 10 mm screw, REF SCR-1290, sterile. Recall # Z-0701-2011;
73) 2.5 mm Inion CPS, 2.5 x 12 mm screw, REF SCR-1291, sterile. Recall # Z-0702-2011;
74) 2.5 mm Inion CPS, 2.5 x 14 mm screw, REF SCR-1292, sterile. Recall # Z-0703-2011;  
75) 2.5 mm Inion CPS, 2.5 x 16 mm screw, REF SCR-1293, sterile. Recall # Z-0704-2011;
76) 2.5 mm Inion CPS, 2.5 x 18 mm screw, REF SCR-1294, sterile. Recall # Z-0705-2011;
77) 2.8 mm Inion CPS, 2.8 x 10 mm screw, REF SCR-1297, sterile. Recall # Z-0706-2011;
78) 2.8 mm Inion CPS, 2.8 x 12 mm screw, REF SCR-1298, sterile. Recall # Z-0707-2011;
79) 2.8 mm Inion CPS, 2.8 x 14 mm screw, REF SCR-1299, sterile. Recall # Z-0708-2011;
80) 2.8 mm Inion CPS, 2.8 x 16 mm screw, REF SCR-1300, sterile. Recall # Z-0709-2011;
81) 2.8 mm Inion CPS, 2.8 x 18 mm screw, REF SCR-1301, sterile. Recall # Z-0710-2011
CODE
Lot numbers of 0700000 and above.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Craniomaxillofacial Division, Portage, MI, by letter dated April 14, 2010.
Manufacturer: Oswald Leibinger, Muhlheim, Germany. Firm initiated recall is ongoing.
REASON
Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time of the plates/meshed is not defined.
VOLUME OF PRODUCT IN COMMERCE
8,631 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Comprehensive Reverse Shoulder Humeral Tray with Locking Ring, 49 mm standard, sterile, REF 115350, Intended for total shoulder replacement in a reverse configuration. Recall # Z-0712-2011;

2)  Custom Comprehensive Shoulder Bio-Modular Base, 44 mm Humeral Tray standard, sterile, REF CP561510, Intended for total shoulder replacement in a reverse configuration. Recall # Z-0713-2011
CODE
1) Lot numbers: 216080, 216090, 216100, 551630, 877130, 8877160, 877180 and 877200;
2) Lot numbers: 068700, 246790, 314260, 437920, 557030, 608210, 746530, 787230, 810390 and 883100
RECALLING FIRM/MANUFACTURER
Biomet Orthopedics, Warsaw, IN, by letter dated September 13, 2010. Firm initiated recall is ongoing.
REASON
The firm received complaints regarding fracturing of the device.
VOLUME OF PRODUCT IN COMMERCE
45 Units
DISTRIBUTION
NY, VA, MD, AL, CO, SD, TX, and OK

___________________________________
PRODUCT
 Polaris Spectra System Control Unit, a component of the StealthStation S7 System. Intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Recall # Z-0715-2011
CODE
Lots received from NDI (supplier) between May 1, 2020, and July 31, 2010
RECALLING FIRM/MANUFACTURER
Medtronic Navigation, Inc., Louisville, CO, by letter on November 5, 2010. Firm initiated recall is ongoing.
REASON
Electronic surgical navigation aid may lose tracking ability or stop working.
VOLUME OF PRODUCT IN COMMERCE
48 units
DISTRIBUTION
Nationwide and countries of Australia, Belgium, Canada, Czech Republic, Italy, Netherlands, Poland, Portugal, Saudi Arabia, Singapore, South Korea, Spain, Turkey, and UAE
___________________________________
PRODUCT
1) Boston Scientific brand Matrix2 2D Standard SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature. Recall # Z-0854-2011;

2) Boston Scientific brand Matrix2 Helical Soft SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature. Recall # Z-0855-2011;

3) Boston Scientific brand Matrix 2D Soft SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature. Recall # Z-0856-2011;

4) Boston Scientific brand Matrix 3D Omega Standard Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature. Recall # Z-0857-2011;

5) Boston Scientific brand Matrix2 Firm 2D Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature. Recall # Z-0858-2011;

6) Boston Scientific brand Matrix2 360 Soft SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature. Recall # Z-0859-2011;

7) Boston Scientific brand Matrix2 360 Standard SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature. Recall # Z-0860-2011;

8) Boston Scientific brand Matrix2 360 Firm Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature. Recall # Z-0861-2011;

9) Boston Scientific brand Matrix2 Helical UltraSoft SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature. Recall # Z-0862-2011;

10) Boston Scientific brand Matrix2 360 UltraSoft SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature. Recall # Z-0863-2011
CODE
1) Material Product Description Catalog # Batch Numbers Expiry Date Matrix2� 2D Standard SR Coils 11286278,11535148,11975068,11975079, Oct2010 through M003470103SRO 470103-SR 11985922,12156355,12156606,12176009, 10mm x30cm 12330517,12356322,12392934,13602979 Jun2013 M003470308SRO Matrix2� 2D Standard SR Coils 470308-SR 11766418,11775113 May2011 through 3mm x8cm May2011 Matrix2� 2D Standard SR Coils 11423155,11766419,11836539,11963593, Dec2010 through M003470410SRO 470410-SR 12156359,12176012,12260125,12358023, 4mm x 10cm 12792923, 13705207 Jul2013 M003470510SRO Matrix2� 2D Standard SR Coils 470510-SR 12246984 Nov2011 5mmx10cm Matrix2� 2D Standard SR Coils 11344392,11697463,11873433,11967353, Nov2010 through M003470515SRO 470515-SR 12156357, 12156624, 12176010, 12259384, 5mmx15cm 12368756,12469532 Feb2012 M003470610SRO Matrix2� 2D Standard SR Coils 470610-SR 11800373,12520967 May2011 through 6mmx10cm Mar2012 M003470615SRO Matrix2� 2D Standard SR Coils 470615-SR 11377053,11985920,13201010,13220262 Dec2010 through 6mmx15cm Dec2012 Matrix2� 20 Standard SR Coils 11414852,11869799,11925610,11967354, Dec2010 through M003470620SRO 470620-SR 12156352,12156602,12156627,12176016, 6mm x20cm 12261954, 12359026, 13015863, 13115971 Nov2012 M003470715SRO Matrix2� 2D Standard SR Coils 470715-SR 11622085,12379812,12853030 Mar2011 through 7mm x 15cm Jul2012 M003470720SRO Matrix2� 2D Standard SR Coils 470720-SR 11800378,11984852,13201011,13220457 May2011 through 7mm x20cm Oec2012 Matrix2� 2D Standard SR Coils 11869790,11925609,11940380,11992208, Jun2011 through .J1003470730SRO 470730-SR 12156353,12156605,12176081,12176125, 7mm x30cm 12261953,12311506 Dec2011 M003470820SRO Matrix2� 2D Standard SR Coils 470820-SR 11248568,11946183,13201012 Oct2010 through 8mm x20cm Dec2012 Matrix2� 2D Standard SR Coils 11552555, 11925611, 11940382, 11975162, Feb2011 through M003470830SRO 470830-SR 12176014,12261957,12316891,12361241, 8mm x 30cm 12401291 Jan2012 M003470920SRO Matrix2� 2D Standard SR Coils 470920-SR 13602873 9mm x20cm Jun2013 Matrix2� 2D Standard SR Coils 11869791, 11925176, 11975070, 11975185, Jun2011 through M003470930SRO 470930-SR 12156358,12156615,12176011,12261956, 9mm x30cm 12370630 Jan2012;

