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Enforcement Report for February 14, 2007

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

February 14, 2007
07-07

RECALLS AND FIELD CORRECTIONS: FOOD and COSMETICS -- CLASS I

___________________________________
PRODUCT
Sara Lee Premium White Hamburger Buns, 8 count, Net Wt. 12 oz. plastic bag; UPC 0 72945-75177 4, Recall # F-119-7
CODE
Best If Purchased By SEPT 10 3452401226
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sara Lee Food & Beverage, Downers Grove, IL. by press release and email on October 27, 2006.
Manufacturer: Sara Lee Making Co., Inc., Valdese, NC. Firm initiated recall is complete.
REASON
The hamburger buns may contain undeclared milk protein.
VOLUME OF PRODUCT IN COMMERCE
4,826 packages
DISTRIBUTION
NC and SC

 RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I

___________________________________
PRODUCT
NASUTRA Herbal Supplement for Men, proprietary blend of ten chinese herbs, 300mg, packaged in blisters of 2 capsules, Recall # D-438-7
CODE
Lot #: WP-505, WP904, WP1005, WP106, WP206, WPNA5O6 & WPNA7O6
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nasutra LLC, Beverly Hills, CA, by letter and press release on September 20, 2006.
Manufacturer: Bactolac Pharmaceutical, Inc., Hauppauge, NY. Firm initiated recall is ongoing.
REASON
Unapproved New Drug; Product contains undeclared acetildenafil, an analogue of sildenafil.
VOLUME OF PRODUCT IN COMMERCE
1,105,000 X 2-capsule units
DISTRIBUTION
Nationwide and via the Internet

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

___________________________________
PRODUCT
TYGACIL (tigecycline) for Injection - 50mg per vial 10 single use vials, Rx only, Each vial contains 50mg tigecycline lyophilized powder for intravenous infusion - Wyeth Pharmaceuticals, Inc. NDC: 0008-5360-02, Recall # D-440-7
CODE
Lot # B67262 and Lot # B67263
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Ayerst Laboratories, Philadelphia, PA, by letters on November 6, 2006.
Manufacturer: Patheon Italia S.p.A., Milano, Italy. Firm initiated recall is ongoing.
REASON
Discolored solution upon reconstitution.
VOLUME OF PRODUCT IN COMMERCE
7,458 units
DISTRIBUTION
Nationwide, Venezuela and Chile

___________________________________
PRODUCT
Compressed Gas, Oxidizing, N.O.S., Medical Gas Mixtures, UN 3156, 20% Carbon Dioxide, 80% Oxygen, Size 44 Steel Cylinders, Recall # D-441-7
CODE
Lot: 0826BG06
RECALLING FIRM/MANUFACTURER
Specialty Gases of America Inc. Toledo, OH, by email on November 17, 2006. Firm initiated recall is ongoing.
REASON
Product was fitted with incorrect CGA valve connection. Correct valve is CGA 500, but product was fitted with CGA 280.
VOLUME OF PRODUCT IN COMMERCE
3 cylinders
DISTRIBUTION
MI

___________________________________
PRODUCT
Systane® free Lubricant Eye Drops Liquid Gel, (polyethylene glycol 400, 0.4% and polyethylene glycol 0.3%), 3mL (sample size) and 10mL, Sterile, Recall # D-442-7
CODE
3mL size lot codes: 63722F, 114115F, 60907F, 63239F, 121916F, 120742F, 122349F, 114984F, 120081F, and 121936F;
10mL size lot codes: 63190F, 61410F, 113575F, 113576F, 115267F, 115809F, 115808F, and 115268F
RECALLING FIRM/MANUFACTURER
Alcon Laboratories, Inc. Fort Worth, TX, by press release on December 14, 2006 and by letters on December 15, 2006. Firm initiated recall is ongoing.
REASON
Mold Contamination (Curvularia sp and Alternaria sp)
VOLUME OF PRODUCT IN COMMERCE
4,191,451 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS lll

