Enforcement Report

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.

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June 13, 2007
07-24

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS I

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PRODUCT
Dry roasted whole soy nuts, unsalted. Brand name: Peanuts. The roasted whole soy nuts are packaged in 15.25 x 12.5 x 8.5 cardboard boxes that are lined with a clear plastic bag. Individual boxes weigh 25 pounds. Each individual case is identified with one stick-on adhesive label with the Item # CO432. Recall # F-302-7
CODE
Individual 25 lb. boxes are identified with the product code CO8-07082WU-1. Product code date is further broken down as: CO8 - production lot of raw soybeans marked on its original container; 07082 - Julian date of manufacture or roasting of soybeans; WU - stands for Whole Unsalted; 1 - refers to the production line.
RECALLING FIRM/MANUFACTURER
Pacific Harvest Products, Inc., Bellevue WA, by telephone on March 29, 2007. Firm initiated recall is complete.
REASON
Bulk roasted Soybean nuts contained undeclared almond slivers.
VOLUME OF PRODUCT IN COMMERCE
450 25 lb. cases for a total of 11,250 lbs.
DISTRIBUTION
CA
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PRODUCT
a) Tony Nuccio & Sons Potatoes, peeled and sold in 20 and 25 pound bulk
packages as whole, diced and quartered, Recall # F-303-7;
b) Nuccio & Sons Yams, peeled and sold in 20 and 25 pound bulk packages
as whole and sliced, Recall # F-304-7
CODE
All product sold on12/20/06 and 12/21/06 (uncoded).
RECALLING FIRM/MANUFACTURER
Tony Nccio & Sons Sales, Inc., Detroit, MI, by telephone and letter on December 22, 2006. Firm initiated recall is complete.
REASON
The product contained undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
a) 2,415 pounds;
b) 270 pounds
DISTRIBUTION
MI and OH

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS II

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PRODUCT
Vantia brand Calabrese Olives, Net Drained Wt. 11 Lbs (5 kg). The product is packaged in a plastic pail and labeled in part, "*** Vantia Calabrese Olives *** GROWN AND PACKED IN ITALY ** GROSS WEIGHT 20 Lbs (9 kg) *** NET DRAINED WEIGHT 11 Lbs (5 kg) *** INGREDIENTS: OLIVES, WILD FENNEL, RED HOT CHILI PEPPER, GARLIC, WATER, SALT. Production codes beginning with the letter G followed by three digits, Recall # F-305-7
CODE
Lot l-:030
RECALLING FIRM/MANUFACTURER
Recalling Firm: Musco Food Corp., Maspeth, NY, by telephone on March 30, 2007 and letters dated April 20, 2007.
Manufacturer: Charlie Brown di Rutigliano & Figli S.r.l., Binetto, Italy. Firm initiated recall is complete.
REASON
The product was manufactured under conditions whereby it may have been rendered hazardous to health. It may not have been adequately processed to prevent the growth of harmful bacteria such as those which cause botulism.
VOLUME OF PRODUCT IN COMMERCE
43 cases (11 lbs. each)
DISTRIBUTION
NY, NJ, MA, and CT

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PRODUCT
a) Manischewitz Niagara Sparkling Grape Juice 100% Juice, Non Alcoholic,
    750 ml glass bottle (green) Bottled in USA Kosher for Passover and all
    year long. UPC 72700 05362, Recall # F-306-7;
b) Manischewitz Concord Sparkling GrapeJuice 100% Juice, Non Alcoholic,
    750 ml glass bottle (green) Bottled in USA Kosher for Passover and all
    year long. UPC 72700 05361, Recall # F-307-7
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: R.A.B. Food Group LLC, Secaucus, NJ, by press release and letter on May 24, 2007.
Manufacturer: Doyle Acquisition Corporation, d/b/a Pleasant Valley Wine Co, Hammondsport, NY. Firm initiated recall is ongoing.
REASON
The firm has received several complaints of bottles exploding due to yeast fermentation, which causes gas formation and additional pressure in the bottle.
VOLUME OF PRODUCT IN COMMERCE
5,972 cases (12 x 750 ml bottles)
DISTRIBUTION
Nationwide and Internationally
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PRODUCT
a) Black Cerignola Olives, packed in brine; Net drained weight: 5.5 Lbs (2.5 kg) cans,
    4 cans per case; Product of Italy; UPC 8 23106 00031 2, item #37068-0,
    Recall # F- F-308-7;
b) Castelvetrano Olives, packed in brine; Net drained weight: 11 Lbs (5 kg) clear
    plastic pails; Product of Italy, UPC 8 23106 00045 9, item #37078-0,
    Recall # F-309-7;
c) Red Cerignola Olives, packed in brine; Net drained weight: 5.5 Lbs (2.5 kg) cans,
    4 cans per case; Product of Italy; UPC 8 23106 00112 8, item #370950,
    Recall # F-310-7;
d) Dark Green Cerignola Olives, packed in brine; Net drained weight: 5.5 Lbs (2.5 kg)
    cans, 4 cans per case; Product of Italy; UPC 8 23106 00113 5, item #370961,
    Recall # F-311-7;
e) Natural Green Cerignola Olives, packed in brine; Net drained weight: 5.5 Lbs (2.5 kg)
    cans, 4 cans per case; Product of Italy; UPC 1 23106 00030 5, item #VP1615,
    Recall # F-312-7;
f) Original Gaeta Olives, packed in brine; Net drained weight: 11 Lbs (5 kg)
    clear plastic pails; Product of Italy; UPC 8 23106 00016 9, item #37067-9,
    Recall # F-313-7;
g) Ligurian Olives, packed in brine; Net drained weight: 11 Lbs (5 kg) clear
    plastic pails; Product of Italy; UPC 23106 00069, item #37092-5,
    Recall # F-314-7
CODE
All lots beginning with “G” followed by 3 or 4 digits
RECALLING FIRM/MANUFACTURER
Recalling Firm: European Imports, Ltd, Chicago, IL, by telephone or e-mail and letters on April9, 2007.
Manufacturer: Charlie Brown di Rutigliano & Figli S.r.l., Binetto, Italy. Firm initiated recall is ongoing.
REASON
The product was manufactured under conditions whereby it may have been rendered hazardous to health. It may not be adequately processed to prevent the growth of harmful bacteria such as those which cause botulism.
VOLUME OF PRODUCT IN COMMERCE
2,720 cans, 712 pails
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS III

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PRODUCT
a) Save-A-Lot Fat Free Skim Milk. Product is packaged in plastic gallons with
    UPC # 51933 65920 and plastic 1/2 gallons with UPC 51933 65850,
    Recall # F-315-7;
b) SAVE-A-LOT 2% Reduced Fat Milk. Product is packaged in plastic gallons with
    UPC # 51933 65870 and plastic 1/2 gallons with UPC 51933 65900,
    Recall # F-316-7
CODE
Date Code: May 11 36: 1376
RECALLING FIRM/MANUFACTURER
Recalling Firm: H. P. Hood, Inc., Chelsea, MA, by letter on May 2, 2007.
Manufacturer: Crowley Foods, Inc., Albany, NY. Firm initiated recall is complete.
REASON
Spoilage of milk prior to expiration date.
VOLUME OF PRODUCT IN COMMERCE
2,093 cases
DISTRIBUTION
CT, MA, NY, RI