2) Material Product Description Catalog # Batch Numbers Expiry Date M003471204SRO Matrix2� Helical Soft SR Coils 471204-SR 11297523,12469527 Oct2010 through 2mm x4cm Feb2012 M003471206SRO Matrix2� Helical Soft SR Coils 471206-SR 11422256,11697451,11952856,12361059 Dec2010 through 2mm x6cm Dec2011 M003471208SRO Matrix2� Helical Soft SR Coils 471208-SR 11389025,11552556,12514612,13606645 Dec2010 through 2mm x8cm Jun2013;

3) Material Product Description Catalog # Batch Numbers Expiry Date M003471304SRO Matrix2� 2D Soft SR Coils 3mm 471304-SR 11391991,11697446,11721433,11775115, Dec2010 through x4cm 12579020 Mar2012 M003471306SRO Matrix2� 2D Soft SR Coils 3mm 471306-SR 11498868,11775116,12194493,12385403, Jan2011 through x6cm 12520966, 12861735 Jul2012 M003471308SRO Matrix2� 2D Soft SR Coils 3mm 471308-SR 11481348,11792449,11820171,12401292, Jan2011 through x8cm 12514514, 12792920 Jun2012 M003471310SRO Matrix2� 2D Soft SR Coils 3mm 471310-SR 11342011,11634830,12390151,12439220, Nov2010 through x 10cm 12982264 Sep2012 M003471406SRO Matrix2� 2D Soft SR Coils 4mm 471406-SR 11502704,11641203,12081496,12474445, Jan2011 through x6cm 12795286 Jun2012 11622088,11718835,11869785,11925599, 11940238,11985921,11992220,12156354, M003471408SRO Matrix2� 2D Soft SR Coils 4mm 471408-SR 12156603,12176007,12176017,12194725, Mar2011 through x8cm 12295449,12356324,12356325,12514591, Dec2012 12636738,12748405,12748465,12845925, 12891630,12906595,13200124 Matrix2� 2D Soft SR Coils 4mm 11310206,11552557,11766672,12119904, Oct2010 through M003471410SRO 471410-SR 12161473,12409142,12439231,12791147, x 10cm 12792538 Jun2012 M003471508SRO Matrix2� 2D Soft SR Coils 5mm 471508-SR 11622083,12176098,12229542,12721621, Mar2011 through x8cm 13020445 Sep2012 11800192,11869788,11925606,11940381, 11963592,11996801,12155987,12156601, M003471510SRO Matrix2� 2D Soft SR Coils 5mm 471510-SR 12176008,12194708,12314468,12330568, May2011 through x 10cm 12368755,12409141,12514589,12636752, Jun2013 12669963,12670049,12703140,12753166, 12792908,12861687,12981682,13603463 M003471515SRO Matrix2� 2D Soft SR Coils 5mm 471515-SR 11384554,11641206,12176118,12182654, Dec2010 through x 15cm 12246986,12649894,13020067 Sep2012 11384857,11748388,11925177,11940389, M003471610SRO Matrix2� 2D Soft SR Coils 6mm 471610-SR 11967352,12112307,12155988,12176015, Dec2010 through x 10cm 12330561,12356327,12374220,12847321, Aug2012 12947525,12971457 M003471615SRO Matrix2� 2D Soft SR Coils 6mm 471615-SR 11532410,11800196 Feb2011 through x 15cm May2011 1003471620SRO Matrix2� 2D Soft SR Coils 6mm 471620-SR 11373732,11634833,12261958,12649895, Dec2010 through x20cm 12792911 Jun2012 M003471710SRO Matrix2� 2D Soft SR Coils 7mm 471710-SR 12499178,13108359 Feb2012 through x 10cm Oct2012 M003471715SRO Matrix2� 2D Soft SR Coils 7mm 471715-SR 11820280,12229546,12249163 May2011 through x 15cm Nov2011 M003471720SRO Matrix2� 2D Soft SR Coils 7mm 471720-SR 11622084,11938494,12246985,12579366 Mar2011 through x20cm Mar2012 M003471820SRO Matrix2� 2D Soft SR Coils 8mm 471820-SR 11622082,11766666 Mar2011 through x20cm May2011 M003471830SRO Matrix2� 2D Soft SR Coils 8mm 471830-SR 11697466,12229584 Apr2011 through x30cm Nov2011;

4) Material Product Description Catalog # Batch Numbers Expiry Date M0034751030 Matrix2� 3D-Omega Standard 475103 13097570 Oct2012 Coils 1 Omm x 30cm M0034753060 Matrix2� 3D-Omega Standard 475306 13204826 Dec2012 Coils 3mm x 6cm M0034754060 Matrix2� 3D-Omega Standard 475406 13199749 Dec2012 Coils 4mm x 6cm M0034755080 Matrix2� 3D-Omega Standard 475508 13204829 Dec2012 Coils 5mm x 8cm M0034755100 Matrix2� 3D-Omega Standard 475510 13097571 Oct2012 Coils 5mm x 10cm;