___________________________________
PRODUCT
Loratadine Syrup, Loratadine Oral Solution USP, 5mg/5mL, Fruit Flavored Syrup, 4 oz. and 8 oz. bottles, NDC 51660-207-04 (4 oz. Ohm label) and NDC 51660-207-08 (8 oz. Ohm label), OTC --- The product was distributed under the following labels and NDC #s:
(1) AMERICAN FARE for kids LORATADINE ORAL SOLUTION 5mg/5mL Loratadine Syrup, ANTIHISTAMINE, Fruit Flavored Syrup, 4 FL OZ (120 mL), NDC 49738-207-04, Made for Kmart Corporation, Troy, MI;
(2) BROOKS/ECKERD Children's Allergy Relief LORATADINE SYRUP (LORATADINE ORAL SOLUTION) 5mg/5mL, ANTIHISTAMINE, Fruit Flavored Syrup, 4 FL OZ (118 mL), ITEM# 024540, Distributed By: Brooks/Eckerd Pharmacy Warwick, RI;
(3) CVS pharmacy CHILDREN'S ALLERGY RELIEF LORATADINE ORAL SOLUTION 5mg/5mL, ANTIHISTAMINE, Fruit Flavored Syrup, 4 FL OZ (118 mL), Distributed by: CVS Pharmacy, Inc. Woonsocket, RI;
(4) ECKERD Children's Allergy Relief LORATADINE SYRUP (LORATADINE ORAL SOLUTION) 5mg/5mL, ANTIHISTAMINE, Fruit Flavored Syrup, 4 FL OZ (118 mL), NDC 19458-9403-1, DISTRIBUTED BY: ECKERD DRUG COMPANY CLEARWATER, FL;
(5) Best Choice Brand Children's Loratadine Syrup (Loratadine Oral Solution) 5mg/5mL, Antihistamine, Fruit Flavored Syrup, 4 FL OZ (118 mL), PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO. KANSAS CITY, MO;
(6) Kroger Children's Allergy Relief Loratadine Syrup (Loratadine Oral Solution) 5mg/5mL, ANTIHISTAMINE, Fruit Flavored Syrup, 4 FL OZ (118 mL), NDC 30142-649-26, Distributed by The Kroger Co. Cincinnati, OH;
(7) LEADER Allergy Relief Loratadine Syrup (Loratadine Oral Solution) 5mg/5mL, Antihistamine for kids, Fruit Flavored Syrup, 4 FL OZ (118 mL), NDC 37205-378-26, DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OH;
(8) MEDIC Children's Allergy FRUIT FLAVORED SYRUP Loratadine Oral Solution 5mg/5mL Antihistamine, 4 FL OZ (118 mL), NDC 56039-207-04, Distributed By: Winn-Dixie Stores, Inc. Jacksonville, FL;
(9) ohm Allergy Relief Loratadine Syrup (Loratadine Oral Solution) 5mg/5mL Antihistamine, Children's Fruit Flavored Syrup, 4 FL OZ (118 mL), NDC 51660-207-04, Manufactured by: Ohm Laboratories, Inc., Gloversville, NY;
(10) ohm Allergy Relief Loratadine Syrup (Loratadine Oral Solution) 5mg/5mL, Antihistamine, Children's Fruit Flavored Syrup, 8 FL OZ (236 mL), NDC 51660-207-08, Manufactured By: Ohm Laboratories, Inc. Gloversville, NY;
(11) QC QUALITY CHOICE Children's Allergy Relief Syrup (Loratadine Oral Solution) 5mg/5mL, Antihistamine, Fruit Flavored Syrup, 4 FL OZ (118 mL), NDC 63868-156-04, DISTRIBUTED BY QUALITY CHOICE NOVI, MI;
(12) RITE AID Children's Loratadine Syrup (Loratadine Oral Solution) 5mg/5mL, Antihistamine, Fruit Flavored Syrup, 4 FL OZ (118 mL), DISTRIBUTED BY RITE AID CORPORATION HARRISBURG, PA;
(13) select brand Loratadine Syrup (Loratadine Oral Solution) 5mg/5mL, Antihistamine, Children's Fruit Flavored Syrup, 4 FL OZ (118 mL), NDC 15127-718-04, Distributed by: SELECT BRAND DISTRIBUTORS Pine Bluff, AR;
(14) select brand Loratadine Syrup (Loratadine Oral Solution) 5mg/5mL, Antihistamine, Children's Fruit Flavored Syrup, 8 FL OZ (236 mL), NDC 15127-715-08, Distributed by: SELECT BRAND DISTRIBUTORS Pine Bluff, AR;
(15) The Medicine Shoppe Allergy Relief for kids Loratadine Oral Solution 5mg/5mL, Antihistamine, FRUIT FLAVORED SYRUP, 4 FL OZ (118 mL), NDC 49614-174-26, Distributed by: Medicine Shoppe International, Inc. St. Louis, MO;
(16) Walgreens Children's Wal-itin Loratadine Oral Solution 5mg/5mL, Antihistamine, Fruit Flavored Syrup, 4 FL OZ (118 mL), NDC 0363-207-04, Distributed by: Walgreen Co., Deerfield, IL,
Recall # D-0439-7
CODE
Lots in total: 1428192, 1431263, 1431837, 1440256, 1443259, 1446539, 1447175, 1447176, 1449358, 1453992, 1453995, 1458852, 1461269, 1465392, 1465393, 1466839, 1466840, 1468243, 1471544, 1472957, 1476246, 1477061, 1477062, 1477085, 1477801, 1477802, 1477803, 1477804, 1477806, 1479489, 1479490, 1481287, 1481288, 1481289, 1481294, 1483852, 1483853, 1483854, 1485685, 1485686, 1486071, 1486072, 1487152, 1487154, 1487155, 1487156, 1487157, 1490488, 1491237, 1491731, 1491732, 1492190, 1492191, 1497045, 1498061, 1500107, 1500108, 1508797, 1508798, 1512236, 1512237, 1517700, 1519980, 1519982, 1519984, 1519985, 1520009, 1529147, 1529148, 1531453, 1531454, 1532134, 1534046, 1534072, 1534073, 1535554, 1535555, 1537063, 1537065, 1537066, 1537067, 1537068, 1541069, 1541071, 1543580, 1543581, 1543582, 1543583, 1548242, 1548244, 1549504, 1549505, 1549506, 1549507, 1551442, 1551789, 1551791, 1551792, 1558368, 1558369, 1558370, 1558371, 1562461, 1568759, 1568760, 1576980, 1576981, 1585284, 1586606, 1586615, 1586616, 1586617, 1586619, 1599029, 1599030, 1599031, 1599032, 1599033, 1608385, 1608386, 1612443, 1612444, 1612445, 1621602, 1621629, 1621630, 1621631, 1621632, 1621633, 1626627, 1626628, 1626629, 1630200, 1637979, 1639172, 1639173, 1639175, 1644206, 1644207, 1647251, 1647252, 1647253, 1649825, 1649826, 1649827, 1658678, 1658679, 1660927, 1660928, 1665178, 1665179, 1665180, 1669064, 1669065, 1673431, 1673432, 1673433
RECALLING FIRM/MANUFACTURER
Ohm Laboratories, Inc., Gloversville, NY, by letters dated January 3, 2007. Firm initiated recall is ongoing.
REASON
Exceeded impurity specification
VOLUME OF PRODUCT IN COMMERCE
1,300,750 bottles
DISTRIBUTION
Nationwide and PR