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

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PRODUCT
a) Thyro-Tab (levothyroxine sodium tablets), 0.025 mg, 150,000-tablet bulk
    drums intended for repackaging, Rx only, Recall # D-785-2007;
b) Levothroid (levothyroxine sodium tablets, USP), 25 mcg, 100- and
    1,000-tablet bottles, RX only, NDC 0456-1320-01 (100-ct.) and
    NDC 0456-1320-00 (1,000-ct.), Recall # D-786-2007;
c) Thyro-Tab (levothyroxine sodium tablets), 0.050 mg, 150,000-tablet
    bulk drums intended for repackaging, RX only; Recall # D-787-2007;
d) Levothroid (levothyroxine sodium tablets, USP), 50 mcg, 100- and
    1,000-tablet bottles, NDC 0456-1321-01 (100-ct) and NDC 0456-1321-00
    (1,000-ct), RX only, Recall # D-788-2007;
e) Thyro-Tab (levothyroxine sodium tablets), 0.137 mg, 150,000-tablet bulk
    drums intended for repackaging, RX only, Recall # D-789-2007;
f) Levothroid (levothyroxine sodium tablets, USP), 137 mcg, 100- and
    1,000-tablet bottles, NDC 0456-1331-01 (100-ct) and NDC 0456-1331-00
    (1,000-ct), RX only, Recall # D-790-2007
CODE
a) Lots: HA02306, Exp. 2/07; HA04806, Exp. 3/07; HA11406, Exp. 5/07;
    HA14306, Exp. 6/07; HA17706, Exp. 7/07;
b) Lots: 020652, 020653 Exp. 2/07; 040601, 040623 Exp. 3/07;
    060602, 060603 Exp. 5/07; 060641, 060642, Exp. 6/07;
    070627, 070628, Exp. 7/07;
c) Lot HB02306, Exp. 2/07;
d) Lots: 020655, 020654, Exp. 2/07;
e) Lot: HC24205, Exp. 3/07;
f) Lots: 110545, 110544, Exp. 3/07
RECALLING FIRM/MANUFACTURER
Lloyd Inc., of Iowa, Shenandoah, IA, by letter dated January 24, 2007 and January 29, 2007. Firm initiated recall is ongoing.
REASON
Product may not maintain potency throughout shelf life.
VOLUME OF PRODUCT IN COMMERCE
12,877,900 tablets
DISTRIBUTION
Nationwide
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PRODUCT
Catalina Medical Oxygen Aluminum Cylinders fitted with Young-Do CGA 870 post valves (single 0-ring design). Catalina purchased and installed these valves between February 1999 and March 2003, Recall # D-804-2007
CODE
The valves can be identified by the Young-Do logo and a lot number beginning with the numbers 99, 00, 01, or 02 (for year of manufacture). The Catalina cylinders are marked either M4002 . . . CATALINA or CLIFFDIV, each followed by a serial number. A warning label with the Catalina logo is attached to the side of the cylinder.
RECALLING FIRM/MANUFACTURER
Catalina Cylinders, Garden Grove, CA, by letter on January 26, 2007. Firm initiated recall is ongoing.
REASON
Defective container; oxygen leaking at the valve or cylinder/valve interface.
VOLUME OF PRODUCT IN COMMERCE
770,000 cylinders
DISTRIBUTION
Nationwide and Canada
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PRODUCT
a) Miracle II, by Tedco, Miracle Neutralizer, Nature's Miracle for the Total Body,
    Sopi' H20, Biodegradable, 22 oz (638 mL), 1 gal, 5 gal, 15 gal, and 55 gal,
    Recall # D-805-2007;
b) Miracle II, by Tedco, Neutralizer, Nature's Miracle for the Total Body,
    Sopi' H20, Biodegradable, 2X, 22 oz (638 mL) and 1 gal., Recall # D-806-2007;
c) Miracle II, by Tedco, Neutralizer, Nature's Miracle for the Total Body, Sopi' H20,
    Biodegradable, 3X, 22 oz (638 mL) and 1 gal., Recall # D-807-2007;
d) Miracle II, by Tedco, Neutralizer Gel, Nature's Miracle for the Total Body,
    Sopi' H20, Biodegradable, 8 oz (232mL), 22 oz, 1 gal, 5 gal, and 15 gal,
    Recall # D-808-2007;
e) Miracle II, by Tedco, Neutralizer Gel, Nature's Miracle for the Total Body,
    Sopi' H20, Biodegradable, 7X, 8 oz (232mL), 22 oz, and 1 gal, Recall # D-809-2007
CODE
Recall includes all product without a code number distributed between January 3 and April 7, 2006
RECALLING FIRM/MANUFACTURER
Tedco, Inc., West Monroe, LA, by letter on December 11, 2006. Firm initiated recall is ongoing.
REASON
This is an extension of a recall initiated in January 2006 due to microbial contamination. Because these products have no code number, but have similar labeling, they cannot be distinguished from product having microbial contamination.
VOLUME OF PRODUCT IN COMMERCE
68,711 units
DISTRIBUTION
Nationwide, Australia, Germany, and England

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PRODUCT
a) Thyro-Tab (levothyroxine sodium tablets), 0.050mg, 150,000-tablet bulk
    drums intended for repackaging, Rx only, Recall # D-810-2007;
b) Levothroid (levothyroxine sodium tablets, USP), 50 mcg, 100- and 1,000-tablet
   bottles, RX, NDC 0456-1321-01 (100 tablets) and 0456-1321-00 (1,000 tablets),
    Recall # D-811-2007
CODE
a) Lots: HA05206, HB05206, HC05206, HA08606, HB11406, HC11406, HB14306,
    HC14306, HD14306, HA17806, HB17806, HC17806, HB20206, HC20206,
    HB23606;
b) Lots: 040602, 040603, 040624, Exp. 3/07; 050606, 050608, Exp. 4/07;
    060607, 060613, Exp. 5/07; 060643, 060644, 060658, 060660, 070610, Exp. 6/07;
    070629, 070631, 070632, 070641, 070642, Exp. 7/07; 080648, 080655, 080660,
    080661, Exp. 8/07; 090641, 090642, Exp. 9/07
RECALLING FIRM/MANUFACTURER
Lloyd Inc of Iowa, Shenandoah, IA, by letters on March 26, 2007 and March 27, 2007. Firm initiated recall is ongoing.
REASON
Product may not maintain potency throughout labeled shelf life.
VOLUME OF PRODUCT IN COMMERCE
27,838,500 tablets (repackaged)
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

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PRODUCT
Doxycyline Hyclate 20mg tablets. 100 count bottles. NDC 00172-4626-60, RX only, Recall # D-803-2007
CODE
Lot Numbers: 156268A and 156269A
RECALLING FIRM/MANUFACTURER
IVAX Pharmaceuticals, Miami, FL, by letter on April 19, 2007. Firm initiated recall is ongoing.
REASON
Failed USP dissolution requirements
VOLUME OF PRODUCT IN COMMERCE
10,729 (100 tablet bottles)
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

CORRECTION
In the May 9, 2007 Enforcement Report, Recall # B-1258-07, Smiths Medical Fast Flow Fluid Warmer, The reason for recall should read: “Fluid Warmers, with an added warning to the product labeling, were distributed”.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