5) Material Product Description Catalog # Batch Numbers Expiry Date M003480 1030 Matrix2� Firm 2D 10mm X 30cm 4801030 11253687,11766663 Oct2010 through 10mm X 30cm May2011 M0034801230 Matrix2� Firm 2D 12mm X 30cm 4801230 11766667,12707248 May2011 through 12mm X 30cm May2012 M0034801430 Matrix2� Firm 2D 14mm X 30cm 4801430 11697099 Apr2011 14mm X 30cm M0034801630 Matrix2� Firm 20 16mm X 30cm 480163 11426183,11766662 Dec2010 through 16mm X 30cm May2011 M0034801830 Matrix2� Firm 20 18mm X 30cm 4801830 11411206 Dec2010 18mm X 30cm M0034802030 Matrix2� Firm 20 20mm X 30cm 480203 11777398 May2011 20mm X 30cm M0034805150 Matrix2� Firm 20 5mm X 15cm 480515 11777399 May2011 5mm X 15cm M0034806150 Matrix2� Firm 20 6mm X 15cm 480615 11757096 Apr2011 6mm X 15cm M0034807200 Matrix2� Firm 20 7mm X 20cm 480720 11748387,12365836 Apr2011 through 7mm X20cm Jan2012 M0034808300 Matrix2� Firm 20 8mm X 30cm 480830 11297219,11991894,12365835 Oct2010 through 8mm X30cm Jan2012 M0034809300 Matrix2� Firm 20 9mm X 30cm 480930 11411626,11622081,12365834 Dec2010 through 9mm X30cm Jan2012;

6) Material Product Description Catalog # Batch numbers Expiry Date 11327721,11504445,11552548,11598084, Matrix2� 360 Soft SR Coils 3mm 11658821,11992209,12061946,12074034, Nov2010 through M003490304SRO 490304-SR 12142090,12194733,12229550,12260121, x4cm 12439221,12514518,12570927,12579017, Aug2012 12792914, 12899133 11249858,11314331,11340645,11474490, 11552544,11598080,11658789,11712104, 11730236,11748424,11829804,11850851, 11889315,11924291,11958451,11991899, 11992200,12009564,12061951,12067387, 12074300,12119830,12119908,12142037, Matrix2� 360 Soft SR Coils 3mm 12186121,12194487,12194492,12194709, Oct2010 through ,1003490306SRO 490306-SR 12194729,12214847,12229676,12291688, x6cm 12311954,12315364,12317008,12404354, Dec2012 12431055,12439440,12465571,12514602, 12636739,12670100,12698231,12721495, 12748470,12792883,12810371,12856503, 12861688,12874522,12922027,12929077, 12982322,13164432,13164796,13165110, 13204836 11391994,11451245,11497223,11560544, 11622024,11697452,11697465,11730229, 11790203,11820285,11889311,12009567, 12009651,12043116,12061789,12067386, 12074308,12119826,12119905,12141858, 12142023,12142080,12194713,12194748, M003490308SRO Matrix2� 360 Soft SR Coils 3mm 490308-SR 12229543,12229557,12291689,12311955, Oec2010 through x8cm 12388033,12401320,12418209,12514601, Aug2013 12549500,12549515,12579001,12579011, 12636731,12669965,12669977,12695189, 12698227,12748429,12783352,12792903, 12861733,12878386,12922007,12947549, 12982323,12982331,13108353,13165103, 13611875,13740715 11248431,11435810,11488182,11538866, 11560545,11580674,11586995,11790201, 11820178,11850847,11873431,11925605, 11940385, 11975165, 11975196, 11992221, 12043112,12102495,12102570,12130816, Matrix2� 360 Soft SR Coils 4mm 12141856,12142021,12156618,12176087, Oct2010 through M003490406SRO 490406-SR" 12176123,12214854,12267374,12320493, x6cm 12324045,12330630,12358025,12376354, Dec2012 12401323, 12404357, 12427985, 12434604, 12446873,12579365,12589398,12636758, 12669962,12669976,12703153,12810347, 12861698,12903423,12922029,12947553, 13016331, 13165116 11293329,11378006,11388501,11399189, 11435809,11440484,11486119,11535146, 11552543,11560543,11597979,11622027, 11658787,11676144,11676159,11718824, 11873435,11889920,11908086,11958455, 11975069,11975169,11992215,12009576, 12009646,12026499,12043220,12061955, 12082847,12119839,12130814,12142089, 12156612,12156625,12175821,12176089, 12176103,12176120,12214807,12214856, Matrix2� 360 Soft SR Coils 4mm 12225445,12226291,12228156,12260124, Oct2010 through M003490408SRO 490408-SR 12330661,12370631,12372625,12374139, x8cm 12377446,12388031,12439195,12439232, Jun2013 12465567, 12474440, 12474444, 12495244, 12514511,12514582,12514604,12553672, 12567223, 12570928, 12582206, 12636730, 12636747, 12670043, 12688725, 12703180, 12753145,12753168,12792891,12792918, 12856252,12861683,12861699,12882522, 12909275,12922001,12947529,12947548, 12981235,12982325,12982333,13113667, 13164429,13165088,13165106,13204887, 13614550 11241568,11295953,11318655,11388824, 11418198,11418199,11516242,11552539, 11598087,11676147,11756825,11838296, 11838633,11869781,11889923,11925601, 11940383,11963587,11975076,11975177, 11992204, 11992211, 12009654, 12047550, 12102498,12102572,12112301,12127497, 12142022,12142032,12161233,12194719, M003490510SRO Matrix2� 360 Soft SR Coils 5mm 490510-SR 12194746,12210213,12228826,12229587, Oct2010 through x 10cm 12330645, 12368750, 12370623, 12379815, Aug2013 12427984, 12434603, 12465569, 12495250, 12549419,12549506,12549519,12577901, 12579023,12669966,12669974,12698233, 12703157,12703197,12792900,12810352, 12859278, 12861729, 12902494, 12914299, 12921998, 12947534, 12982326, 12982334, 13016338,13026037,13115713,13165098, 13182062,13190678,13740723 11241926,11323157,11388508,11411633, 11472604,11497222,11497859,11552549, 11606463,11640894,11676145,11721432, 11756827,11820291,11850795,11869792, 11889924,11938493,11940586,11963588, 11967351,11975074,11975172,12000344, 12018387,12047344,12102497,12110476, 12112237,12127025,12142024,12142083, 12161228,12194730,12214802,12214859, M003490515SRO Matrix2� 360 Soft SR Coils 5mm 490515-SR 12229580,12260120,12300881,12306629, Oct2010 through x 15cm 12315370,12325704,12330628,12358024, Dec2012 12388029,12392932,12404351,12404358, 12409148,12413361,12424871,12434608, 12439355,12579003,12632701,12669001, 12670051,12698225,12703147,12703181, 12721620,12721636,12792915,12810345, 12810362,12856010,12861695,12888522, 12909744,12920953, 12921984, 12922004, 12929263,12982271,13165090,13165119, 13182076 11299320,11329549,11340642,11489571, 11552541,11712108,11721431,11748391, 11869789,11908094,11963589,11967349, 11975170,12061949,12074316,12141375, 12156611,12169000,12176013,12176090, M003490610SRO Matrix2� 360 Soft SR Coils 6mm 490610-SR 12214809,12259818,12291684,12295456, Oct2010 through x 10cm 12311956,12330632,12378758,12392930, Jan2013 12401019,12404355,12404521,12424874, 12431054,12431056,12434610,12579027, 12669978,12792895,12918642,12947544, 12982272,12990294,13016325,13113185, 13164431,13182075,13233311 11319664,11344931,11404790,11491182, 11535755, 11552536, 11591703, 11606465, 11658794,11676146,11766676,11800186, 11838299,11850782,11850790,11850850, 11889929,11924290,11934376,11975181, 11992205,12009572,12009647,12061952, 12067384,12074309,12074310,12119828, 12119837,12130808,12142039,12187530, M003490615SRO Matrix2� 360 Soft SR Coils 6mm 490615-SR 12194495,12194712,12194740,12214819, Nov2010 through x 15cm 12299317,12299410,12306630,12315369, Sep2012 12356256,12358026,12401293,12404352, 12404356, 12413360, 12413362, 12424875, 12434602,12439442,12577739,12579015, 12632700,12669000,12670054,12703188, 12721627,12748472,12810341,12810348, 12838009, 12849284, 12860900, 12861724, 12903859,12906596,12921997,12922014, 12981467, 13015393, 13016327 Matrix2� 360 Soft SR Coils 7mm 11396531,11552538,11766668,11992206, Dec2010 through M003490710SRO 490710-SR 12074303, 12259819, 12370622, 12431053, x 10cm 12964403 Aug2012 11247286,11330876,11399084,11520021, 11591598,11697443,11697461,11730232, 11756828,11916973,11991893,12026494, 12047549,12051396,12119832,12168018, 12188228,12194707,12194754,12214195, M003490715SRO Matrix2� 360 Soft SR Coils 7mm 490715-SR 12225279,12291685,12296703,12315365, Oct2010 through x 15cm 12330625,12356320,12365840,12392933, Aug2013 12404522,12409149,12434607,12439356, 12549524,12579012,12636741,12670048, 12783355,12810342,12912905,12922030, 12982327,12982335,13182064,13202907, 13740724 11377048,11388828,11433319,11475013, 11491419,11497447,11560339,11697464, 11730226, 11748420, 11756830, 11829805, M003490720SRO Matrix2� 360 Soft SR Coils 7mm 490720-SR 11838635, 11908085, 11985698, 12102494, Dec2010 through x20cm 12102565,12127495,12161470,12214855, Dec2012 12228403,12519871,12549526,12703220, 12791151,12792885,12917401,12982273, 13164433,13174305 11249122,11307527,11396327,11521506, 11552545,11622021,11712106,11748392, 11756831,11850798,11869806,11940395, 11963590,11975175,12018395,12061950, 12082824,12102573,12130175,12155990, M003490820SRO Matrix2� 360 Soft SR Coils 8mm 490820-SR 12176091,12176132,12214706,12214712, Oct2010 through x20cm 12214848,12295450,12295454,12296712, Dec2012 12296713,12304194,12304198,12330636, 12358027,12364673,12474441,12514599, 12577900, 12636735, 12792882, 12922025, 12982274,13016323,13115792,13164434, 13182066 11342412,11475011,11504449,11543008, 11560541, 11658790, 11676153, 11790202, M003490830SRO Matrix2� 360 Soft SR Coils 8mm 490830-SR 11850783, 11850796,11946181,12047553, Nov2010 through x30cm 12119902,12214863,12225442,12229613, Dec2012 12567225, 12636736, 12906335, 12947546, 13019231,13164435,13181899,13190677;