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I

__________________________
PRODUCT
Human Tissue for Transplantation, Recall # B-0513-07
a) Blackstone Lumbar, 12mm, Irradiated, Lyophilized;
b) Cancellous Chips, 60cc, Irradiated, Lyophilized;
c) Fascia Lata, 20x70mm, Irradiated, Lyophilized;
d) Cancellous Cubes, 4-10mm, Irradiated, Lyophilized;
e) Left Achilles Tendon, 205 mm, Fresh Frozen, Gamma Irradiated;
f) Hemi-Patella Tendon, Fresh Frozen, Gamma Irradiated;
g) Gracilis, Fresh Frozen, Gamma Irradiated;
h) Semitendinosus, Fresh Frozen, Gamma Irradiated;
i) Blackstone Lumbar, 10 mm, Irradiated, Lyophilized;
j) Ilium Tricortical, 48x25x13mm, Irradiated, Lyophilized;
k) Fibular Strut, Fresh Frozen, Gamma Irradiated;
l) Patellar Tricortical, 15x25x18mm, Irradiated, Lyophilized;
m) Blackstone Lumbar, 8mm, Irradiated, Lyophilized;
n) Fascia Lata, Irradiated, Lyophilized;
o) Fibular Wedge 8x14mm, Irradiated, Lyophilized;
p) Cervical Allograft, 8mm Fresh Frozen, Gamma Irradiated;
q) Left Achilles Tendon, Fresh Frozen, Gamma Irradiated;
r) Frozen Skin 1/3 Sq. Ft;
s) AllOss Block Allograft, Lyophilized, Irradiated;
t) Cancellous Part. 0.5cc (1000-20000um);
u) Cancellous Part. 1.0cc (1000-2000um);
v) Cancellous Part. 2.0cc (1000-2000um);
w) Dowel, 35mm, Irradiated, Lyophilized;
x) Cortical Strut, 24x200mm, Irradiated, Lyophilized;
y) Tibial Shaft, Irradiated, Lyophilized;
z) Right Achiles Tendon, Fresh Frozen, Gamma Irradiated;
aa) Anterior Tibialis, Fresh Frozen, Gamma Irradiated;
bb) Vertebron ACIF, 7mm, Irradiated Lyophilized;
cc) Cancellous Part., 0.5cc (250-1000um);
dd) Cancellous Part, 1.0cc (250-1000um);
ee) Cancellous Part., 2.0cc (250-1000um);
ff) Biportal 8x11x25mm;
gg) Femoral Shaft, Fresh Frozen, Gamma Irradiated
CODE
a) 050404183001, 050404183002, 050404183003, 050404183004, 050404183005,
050404183006, 050404183007, 050404183008, 050404183009, 050404183010,
050404183011;
b) 0843711221, 0843711222, 0846811209, 0849011208, 0850011207;
c) 0843711903, 0843711904, 0846811915;
d) 0843721105, 0843721106, 0843721107, 0843721108, 0843721109, 0843721110,
0843721111, 0843721112, 0843721113, 0843721114, 0843721115, 0843721116,
0843721117, 0843721118, 0843721119, 0843721120, 0846821101, 0846821102,
0846821103, 0846821104, 0846821105, 0846821106, 0846821107, 0846821108,
0849021101, 0849021102, 0849021103, 0849021104, 0849021105, 0849021106,
0849021107, 0850021101, 0850021102, 0850021103, 0850021104, 0850021105,
0850021106;
e) 0843701401;
f) 0843704501, 0843704502, 0843704503, 0843704504, 0849004501, 0863604501,
0863604502, 0863604503, 0866304501, 0866304502, 0889704501, 0889704502,
0889704503, 0889704504, 0906704501, 0906704502, 0906704503, 0906704504;
g) 0843706501, 0843706502, 0846806501;
h) 0843706601;
i) 050405183001, 050405183002, 050405183003, 050405183004, 050405183006,
050405183007, 050405183008, 050405183009, 050404183012, 050404183013,
050404183014, 050404183015;
j) 0846810910, 0849010909, 0850010910;
k) 0846811511, 0846811512, 0846811513, 0866311501, 0866311502, 0866311503;
l) 0846814114, 0863414106, 0863414107, 0863514106;
m) 050433183001, 050433183002, 050405183010, 050405183011, 050405183012,
050405183013, 050405183014, 050405183015, 050405183016, 050405183017,
050405183018, 050405183019, 050405183020, 050405183021;
n) 0849011915;
o) 0849014010, 0849014011, 0849014012, 0849014013, 0849014014, 0850014008,
0850014009;
p) 050498184007;
q) 0866301401;
r) 0889300101, 0889300102, 0889300103, 0889300104, 0889300105, 0889300106,
0889300107, 0889300108, 0889300109, 0889300110, 0889300111, 0889300112,
0889300113, 0889300114, 0889300115, 0889300116, 0889300117, 0895100101,
0895100102, 0895100103, 0895100104, 0895100105, 0895100106, 0895100107,
0895100108, 0895100109, 0895100110, 0895100111, 0896600101, 0896600102,
0896600103, 0896600104, 0896600105, 0896600106, 0896600107, 0896600108;
s) 060056241001, 060056241002, 060056241003, 060056241004, 051009241078,
051009241079;
t) 060056107012, 060056107013, 060056107014, 060056107015, 060056107016,
060056107017, 060056107018, 060056107019, 060056107020, 060056107021,
060056107022, 060056107023, 060056107024, 060056107025, 060056107026,
060056107027, 060056107028, 060056107029, 060056107030, 060056107031,
060056107032, 060056107033, 060056107034, 060056107035, 051009107067,
051009107068, 051009107069, 051009107070;
u) 060056107036, 060056107037, 060056107038, 060056107039, 060056107040,
060056107041, 060056107042, 060056107043, 060056107044, 060056107045,
060056107046, 060056107047, 060056107048, 060056107049, 060056107050,
060056107051, 060056107052, 060056107053, 060056107054, 060056107055,
060056107056, 060056107057, 051009107071, 051009107072, 051009107073,
051009107074;
v) 060056107058, 060056107059, 060056107060, 060056107061, 060056107062,
060056107063, 060056107064, 060056107065, 060056107066, 060056107067,
060056107068, 060056107069, 060056107070, 060056107071, 060056107072,
060056107073, 060056107074, 060056107075, 060056107076, 060056107077,
060056107078, 060056107079, 051009107075, 051009107076, 051009107077;
w) 0889710101, 0889710102;
x) 0889711405, 0866211408;
y) 0889714507, 0889714508;
z) 0889701402, 0906701402, 0843701402;
aa) 0889706801;
bb) 051009159001, 051009159002, 051009159003, 051009159004, 051009159005,
051009159006, 051009159007, 051009159008, 051009159009;
cc) 051009107001, 051009107002, 051009107003, 051009107004, 051009107005,
051009107006, 051009107007, 051009107008, 051009107009, 051009107010,
051009107011, 051009107012, 051009107013, 051009107014, 051009107015,
051009107016, 051009107017, 051009107018, 051009107019, 051009107020,
051009107021, 051009107022, 051009107023, 060056107005;
dd) 051009107024, 051009107025, 051009107026, 051009107027, 051009107028,
051009107029, 051009107030, 051009107031, 051009107032, 051009107033,
051009107034, 051009107035, 051009107036, 051009107037, 051009107038,
051009107039, 051009107040, 051009107041, 051009107042, 051009107043,
060056107006, 060056107007, 060056107008;
ee) 051009107044, 051009107045, 051009107046, 051009107047, 051009107048,
051009107049, 051009107050, 051009107051, 051009107052, 051009107053,
051009107054, 051009107055, 051009107056, 051009107057, 051009107058,
051009107059, 051009107060, 051009107061, 051009107062, 051009107063,
051009107064, 051009107065, 051009107066, 060056107009, 060056107010,
060056107011;
ff) 060267173001, 060267173002, 060267173003, 060267173004, 060267173005,
060267173006, 060267173007, 060267173008;
gg) 0863705301, 0863705302, 0866305301
RECALLING FIRM/MANUFACTURER
Recalling Firm: U.S. Tissue & Cell, Cincinnati, OH, by telephone on July 6, 7, 8 and 24, 2006 and by letter dated August 25, August 30, 2006 and January 2, 2007.
Manufacturers: U.S. Tissue & Cell, Cincinnati, OH, and U.S. Tissue & Cell, Salt Lake City, UT. Firm initiated recall is complete.
REASON
Human tissues, recovered from donors without adequate donor eligibility determinations, were distributed.
VOLUME OF PRODUCT IN COMMERCE
352 allografts
DISTRIBUTION
Nationwide and Korea

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

___________________________________
PRODUCT
Source Plasma, Recall # B-0045-07
CODE
Units: 0150101374, 0150101555, 0150102084, 0150102323, 0150103374, 0150103568 and 0150108524
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Kalamazoo, MI, by facsimile on May 16, 2006. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was incarcerated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
Spain

___________________________________
PRODUCT
Red Blood Cells, Recall # B-0049-07
CODE
Unit: 9468279
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc. New York, NY, by telephone and facsimile on October 2, 2003, and by letter dated October 16, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose health history screening was not adequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY

___________________________________
PRODUCT
Source Plasma, Recall # B-0050-07
CODE
Units: 150082016, 150082683, 150082847, 150083436, 150083876, 150084069, 150084803, 150084999, 150085858, 150086746, 150087013, 150087784, 150088401, 150088640, 150089414, 150089812, 150091490, 150092479, 150092844, 150093951, 150094199, 150094637, 150094967, 150095237, 150095596, 150096061, 150096406, 150096882, 150097089, 150097629, 150097687, 150098335, 150098479, 150099004, 150099277, 150099691, 150099929, 150100272, 150100620, 150109593, 150109874, 150110255, 150110645 and 150111095
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Kalamazoo, MI, by facsimile on April 3, 2006. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was incarcerated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
44 units
DISTRIBUTION
Spain

___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0502-07
CODE
Unit: 2052676
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by fax on December 30, 2004. Firm initiated recall is complete.
REASON
Blood product, processed from a low volume unit of whole blood, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN

___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0655-07
CODE
Unit: 6722215
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on June 29, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who received a piercing within 12 months of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

___________________________________
PRODUCT
Human Corneas for transplantation, Recall # B-0706-07
CODE
Tissues: 0297-06-01 and 0297-06-02
RECALLING FIRM/MANUFACTURER
Northeast Pennsylvania Lions Eye Bank, Inc., Allentown, PA, by telephone, fax and letter on June 13, 2006. Firm initiated recall is complete.
REASON
Human Corneas, subsequently tested for antibodies to hepatitis B core antigen (anti-HBcore) by a different facility, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues
DISTRIBUTION
GA and CA