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PRODUCT
Silver Speed Hydrophilic Guidewire, for placement of vascular catheters. Model # 103-0601-200, Recall # Z-0839-2007
CODE
US: Lot # : 2295725; 2382836; 2355074; 2390635; 2348116; 2355074; 2374619; 2216295; 2257803;2390635; 2342166; ;2390635;2348116; 2310664; 2382836; 2257803; 2216295; 2310664; 2390635; 2247199; 2247200; 2221847; 2247200; 2295725; 2310664; 2221845; 2310664; 2216296; 2257803; 2342166; European Union & Rest-Of-World Lot #: 2374619 ; 2209708;2216295; 2247200; 2310664; 2348116; 2221845 ; 2355074; 2247200; 2310664; 2216295; 2166877; 2247199; 2209708; 2367901; 2370509; 2374619; 2216295; 2163496; 2174470; 2295725; 2370509; 2376907; 2209708; 2295725; 2310664; 2221845; 2247200; 2216291; 2390635; 2360938; 2370509; 2376907; 2310664; 2355074; 2163496; 2276405; 2370508; 2221847; 2257803; 2390635; 2257803; 2370509; 2200727;
RECALLING FIRM/MANUFACTURER
EV3 Neurovascular, Irvine, CA, by letter on April 5, 2007. Firm initiated recall is ongoing.
REASON
Two customer complaints were received from physicians in Japan indicating the hydrophilic coating was observed flaking from the guidewire while immersed in hydrating media following use during aneurysm embolization procedures.
VOLUME OF PRODUCT IN COMMERCE
2,120 units
DISTRIBUTION
Nationwide and Internationally
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PRODUCT
Smith & Nephew, 420XL Xenon Light Source, 180 Watt; for endoscopic use. Catalog/Part #72200510, Recall # Z-0840-2007
CODE
Serial #s: 420L-1263, 420L-1264, 420L-1265, 420L-1266, 420L-1267, 420L-1268, 420L-1269, 420L-1270, 420L-1271, 420L-1272, 420L-1273, 420L-1275, 420L-1277, 420L-1280, 420L-1281, 420L-1282, 420L-1283, 420L-1284, 420L-1285, 420L-1286, 420L-1287, 420L-1288, 420L-1292, 420L-1293, 420L-1294, 420L-1295, 420L-1296, 420L-1298, 420L-1300, 420L-1301, 420L-1303, 420L-1304, 420L-1305, 420L-1306, 420L-1307, 420L-1308, 420L-1309, 420L-1310, 420L-1311, 420L-1312, 420L-1313, 420L-1314, 420L-1315, 420L-1316, 420L-1317, 420L-1318, 420L-1319, 420L-1320, 420L-1321, 420L-1322, 420L-1344, 420L-1345, 420L-1346, 420L-1347, 420L-1348, 420L-1349, 420L-1351, 420L-1352, 420L-1353, 420L-1354, 420L-1355, 420L-1370, 420L-1403, 420L-1404, 420L-1409, 420L-1422 and 420L-1426
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith & Nephew, Inc., Endoscopy Division, Oklahoma City, OK, by letter on April 9, 2007.
Manufacturer: Sopro, La Ciotat Cedex, France. Firm initiated recalls ongoing.
REASON
Several units were manufactured using a power supply that contains a 1 amp fuse where a 5 amp fuse is required. When the unit's power supply draws more that 1A, the fuse will fail causing the light to cease operating. The problem can occur anytime: from the initial turning on (powering up), to anytime during use.
VOLUME OF PRODUCT IN COMMERCE
67 units
DISTRIBUTION
Nationwide and Internationally
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PRODUCT
a) CryoValve, Pulmonary Valve & Conduit; Donor number 87980,
    Model Number PV00, Recall # Z-0841-2007;
b) Aortic Valve & Conduit; Donor number 87980, Model Number AV00,
    Recall # Z-0842-2007
CODE
a) Serial number 8897314;
b) Serial number 8892143
RECALLING FIRM/MANUFACTURER
CryoLife, Inc., Kennesaw, GA, by telephone on April 17 and 18, 2007. Firm initiated recall is complete.
REASON
Donor tissue was released prior to information received regarding a pericardial effusion.
VOLUME OF PRODUCT IN COMMERCE
2 tissues
DISTRIBUTION
AZ, and CO
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PRODUCT
a) Infant Nasal CPAP Cannula, Size 0; an Rx infant nasal prong continuous positive
    airway pressure (CPAP) cannula one inspiratory and one expiratory elbow connector;
    10 units per case; Made in Mexico; The cannulas are sold as components in the
    following configurations: a) catalog No. 1690 and 41690 (International): Infant CPAP
    Set intended for use with mechanical ventilators, which includes one cannula with
    one inspiratory and one expiratory elbow connector, two 10mm to 7.5mm adapters,
    one knit cap and two 6 inch sections of Velcro securing tape; b) catalog No. 1683:
    Infant CPAP System intended for use with a water seal or spring loaded valve,
    and includes one cannula with one inspiratory and one expiratory elbow connector,
    two 4 ft. lengths of 10mm I.D. corrugated tubing, one 4 ft. pressure monitoring line,
    one 22mm to 10mm humidifier adapter, one knit cap and two 6 inch sections of
    Velcro securing tape, Recall # Z-0857-2007;
b) Infant Nasal CPAP Cannula, Size 1; an Rx infant nasal prong continuous positive
    airway pressure (CPAP) cannula one inspiratory and one expiratory elbow connector;
    10 units per case; Made in Mexico; The cannulas are sold as components in the
    following configurations: a) catalog No. 1691and 41691 (International): Infant CPAP
   Set intended for use with mechanical ventilators, which includes one cannula with one
    inspiratory and one expiratory elbow connector, two 10mm to 7.5mm adapters,
    one knit cap and two 6 inch sections of Velcro securing tape; b) catalog No. 1685:
    Infant CPAP System intended for use with a water seal or spring loaded valve, and
    includes one cannula with one inspiratory and one expiratory elbow connector,
    two 4 ft. lengths of 10mm I.D. corrugated tubing, one 4 ft. pressure monitoring line,
    one 22mm to 10mm humidifier adapter, one knit cap and two 6 inch sections of
    Velcro securing tape, Recall # Z-0858-2007;
c) Infant Nasal CPAP Cannula, Size 2; an Rx infant nasal prong continuous positive
    airway pressure (CPAP) cannula one inspiratory and one expiratory elbow connector;
    10 units per case; Made in Mexico; The cannulas are sold as components in the
    following configurations: a) catalog No. 1692: Infant CPAP Set intended for use
    with mechanical ventilators, which includes one cannula with one inspiratory and
    one expiratory elbow connector, two 10mm to 7.5mm adapters, one knit cap and
    two 6 inch sections of Velcro securing tape; b) catalog No. 1686: Infant CPAP System
    intended for use with a water seal or spring loaded valve, and includes one cannula
    with one inspiratory and one expiratory elbow connector, two 4 ft. lengths of 10mm I.D.
    corrugated tubing, one 4 ft. pressure monitoring line, one 22mm to 10mm humidifier
    adapter, one knit cap and two 6 inch sections of Velcro securing tape; Recall # Z-0859-2007
d) Infant Nasal CPAP Cannula, Size 3; an Rx infant nasal prong continuous positive
    airway pressure (CPAP) cannula one inspiratory and one expiratory elbow connector;
    10 units per case; Made in Mexico; The cannulas are sold as components in the
    following configuration: catalog No. 1693: Infant CPAP Set intended for use with
    mechanical ventilators, which includes one cannula with one inspiratory and one
    expiratory elbow connector, two 10mm to 7.5mm adapters, one knit cap and two
    6 inch sections of Velcro securing tape, Recall # Z-0860-2007;
e) Infant Nasal CPAP Cannula, Size 4; an Rx infant nasal prong continuous positive
    airway pressure (CPAP) cannula one inspiratory and one expiratory elbow connector;
    10 units per case; Made in Mexico. The cannulas are sold as components in the
    following configuration: catalog No. 1694: Infant CPAP Set intended for use with
    mechanical ventilators, which includes one cannula with one inspiratory and one
    expiratory elbow connector, two 10mm to 7.5mm adapters, one knit cap and two
    6 inch sections of Velcro securing tape; Recall # Z-0861-2007
CODE
a) a) Lot numbers 32069/21406, 33069/22206, 34069/22606; (International) lot number 33069/22206;
    b) lot number 33069/22106;
b) a) Lot numbers 33069/22206, 33069/22306; (International) lot number 32069/21406, 33069/21906; b) lot numbers 32069/21506, 32069/21606;
c) a) Lot number 35069/23405; b) lot numbers 32069/21606, 32069/21706, 33069/22306;
d) Lot numbers 32069/21406, 32069/21506;
e) Lot numbers 32069/21406, 33069/22306
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teleflex Medical, Bannockburn, IL, by letters dated March 23, 2007.
Manufacturer: Teleflex Medical, Nueva Laredo, Mexico. Firm initiated recall is ongoing.
REASON
The luer-port in the expiratory elbow may be occluded, which interferes with a ventilator's ability to detect an accurate pressure reading.
VOLUME OF PRODUCT IN COMMERCE
13,530 units
DISTRIBUTION
Nationwide and Internationally
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PRODUCT
a) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor,
    46 mm cup Ref.: 74120146, Recall # Z-0862-2007;
b) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor,
    50 mm cup Ref.: 74120150, Recall # Z-0863-2007;
c) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor,
    56 mm cup Ref.: 74120156, Recall # Z-0864-2007;
d) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor,
    58 mm cup Ref.: 74120158, Recall # Z-0865-2007;
e) Smith + Nephew, Birmingham Hip Resurfacing, Acetabular Cup W/ Impactor,
    60 mm cup Ref.: 74120160, Recall # Z-0866-2007
CODE
a) Lot Number: 64803;
b) Lot Number: 64603;
c) Lot Numbers: 64597, 65004, 57078;
d) Lot Number: 65015;
e) Lot Number: 66701
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith & Nephew Inc., Memphis, TN, by letter on March 13, 2007.
Manufacturer: Smith & Nephew Orthopedics, Warwick, UK. Firm initiated recall is ongoing.
REASON
The carton label reads BHR Acetabular Cup 60mm contained a 58mm cup.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
Europe
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PRODUCT
a) Profemur® R, Revision Hip system, Proximal Body (part), X-Small model,
    REF: PPW38364, Cementless, Titanium Plasma Spray Coated, Sterile,
    Rx only Hip implant, Recall # Z-0867-2007;
b) Profemur® R, Revision Hip system, Proximal Body (part), STD 4,
    REF: PPW38354, Cementless, Titanium Plasma Spray Coated, Sterile,
    Rx only. Hip implant, Recall # Z-0868-2007
CODE
a) Lot Numbers: W09356957, W09358977;
b) Lot Number: W09350601
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wright Medical Technology Inc., Arlington, TN, by letter dated March 27, 2007.
Manufacturer: Wright Cremascoli Ortho SA, Toulon, France. Firm initiated recall is ongoing.
REASON
The titanium plasma coating was found to have missing fragments.
VOLUME OF PRODUCT IN COMMERCE
22 units
DISTRIBUTION
Nationwide, Puerto Rico and Japan
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PRODUCT
Light Source 300 Watt Xenon Lamp used in the following models: Viking EndoSite Xenon, Model 8050-1 and Boston Scientific Spyglass 300W Light Source (M00546190), Recall # Z-0873-2007
CODE
Units manufactured from 1/23/07 through 3/14/07 with serial numbers: 120906, 016707, 016907, 017007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Vision Systems Group, A Div of Viking Systems, Westborough, MA, by telephone on March 15, 2007.
Manufacturer: Luxtec Corporation, A Division of LXU Healthcare I, West Boylston, MA. Firm initiated recall is complete.
REASON
Incorrect power entry module assembled into unit may cause burning to insulation, compromised electrical emissions and premature light source failure.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA, and NC