7) Material Product Description Catalog # Batch numbers Expiry Date 11322013,11341317,11395760,11407118, 11484317,11500845,11538872,11580676, 11586996,11591704,11676172,11786207, 11800707,11843132,11889308,11889310, 11924294, 11946182, 11975161, 11975197, Matrix2� 360 Standard SR Coils 12000345,12119829,12127493,12156626, Nov2010 through M003492103SRO 492103-SR 12176110, 12194735, 12214709, 12214800, 10mm x 30cm 12214853, 12229661, 12291690, 12299408, Jun2013 12315367,12330591,12409146,12418207, 12439180,12439189,12514594,12669964, 12670044,12703195,12791152,12792881, 12863906,12909368,12913888,12921982, 13165100,13182071,13602875 11296519,11329483,11422711,11477789, 11606464,11711221,11712103,11786210, 11908091,11924295,11940396,11975180, 11996498,12009649,12112236,12119825, Matrix2� 360 Standard SR Coils 12141857,12156617,12214707,12214715, Oct2010 through M003492123SRO 492123-SR 12214861,12291695,12295742,12314469, 12mm x 30cm 12392928,12401322,12458011,12462033, Jun2013 12519869, 12523479, 12669970, 12810344, 12861691,12912140,12920952,12921980, 12921996,12982276,13164798,13165084, 13603462 Matrix2� 360 Standard SR Coils 11286172,11327021,11552550,11756832, Oct2010 through M003492308SRO 492308-SR 11792451,12082838,12194728,12494078, 3mm x8cm 12947522 Aug2012 11310925,11340517,11513571,11598083, 11748422,11820289,11850852,11924296, 11940398,11975077,12007427,12026497, Matrix2� 360 Standard SR Coils 12026741,12074031,12074306,12110477, Oct2010 through M003492408SRO 492408-SR 12130818,12142084,12156609,12176095, 4mm x8cm 12176129,12214851,12304396,12418211, Dec2012 12434605, 12439350, 12579013, 12702894, 12721623,12792899,12810370,12917824, 12947545, 13164799 11289583,11341604,11500842,11622022, M003492510SRO Matrix2� 360 Standard SR Coils 492510-SR 11730241, 11786201, 11820321, 12194490, Oct2010 through 5mm x 10cm 12214705, 12434606, 12450913, 12465570, Aug2012 12922017 11299199,11318111,11389194,11500843, 11550742,11606466,11697460,11711220, 11748398,11838629,11889318,11916974, 11958443,11958463,11984850,12043111, 12061948,12082851,12086034,12142091, M003492515SRO Matrix2� 360 Standard SR Coils 492515-SR 12150131,12176136,12188226,12194738, Oct2010 through 5mmx15cm 12214194,12225443,12229718,12330640, Aug2013 12361044,12378759,12383763,12431052, 12439197, 12636726, 12656660, 12792894, 12805887,12861538,12861680,12899138, 12921993,12922024,12929260,12982324, 13164797,13182067,13197169,13740709 Matrix2� 360 Standard SR Coils 11300189,11697441,11748423,12102562, Oct2010 through M003492610SRO 492610-SR 12194744,12650932,13109926,13201013, 6mm x 10cm 13220484 Dec2012 11281622,11311916,11314681,11491189, 11521070, 11591707, 11676160, 11730225, 11766704,11838625,11934378,11958468, 11975166,11975191,11992203,11992212, 12009577,12009653,12082842,12130810, Matrix2� 360 Standard SR Coils 12142036,12161320,12168019,12176126, Oct2010 through M003492615SRO 492615-SR 12214841,12229589,12300888,12330615, 6mmx15cm 12379816, 12388035,12409150,12427992, Dec2012 12439353, 12519870, 12549504, 12549518, 12636727, 12670053, 12721624, 12748411, 12791149, 12792892, 12861690, 12889253, 12912271,12922000,12947541,12982277, 13016751,13165091 Matrix2� 360 Standard SR Coils 11311649,11552534,11697440,11697450, Oct2010 through M003492715SRO 7mm x 15cm 492715-SR 11766703,12176124,12229551,12372622, Dec2012 12494180,12698228,12922016,13201014 11325958,11330877,11448223,11516241, 11591599, 11640896, 11676142, 11676149, 11766671, 11786209, 11795499, 11820176, 11868816,11925596,11975072,11975182, 11992202,11992218,12009562,12009570, M003492720SRO Matrix2� 360 Standard SR Coils 492720-SR 12051397,12082854,12142030,12188227, Nov2010 through 7mm x20cm 12194711,12194747,12214845,12225440, Jul2013 12291691,12299412,12314471,12324046, 12355111,12401321,12409152,12418208, 12427990,12636754,12810346,12841940, 12861722, 12917822, 12922005, 12947520, 12947528, 13165089, 13705204 11303726, 11344541, 11491183, 11597978, 11697453,11730059,11766677,11800708, M003492820SRO Matrix2� 360 Standard SR Coils 492820-SR 11836538,11838623,11958239,12043226, Oct2010 through 8mm x20cm 12130809,12194736,12260123,12388030, Jun2013 12669969, 12791148, 12792880, 12922002, 13201015, 13202909, 13606213 11310595,11410936,11470446,11552546, 11606467,11658788,11712109,11766665, 11800187,11838294,11869782,11925588, 11975179,11992216,12009571,12043110, Matrix2� 360 Standard SR Coils 12061953, 12069212, 12074311, 12119903, Oct2010 through M003492830SRO 492830-SR 12150137,12188230,12194489,12194704, 8mm x30cm 12229669, 12291686, 12296707, 12314472, Dec2012 12330585,12356257,12361056,12636753, 12669979, 12703142, 12753169, 12783354, 12792913, 12895634, 12899136, 12912676, 12922009,13165096 .,tl003492920SRO Matrix2� 360 Standard SR Coils 492920-SR 11318113,11441724,11542877,11711222, Nov2010 through 9mm x20cm 11838626,12150132,12579018,13614169 Jun2013 11290201,11318378,11403946,11488185, 11520165,11598081,11658797,11748390, 11889313,11940587,11952858,12009643, 12026498,12061945,12069211,12074037, Matrix2� 360 Standard SR Coils 12130804,12176121,12194485,12194498, Oct2010 through M003492930SRO 492930-SR 12194734,12229597,12295451,12296708, 9mm x 30cm 12325703,12355110,12549418,12549503, Aug2013 12564285,12579005,12589397,12656661, 12669971,12792539,12792897,12853506, 12861697,12891631,12922012,12982278, 13182063, 13204832, 13740457;