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0728-07
CODE
Unit: 5457879
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on November 17, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with an elevated body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK

___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0733-07;
b) Platelets, Recall # B- 0734-07
CODE
a) and b) Unit: 5333205
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on April 20, 2006. Firm initiated recall is complete.
REASON
Blood Products, collected from a donor whose eligibility to donate was not fully assessed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX and NY

 RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

___________________________________
PRODUCT
a) Boston Scientific Mach 1 Guide Catheter Femoral Approach, 6F, 0.070',
Internal Mammary Curve, UPN # H74934356260, Catalog # 34356-26.
Made in Mexico, Recall # Z-0382-2007;
b) Boston Scientific Mach 1 Guide Catheter Femoral Approach, 6F, 0.070',
Voda Left Curve, UPN # H74934356710, Catalog # 34356-71. Made in Mexico,
Recall # Z-0383-2007;
c) Boston Scientific Mach 1 Guide Catheter Femoral Approach, 7F, 0.081',
Multipurpose Curve, UPN # H74934357380, Catalog # 34357-38. Made in
Mexico, Recall # Z-0384-2007;
d) Boston Scientific Mach 1 Guide Catheter Femoral Approach, 8F, 0.091',
Amplatz Right Curve, UPN # H74934358180, Catalog # 34358-18. Made in
Mexico, Recall # Z-0385-2007;
e) Boston Scientific Mach 1 Guide Catheter Femoral Approach, 8F, 0.091',
Amplatz Left Curve, UPN # H74934358190, Catalog # 34358-19. Made in
Mexico, Recall # Z-0386-2007;
f) Boston Scientific Mach 1 Guide Catheter Femoral Approach, 7F, 0.081',
Voda Left Curve, UPN # H74934357730, Catalog # 34357-73. Made in Mexico,
Recall # Z-0387-2007;
g) Boston Scientific Mach 1 Peripheral Guide Catheter, 6F, 55cm, LIMA Tip Shape,
UPN # M001196620, Catalog # 19-662. Made in Mexico, Recall # Z-0388-2007
CODE
a) Batch / Lot # 687532;
b) Batch / Lot #: 687586, 687593, 687596;
c) Batch / Lot # 687654;
d) Batch / Lot # 687753;
e) Batch / Lot # 687754;
f) Batch / Lot # 688035;
g) Batch / Lot #: 687877, 687878, 687879, 688002
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific, Maple Grove, MN, by letters dated December 13 and December 14, 2006.
Manufacturer: Pacific Device De Mexico S A De C V, Tijuana B C Mex, Mexico. Firm initiated recall is ongoing.
REASON
Excess strands of resin may exist in the lumen near the hub of certain batches/lots of the Mach 1 Guide Catheters. If this excess resin is present in the catheter, there is the potential of an embolization resulting from the excess resin detaching from the device during the procedure.
VOLUME OF PRODUCT IN COMMERCE
51 units
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
Perry-Kolberg Titanium Motility/Support System (Threaded Sleeve and Flat Peg), for use in ocular implants, Model Number 100045 The threaded sleeve and flat peg are two components of the P-K Titanium Motility/Support System. The threaded sleeve is an externally threaded cylinder and an internal drilled hole designed to receive a peg. It is placed in the Bioeye Hydroxyapatite Implant with the use of the P-K Titanium threaded sleeve wrench after a hole has been prepared in the implant by drilling with a series of hypodermic needles of gradually increasing sizes. After the threaded sleeve is placed in the implant, any of the P-K Pegs can be inserted. The affected model which is the subject of this recall comes with the flat peg. Product is not serialized. Note: Lot code assigned by the contract manufacturing firm, Recall # Z-0396-2007
CODE
Lot number: M-50021
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integrated Orbital Implants Inc., San Diego, CA, by telephone, fax and letter on December 20, 2006.
Manufacturer: Kolberg Ocular Products Inc., San Diego, CA. Firm initiated recall is ongoing.
REASON
The threads on the threaded sleeve were manufactured with left-handed threads, requiring a modification to the surgical technique for proper insertion. Failure to properly identify the affected components and apply the modified insertion technique will result in an inability to insert the sleeve into the implant.
VOLUME OF PRODUCT IN COMMERCE
234 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
Mucotrol Concentrated Oral Gel Wafer contained in HDPE Bottle, Recall # Z-0398-2007
CODE
Batch/Lot numbers 65AB, 97AB, and 99 AB
RECALLING FIRM/MANUFACTURER
Belcher Pharmaceuticals, Inc., Largo, FL, by letter dated September 25, 2006. Firm initiated recall is ongoing.
REASON
Processing and cleaning process validation were not completed before production. Product had some GMP failures related to the quality system.
VOLUME OF PRODUCT IN COMMERCE
1,097 bottles (21 & 45 count / bottles)
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
a) Triathlon X3 CR Tibial Bearing Insert for knee prosthesis Size #2 - 11MM,
Ref # 5530-G-211 2011-09, Recall # Z-0399-2007;
b) Triathlon X3 CR Tibial Bearing Insert for knee prosthesis Size #7 - 11MM
Ref # 5530-G-711 2011-09, Recall # Z-0400-2007
CODE
a) Lot code G9XF6 LAF974;
b) Lot G9XF7 LAF978
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica Osteonics, Corp., Mahwah, NJ, by letters on December 8, 2006.
Manufacturer: Stryker Orthopaedi, Limerick, Ireland. Firm initiated recall is ongoing.
REASON
A product mix -up in which the labeling indicates a Triathlon X# CR Tibial Bearing Insert Size #2 - 11MM, however, the device inside the package is actually a Triathlon X3 CR Tibial Bearing insert Size # 7 - 11MM and vice versa.
VOLUME OF PRODUCT IN COMMERCE
47 units
DISTRIBUTION
Nationwide and Canada