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PRODUCT
a) Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 18 mm,
    guidewire stylet, sterile, REF CODE: RSG-M014S, Recall # Z-0892-2007;
b) Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 18 mm,
    guidewire stylet, 12.5' (31.8cm), sterile, REF CODE: RSG-M014S-L, Recall # Z-0893-2007;
c) Surge Medical Solutions Retrograde Cardio. Cannula, 18mm self-inflating textured balloon,
    15Fr (5.0mm), guidewire stylet, 12.5'(31.8cm), sterile, REF CODE: RSG-T014S-L, Recall # Z-0894-2007;
d) Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 20 mm,
    handle stylet, sterile, REF CODE: RSH-L014S, Recall # Z-0895-2007;
e) Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 18 mm,
    handle stylet, sterile, REF CODE: RSH-M014S, Recall # Z-0896-2007;
f) Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, 18 mm self-inflating balloon,
    sure-touch handle, rigid insertion stylet, 12.5' length (31.8cm), sterile, REF CODE: RSH-M014S-L,
    Recall # Z-0897-2007;
g) Surge Medical Solutions brand 15 Fr. (5.0mm) Surge Medical Solutions 15 Fr. (5.0mm) Retrograde
    Cardioplegia Cannula, self-inflating balloon 14 mm, handle stylet, sterile, REF CODE: RSH-S014S,
    Recall # Z-0898-2007;
h) Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating textured balloon
    18 mm, handle stylet, sterile, REF CODE: RSH-T014S, Recall # Z-0899-2007;
i) Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, 18mm self-inflating textured
    balloon, sure-touch handle, rigid insertion stylet, 12.5' length (31.8cm), sterile, REF CODE: RSH-T014S-L,
    Recall # Z-0900-2007;
j) Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon 20 mm,
    rigid insertion stylet, sterile, REF CODE: RSR-L014S, Recall # Z-0901-2007;
k) Surge Medical Solutions brand 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon
    18 mm, rigid insertion stylet, sterile, REF CODE: RSR-M014S, Recall # Z-0902-2007;
l) Surge Medical Solutions brand 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating balloon
    18 mm and rigid stylet, 12.5'(31.8cm), sterile, REF CODE: RSR-M014S-L, Recall # Z-0903-2007;
m) Surge Medical Solutions brand 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, self-inflating textured
     balloon 18 mm, rigid stylet, sterile, REF CODE: RSR-T014S, Recall # Z-0904-2007
CODE
All lot numbers beginning with 0610, 0611, 0612, 0701 or 0702
RECALLING FIRM/MANUFACTURER
Surge Medical Solutions, LLC, Grand Rapids, MI, by letter dated April 17, 2007. Firm initiated recall is ongoing.
REASON
The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings.
VOLUME OF PRODUCT IN COMMERCE
2,211 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
FramelessArray software, Version 1.0., Recall # Z-0905-2007
CODE
Serial No’s: HZ60006 HZ60008 HZ60012 HZ60035 HZ60049 HZ60053 HZ60054 HZ60057 HZ60061 HZ60062 HZ60064 HZ60072 HZ60079 HZ60095 HZ60096 HZ60106 HZ60109 HZ60112 HZ60119 HZ60144 HZ60161 HZ60162 HZ60168 HZ60185 HZ60186 HZ60218 HZ60222 HZ60225 HZ60232 HZ60233 HZ60234 HZ60266 HZ60267 HZ60268 HZ60269 HZ60270 HZ60293 HZ60294 HZ60308 HZ60350 HZ60389 HZ60390 HZ60398 HZ60399 HZ60403 HZ60404 HZ60406 HZ60414 HZ60415 HZ60416 HZ60426 HZ60460 HZ60463 HZ60464 HZ60471 HZ60478 HZ60507 HZ60508 HZ60509 HZ60513 HZ60532 HZ60533 HZ60537 HZ60540 HZ60549 HZ60557 HZ60561 HZ60564 HZ60569 HZ60577 HZ60595 HZ60612 HZ60617 HZ60620 HZ60625 HZ60626 HZ60639 HZ60640 HZ60646 HZ60649 HZ60654 HZ60656 HZ60662 HZ60667 HZ60670 HZ60674 HZ60675 HZ60681 HZ60683 HZ60684 HZ60686 HZ60698 HZ60703 HZ60713 HZ60726 HZ60731 HZ60740 HZ64006 HZ65070 HZ66006 HZ66026 HZ66041 HZ66070 HZ66077 HZ66118 HZ66175 HZ66299 HZ67029 HZ67035 HZ67066 HZ67068 HZ67079 HZ67085 HZ67118 HZ67126 HZ67131 HZ67142 HZ68004 HZ68010 HZ68017 HZ68018 HZ68026 HZ68035 HZ68043 HZ68051 HZ68055 HZ68060 HZ68066 HZ68068 HZ68069 HZ68078 HZ68079 HZ68087 HZ68095 HZ68099 HZ68118 HZ68128 HZ68134 HZ68197 HZ68264 HZ68998 HZ69001 HZ69003 HZ69004 HZ69007 HZ69013 HZ69028 HZ69036 HZ69043 HZ69045 HZ69046 HZ69068 HZ69072 HZ69077 HZ69085 HZ69088 HZ69096 HZ69098 HZ69109 HZ69118 HZ69120 HZ69121 HZ69126 HZ69131 HZ69134 HZ69155 HZ69158 HZ69170 HZ69171 HZ69172 HZ69175 HZ69186 HZ69190 HZ69201 HZ69223 HZ69330 HZ60495 HZ60586
RECALLING FIRM/MANUFACTURER
Recalling Firm: Varian Medical Systems Oncology Systems, Palo Alto, CA, by letter on March 14, 2007.
Manufacturer: Varian Medical Systems, Inc., Charlottesville, VA. Firm initiated recall is ongoing.
REASON
Localization error; with planning data transferred to the Optical Guidance Platform via DICOM RT; The software incorrectly computes the center of the CT volume, resulting in a potential axial error ranging from 0.3 mm to 1.5 mm, affecting both Fractionated and Stereotactic Radiosurgery (SRS) Treatments.
VOLUME OF PRODUCT IN COMMERCE
178 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
c.cam Gamma Camera, Model 9VIR1200; Made in Denmark, Recall # Z-0906-2007
CODE
Model 9VIR1200, serial numbers 1001 thru 1243, 1245 thru 1263, 1265 thru 1283, 1285 thru 1303, 1305 thru 1316, 1320, 1321, 1322, 1323, 1325 thru 1343, 1345 thru 1363, 1365 thru 1383, 1385 thru 1403, 1405 thru 1422, 1507, 1508, 1509.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Hoffman Estates, IL, by letters dated April 30, 2007.
Manufacturer: Danish Diagnostic Dev. A/S, Horsholm, Denmark. Firm initiated recall is ongoing.
REASON
Chair Breakage: Under extreme load, the chair back of the c.cam emission computed tomography system may bend and eventually break. This could be caused by the accumulated stress from heavy patients seating or stretching themselves in the chair or simply from long time use.
VOLUME OF PRODUCT IN COMMERCE
413 cameras
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System
    (Versatile cardiac and vascular imaging system.), Recall # Z-0913-2007;
b) GE Healthcare Innova 3100/3100 IQ Digital Fluoroscopic Imaging System
    ( Cardiovascular Imaging System), Recall # Z-0914-2007;
c) GE Healthcare Innova 4100/ 4100 IQ Digital Fluoroscopic Imaging System
    (Vascular Angiography System), Recall # Z-0915-2007
CODE
a) 65049321 2035762100 4436432100 0002600531A 0002628342A 208227CATH1
    208367INNOVA 212305CATH1 215453INNOVA21 217383CCL2A 219932DCL2
    229228INNOV21C 239436CATH4 251435ICV3 262255INNOVA2 303425CL3
