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U.S. Department of Health and Human Services

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Enforcement Report for April 25, 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.

April 25, 2007
07-17

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS I

___________________________________
PRODUCT
Weg,ams "Food You Feel Good About" Fat Free Garden French Dressing. The product is sold in 16 oz. bottles and shipped in cases containing 12 bottles. UPC 77890 81871, Recall # F-193-7
CODE
Best Before AUG 22 07
RECALLING FIRM/MANUFACTURER
E. D. Smith and Sons LP, Seaforth, Ontario, Canada, by email on January 24, 2007 and by press release and letter on January 25, 2007. Firm initiated recall is complete.
REASON
Product contains undeclared milk.
VOLUME OF PRODUCT IN COMMERCE
191 cases (each case contains 12 bottles)
DISTRIBUTION
NY, PA, NJ, MD, and VA

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS II

___________________________________
PRODUCT
Foam cosmetic applicators and sponges, Made in Korea
a) UPC 0-79625-02007-6, Studio Basics professional tools face, 2 rectangle compact sponges,
non-latex replacement sponges;
b) UPC 0-79625-02014-4, Studio Basics professional tools face, 2 contouring sponges, non-latex;
c) UPC 0-79625-02015-1, Studio Basics professional tools face, travel sponge multi-pack
includes 2 disposable exfoliating sponges, 2 cosmetic cleansing sponge, 7 cosmetic wedges
non-latex, 1 round compact sponge, non-latex;
d) UPC 0-79625-02167-7, Studio Basics professional tools, 2 round blending sponges for a
smooth streak-free finish;
e) UPC 0-79625-02183-7, Studio Basics professional tools, 6 cosmetic wedges, non-latex;
f) UPC 0-79625-02189-9, Studio Basics professional tools face, 12 round blending sponges for a
smooth streak-free finish, non-latex;
g) UPC 0-79625-02190-5, Studio Basics professional tools face, 32 cosmetic wedges, non-latex;
h) UPC 0-79625-02018-2, Studio Basics professional tools face, 4 finger sponges for quick
touch-ups, non-latex;
i) UPC 0-79625-02020-5, Studio Basics professional tools face, make-up artist sponge for
full make-up coverage, non-latex;
j) UPC 0-79625-02006-9, Studio Basics professional tools, 2 round compact sponges, oil resistant,
non-swelling and non-crumbling replacement sponges, non-latex;
k) UPC 0-79625-02016-8, Studio Basics professional tools face, 2 foundation diamonds for
blending make-up in contours of face, non-latex sponges;
l) UPC 0-79625-02019-9, Studio Basics professional tools face, oval sponge with carry case, non-latex;
m) UPC 0-79625-01013-8, Mon Image, 2 Round Blending Sponges, 2-1/2' diameter;
n) UPC 0-79625-01175-3, Mon Image, 12 Round Blending Sponges, Non-Latex;
o) UPC 0-79625-01176-0, Mon Image, 32 Blending Sponge Wedges, Non-Latex,
Recall Number: F-197-7
CODE
All packages of the following UPC codes: 0-79625-02007-6, 0-79625-02014-4, 0-79625-02015-1, 0-79625-02167-7, 0-79625-02183-7, 0-79625-02189-9, 0-79625-02190-5, 0-79625-02018-2, 0-79625-02020-5, 0-79625-02006-9, 0-79625-02016-8, 0-79625-02019-9, 0-79625-01013-8, 0-79625-01175-3, 0-79625-01176-0
RECALLING FIRM/MANUFACTURER
Recalling Firm: Paris Presents, Inc., Gurnee, IL., by letters dated May 26, 2006 and June 6, 2006.
Manufacturer: S & G Sponge Co., Ltd., Sungnam City, Kyungki-Co, Korea, Republic Of (South). Firm initiated recall is complete.
REASON
The cosmetic sponges contain latex residue, which can lead to severe allergic reactions in persons sensitive to latex.
VOLUME OF PRODUCT IN COMMERCE
1,207,821 packages
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
a) Pak’n Save brand Wheat Bread, Recall # F-208-7;
b) Safeway brand Butter Top Wheat Bread, Recall # F-209-7;
c) Safeway brand Butter Top White Bread, Recall # F-210-7;
d) Safeway brand Crushed Wheat Bread, Recall # F-211-7;
e) Safeway brand Super Kids Bread, Recall # F-212-7;
f) Safeway brand Whole Grain Bread, Recall # F-213-7;
g) Safeway brand Premium White Bread, Recall # F-214-7;
h) Safeway brand Premium Wheat Bread, Recall # F-215-7;
i) Safeway brand Oven Joy White Bread, Recall # F-216-7;
j) Safeway brand Oven Joy Wheat Bread, Recall # F-217-7;
k) Safeway brand Texas Toast Bread, Recall # F-218-7;
l) Pak’n Save brand White bread, Recall # F-219-7;
m) Safeway brand Premium White Sandwich Bread, Recall # F-220-7;
n) Safeway brand Pan Blanco Bread, Recall # F-221-7;
o) Safeway brand French Toasting Bread, Recall # F-222-7;
p) Safeway brand 100% Wheat Bread, Recall # F-223-7
CODE
a) thru k) "Best Before" dates up to and including March 17, 2007, (Example: Mar 17);
l) thru p) "Best Before" dates up to and including March 15, 2007, (Example: Mar 15)
RECALLING FIRM/MANUFACTURER
Safeway Stores, Inc., Pleasanton, CA., by email, telephone, press release and on-site visit on March 9, 2007. Firm initiated recall is complete.
REASON
Product may contain stainless steel wire fragments.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
CA and NV