___________________________________
PRODUCT
a) BD Beaver™ Mini-Blade, Blade Mini Orthopedic 1.255 in,
Catalog Number: 374562, Recall # Z-0401-2007;
b) BD Beaver™ Mini-Blade, Blade Mini Orthopedic 1.31 in,
Catalog Number: 376100, Recall # Z-0402-2007;
c) BD Beaver™ Mini-Blade, Blade Sharp Two Sides Pointed,
Catalog Number: 376300, Recall # Z-0403-2007;
d) BD Beaver™ Mini-Blade, Blade Mini RND Tip Sharp One Side,
Catalog Number: 376400, Recall # Z-0404-2007;
e) BD Beaver™ Mini-Blade, Blade Mini Pointed Tip S/SU,
Catalog Number: 376500, Recall # Z-0405-2007;
f) BD Beaver™ Mini-Blade, Blade Mini Curved Sharp on One,
Catalog Number: 376700, Recall # Z-0406-2007;
g) BD Beaver™ Mini-Blade, Blade Mini Sharp All Around S/SU,
Catalog Number: 376900, Recall # Z-0407-2007;
h) BD Beaver™ Mini-Blade, Mini/Bulk 64, Catalog Number: 374820,
Recall # Z-0408-2007;
i) BD Beaver™ Mini-Blade, Mini/Bulk 67, Catalog Number: 374822,
Recall # Z-0409-2007;
j) BD Beaver™ Mini-Blade, Mini/Bulk 69, Catalog Number: 374823,
Recall # Z-0410-2007
CODE
a) Lot Numbers: 6164130, 6233130, 6265005;
b) Lot Numbers: 6158640, 6215941, 6258011
c) Lot Number: 6159927;
d) Lot Numbers: 6138940, 6146142, 6156739, 6166196, 6167300, 6172592, 6177437,
6186449, 6191356, 6193323, 6195540, 6200787, 6205116, 6212332, 6215951,
6222023, 6228063, 6233806, 6241023, 6255156, 6262012, 6269131, 6278501
6296135* 6300614* 6312509* 6331680* 6338257* 6346693*;
e) Lot Numbers: 6136891, 6158973, 6164128, 6167321, 6172845, 6179889, 6186623,
6198098, 6213333, 6248635, 6251884 6265045* 6275006* 6297349* 6321708*
f) Lot Numbers: 6143495, 6153297, 6160837, 6167304, 6173905, 6179920, 6230311,
6236605, 6244982, 6251826, 6257987, 6264189, 6272049 6279648* 6289452*
6311753* 6321505*;
g) Lot Numbers: 6137932, 6142435, 6158382, 6180374, 6187250, 6192282, 6194468,
6198656, 6209256, 6220182, 6223296, 6234908, 6240871, 6243911, 6248083, 6261021,
6271650, 6276887 6283485* 6289455* 6304844* 6317038* 6333608* 6338256* 6342185*;
h) Lot Numbers: 6166194, 6180373, 6222021, 6249826, 6278493;
i) Lot Numbers: 6159386, 6293719;
j) Lot Numbers: 6151098, 6202027, 6216915, 6227071, 6237675, 6276883 6293717*
RECALLING FIRM/MANUFACTURER
BD Opathalmic Systems, Waltham, MA, by letters on December 26, 2006 and January 10, 2007. Firm initiated recall is ongoing.
REASON
Product sterility may be compromised due to incomplete package seal.
VOLUME OF PRODUCT IN COMMERCE
664,050 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
AutoSuture Bladed Trocar, equipped with safety shield. Model number 179094. Available with smooth or threaded sleeve in sizes 5-15mm inner diameter and 70-100mm length, Recall # Z-0414-2007
CODE
94724 95261 104057 94853 95272 104217 94893 100062 104335 94894 102389 104337 94897 102394 104343 94953 102681 104584 94957 102851 105517 94962 103100 94964 103103 95024 103200 95026 103288 95029 103293 95069 103297 95135 103566 95259 103570
RECALLING FIRM/MANUFACTURER
Ascent Healthcare Solutions, Inc., Lakeland, FL, by facsimile letter on October 19, 2006. Firm initiated recall is ongoing.
REASON
The tip of the trocars may separate before and while in use. In some instances the trocars have been found with exposed blades upon opening the packaging.
VOLUME OF PRODUCT IN COMMERCE
1,566 units
DISTRIBUTION
Nationwide
______________________________
PRODUCT
a) ARCHITECT i2000 Processing Module, for in vitro diagnostics,
List Number 08C89-01; Temperature Controller Board Part #78560-109;
Recall # Z-0415-2007;
b) ARCHITECT i2000SR Processing Module, for in vitro diagnostics,
List Number 3M74-01; Temperature Controller Board Part #78560-109;
Recall # Z-0416-2007
CODE
a) Serial numbers: 1202790, 1202804, 1202805, 1202806, 1202807, 1202808, 1202809, 1202810, 1202811, 1202812, 1202813, 1202814, 1202815, 1202816, 1202817, 1202818, 1202819, 1202820, 1202821, 1202822, 1202823, 1202824, 1202825, 1202826, 1202827, 1202828, 1202829, 1202830, 1202831, 1202832, 1202833, 1202834, 1202835, 1202836, 1202837, 1202838, 1202839, 1202840, 1202841, 1202842, 1202843, 1202844, 1202845, 1202846, 1202847, 1202848, 1202849, 1202850, 1202851, 1202852, 1202853, 1202854, 1202855, 1202856, 1202857, 1202858, 1202859.