    303788CL1 303839CL2 304424INNOVA 305364P2100 305682IN2 308865GIN1
    317355INNOVA3 318448CA1000 330363LAB3 330375LAB2 360456XCL4
    405604D2100 408559INV1 410337INNOVA6 414447CA1 414649INNOVA2
    417347FCV4 501257VALAB1 508856IN21 516562INNOVA6 516562INNOVA7
    518243LAB1 518243LAB2 541732CV2 570476INNOVA21 573761SMC2 573815BCR2
    573815BCR3 573815BCR4 574535IN21 602239CLAB2 607737CL1 610250INNOVA1
    610250INNOVA3 610776INNOVA21 615446CV1 617636CL1 630856H2100 650369SV4
    651582IN3 661327INNOVA1 713375U2100 713375UCA 713794LAB1 717217CA10002
    717217INN21 717544GECATH2 717544GECATH3 718470EP 727869CATH3 727942CATH2
    732324INN1 732923INN 770HMCCL1 781340IN3 785354HRTEP 804764CATH2 808547QCV1A
    808547QCV3A 812238UN21 813615CL1 813615CL8 813615CL9 813615EP3 815741CA1000
    817329BG2100 843724CL1 843724CL2 843724CL3 845365V13 845368CATH1 858554INNOVA2
    901765EP 910343EP1 910343EP2 910671CICR 910671INOV21 954987CCL7 954987CCL8
    970350CL2 973579LAB1 985898INNOVAB BGRPWSCA01 CM2100 00060VAS02 00159VAS04
    00192VAS04 00234VAS01 00282VAS02 00371VAS01 00440VAS02 00440VAS03 00463VAS06
    00888VAS02 01065VAS01 05208VAS02 05217VAS02 35021VAS02 468668XR01 58010VAS01
    600042VA03 A004RX01 A4166952 A5125125 A5164510 A5624112 A5807919 B1650215
    C5123625 C5123626 DK1066VA02 DZ1006VA01 H17654VAS8 H2077VAS27 HC4355XR06
    HU1094VA01 M1334109 M2068110 M2569315 M2844529 M4198195 M4200108 M4211066
    MA1004VA02 NO1009VA03 PC0052XR07 PC0052XR08 SA1011VA01 SA1054VA02 SY
    1001VA02 cee15663 416480INNOVA 604682INNOVA2 835160018 850060723 910162009
    910162010 910162011 910162012 910163011 83016862101656 082416030004 082416040011
    082416040012 082416070006 082416100012 082416120008 082416120009 082416130016
   082416130019 082416130024 082416200004 082416220010 83016002101586 83016102100795
    83016202101036 83016242100936 83016802100516 83016802100866 83016802100916
    83016862101656 83016862101916 920169006 YV0054 YV0055 YV0056 YV0057 YV0058
    YV0059 YV0060 YV0061 YV0062 YV0063 YV0064 YV0065 YV0066 YV0067 YV0068
    YV0070 YV0071 YV0072 YV0073 YV0077 YV0080 YX1483;
b) 65049331 2035763100 3027443100 5033703100 6106483100 6619483100
    7022333100 7028533100 8014793100 8157413100 9734293100 201996LAB1
    207351YCL1 207662CL4 208227CATH2 214590PH3100 219326IN31 239513CRLAB1
    239939CLA 251633PROV 281420LAB23100 303425CL4 305364P3100 316651INNOVA31
    352333CATH1 352333CATH2 361857CATH1 361980INNOVA2 405272SCL2 406543IN3
    413582C3100 414649CL3 414649CL4 415925INV1 423844CCL1 479441SP3100
    480728LAB2 480821IN2 502587LAB1 508856IN2 512901NI3100 516562INNOVA8
    516562INNOVA9 530244XC106 561548CL4 570476INNOVA31 573632CRC2 573882UMC1
    610447CL1 610595CL1 610891CL1 616392INNOVA 617732IN9 618241GSI3100
    708WESTSUB3100 717782INNOVA31A 718470INNOVA2 760242CATH1 775982CATH2
    781340IN2 812450CATH1 812858GWLAB1 812858GWLAB2 814676C1 816478MC1
    816943STJIC1 816985NKCI 847362CONCATH4 864255SFCL3 865481CCL2 870864LAB2
    901516R3 903UT3100 904276CTH1 907562CATH1 909464IN3 909825VAINNOVA
   913345MI1 916781INNOVA1 916781INNOVA1 918494IN31A 940626DCH3100 954987CCL9
    970350CL1 970945CL1 405604D3100 405840OIC3100 412623LAB2 414647CL1
    541MWHINNOVA 617789IN1 671GMHAINVA 770991CL1 41018VAS01 600098VA01
    A5112597 A5125119 A5127281 A5162256 A5333035 B5274834 CS1006VA03 DPM32143
    FI1064VA01 FPG86403 FPG93008 GE1005VA01 JO1000VA01 M4016034 M40480151
    M4163030 M5480755 NO1005VA05 RU1142VA01 SA1010VA02 dpn88402 850060724
    910064007 910162006 910163006 910163009 910163012 910163015 082416010006
    082416020004 082416030003 082416040015 082416040018 082416040019 082416080001
    082416100006 082416100013 082416110002 082416120007 082416120010 082416130015
    082416130017 082416140002 082416150001 082416160003 082416160008 082416160009
    082416190001 082416190003 082416190004 082416210003 082416210004 082416210006
    082416210008 082416220008 082416220009 082416270002 082416300001 082416310003
    082416310006 082449120007 0910064009X 834160003 910064008 920169007 YV0034
   YV0043 YV0045 YV0046 YV0047;
c) 5135844100 5136864100 314569SJRM12 530888ANG206 713375U4100
    804320CATH2B 804764CATH3 812238UN41 812238UN41 813615CL10
    843577CL2 972566INNOVA3 80140841 3016094100 3027444100 4134474100
    5033704100 5094744100 5417684100 6309784100 7028804100 201541SP1
    251435I12 252847PRS3 309672M4100 330489SPEC9 360754INNOVA 386HPOS1
    412623LAB1 412623LAB3 414328INN4100 419696LAB1 509482HFI 605333RM10
    608263XMR 610954INNOVA41 617525IN1 617636IN1 630275G41 678EJCIR1
    719560INN41 727791INNOVA 770535N4100 803256SP 804594ANGIO 816943SP1
    817433HSW4100 845368RM10 904202SP1 904BSSP 908522SP1 915577SP1
    918682IN41 952993INNOVA2 970247INNOVA 972335LIB COR359867 00171VAS01
    00490VAS02 10091VAS01 190020RX09 600152VA01 A5605732 BRD0411 IE1100VA01
   IL1043VA01 N4192927 NO1015VA04 R4211476 RU1106VA02 UC1129XR33 850060707
    850060722 082406120016 082416130020 XF0154 XF0155 XF0200 306766INNOVA
    519663INNOVA2
RECALLING FIRM/MANUFACTURER
Recalling Firm: General Electric Med Systems LLC, Waukesha, WI, by letter dated February 5, 2007.
Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Firm initiated recall is ongoing.
REASON
Unintended Gantry Movements : GE Healthcare has recently become aware of accidental, operated-initiated activation of gantry movements associated with the new, metallic Smart Box controller, that may impact patient or staff safely.
VOLUME OF PRODUCT IN COMMERCE
446 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
AcuMatch M-Series Straight Fluted Stem Segment and AcuMatch M-Series Curved Fluted Stem Segment. Catalog numbers 150-07-19 and 150-07-44, Recall # Z-0916-2007
CODE
0797860, 0797861, 0797862, 0797857, 0797858, 0797859.
RECALLING FIRM/MANUFACTURER
Exactech, Inc., Gainesville, FL, by fax and email on July 21, 2006. Firm initiated recall is ongoing.
REASON
The packaging was mislabeled: Exterior and interior packaging on the device was labeled with catalog number 150-07-19 15mm x 200mm, however, the actual part inside the packaging was a 21mm x 200mm (catalog number 150-07-44) device.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
AL, Columbia and Australia