8) Material Product Description Catalog # Batch numbers Expiry Date Matrix2� 360 Firm Coils 1 Omm x 11252548,11403351,11513899,11552537, Oct2010 through M0034941 030 494103 11640881,12009568,12102561,12229607, 30cm 12365838, 12366382 Jan2012 M0034941230 Matrix2� 360 Firm Coils 12mm x 494123 11560338,11766417,11782395,11925586, Feb2011 through 30cm 12026743, 12316656, 12636596 Apr2012 11244766,11336915,11456769,11484774, M0034941430 Matrix2� 360 Firm Coils 14mm x 494143 11526777, 11766660, 11850791, 11958233, Oct2010 through 30cm 11958454,12317003,12396265,12753164, Jan2013 13165081,13182077,13230095 11253266,11336717,11454608,11489048, M0034941630 Matrix2� 360 Firm Coils 16mm x 494163 11526778,11697444,11697471,11958444, Oct2010 through 30cm 12176133,12214864,12319343,12396264, Dec2012 12859706, 13194482 11385269,11389724,11454839,11498643, M0034941 830 Matrix2� 360 Firm Coils 18mm x 494183 11609723,11766661,11869780,11958440, Dec2010 through 30cm 12036898,12225706,12316657,12365837, Aug2012 12396263, 12854017, 12929266 Matrix2� 360 Firm Coils 20mm x 11330476,11483884,11526779,11697442, Nov2010 through M0034942030 494203 11766414,11766673,11958234,11999799, 30cm 12194742,12317006,12753163,12859707 Jul2012 11252232,11380482,11551322,11785187, 11785188,11785190,11785191,11785192, M0034942440 Matrix2� 360 Firm Coils 24mm x 494244 11785193,11785194,11785195,11813607, Oct2010 through 40cm 11813608,11813609,11813610,11850841, Jul2012 12176108,12316654,12395388,12395420, 12428559,12429040,12841941,12861721 M0034945150 Matrix2� 360 Firm Coils 5mm x 494515 12214867,12636725 Oct2011 through 15cm Apr2012 M00349461 50 Matrix2� 360 Firm Coils 6mm x 494615 11340651,11474492,11958445 Nov2010 through 15cm Jul2011 M0034947200 Matrix2� 360 Firm Coils 7mm x 494720 11338767,11697459 Nov2010 through 20cm Apr2011 M0034948300 Matrix2� 360 Firm Coils 8mm x 494830 11488191,11850853,12000340 Jan2011 through 30cm Aug2011 M0034949300 Matrix2� 360 Firm Coils 9mm x 494930 11327025,11697448,11838298,11958230, Nov2010 through 30cm 12365839,12367860 Jan2012;