b) Serial numbers: 1SR03771 1SR03653 1SR03823 1SR03720 1SR03565 1SR03839 1SR03835 1SR03708 1SR04077 1SR03719 1SR03621 1SR03626 1SR04030 1SR03618 1SR03570 1SR04031 1SR03891 1SR04033 1SR03562 1SR04048 1SR03698 1SR03567 1SR03813 1SR03868 1SR03747 1SR03615 1SR03826 1SR04032 1SR03752 1SR03772 1SR03983 1SR03623 1SR03520 1SR03553 1SR03680 1SR03713 1SR03725 1SR03746 1SR03757 1SR03168 1SR03530 1SR03533 1SR03537 1SR03538 1SR03569 1SR03676 1SR03862 1SR03832 1SR03678 1SR03679 1SR03819 1SR03484 1SR03588 1SR03778 1SR03673 1SR03518 1SR03510 1SR03825 1SR03767 1SR03754 1SR03659 1SR03844 1SR03809 1SR03880 1SR03882 1SR03705 1SR03596 1SR03549 1SR03590 1SR03514 1SR03571 1SR03513 1SR03612 1SR03859 1SR03489 1SR03524 1SR03522 1SR03852 1SR03853 1SR03740 1SR03662 1SR03564 1SR03517 1SR03741 1SR03663 1SR03830 1SR03884 1SR03576 1SR03768 1SR03786 1SR03769 1SR03774 1SR03775 1SR03886 1SR03531 1SR03577 1SR03486 1SR03821 1SR03541 1SR03759 1SR03921 1SR03671 1SR03760 1SR03692 1SR03501 1SR03582 1SR03583 1SR03516 1SR03723 1SR03528 1SR03790 1SR03700 1SR03896 1SR03608 1SR03729 1SR03487 1SR03593 1SR03632 1SR03620 1SR03619 1SR03464 1SR03597 1SR03598 1SR03600 1SR03482 1SR03485 1SR03601 1SR03827 1SR03674 1SR03745 1SR03779 1SR03807 1SR03818 1SR03883 1SR03890 1SR03242 1SR03481 1SR03499 1SR03503 1SR03525 1SR03547 1SR03559 1SR03568 1SR03594 1SR03595 1SR03603 1SR03605 1SR03606 1SR03622 1SR03625 1SR03629 1SR03633 1SR03634 1SR03677 1SR03707 1SR03712 1SR03721 1SR03770 1SR03777 1SR03782 1SR03783 1SR03789 1SR03795 1SR03801 1SR03808 1SR03840 1SR03842 1SR03848 1SR03849 1SR03850 1SR03854 1SR04063 1SR04064 1SR04065 1SR04066 1SR04068 1SR04069 1SR04070 1SR04071 1SR04072 1SR04074 1SR04084 1SR04085 1SR04086 1SR04087 1SR04091 1SR04092 1SR04093 1SR04094 1SR04098 1SR04101 1SR04102 1SR04112 1SR04116 1SR04119 1SR04120 1SR04122 1SR04123 1SR04124 1SR04126 1SR04127 1SR04128 1SR04129 1SR04130 1SR04131 1SR04132 1SR04134 1SR04137 1SR04138 1SR04139 1SR04140 1SR04141 1SR04145 1SR04149 1SR04111 1SR04121 1SR04125 1SR04133 1SR03544 1SR03578 1SR03924 1SR03946 1SR03953 1SR04136 1SR04146 1SR04147 1SR04148 1SR04153 1SR04154 1SR03627 1SR03952 1SR03997 1SR03766 1SR03534 1SR03806 1SR04023 1SR03695 1SR03664 1SR03976 1SR03580 1SR04055 1SR03816 1SR03684 1SR03773 1SR03631 1SR03824 1SR03628 1SR03505 1SR03682 1SR03515 1SR03507 1SR03820 1SR03498 1SR03765 1SR04045 1SR03967 1SR04089 1SR03828 1SR03846 1SR04028 1SR04002 1SR04076 1SR03635 1SR03660 1SR04113 1SR04114 1SR03793 1SR04001 1SR03656 1SR04034 1SR03694 1SR03874 1SR04118 1SR03589 1SR04150 1SR03714 1SR03738 1SR03909 1SR04081 1SR03800 1SR03805 1SR03756 1SR04097 1SR03502 1SR03906 1SR04151 1SR03555 1SR03607 1SR03617 1SR03812 1SR03814 1SR03831 1SR03152 1SR04156 1SR04162 1SR04166 1SR04155 1SR04160 1SR03554 1SR03558 1SR03560 1SR03591 1SR03613 1SR03655 1SR03717 1SR03718 1SR03722 1SR03726 1SR03727 1SR03735 1SR03776 1SR03791 1SR03794 1SR03799 1SR03822 1SR03836 1SR03841 1SR03843 1SR03845 1SR03851 1SR03855 1SR03857 1SR03894 1SR03904 1SR03962 1SR03971 1SR03982 1SR03986 1SR03994 1SR03998 1SR04012 1SR04013 1SR04018 1SR04019 1SR04021 1SR04024 1SR04035 1SR04052 1SR04067 1SR04073 1SR04075 1SR04079 1SR04080 1SR04090 1SR04104 1SR04107 1SR03731 1SR03661 1SR03743 1SR03834 1SR03733 1SR03734 1SR03585 1SR03490 1SR03811 1SR03748 1SR03810 1SR03804 1SR03654 1SR03637 1SR03732 1SR03523 1SR03636 1SR03860 1SR03792 1SR03614 1SR03798 1SR03552 1SR03667 1SR03657 1SR03847 1SR03683 1SR03497 1SR03545 1SR03701 1SR03574 1SR03575 1SR03630 1SR03535 1SR03892 1SR03803 1SR03458 1SR03573 1SR03536 1SR03761 1SR03493 1SR03561 1SR03864 1SR03867 1SR03572 1SR03556 1SR03960 1SR03675 1SR03581 1SR03539 1SR03763 1SR03641 1SR03665 1SR03604 1SR03699 1SR03829 1SR03557 1SR03500 1SR03670 1SR03511 1SR03526 1SR03579 1SR03703 1SR03755 1SR03509 1SR03750 1SR03586 1SR03587 1SR03666 1SR03669 1SR03611 1SR03551 1SR03616 1SR03638 1SR03642 1SR03643 1SR03644 1SR03645 1SR03646 1SR03647 1SR03648 1SR03649 1SR03650 1SR03651 1SR03658 1SR03728 1SR03730 1SR03817 1SR03833 1SR03838 1SR03863 1SR03865 1SR03869 1SR03870 1SR03873 1SR03879 1SR03897 1SR03899 1SR03900 1SR03856 1SR03858 1SR03866 1SR03872 1SR03876 1SR03877 1SR03878 1SR03887 1SR03888 1SR03889 1SR03907 1SR03908 1SR03910 1SR03916 1SR03920 1SR03922 1SR03923 1SR03926 1SR03927 1SR03945 1SR03957 1SR03958 1SR03961 1SR03972 1SR03973 1SR03974 1SR03978 1SR09803 1SR03981 1SR03989 1SR03995 1SR04000 1SR04004 1SR04005 1SR04006 1SR04007 1SR04008 1SR04011 1SR04015 1SR04016 1SR04017 1SR04025 1SR04026 1SR04027 1SR04029 1SR04036 1SR04039 1SR04040 1SR04041 1SR03764 1SR03542 1SR03668 1SR03690 1SR03903 1SR03762 1SR03788 1SR03913 1SR04106 1SR03563 1SR04056 1SR03685 1SR03527 1SR03521 1SR03895 1SR04022 1SR03912 1SR04053 1SR04105 1SR03918 1SR03901 1SR04096 1SR03893 1SR03610 1SR03984 1SR03744 1SR04038 1SR04044 1SR04014 1SR03992 1SR03751 1SR03780 1SR03691 1SR03702 1SR03693 1SR03787 1SR03686 1SR03602 1SR03975 1SR03546 1SR03736 1SR03529 1SR03932 1SR03672 1SR03711 1SR03599 1SR03977 1SR03540 1SR03881 1SR03739 1SR03715 1SR03709 1SR03724 1SR03543 1SR03696 1SR03688 1SR03689 1SR03697 1SR03710 1SR03784 1SR03797 1SR03917 1SR03942 1SR03987 1SR04009 1SR04020 1SR04043 1SR04050 1SR04082 1SR04083 1SR04088 1SR04095 1SR04099 1SR04115 1SR04135 1SR03753 1SR04117 1SR03914 1SR03749 1SR03758 1SR03898 1SR03875 1SR03532 1SR03550 1SR03796 1SR03802 1SR03592 1SR03624 1SR03742 1SR04037 1SR04010 1SR04046 1SR04100 1SR04042 1SR04060 1SR03979 1SR03999 1SR03885 1SR03566 1SR03491 1SR03492 1SR03504 1SR03506 1SR03512 1SR03704 1SR03508 1SR03815 1SR03609 1SR03687 1SR03781 1SR03584 1SR03496 1SR03985 1SR03991 1SR03519 1SR03639 1SR03640 1SR03706 1SR03716 1SR03737 1SR04047 1SR04049 1SR04051 1SR04057 1SR04058 1SR04059 1SR04061 1SR04062 1SR03652 1SR03993 1SR04003 1SR04054 1SR04103 1SR04108 1SR04109 1SR04110 1SR03785 1SR03871 1SR03919 1SR03988 1SR03990 1SR03488 1SR03495 1SR03681 1SR03480