___________________________________
PRODUCT
a) Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 911,912, 917
    and Modular P; Catalog No. 04642511190, Recall # Z-0917-2007;
b) Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 917 and
    Modular P; catalog no. 0464250319011190, Recall # Z-0918-2007
CODE
a) and b) Lots 144114, exp. 9/30/2007; 144167, exp. 12/31/2007; 144178, exp. 3/31/2007 and 144196, exp. 5/31/2007;
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp., Indianapolis, IN, by letter dated April 5, 2007. Firm initiated recall is ongoing.
REASON
Reported results may have a positive bias of up to 113% because inadequate cleaning instructions may result in carry-over of the following reagents: Online TDM carbamazepine, Online TDM gentamycin, Online TDM phenytoin, Online DAT cocaine II, Online DAT methadone II, Online DAT opiates II and Online DAT THC II.
VOLUME OF PRODUCT IN COMMERCE
474 units
DISTRIBUTION
Australia, Canada and Germany
___________________________________
PRODUCT
a) Roche VANC2, Online TDM Vancomycin, for use with the Roche/Hitachi Cobas c 501analyzer;
    Catalog No.04491050190, Recall # Z-0919-2007;
b) Roche VALP2, Online TDM Valproic acid , for use with the Roche/Hitachi Cobas c 501 analyzer;
    Catalog No.04491041190, Recall # Z-0920-2007
CODE
a) Lots 144174, exp. 7/31/2007; 144195, exp. 9/30/2007 and 144207, exp. 11/30/2007;
b) Lots 144107, exp. 9/30/2007; 144166, exp. 1/31/2008 and 144208, exp. 6/30/2008
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp., Indianapolis, IN, by letter dated April 30, 2007. Firm initiated recall is ongoing.
REASON
Probe Wash: Reported results may have a positive bias because inadequate analyzer probe wash instructions may result in carry-over from the following assays: Creatinine Kinase L and Creatine Kinase-MBL.
VOLUME OF PRODUCT IN COMMERCE
1,654 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
LIFEPAK 20 defibrillator/monitor. The device is an AC powered defibrillator device with battery backup. The defibrillators are primarily used by healthcare providers in device user facilities such as hospitals and clinics. Affected part numbers: 3202487-073 through -083; 3202487-087 through -090; 3202487-092; 3202487-093; 3202487-098; 3202488-036; 3202488-038 through -042; 3202488-045; 3202488-046; and 3202488-050., Recall # Z-0925-2007
CODE
LP 20 defibrillator serial numbers: DOMESTIC 35246397, 35222145, 35222147, 35222171, 35246407, 35195082, 35202031, 35202041, 35213722, 35213784, 35216799, 35216801, 35219423, 35219450, 35213803, 35213807, 35216785, 35216786, 35216791, 35216793, 35216797, 35219435, 35219444, 35219446, 35219447, 35219448, 35219451, 35219452, 35219463, 35219464, 35219465, 35219467, 35219469, 35222141, 35232801, 35237779, 35237782, 35237784, 35237785, 35237786, 35237788, 35237789, 35237792, 35237793, 35237794, 35237800, 35237802, 35237803, 35239818, 35222169, 35232448, 35232925, 35233140, 35195289, 35213796, 35216787, 35219445, 35216794, 35216795, 35219441, 35219457, 35219459, 35232449, 35213805, 35216784, 35216788, 35219453, 35219454, 35219461, 35150433, 35150435, 35154911, 35158493, 35158499, 35161156, 35161163, 35161242, 35161244, 35161247, 35161249, 35161251, 35161252, 35161253, 35161255, 35161257, 35161258, 35161259, 35161260, 35161262, 35161263, 35161264, 35161267, 35161268, 35161269, 35161270, 35161271, 35161272, 35161273, 35161274, 35161275, 35161276, 35161278, 35161280, 35161281, 35161282, 35161283, 35161286, 35161291, 35166342, 35166344, 35166346, 35166351, 35166354, 35166355, 35166356, 35166357, 35166359, 35166363, 35166365, 35166367, 35166371, 35166372, 35166375, 35166377, 35166381, 35166385, 35166386, 35152846, 35152854, 35150429, 35150431, 35152839, 35152862, 35154877, 35154882, 35154908, 35158482, 35226477, 35226479, 35226482, 35226483, 35226484, 35226487, 35226489, 35226492, 35226493, 35226494, 35226496, 35226498, 35226499, 35226502, 35226515, 35226516, 35233136, 35233149, 35233154, 35233153, 35152851, 35152860, 35047103, 35065639, 35065640, 35065644, 35065649, 35065652, 35065655, 35088936, 35150422, 35150424, 35151610, 35151613, 35151615, 35152861, 35154873, 35154876, 35154883, 35154888, 35152847, 35152853, 35043904, 35084040, 35088934, 35150408, 35150414, 35151616, 35152845, 35154890, 35161171, 35161261, 35161265, 35161288, 35166347, 35166352, 35166353, 35166360, 35166364, 35166366, 35166368, 35166369, 35166370, 35166373, 35166374, 35166376, 35166378, 35166379, 35166380, 35166382, 35172605, 35172611, 35172613, 35226504, 35226510, 35226481, 35233138, 35226500, 35226506, 35226519, 35226520, 35226526, 35244234, 35213806, 35219432, 35219440, 35219442, 35244337, 35226486, 35226497, 35233137, 35245167, 35226518, 35202048, 35219443, 35222137, 35219472, 35222146, 35222153, 35222168, 35219449, 35246388, 35233122, 35233144, 35232447, 35166358, 35222142, 35219456, 35239851, 35158490, 35166361, 35161254, 35226505, 35226509, 35226513, 35226521, 35226524, 35226525, 35233120, 35233123, 35233125, 35233127, 35233129, 35233131, 35233132, 35233134, 35233135, 35233139, 35233141, 35233143, 35233148, 35233150, 35233155, 35233158, 30778465, 31004425, 35233110, 35233142, 35202046, 35213791, 35219458, 35222138, 35222150, 35222156, 35222167, 35222170, 35233116, 35233145, 35233147, 35233152, 35233126, 35213732, 35216789, 35219434, 35232452, 35232810, 35233099, 35233102, 35226378, 35226508, 35233117, 35213790, 35233115, 35233151, 35213801, 35213808, 35213809, 35213810, 35216780, 35219462, 35219466, 35219468, 35219470, 35222139, 35222151, 35222157, 35222163, 35226164, 35226165, 35226166, 35226167, 35226169, 35226170, 35232443, 35232450, 35232806, 35232809, 35232910, 35232915, 35232928, 35232931, 35233090, 35233092, 35233101, 35233103, 35233104, 35233108, 35233109, 35237791, 35065654, 35233133, 35244348, 35245143, 35245162, 35245165, 35246386, 35246391, 35246394, 35246396, 35246399, 35246402, 35246416, 35246420, 35246421, 35246422, 35246423, 35246425, 35246430, 35246431, 35246432, 35246433, 35249248, 35249255, 35222140, 35226490, 35226491, 35233156, 35232442, 35232451, 35219471, 35233128, 35222148, 35222165, 35246393, 35246417, 35246426, 35249256, 35249264, 35250340, 35250349, 35250352, 35250354, 35246406, 35246408, 35187570, 35187729, 35187733, 35187740, 35187745, 35187750, 