9) Material Product Description Catalog # Batch numbers Expiry Date 11248651, 11291053, 11310207, 11323633, 11324250, 11385087, 11407756, 11410972, 11422254,11448538,11485969,11498926, 11505015,11531494,11550740,11552553, 11552580,11597969,11606471,11606472, 11676141,11676143,11676154,11676161, 11676175, 11730058, 11730228, 11730244, 11748054, 11800191, 11820286, 11838627, 11889317,11924292,11958237,11958446, 11958453,11958471,11975195,11988267, 12000346, 12008847, 12009650, 12018903, 12043119,12061957,12082823,12082831, 12082850,12102560,12102569,12112304, 12112308,12119827,12119836,12119901, 12130250, 12142092,12156613,12156623, 12161471,12176094,12176106,12176116, M003497202SRO Matrix2� Helical UltraSoft SR 497202-SR 12176127,12194710,12194727,12194750, Oct2010 through Coils 2mm x 2cm 12218091,12229544,12229549,12229554, Jun2013 12229582,12229588,12370629,12370632, 12378756,12379811,12379813,12413136, 12424868,12431048,12434612,12439198, 12439223,12468833,12495249,12514510, 12514517,12514583,12514600,12541586, 12549501,12549505,12549508,12549516, 12567226,12577905,12579009,12636525, 12636595,12636597,12636599,12636721, 12636734, 12659325, 12659332, 12703186, 12721622, 12721629, 12745887, 12748430, 12786766, 12792889,12792902,12810349, 12810366, 12841849, 12841850, 12841852, 12849196, 12861693, 12861725, 12891431, 12891438, 12914154, 12947533, 12947547, 12986455,13016337,13165099,13165118, 13194022, 13606643, 13606644 11285639, 11337201, 11373711, 11392488, 11395916,11445479,11472230,11494690, 11497220,11535565,11552559,11552581, 11639657,11676156,11788747,11850784, 11850797,11925583,11946186,11958478, 11975189,11996499,12008848,12018900, 12051398,12082825,12082840,12082861, 12112238,12119833,12127027,12149738, 12156620,12176104,12176119,12194716, M003497203SRO Matrix2� Helical UltraSoft SR 497203-SR 12194726,12194752,12229548,12229596, Oct2010 through Coils 2mm x 3cm 12306628,12320490,12359522,12361245, Jun2013 12396159,12409144,12418204,12424870, 12439224,12465526,12495252,12514506, 12514515,12514590,12521676,12567229, 12579025,12636729,12636751,12669006, 12674065,12703141,12703159,12703194, 12721499,12721630,12792887,12792906, 12792964,12861731,12895492,12903293, 12917355,12981468,13009557,13165104, 13204891,13608890 11287783,11300979,11319984,11432669, 11433113,11494689,11495753,11552552, 11597970,11634832,11676155,11712107, 11747856,11748041,11800376,11820294, 11850787,11850845,11925179,11925604, 11940589,11952667,11975171,12000343, 12018378,12018901,12047551,12069209, 12074315, 12119824, 12119831, 12119909, 12142085,12161472,12165272,12176115, Matrix2� Helical UltraSoft SR 12194705,12194732,12228152,12258932, Oct2010 through .J1003497204SRO 497204-SR 12299402,12330600,12359521,12392935, Coils 2mm x 4cm 12396260,12409145,12413137,12418203, Jun2013 12424876,12434613,12491075,12514508, 12514580,12514606,12521678,12578758, 12579000,12579006,12579014,12669975, 12702895,12703144,12703149,12721633, 12745888,12748426,12792907,12810358, 12841853,12841854,12841855,12841856, 12856504,12861689,12861730,12899758, 12917356,12922023,12968201,12981315, 12982266,13016333,13606211 11289497,11384552,11425586,11550741, 11597972, 11606469, 11676171, 11717889, 11820290,11838641,11925603,11940387, 11958450, 11975190, 11988269, 12007430, 12047552,12112300,12119900,12130811, 12155989,12156622,12176084,12176100, Matrix2� Helical UltraSoft SR 12176128,12194706,12194721,12228145, Oct2010 through M003497206SRO 497206-SR 12229670,12300719,12361244,12370633, Coils 2mm x 6cm 12379814,12383762,12390150,12413134, Jun2013 12431051,12450911,12495254,12514519, 12514611,12559585,12636722,12636745, 12703146,12703192,12721631,12745886, 12783350,12792909,12845819,12861723, 12891437,12912266,12914288,12981912, 12982279,13194132,13608891 11287570,11345097,11415538,11502184, Matrix2� Helical UltraSoft SR 11538868, 11588278, 11641201, 11718833, Oct2010 through M003497208SRO 497208-SR 11838628,12007429,12229547,12299413, Coils 2mm x 8cm 12434615,12520964,12579022, 12695190, Jun2013 12792912,12947542,12982320,13610848 Matrix2� Helical UltraSoft SR 11249332,11337880,11501859,11606470, Oct2010 through M003497210SRO 497210-SR 11712100,11800700,12229558,12377448, Coils 2mm x 10cm 12469866,12514598,12982267,13204828 Dec2012 11378010,11502182,11622090,11697455, M003497215SRO Matrix2� Helical UltraSoft SR 497215-SR 11730220, 11786208, 12194494, 12214868, Dec2010 through Coils 2mm x 15cm 12374370,12439193,12495251,12514512, Dec2012 12634402,12792904,12982268,13194285 M003497253SRO Matrix2� Helical UltraSoft SR 497253-SR 11766416,12514587,12702892,12841857, May2011 through Coils 2.5mm x 3cm 13201016, 13221197 Dec2012 M003497254SRO Matrix2� Helical UltraSoft SR 497254-SR 11373706,11447829,11634829,11892358, Dec2010 through Coils 2.5mm x 4cm 12194722,12748425,13165111,13201017 Dec2012 M003497256SRO Matrix2� Helical UltraSoft SR 497256-SR 11766415,11782389,11788748,12214843, May2011 through Coils 2.5mm x 6cm 12377447,12383760,13201018,13233176 Jan2013 