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX, by telephone and fax beginning December 13, 2006. Firm initiated recall is ongoing.
REASON
The re-designed ARCHITECT Temperature Controller Board has been identified as being susceptible to electromagnetic interference (EMI) in the laboratory. This can cause a board reset condition, stopping temperature control function of the board. Situation does not stop analyzer operation and does not generate an error condition alerting operator when condition occurs.
VOLUME OF PRODUCT IN COMMERCE
701
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
a) Cytomics FC 500 with CXP software, Versions 2.0 & 2.1: Part #722645,
Software Kit; CXP version 2.1 New User; Part #723113 Software Kit;
CXP version 2.1 Upgrade; Part #629637 Software Kit; CXP version 2.0
New User; Part #629636 Software Kit; CXP version 2.0 Upgrade.
The Cytomics FC 500 is a system for the qualitative and quantitative
measurement of biological and physical properties of cells and other
particles, Recall # Z-0418-2007;
b( Cytomics FC 500 MPL with MXP software, Versions 2.0 & 2.1:
Part #731419 KIT; FOC MXP 2.0 UPGRADE KIT; Part #731418
SWRE KIT; MXP 2.0 NEW USER; Part #772145 MXP 2.1 FOC
Upgrade Kit; 771938 MXP 2.1 Software; Part #771952 FOC MXP 2.1
Upgrade Kit; Part #771953 New User MXP 2.1 Kit. The Cytomics
FC 500 is a system for the qualitative and quantitative measurement
of biological and physical properties of cells and other particles,
Recall # Z-0419-2007;
c) CXP Analysis Software, Versions 2.0 & 2.1: Part #722396 CXP
Analysis Software Kit V2.1, Single User; Part #722395 CXP Analysis
Software Kit V2.1, Single User Upgrade; Part #722397 CXP Analysis
Software Kit V2.1, 3 User Pack; Part #722398 CXP Analysis Software
Kit V2.1, 5 User Pack; Part #722399 CXP Analysis Software Kit V2.
1, 15 User Pack; Part # 722593 CXP Analysis Software Kit V2.1,
5 Network User Pack Part #722594 CXP Analysis Software Kit V2.1,
10 Network User Pack; Part #722595 CXP Analysis Software Kit V2.1,
15 Network User Pack; Part #629640 CXP Analysis Software Kit V2.0,
Single User; Part #629639 CXP Analysis Software Kit V2.0, Single User
Upgrade; Part #629641 CXP Analysis Software Kit V2.0, 3 User Pack;
Part #629642 CXP Analysis Software Kit V2.0, 5 User Pack; Part #629643
CXP Analysis Software Kit V2.0, 15 User Pack; Part #629644 CXP Analysis
Software Kit V2.0, 5 Network User Pack; Part #629645 CXP Analysis
Software Kit V2.0, 10 Network User Pack; Part #629646 CXP Analysis
Software Kit V2.0, 15 Network User Pack. The Cytomics FC 500 is a system
for the qualitative and quantitative measurement of biological and physical
properties of cells and other particles, Recall # Z-0420-2007
CODE
Versions 2.0 & 2.1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc, Brea, CA, by letter beginning August 29, 2006.
Manufacturer: Applied Cytometry, Sheffield, UK. Firm initiated recall is ongoing.
REASON
Two workflow scenarios associated with renaming regions may produce incorrect results.
VOLUME OF PRODUCT IN COMMERCE
423 units, 200 pieces
DISTRIBUTION
Nationwide and Canada
______________________________
PRODUCT
iE33 Ultrasound System (System, imaging, pulsed doppler, ultrasonic and system, imaging, pulsed echo, ultrasonic), Recall # Z-0422-2007
CODE
Base id numbers: 02RCZW, 02KHVQ, 02L57V, 02L5HV, 02KG8D, 02LJ5B, 02LJBB, 02RC00, 02HWQJ, 02BV73, 02LFMR, 02HXCQ, 02KHQ7, 02HWRH, 02HWT2, 02LJ1R, 02RC92, 02KHWF, 02LHZT, 02L6Y3, 02L6Z7, 02RC8Y, 02KHMD, 02LJ85, 02KHXP, 02KHWK, 02KHZH, 02HXP2, 02HXPN, 02D391, 02KJ47, 02L54X, 02RC0Y, 02RC11, 02L598, 02KHQQ, 02RC7B, 02LJBC, 02KHLC, 02KHJ1, 02KHMX, 02LFKV, 02LFKW, 02LFMB, 02LFML, 02LFMP, 02LJP0, 02RCFT, 02RCY3, 02RCXZ, 02RCQL, 02RCXC, 02D38B, 02BV74, 02DPCL, 02LJ56, 02LJ47, 02LJL3, 02RD0X, 02HWQ5, 02D3VM, 02RCXG, 02L4TW, 02RCHN, 02L5KG, 02RC0Q, 02LJ5L, 02L6B4, 02L6F6, 02L5RZ, 02LJPL, 02KH91, 02KH87, 02KHG5, 02HXKQ, 02HXL5, 02HWV9, 02RCXX, 02HXBW, 02HXN6, 02KJ3L, 02L6W7, 02L552, 02HXFX, 02RCV6, 02KHPD, 02KHNW, 02KHPT, 02KHNQ, 02L6YX, 02L5NP, 02DPL9, 02DPK5, 02KJ5Y, 02DPMN, 02KHMY, 02L51R, 02L57W, 02KHHH, 02KHHW, 02LJJH, 02LJK8, 02L6CD, 02L559, 02KHKM, 02RCX6, 02RCWB, 02RCX7, 02RCPJ, 02LJ0M, 02L50F, 02KHVH, 02BVM0, 02L5XW, 02RCHP, 02RCW8, 02RCW5, 02RCW6, 02RCJN, 02RCY1, 02LJ0J, 02RCV8, 02KHG1, 02L5L9, 02KH9J, 02L52X, 02LJ8K, 02LJ91, 02BV6Z, 02LJ0V, 02LJ0P, 02LJ08, 02L4XN, 