___________________________________
PRODUCT
Ben & Jerry's Country Peach Cobbler Ice Cream: Peach Ice Cream with Cinnamon-Sugar Shortbread Pieces & a Peach Swirl ("Country Peach Cobbler"), pint size UPC #7684010182, Recall # F-224-7
CODE
Best If Used By Date: Jan 23, 2008; Jan 24, 2008; Feb 8, 2008; Feb 9, 2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Unilever United States, Inc., Englewood, NJ, by telephone, email, facsimile, and press release on March 16, 2007.
Manufacturer: Ben & Jerry, Saint Albans, VT. Firm initiated recall is complete.
REASON
Product contains undeclared wheat
VOLUME OF PRODUCT IN COMMERCE
140,000 pints
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
a) SEELECT® Flavored Pancake Syrup All Natural Sweetened with Xylitol
NET 12FL. OZ. (355 mL), Hazelnut flavor, Recall # F-225-7;
b) SEELECT® Flavored Pancake Syrup All Natural Sweetened with Xylitol
NET 12FL. OZ. (355 mL), Butter Pecan flavor, Recall # F-226-7;
c) SEELECT® Flavored Pancake Syrup All Natural Sweetened with Xylitol
NET 12FL. OZ. (355 mL), Pecan Praline flavor, Recall # F-227-7;
d) SEELECT® Flavored Pancake Syrup All Natural Sweetened with Xylitol
NET 12FL. OZ. (355 mL), Banana flavor, Recall # F-228-7;
e) SEELECT® Flavored Pancake Syrup All Natural Sweetened with Xylitol
NET 12FL. OZ. (355 mL), Peanut Butter flavor, Recall # F-229-7;
f) SEELECT® Flavored Pancake Syrup All Natural Sweetened with Xylitol
NET 12FL. OZ. (355 mL), Butterscotch flavor, Recall # F-230-7
CODE
a) 06052610;
b) 06052607;
c) 06052613;
d) 06052604;
e) 06052612;
f) 06052606
RECALLING FIRM/MANUFACTURER
Seelect, Inc., Orange, CA., by telephone and e-mail on March 5, 2007. A recall letter is also being prepared. Firm initiated recall is ongoing.
REASON
Syrups are not adequately processed to prevent outgrowth and toxin formation by pathogens.
VOLUME OF PRODUCT IN COMMERCE
39, 12 oz bottles
DISTRIBUTION
Nationwide

 RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

___________________________________
PRODUCT
PAXIL CR Tablets, (Paroxetine HCl), 12.5mg Controlled-Release Tablets, 30 tablet bottles, NDC 0029-3206-13, Recall # D-781-2007
CODE
Lot # 9-6P06 Exp date 02-29-08, Lot # 14-6P06 Exp date 05-31-08, Lot # 15-6P06 Exp date 5-31-08 and Lot # 16-6P06 Exp Date 05-31-08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smithkline Beecham Pharmaceuticals Co., Cidra, PR, by letters on January 17, 2007.
Manufacturer: Sb Pharmco Puerto Rico, Inc., Cidra, PR. Firm initiated recall is ongoing.
REASON
Incorrect Package Insert. Medical Guidance leaflet may have an incorrect dosage strength (25mg).
VOLUME OF PRODUCT IN COMMERCE
337,638 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

___________________________________
PRODUCT
50% Urea Ointment In a vehicle containing Vitamin E, Lactic Acid and Zinc, Rx Only, Net Wt. 1.5 oz (45 g), NDC 68032-130-45, Recall # D-782-2007
CODE
Lot numbers: 5553, 5554 and 5555
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rivers Edge Pharmaceuticals, Suwanee, GA., by letter/email on October 16, 2006.
Manufacturer: Sonar Products, Inc., Carlstadt, NJ. Firm initiated recall is complete.
REASON
Crystallization; Urea crystals are forming in the ointment base.
VOLUME OF PRODUCT IN COMMERCE
1,524 units
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
Sleepinal Softgels, (Diphenhydramine Hydrochloride), 50mg, 16 count blisterpacks, Maximum Strength, night-time sleep-aid, UPC 3-50486-621-16-0, Recall # D-783-2007
CODE
Lots 10574002A, 10574003, 10574004. Expiration Date: Nov-06
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blairex Laboratories, Inc., Columbus, IN., by letter on October 31, 2006.
Manufacturer: Strides, Inc., Somerset, NJ. Firm initiated recall is complete.
REASON
Failed USP Dissolution Requirement; 21 month test station
VOLUME OF PRODUCT IN COMMERCE
57,378 capsules
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

___________________________________
PRODUCT
Source Plasma, Recall # B-1078-07
CODE
Units: 364010993, 364010795, 364010325, 364009973, 364009571, 364009337, 364008902, 364008673, 364007693, 364007434
RECALLING FIRM/MANUFACTURER
International BioResources, LLC, Fort Worth, TX., by facsimile on July 5, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred by another donor center, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
NC

___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1212-07
CODE
Units: 71P822803, 71P815720, 71P815511, 71P822759, 71P822876, 71P815535
RECALLING FIRM/MANUFACTURER
Recalling Firm: Life South Community Blood Centers, Inc., Gainesville, FL., by facsimile on August 11, 2005.
Manufacturer: Life South Community Blood Centers, Inc., Huntsville, AL. Firm initiated recall is complete.
REASON
Blood product, which was labeled leukoreduced, but had an unacceptable white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
AL

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0839-07
CODE
Unit: 8022218
RECALLING FIRM/MANUFACTURER
Houchin Blood Services, Bakersfield, CA., by telephone on July 1, 2005. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with a Bacillus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1050-07
CODE
Unit: LJ00146
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI., by facsimile on August 5, 2003. Firm initiated recall is complete.
REASON
Blood product, which may have been exposed to unacceptable storage temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI

___________________________________
PRODUCT
Source Plasma, Recall # B-1051-07
CODE
Unit: I72051494
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, LLC, Fort Worth, TX., by facsimile on May 23, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1052-07
CODE
Unit: 1769382
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Indianapolis, IN., by telephone on January 22, 2007 and by letter on March 2, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with an incorrect documented body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN

___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1056-07
CODE
Unit: 21FS42122
RECALLING FIRM/MANUFACTURER
American National Red Cross, Pacific Northwest Region, Portland, OR., by telephone on July 1, 2005 and by letter dated July 20, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not have a hematocrit test during the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

___________________________________
PRODUCT
Source Plasma, Recall # B-1071-07
CODE
Unit: 364003452
RECALLING FIRM/MANUFACTURER
International BioResources, LLC, Fort Worth, TX.,
by facsimile on July 31, 2006. Firm initiated
recall is complete.
REASON
Blood product, collected from a donor for whom there was no documentation on the donor record of an arm inspection or general appearance of the donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

___________________________________
PRODUCT
Source Plasma, Recall # B-1072-07
CODE
Unit: 172058333
RECALLING FIRM/MANUFACTURER
International BioResources, LLC, Fort Worth, TX.,
by facsimile on July 18, 2006. Firm initiated
recall is complete.
REASON
Blood product, collected from a donor for whom there was no documentation on the donor record of an arm inspection or general appearance of the donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

___________________________________
PRODUCT
Source Plasma, Recall # B-1076-07
CODE
Unit: 364014365
RECALLING FIRM/MANUFACTURER
International BioResources, LLC, Fort Worth, TX., by facsimile on November 27, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

___________________________________
PRODUCT
Source Plasma, Recall # B-1077-07
CODE
Unit: 364001305
RECALLING FIRM/MANUFACTURER
International BioResources, LLC, Fort Worth, TX., by facsimile on August 9, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom there was no documentation on the donor record of an arm inspection or general appearance of the donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

___________________________________
PRODUCT
Source Plasma, Recall # B-1079-07
CODE
Units: 364002205, 364015175
RECALLING FIRM/MANUFACTURER
International BioResources, LLC, Fort Worth, TX.,
by facsimile on November 27, 2006. Firm
initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC

___________________________________
PRODUCT
Source Plasma, Recall # B-1080-07
CODE
Units: I72054941, I72058115, I72058488, I72059226, I72060248, 364002607, 364005128, 364007806, 364010071, 364011803, 364016769
RECALLING FIRM/MANUFACTURER
International BioResources, LLC, Fort Worth, TX., by facsimile on November 27, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
NC

___________________________________
PRODUCT
Source Plasma, Recall # B-1081-07
CODE
Units: I72060152, 364009502, 364011771, 364012386
RECALLING FIRM/MANUFACTURER
International BioResources, LLC, Fort Worth, TX.,
by facsimile on November 24, 2006. Firm
initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NC

___________________________________
PRODUCT
Source Plasma, Recall # B-1082-07
CODE
Units: 364000557, 364009684
RECALLING FIRM/MANUFACTURER
International BioResources, LLC, Fort Worth, TX.,
by facsimile on November 27, 2006. Firm
initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC

___________________________________
PRODUCT
Source Plasma, Recall # B-1083-07
CODE
Unit: 364013111
RECALLING FIRM/MANUFACTURER
International BioResources, LLC, Fort Worth, TX., by facsimile on November 29, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

___________________________________
PRODUCT
Fresh Frozen Plasma Pheresis, Recall # B-1084-07
CODE
FW60027 (parts 2 & 3), FW60257 (parts 1 & 3), FW60385 (parts 1, 2, & 3), KZ86904 (parts 2 & 3), FW60577 (part 3), LC35724 (parts 2 & 3), FR58861 (parts 1 & 2), FW61260 (part 1), LC36333 (part 1)
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI.,
by facsimile on June 13, 2003. Firm initiated
recall is complete.
REASON
Blood products, which were not frozen within the appropriate time frame following collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
WI

 RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

___________________________________
PRODUCT
a) DeVilbiss PD1000A Pulse Dose Oxygen Conserving Cylinder, Recall # Z-0731-2007;
b) 535D-X CF Continuous Flow Cylinder, Recall # Z-0732-2007
CODE
a) Model PD1000A-M4, serial numbers 06AM4111006 through 06AM4111055;
Model PD1000A-M6, serial numbers 06AM6111008 through 06AM6114328;
Model PD1000A-ML6, serial numbers 06AML111006 through 06AML111922;
Model PD1000A-C, serial numbers 06AC0111001 through 06AC0111191;
Model PD1000A-D, serial numbers 06AD0111011 through 06AD0111132;
and Model PD1000A-E, serial numbers 06AE0111006-06AE0111267;
b) Model 535D-M6-CF, serial numbers 06195A051 through 06276B225;
Model 535D-ML6-CF, serial numbers 06198A026 through 06277B196;
Model 535D-C-CF, serial numbers 06230A008 through 06230A124;
Model 535D-D-CF, serial numbers 06230A001 through 06262B126; and
Model 535D-E-CF, serial numbers 06230A055 through 06313B122
RECALLING FIRM/MANUFACTURER
Sunrise Medical, Somerset, PA, by telephone beginning on January 24, 2007 and by letter on January 29, 2007. Firm initiated recall is ongoing.
REASON
Cylinder could lose oxygen at high pressure after the filling process
VOLUME OF PRODUCT IN COMMERCE
4,169 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
a) Mobilett XP, mobile X-ray system, Model number 1818454, Recall # Z-0749-2007;
b) Mobilett XP, mobile X-ray system, Model number 1818447, Recall # Z-0750-2007;
c) Mobilett XP, mobile X-ray system, Model number 1818363, Recall # Z-0751-2007
CODE
a) Serial numbers 1109, 1153, 1205, 2128, 1075, 1315, 1316, 1335,
1130, 1281, 1282, 1176, 1339, 1224, 1301, 2008, 1021, 1154,
1180, 1181, 1009, 1189, 1211, 1212, 2003, 2010, 1341, 1342,
2049, 2077, 2108, 1314, 1334, 1192, 1213, 1043, 1126, 1135,
2047, 2090, 2123, 1024, 1031, 1034, 1035, 1111, 2004, 1113,
1178, 1240, 1261, 2040, 1058, 1115, 1159, 1203, 1247, 1309,
1345, 2032, 1010, 1049, 1151, 1297, 1298, 2051, 1206, 1218,
1238, 1332, 1333, 2034, 2035, 2065, 1138, 1299, 1300, 2020,
2021, 2022, 2052, 2017, 2027, 1086, 1029, 1145, 1027, 1164,
1234, 2115, 1110, 1152, 1156, 1235, 1089, 1022, 1241, 1254,
1286, 1073, 1079, 1084, 1131, 1165, 1208, 2028, 2120, 2124,
2132, 1037, 1045, 1185, 1251, 1252, 1259, 1294, 1295, 2048,
1025, 1087, 1146, 1173, 1186, 1187, 1198, 1199, 1258, 1275,
1307, 2009, 1042, 1060, 1076, 1092, 1228, 1229, 1230, 1231,
1239, 1246, 1078, 2080, 2109, 2113, 1088, 1103, 1049, 1040,
1055, 1059, 1090, 1177, 1204, 1210, 1214, 1216, 1263, 1284,
1285, 1289, 1290, 1306, 1308, 2029, 2041, 2042, 2075, 2099,
2110, 1023, 1050, 1267, 1336, 1277, 1278, 1279, 1280, 2093,
1028, 1080, 1217, 1349, 1136, 1137, 1143, and 2100;
b) Serial numbers 2033, 1034, 1010, 1020, 1041, 1053, 2044, 2045,
1008, 1043, 1025, 1026, 1027, 1028, 1029, 1030, 1031, 1032,
1033, 1040, 2007, 1052, 2001, 1017, 2002, 2040, 2021, 2022,
1011, 1016, 1018, 1021, 1039, 1054, 2005, and 2017;
c) Serial numbers 1035, 1038, 1051, 1052, and 1056
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA., by visit beginning March 21, 2007.
Manufacturer: Siemens MED FG, Getafe-Madrid, Spain. Firm initiated recall is ongoing.
REASON
Mounting bolts for tank fork assembly and collimator flange may become loose.
VOLUME OF PRODUCT IN COMMERCE