35187753, 35187754, 35192461, 35192465, 35192467, 35192474, 35192475, 35192488, 35192492, 35192494, 35195062, 35195069, 35195073, 35195074, 35195075, 35195077, 35195085, 35195086, 35195240, 35195243, 35195245, 35195246, 35195247, 35195248, 35195249, 35195250, 35195251, 35195252, 35195253, 35195254, 35195255, 35195256, 35195257, 35195258, 35195259, 35195260, 35195261, 35195262, 35195263, 35195264, 35195265, 35195266, 35195267, 35195269, 35195270, 35195271, 35195272, 35195273, 35195274, 35195276, 35195277, 35195279, 35195280, 35195282, 35195283, 35195284, 35195285, 35195286, 35195287, 35195288, 35200196, 35200197, 35200198, 35202024, 35202025, 35202026, 35202027, 35202032, 35202033, 35202042, 35202043, 35202044, 35202045, 35202047, 35202049, 35202050, 35213720, 35213723, 35213724, 35213726, 35213728, 35213730, 35213781, 35213782, 35213783, 35213785, 35213786, 35213788, 35213789, 35213792, 35213793, 35213797, 35213798, 35213799, 35213800, 35213802, 35216776, 35216777, 35216778, 35216779, 35216781, 35216790, 35216792, 35216796, 35216802, 35216803, 35216807, 35216808, 35216809, 35216811, 35216812, 35216814, 35216815, 35216816, 35219424, 35219425, 35219426, 35219427, 35219428, 35219429, 35219430, 35219431, 35219433, 35219437, 35219438, 35219439, 35232921, 35233114, 35233146, 31339155, 35222160, 35222162, 35213795, 35226480, 35226501, 35226507, 30476108, 35222166, 35232444, 35232804, 30843087, 35154880, 35244327, 35244349, 35244354, 35245145, 35245163, 35245164, 35246384, 35246385, 35246398, 35216800, 35219436, 35233098, 35233106, 35244321; INTERNATIONAL 35258119, 35258120, 35258122, 35239852, 35258124, 35222143, 35222149, 35222155, 35239835, 35239836, 35239837, 35239838, 35239855, 35239860, 35242864, 35179778, 35244352, 35246400, 35237525, 35179763, 35179769, 35179775, 35179780, 35179785, 35179786, 35179789, 35200422, 35200431, 35247341, 35252146, 35257876, 35200433, 35247343, 35244353, 35252153, 35237798, 35237799, 35237801, 35237805, 35239739, 35239741, 35239826, 35239829, 35258121, 35258123, 35257953, 35237806, 35252152, 35252709, 35256669, 35258118, 35258135, 35265693, 35222154, 35222158, 35233100, 35239839, 35237808, 35258132, 35258141, 35246419, 35257965, 35257967, 35257969, 35257972, 35257973, 35179739, 35247342, 35258125, 35258127, 35258128, 35258129, 35246389, 35246404, 35250356, 35252123, 35252129, 35239744, 35239817, 35239844, 35239845, 35242868, 35179729, 35257875, 35257874, 35258130, 35237787, 35258139, 35258140, 35237523, 35239740, 35258137, 35258142, 35265695, 35258003, 35237526, 35237810, 35239841, 35265689, 35266602, 35266603, 35252150, 35258126, 35258133, 35265687, 35265690, 35265692, 35266598, 35272212, 35272220, 35272223, 35257974, 35257975, 35239834, 35257968, 35257980, 35257987, 35252147, 35252148, 35257992, 35257995, 35258004, 35258013, 35258015, 35258016, 35258136, 35269726, 35252155, 35257832, 35258131, 35257979, 35257996, 35272213, 35272216, 35252143, 35252151, 35257993, 35257998, 35237809, 35239859, 35242858, 35258138, 35265694, 35266597, 35239843, 35257813, 35257978, 35257984, 35258002, 35257864, 35258018, 35252145, 35252154, 35257877, 35257957, 35252121, 35252135, 35252138, 35222159, 35237796, 35237804, 35237807, 35239624, 35239743, 35239820, 35239821, 35239824, 35239827, 35239850, 35242862, 35266604, 35269733, 35269751, 35270068, 35270074, 35233096, 35233097, 35232800, 35179776, 35265686, 35269723, 35269724, 35269727, 35269729, 35269730, 35269731, 35269732, 35269734, 35269735, 35269739, 35269750, 35269752, 35269754, 35270072, 35270073, 35272211, 35272214, 35272215, 35272217, 35272219, 35272221, 35272222, 35272224, 35272225, 35272226, 35272227, 35272228, 35272229, 35272230, 35272231, 35272232, 35272233, 35272234, 35272235, 35272236, 35272237, 35272238, 35272239, 35272240, 35272241, 35272242, 35272243, 35272245, 35272246, 35272247, 35272248, 35272249, 35272250, 35272251, 35272252, 35272253, 35272254, 35272255, 35272256, 35272257, 35272258, 35272259, 35272260, 35272261, 35272263, 35272264, 35272265, 35272266, 35272267, 35272268, 35272269, 35272271, 35272272, 34973329, 34975026, 35233124, 35249251, 35252113, 35252149, 35252156, 35257865, 35257866, 35257955, 35257960, 35257961, 35257962, 35257963, 35257966, 35257970, 35257976, 35257977, 35257981, 35257983, 35257986, 35257988, 35257989, 35257990, 35257997, 35257999, 35258000, 35258005, 35258006, 35258014, 35233086, 35232924, 35032726, 35274442, 35275472, 35275473, 35275475, 35027242, 35154910, 35172853, 35257856, 35213787, 35237524, 35065618, 35084010, 35179700, 35269725, 35269736, 35269746, 35269747, 35269748, 35269749, 35272244, 35272262, 35272270, 35293823, 34944167, 34975015, 35027260, 35092960, 35112569, 35113161, 35154905, 35270066, 35275476, 35275477, 35275478, 35275481, 34988041, 35239854, 35275482, 34973330, 35269722, 35272218, 34770866
RECALLING FIRM/MANUFACTURER
Medtronic Emergency Response Systems, Inc., Redmond, WA, by letters on April 27, 2007. Firm initiated recall is ongoing.
REASON
White Screen Lock up: LifePak 20 defibrillators with software version 48 or version 52 may experience an intermittent timing issue during the power on sequence. This may lock up the device resulting in the monitor screen going white, and may cause a potential delay or prevention of shock treatment.
VOLUME OF PRODUCT IN COMMERCE
859 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) NeatNick Sweeping Action Heel Lancet -Full-Term- Item Number: 1030085 (box of 100)
    and Item Number: 1030086, case of 1,000 (10 boxes of 100), Recall # Z-0926-2007;
b) NeatNick Sweeping Action Heel Lancet - Preemie- Item Number: 1030083 (box of 100)
    and Item Number: 1030084, case of 1,000 (10 boxes of 100), Recall # Z-0927-2007
CODE
a) M073010, M085019, M088037, M094012, M106010, M107016, M116013, M122004;
b) Lot Number: M095007, M066008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hawaii Medical LLC, Pembroke, MA, by telephone and follow-up letter on May 15, 2007.
Manufacturer: Facet Technologies Llc, Marietta, GA. Firm initiated recall is ongoing.
REASON
Lancet may misfire and an inadequate blood sample may result; additionally, the blade may not retract after use and result in a needle stick to the user/patient
VOLUME OF PRODUCT IN COMMERCE
344,434 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