11378011,11560337,11634831,11748042, 11850799,11869795,11925581,11940585, 11952852,11975184,12026746,12061959, 12074301,12074302,12142034,12161321, 12165270,12194749,12229671,12241647, M003497304SRO Matrix2� Helical UltraSoft SR 497304-SR 12246983,12358559,12368753, 12383679, Dec2010 through Coils 3mm x 4cm 12388037, 12396261, 12418205, 12450912, Dec2012 12514509,12514605,12577902,12577910, 12634401,12659324,12692367,12702867, 12703156,12703199,12753183, 12786768, 12858818,12891629,12947531,12981683, 12999165,13204890 11286452,11327336,11408586,11444957, 11485583, 11531650, 11597971, 11800377, 11850785,11889927,11925598,11940588, 11958475,11996800,12004083,12026747, 12043117,12061981,12074038,12074039, 12112239,12142027,12156610,12176105, 12194484,12194488,12194496,12194714, Matrix2� Helical UltraSoft SR 12214713,12214811,12306635,12359020, Oct2010 through M003497306SRO 497306-SR 12365843,12378757,12385402,12390152, Coils 3mm x 6cm 12392936,12423456,12431049,12468832, Dec2012 12469526,12495245,12514513,12514593, 12549502,12549510,12549527,12636598, 12669972,12670047,12702626,12721496, 12721625,12721639,12753187,12786767, 12792901,12810351,12861737,12895628, 12909841,12929079,12947535,12968747, 13165105 11285911,11374154,11415732,11495563, M003497308SRO Matrix2� Helical UltraSoft SR 497308-SR 11526776, 11597973, 11838631, 11958464, Oct2010 through Coils 3mm x 8cm 12004084,12051399,12359021,12523447, Jun2013 12579021,12912187,13165094,13611268 11289762,11327222,11430208,11538867, M003497310SRO Matrix2� Helical UltraSoft SR 497310-SR 11580673,11711977,11748045,11792445, Oct2010 through Coils 3mm x 10cm 11820293,12102566,12142029,12359022, Dec2012 12523446,12947537,13204827,13204892 11374084,11425585,11495750,11531651, Matrix2� Helical UltraSoft SR 11552554,11622089,11712110,11795625, Dec2010 through M003497315SRO 497315-SR 11800194,11984851,12004085,12194751, Coils 3mm x 15cm 12514584,12559586,12636750,12779826, Dec2012 12903471, 13116656, 13165113 11377055,11426750,11477786,11505008, 11597975,11640819,11676158,11697457, 11697467,11718257,11719462,11748046, M003497320SRO Matrix2� Helical UltraSoft SR 497320-SR 11958460,11959904,12007428,12018397, Dec2010 through Coils 3mm x 20cm 12069208,12258931,12413138,12439181, Dec2012 12439194,12514507,12514595,12521677, 12636728,12753167,12792919,13165114, 13190676 11392486,11502702,11552558,11869786, 11934763,11952853,12009575,12021622, Matrix2� Helical UltraSoft SR 12043108,12069207,12074305,12093266, Dec2010 through M003497 406S RO 497406-SR 12110475, 12169001, 12214710, 12315368, Coils 4mm x 6cm 12372621,12385406,12514581,12549507, Nov2012 12670040,12702893,12703191,12810350, 12841858,12929267,12947521,13118720 1.1292934,11380184,11447831,11597968, 11800195,11843131,11924293,11934379, 11938495,11963591,11992217,12043114, 12069206,12074032,12074307,12093267, Matrix2� Helical UltraSoft SR 12161236,12176018,12176114,12306450, Oct2010 through M003497408SRO 497408-SR 12330566,12359024,12385401,12390153, Coils 4mm x 8cm 12392938,12431050,12514505,12514585, Dec2012 12521675,12636746,12669967,12670045, 12703143,12703196,12748434,12792254, 12792910,12841859,12899757,12947526, 12947554,13165109 11392633,11477710,11535147,11639656, M003497410SRO Matrix2� Helical UltraSoft SR 497410-SR 11766700,11850786,11934764,12102568, Dec2010 through Coils 4mm x 10cm 12165269,12374138,12514588,12912763, Aug2013 13165097,13204889,13569790,13740720 11374155,11403350,11444954,11484426, Matrix2� Helical UltraSoft SR 11542681,11597974,11697474,11792447, Dec2010 through M003497415SRO 497415-SR 11820179,12082862,12165271,12214844, Coils 4mm x 15cm 12229556,12377449,12383761,12579008, Aug2012 12792916,12896408,12947540 11391872,11472233,11538871,11586993, 11697472,11785998,11800709,11820177, M003497420SRO Matrix2� Helical UltraSoft SR 497420-SR 11850854,11934766,11958461,12000347, Dec2010 through Coils 4mm x 20cm 12012195,12069205,12439228,12514608, Dec2012 12549511,12783351,12810354,12971787, 13182061 M003497510SRO Matrix2� Helical UltraSoft SR 497510-SR 11448920,11580671,11785997,11820169, Dec2010 through Coils 5mm x 10cm 12229540,12439184,12965681 Aug2012 M003497515SRO Matrix2� Helical UltraSoft SR 497515-SR 11481347,11697449,11782386,11800703, Jan2011 through Coils 5mm x 15cm 12142081,12182653,12377451,12586142 Mar2012 11287209,11329750,11474491,11500844, M003497520SRO Matrix2� Helical UltraSoft SR 497520-SR 11634834,11838295,11850842,11958458, Oct2010 through Coils 5mm x 20cm 12194739,12258930,12439185,12465527, Sep2012 12849285,12906594,12982321,12989985 M003497610SRO Matrix2� Helical UltraSoft SR 497610-SR 11415310,11494692,11697447,11747879 Dec2010 through Coils 6mm x 10cm Apr2011 1003497615SRO Matrix2� Helical UltraSoft SR 497615-SR 11697445,11775114,12082856,12260480, Apr2011 through Coils 6mm x 15cm 12947552 Aug2012 Matrix2� Helical UltraSoft SR 11422255,11480517,11597977,11868815, Dec2010 through M003497620SRO 497620-SR 12119834,12142025,12182652,12494077, Coils 6mm x 20cm 12791146,12792893,12982269,13165112 Dec2012;