227 units
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
a) RITA® Starburst™ XL (3-5 cm Diameter/25cm Length),
Electro-surgical Device, Recall # Z-0752-2007;
b) RITA® StarBurst™ (2-3cm Diameter/25cm Length),
Electro-surgical Device, Recall # Z-0753-2007;
c) RITA® Starburst™ MRI SemiFlex (3-5 cm Diameter/25cm Length),
Electro-surgical Device, Recall # Z-0754-2007
CODE
a) Part number: 700-101317, Lot number: 22330, 22793, 23297, 23306,
24413, 24655, 25120, 25355, 25425, 25545, 25546, 25547, 25632,
25747, 25748, 25806, 25807, 25808, 25850, 25851, 25876, 25940,
25941, 25971, 25979, 25980, 25981, 26145, 26146, 26456, 26457,
26458, 26496, 26555, 26556, 26581, 26663, 26664, 26930, 26931,
26986, 26987, 27068, 27158, 27168, 27326, 27401, 27437, 27554,
27555, 27711, 27818, 27874, 28189, 28200, 28314, 28462, 28471,
28474, 28556, 28557, 28578, 28635, 28636, 28637, 28709, 28902,
28903, 28965, 28967, 28979, 29041, 29052, 29153, 29250, 29277,
29278, 29426, 29542, 29543, 29670, 29775, 29793 and 29794
Part number 700-101317J (Japanese distribution), Lot numbers 26714,
26715, 27327, 27328, 27329, 27526, 27626, 27969, 28084, 28190,
and 28250;
b) Product number: 700-101493, Lot number: 22442, 25551, 26583,
26937, 27439, 27807 & 29778 and
Product number: 700-101493J (Japanese distribution), Lot number: 25599,
25640, 25641, 25642, 25982, 26718, 26719, 26805, 26806, 27045, 27177,
27716, 27717, 27808, 27809, 27941, 27959, 27960, 27975, 27976, 27977,
28436, 28437, 28438, 28518, 28519, 28520, 28521, 28522, 28523, 28524,
28558, 28582, 28583 & 28584;
c) Part number: 700-102615, Lot number: 22445, 24657, 24772, 24557,
24824, 24921, 25126, 25360, 25361, 25431, 25432, 25554, 25601, 25555,
25644, 25755, 25645, 25756, 25815, 25816, 25860, 25859, 25947, 25948,
26153, 26239, 26312, 26466, 25977, 25978, 26240, 26311, 26467, 26564,
26580, 26587, 26588, 26672, 26673, 26730, 26940, 26941, 26994, 27071,
27165, 27179, 27256, 27358, 27408, 27407, 27409, 27444, 27562, 27594,
27719, 27720, 27811, 27875, 27877, 27961, 27962, 27968, 28091, 28098,
28257, 28322, 28440, 28441, 28468, 28525, 28526, 28560, 28638, 28714,
28639, 28719, 28906, 28881, 28971, 28972, 29044, 29113, 29158, 29159,
29256, 29340, 29548, 29045, 29667, 29856 & 29969
RECALLING FIRM/MANUFACTURER
Rita Medical Systems, Inc., Manchester, GA., by letter beginning on April 2, 2007. Firm initiated recall is ongoing.
REASON
The product may have a cracked tray which can compromise the sterility of the product.
VOLUME OF PRODUCT IN COMMERCE
5,103 devices
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
a) PADPRO™ ADULT Radiotranslucent Pad w/Zoll® connector.
Defibrillation/Pacing/Cardioversion/Monitoring Electrodes,
REF/Catalog # 2516Z. RX ONLY. Made in the USA,
Recall Number: Z-0756-2007
b) PADPRO™ADULT Radiotranslucent Pad w/Medtronic® connector,
REF/Catalog #2516M. RX ONLY. Defibrillation/Pacing/Cardioversion/
Monitoring Electrodes. Made in USA, Recall Number: Z-0757-2007
CODE
a) Lots: Y040605-1, Y040605-2, Y052605-4, Y120805-2, Y111605-3,
Y092805-6, Y010506-10, Y010506-9;
b) Lot: Y101105-4
RECALLING FIRM/MANUFACTURER
Recalling Firm: Conmed Corporation, Utica, NY, by letters dated March 5, 2007.
Manufacturer: Katecho Inc, Des Moines, IA. Firm initiated recall is ongoing.
REASON