02RC10, 02RC1W, 02RC27, 02RC28, 02KH8C, 02LJ09, 02D28Y, 02HXJR, 02KHVK, 02KHQX, 02KHX4, 02LJ4D, 02LJC1, 02LJB6, 02LJ96, 02LJBD, 02LJBG, 02L6CC, 02HWRJ, 02L5X0, 02L6QV, 02L5MF, 02HXL7, 02L66Y, 02L66Z, 02L6M9, 02L4Z8, 02RCTK, 02DQBF, 02HWRK, 02LJC5, 02LJG1, 02LJDD, 02LJKC, 02LJKZ, 02LFJB, 02BVJ6, 02LJ3F, 02LJ1N, 02L603, 02L5WJ, 02L6FL, 02L6F5, 02LJKT, 02RCZX, 02D4BK, 02DPFV, 02L6NP, 02D4C2, 02DQ10, 02RD05, 02RCHQ, 02HX8L, 02LJM6, 02L6H9, 02RD01, 02RCZY, 02RCZR, 02LJ0K, 02LJ0Z, 02LJ1G, 02LJ1K, 02LK02, 02LK09, 02RCWC, 02RCW9, 02KHB1, 02LHYK, 02LHYG, 02DPXK, 02BV72, 02HWQ0, 02RCCF, 02RCMW, 02RCM8, 02RCZZ, 02RCBC, 02RCM5, 02L56K, 02L6NQ, 02RCZP, 02L4XH, 02L51Q, 02HXTK, 02HXTN, 02HWW9, 02DR1W, 02KHVX, 02LJ1Y, 02LJ2R, 02HWPT, 02RCTG, 02KHBL, 02KHBM, 02KHC3, 02DPMV, 02DQNF, 02DPMR, 02RCPL, 02LJ1C, 02L70Z, 02DQP4, 02DQNX, 02HXR3, 02HXQK, 02HXR4, 02HXTG, 02HXTV, 02DPDT, 02KH5M, 02L6R5, 02L6RR, 02DPPW, 02KHY8, 02L51K, 02L70R, 02KHDT, 02KHPW, 02RCX8, 02RCX9, 02L57J, 02L4Z1, 02DPPT, 02DR25, 02HWTF, 02LHZV, 02DP8Q, 02L6N8, 02DP9T, 02DPB7, 02DPB9, 02DPPD, 02DPP8, 02DP8P, 02DP86, 02RCRR, 02HXD9, 02HXDD, 02HXDH, 02HXF0, 02LFNR, 02RC16, 02RCW3, 02KHT4, 02RCB3, 02RC88, 02KJ6F, 02KG8F, 02KHJL, 02HX54, 02HX55, 02HX5B, 02HX7H, 02HX7V, 02HXHQ, 02LJCR, 02LJDR, 02L5G5, 02L5CK, 02RCF4, 02RCMX, 02RCMY, 02RCM2, 02L4YM, 02L57X, 02L591, 02L6LX, 02L50Y, 02KHXB, 02KH71, 02L4YG, 02BVLZ, 02DQNJ, 02HX7X, 02HXJH, 02RCZN, 02RCWY, 02RCVB, 02D413, 02RD06, 02HXBY, 02RCXB, 02RCY2, 02DQJH, 02L6N0, 02L6MD, 02DR27, 02HXC0, 02L6MZ, 02L6BP, 02HXBG, 02HX7Y, 02L5QK, 02LJ1J, 02LJC0, 02LJ1H, 02LHZ2, 02L5RY, 02LJ2Q, 02LJ38, 02L6QT, 02HXPL, 02L6YM, 02LHYH, 02KHVW, 02RCG8, 02LFMX, 02L706, 02KJ1V, 02RD00, 02HXN0, 02HWT3, 02KHTM, 02HXKL, 02L5Z8, 02L6R3, 02KHT8, 02LFMW, 02RC0P, 02KHQZ, 02RCN0, 02RCXD, 02DPDP, 02L6J9, 02LFH9, 02LK0Y, 02LK10, 02RCRQ, 02HWZV, 02HX8B, 02L50K, 02KJ0H, 02KJ0N, 02LJNM, 02LJM4, 02LJK9, 02LJKX, 02HXMG, 02HXMB, 02HXKK, 02HXKN, 02LHYD, 02KG8C, 02HXHW, 02L4XG, 02KHRN, 02HXP5, 02KHRH, 02DPWZ, 02RCLF, 02BTMJ, 02HWPZ, 02RCX3, 02KHJH, 02HXFP, 02KHMF, 02KH9H, 02KHM5, 02KHM7, 02HXD5, 02LJH4, 02LJKJ, 02LJKH, 02LJM5, 02L6GX, 02RD10, 02HXR2, 02LJF8, 02L6TB, 02LJH3, 02LJG7, 02D3VK, 02HXHN, 02HWXL, 02RCXH, 02LFHB, 02L67L, 02L61D, 02HWV8, 02HXBV, 02LJDN, 02LJH2, 02LJ1Z, 02LJ9R, 02LK0X, 02LJ8Q, 02RCRP, 02RCV9, 02L6G9, 02L6Y6, 02L6QW, 02LJ88, 02RCQJ, 02KHM2, 02RCJB, 02L4XJ, 02L56N, 02L55C, 02HXBH, 02L6GY, 02KH5L, 02RC01, 02DPP9, 02L6KX, 02HXK9, 02RCZT, 02L4Y7, 02L6C4, 02KHXL, 02L4YH, 02L6V2, 02L6V3, 02L6MY, 02RC7Q, 02RC7P, 02RC5N, 02RC7Y, 02LFMD, 02LFMM, 02LFNL, 02RC08, 02RC0V, 02RC14, 02KHHR, 02L699, 02L68J, 02L68F, 02L6B2, 02L70N, 02LJ1V, 02LJCY, 02LJ5N, 02L5G6, 02D4C3, 02DP9Q, 02DPQP, 02KHW0, 02KHQ3, 02HWTX, 02KHNR, 02RCJJ, 02RC29, 02RCTD, 02HXHP, 02LJJG, 02LJ5M, 02KHQ9, 02LJP1, 02L6BG, 02L5FY, 02KG8H, 02KHVL, 02RCC1, 02RCFW, 02L5P8, 02LFMK, 02L5VC, 02L5PP, 02RCZQ, 02RCTC, 02L605, 02L60X, 02RD0Z, 02DPRK, 02DPTZ, 02RD04, 02RD12, 02RD13, 02L6ZN, 02LJC9, 02RCM4, 02DPQR, 02HWRG, 02KHPZ, 02DPVB, 02KHXN, 02KHWJ, 02RC5J, 02KJ42, 02RCT7, 02LK0B, 02L5FH, 02RCX4, 02L71D, 02L70T, 02LHZ4, 02L5TC, 02L6V6, 02HXF5, 02HXPT, 02L602, 02RCPP, 02LFMC, 02KHP9, 02KHRM, 02RCY4, 02RCY5, 02RCXY, 02RD0Y, 02RCHM, 02RCTN, 02RCW7, 02RCVC, 02RD03, 02L6Q6, 02L681, 02LFMZ, 02LFMG, 02LFMJ, 02LFM9, 02LFMV, 02LFN2, 02HXBM, 02HWZF, 02L6K9, 02L6KW, 02L6Y9, 02LJ4B, 02L6NX, 02L6LV, 02KJ5X, 02RCZV, 02RCPR, 02L6NB, 02HX53, 02HXNL, 02D4BG, 02HWT0, 02L6GB, 02L6FT, 02L5MP, 02L69C, 02L6B0, 02L6GD, 02L6MB, 02L6LY, 02L6KC, 02RCRV, 02RCRT, 02KHD5, 02HXL2, 02RC7T, 02DPQ6, 02L4WW, 02DPZV, 02L6BF, 02L6BC, 02L69B, 02L68N, 02L68G, 02L662, 02L64N, 02L64Z, 02L64P, 02HWQ6, 02LJKK, 02LJ2N, 02KJ0G, 02RCB1, 02RCXF, 02RCTP, 02KJ5P, 02L4VC, 02L4VH, 02L667, 02L663, 02L64Y, 02L64Q, 02L682, 02L683, 02L67X, 02L67N, 02L63T, 02L61F, 02DQ3N, 02KH89, 02LFMT, 02HXNK, 02RCY0, 02HXJG, 02LFMN, 02RC17, 02RC2B, 02RC2Q, 02L6XC, 02L6NC
RECALLING FIRM/MANUFACTURER
Phillips Ultrasound, Inc., Bothell, WA, by letter dated October 31, 2006. Firm initiated recall is ongoing.
REASON
Acoustic output intensity may exceed maximum specified limits and the patient contact temperature may exceed 43 degree C (when the system is used with the S12-4 transducer in CW-mode).
VOLUME OF PRODUCT IN COMMERCE
1,429 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

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PRODUCT
Desktop Pro™ R6.0 & R6.1, Linear Medical Accelerator, Model number MRT 9871/ MRT 10601, Recall # Z-0421-2007
CODE
This issue affects all Desktop Pro 6.0 and 6.1 users with a 3rd party R & V System, with the exception of Sigma Micro Users.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Elekta, Inc. Norcross GA, by letter dated November 23, 2006.
Manufacturer: Elekta Oncology, Sussex, UK. Firm initiated recall is ongoing.
REASON
Unexpected Diaphragm movement when manual field size modifications are not saved.
VOLUME OF PRODUCT IN COMMERCE
37 units
DISTRIBUTION
Nationwide and Canada

END OF ENFORCEMENT REPORT FOR FEBRUARY 14, 2007.

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