10) Material Product Description Catalog # Batch numbers Expiry Date 11252230,11308509,11314276,11325957, 11336598, 11393159, 11395513, 11407112, 11451244,11531641,11550997,11560540, 11591562,11591706,11622023,11658783, 11658785,11658822,11676148,11676157, 11719463, 11730234, 11790200, 11800701, 11800705,11820288,11850793,11850843, 11873434,11908088,11934094,11958442, 11958449,11958467,11975078,11975174, 12018396,12061956,12082830,12093269, 12102499, 12102571, 12112302, 12119035, M003498204SRO Matrix2� 360 UltraSoft SR Coils 498204-SR 12130177,12156608,12156619,12172635, Oct2010 through 2mm x4cm 12175697,12176083,12176088,12176096, Aug2013 12176113,12176130,12214865,12229603, 12229665,12229709,12300883,12304385, 12316893,12330638,12372623,12383765, 12388036,12498742,12514610,12549119, 12549517,12579004,12669973,12670052, 12702899,12703158,12721628,12748406, 12775526,12792905,12810367,12847198, 12856251,12861682,12861685,12861728, 12902495,12909257,12920788,12922010, 12922031,12947555,13165095,13182078, 13740728 11285904, 11325811, 11330308, 11336721, 11344686,11429308,11430218,11491190, 11535756,11551320,11580678,11586999, 11606468,11640887,11676151,11676165, Matrix2� 360 UltraSoft SR Coils 11792442,11820281,11820295,11850792, Oct2010 through M003498206SRO 498206-SR 11850844,12043227,12119036,12130803, 2mm x6cm 12130817,12194743,12229581,12229605, Jun2013 12299406,12304391,12514596,12549520, 12650936,12792884,12861539,12861681, 12861726,12929268,12947551,12982270, 13165082,13165102,13600453 11290821,11306854,11414844,11415101, 11488903,11524527,11535144,11598085, 11658796,11730211,11756822,11800379, 11850788,11873437,11889319,11889933, 11958235,11958447,11975073,11975199, 11992222,12009642,12043109,12082849, 12102496,12112306,12130249,12156604, Matrix2� 360 UltraSoft SR Coils 12156607,12156621,12172961,12175696, Oct2010 through M003498304SRO 498304-SR 12175827,12176080,12176086,12176101, 3mm x4cm 12229674,12229678,12304388,12315366, Jan2013 12330621,12368749,12370624,12374136, 12374221,12376353,12379817,12383766, 12514603,12541587,12549512,12549525, 12579028,12636755,12703154,12703190, 12748467,12792896,12861696,12902497, 12922003,12922028,12947530,13165085, 13165101,13198188,13204883,13230537 I 11302950,11385614,11385615,11403344, 11440497,11444540,11475012,11523684, 11552540,11591597,11598082,11622020, 11640889, 11676150, 11730057, 11730213, 11788744, 11820175, 11820292, 11836537, 11850840,11873438,11908089,11925597, 11958473,11975164,11975183,11992201, 12009563,12009573,12009640,12026744, 12043228, 12067385, 12082843, 12082859, Matrix2� 360 UltraSoft SR Coils 12112303,12127498,12142026,12142038, Oct2010 through M003498306SRO 498306-SR 12176131,12188229,12194499,12194715, 3mm x6cm 12194731,12214717,12214815,12214857, Aug2013 12229662, 12299405, 12304191, 12304196, 12368752,12388034,12396262,12418213, 12424869,12427988,12439191,12439351, 12549523,12636732,12636756,12670041, 12702896,12703155,12703187,12753182, 12783356,12792890,12792921,12858819, 12861684, 12861720, 12922011, 12929262, 13109928, 13165083, 13165093, 13606646, 13740721 11321963,11325815,11341602,11440812, 11444365, 11488901, 11489569, 11550743, 11560542, 11598086, 11658799, 11730230, 11788749,11820283,11850855,11916970, M003498308SRO Matrix2� 360 UltraSoft SR Coils 498308-SR 11958232, 11958238, 11958448, 11958466, Nov2010 through 3mm x8cm 11996497,12102567,12130806,12194700, Jun2013 12194723,12214852,12229590,12549509, 12578759,12636733,12810343, 12885370, 12918062,12942555,12946179,13118674, 13165108,13182069,13600456 11293279,11318108,11345092,11407741, 11489572,11538865,11580677,11586997, 11658786,11712101,11719464,11789879, 11792443, 11820170, 11820282, 11850856, 11889925,11958236,11958456,12021661, Matrix2� 360 UltraSoft SR Coils 12026495,12026742,12082848,12112305, Oct2010 through M003498406SRO 498406-SR 12141859,12142033,12186120,12194702, 4mm x6cm 12194724, 12214850, 12229704, 12295452, Jun2013 12296704,12315362,12330599, 12439225, 12514516,12549514,12570929, 12669968, 12670046,12779824,12792888, 12805886, 12899134,12922013,12947538,13112464, 13165107,13610468 . 11314326,11320203,11336864,11396043, 11444147,11444545,11489567,11523682, 11538870, 11552547, 11560546, 11591708, 11658820,11676163,11676203,11788743, 11820174, 11820287, 11850846, 11873436, 11925602,11938492,11975160,11975176, 11975222,11992210,12009652,12061958, 12074313,12082844,12102564,12110478, Matrix2� 360 UltraSoft SR Coils 12119835, 12130819, 12194486, 12194491, Oct2010 through M003498408SRO 498408-SR 12194701,12194717,12194737,12214191, 4mm x8cm 12214718,12214817,12299414,12300716, Jun2013 12304387, 12330612, 12330647, 12385409, 12409147,12413139,12424873,12424877, 12439196, 12439352, 12567224, 12579029, 12669005, 12703185, 12721626, 12748407, 12783357,12791150,12922015,12929076, 12929261,12947543,12982329,12982336, 13116525,13164430,13165087,13182068, 13182074, 13602977 11321964, 11322842, 11432824, 11485038, 11531649, 11591564, 11591700, 11676177, 11697470,11712102,11719465,11721430, 11820323,11889309,11889316,11916971, 11952857,12026496,12043224,12061790, 12115320,12119907,12130813,12142087, M003498510SRO Matrix2� 360 UltraSoft SR Coils 498510-SR 12194718,12214197,12214714,12214842, Nov2010 through 5mmx10cm 12267364, 12304383, 12311944, 12315361, Jun2013 12315363,12356259,12392931,12404359, 12418210, 12439358, 12549513, 12634217, 12703183,12748428,12791153,12792898, 12861694,12922006, 12929075, 13164428, 13164795,13165092,13195731,13200123, 13233310,13603121 11323634,11325812,11329547,11403547, 11552535,11591701,11711974,11711979, Matrix2� 360 UltraSoft SR Coils 11766679, 11838297, 11850794, 11908093, Nov2010 through M003498515SRO 498515-SR 11946180,11991286,12214846,12226292, 5mmx15cm 12229666,12306631,12446872,12468830, Oct2012 12495253,12514592,12523445, 12579019, 12810368,12914092,12946427,13113054 11281623, 11380106, 11552542, 11658791, Matrix2� 360 UltraSoft SR Coils 11748395,11889312,12061947,12115321, Oct2010 through M003498610SRO 498610-SR 12142031,12299316,12370621,12446874, 6mmx10cm 12514609,12632702,13118675,13165080, Aug2013 13740727 11322855, 11385261, 11486201, 11531652, Matrix2� 360 UltraSoft SR Coils 11591702,11658823,11697473,11800199, Nov2010 through M003498615SRO 498615-SR 12194497, 12214193, 12226290, 12229705, 6mmx15cm 12439187,12491070,12495248,12514597, Aug2013 12947527,12965255,13740729
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corporation, Neurovascular, Fremont, CA, by letter on October 19, 2010. 
Manufacturer: Boston Scientific Cork, Ltd., Cork, Ireland. Firm initiated recall is ongoing.
REASON
The product appears to have premature degradation of the PGLA coating on the Matrix Coil.
VOLUME OF PRODUCT IN COMMERCE
77,364 units
DISTRIBUTION
Nationwide and Internationally

END OF ENFORCEMENT REPORT FOR JANUARY 12, 2011

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