___________________________________
PRODUCT
Precision Xtra Blood Glucose monitoring system. Individual test meter and test strip kit. Other Brand names include: Precision Xceed Blood Glucose Monitoring system, Optium Xceed, Omron, HEA-214, Optium Xido, MediSense Optium, Boots, Optium (includes Medline and Liberty), Kroger, ReliOn, Rite Aid, Recall # Z-0856-2007
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Diabetes Care, Inc., Alameda, CA, by letters dated March 5, 2007.
Manufacturer: Benchmark Electronics (Thailand) PCL, Ayudhaya, Thailand. Firm initiated recall is ongoing.
REASON
The front button covers may detach from the meter.
VOLUME OF PRODUCT IN COMMERCE
Approximately 300 lots
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Well Leg Holder with Boot, part of the Supine Universal Hip Distractor System; Ref (Part) #72200632, Recall # Z-0872-2007
CODE
Serial #’s: 286092, 287285, 287287, 287288, 287289, 287290, 287291, 289740, 289743, 290456, 290457 and 290837.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith & Nephew, Inc Endoscopy Division, Oklahoma City, OK, by letter and telephone on November 1, 2006.
Manufacturer: Allen Medical Systems, Inc., Acton, MA. Firm initiated recall is ongoing.
REASON
The device was not manufactured to correct specification causing interference when used in conjunction with Patient Transfer Board.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II

___________________________________
PRODUCT
O-NO-MORE (Formerly ORPHAN-NO-MORE) Calf Claimer Powder, packaged in 11-oz. bottles, For Animal Use Only. Recall # V-043-2007
CODE
A06
RECALLING FIRM/MANUFACTURER
Springer Magrath Co., Mc Cook, NE, by telephone on January 2, 2007, fax dated January 9, 2007, by letters on February 22, 2007, March 12, March 14 and March 21, 2007. Firm initiated recall is ongoing.
REASON
The finished product was manufactured with prohibited bovine blood meal and did not bear the cautionary BSE statement that the product should not be fed to ruminants.
VOLUME OF PRODUCT IN COMMERCE
Approximately 13,255 bottles
DISTRIBUTION

Nationwide

END OF ENFORCEMENT REPORT FOR JUNE 13, 2007

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