Firm was notified of three incidents over the past 15 months in which customers opened the pouch & found an incorrect connector. This error makes the product unusable. The Zoll and Medtronic connectors are not interchangeable and are unique to their specific device.
VOLUME OF PRODUCT IN COMMERCE
10,632 pairs
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
Bio-logic-Ceegraph/Sleepscan Netlink Traveler, Model 580-T2ASM2. (a Digital EEG/Sleep Recorder Electroencephalograph that includes a built-in pulse oximeter, body position sensor, snore monitor, chest, abdominal and air flow transducers and electrode array for EEG, EMG and EOG), Recall # Z-0761-2007
CODE
All battery packs with part number 520-LIBAT4-2
RECALLING FIRM/MANUFACTURER
Bio-Logic Systems Corp., Mundelein, IL, by letter on February 26, 2007. Firm initiated recall is ongoing.
REASON
If the battery pack is installed into a Netlink Traveler unit incorrectly, a short in the wiring of the battery pack may occur and overheat the battery cells. This can cause the plastic overwrap material of the battery pack to melt and smoke.
VOLUME OF PRODUCT IN COMMERCE
130 battery packs
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
a) Bausch & Lomb Millennium Microsurgical System TSV 25 Ga. High Speed Vitrectomy
Cutter, Catalog No. CX5825, packaged individually in a Tyvek pouch, 6/box, RX,
Recall # Z-0765-2007;
b) Bausch & Lomb Millennium TSV 25 Ga. High Speed Posterior Vitrectomy Pack,
Catalog No: CX4925, containing 1/25-ga. cutter along with accessories, RX,
Recall # Z-0766-2007
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bausch & Lomb, Inc., Rochester, NY, by letters on February 12 and February 20, 2007 and by e-mails on February 14, 2007.
Manufacturer: Promex Technologies, LLC, Franklin, IN. Firm initiated recall is ongoing.
REASON
The cutter probe tip breaks during use.
VOLUME OF PRODUCT IN COMMERCE
45,875 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
Miltex Stainless Steel Disposable Scalpel #22, Part Number 4-422. Each box contains 10 individually packaged scalpels, Recall # Z-0767-2007
CODE
Lot number S07A10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Miltex, Inc., York, PA, by letter dated April 9, 2007.
Manufacturer: Kai Industries Co Ltd, Seki City, Gifu Prefecture, Japan. Firm initiated recall is ongoing.
REASON
Sterility may be compromised based on incomplete package seals (manufacturer notified Miltex).
VOLUME OF PRODUCT IN COMMERCE
400 boxes
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

___________________________________
PRODUCT
DiSorin ETI-EBNA-G kits, Catalog No. P001607A. In vitro diagnostic. For the qualitative and/or semi-quantitative detection of IgG antibody to Epstein-Barr Nuclear Antigen in human serum, Recall # Z-0755-2007
CODE
3160240B/1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Diasorin Inc., Stillwater MN, by telephone and faxed letter on March 14, 2007.
Manufacturer: DiaSorin, S.p.A., Saluggia (VC), Italy. Firm Initiated is ongoing.
REASON
A lot to lot inconsistency was noted on kits of ETI EBNA G.
VOLUME OF PRODUCT IN COMMERCE
203 units
DISTRIBUTION
Nationwide and Canada.

END OF ENFORCEMENT REPORT FOR APRIL 25, 2007

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