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U.S. Department of Health and Human Services

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Enforcement Report for January 16, 2008

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.

 

January 16, 2008
08-03

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I

_________________________________
PRODUCT 
Metz Fresh brand Fresh Spinach Leaves in 10 oz., 1 lb., 2.5 lb. and 4 lb. bags. Recall # F-128-8
CODE
12208114, 12208214, 12208314
RECALLING FIRM/MANUFACTURER
Recalling Firm: Metz Fresh Llc, King City, CA, by telephone on August 24, 2007 and press release on August 29, 2007. 
Manufacturer: Watsonville Produce Inc, Moss Landing, CA. Firm initiated recall is complete.
REASON
Spinach is contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
5,755 cartons
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
a) Red speckled beverage container (with spigot) for beverages consumed by humans,
    SKU 370549. Units sold as individual stock items. Diameter is 12 inches, height is
    11 inches, Recall # F-129-8;
b) Blue speckled beverage container (with spigot) for beverages consumed by humans,
    SKU 391163. Units sold as individual stock items. Diameter is 12 inches, height is
    11 inches. Recall # F-130-8;
c) Glass water tank (retro) with spigot for beverages consumed by humans, SKU 378251.
    Units sold as individual stock items. 1.43 gallon capacity (5440 ml). Recall # F-131-8;
d) Green speckled beverage container (with spigot) for beverages consumed by humans,
    SKU 370549. Units sold as individual stock items. Diameter is 12 inches, height is 11
    inches. Recall # F-132-8
e) Yellow speckled beverage container (with spigot) for beverages consumed by humans,
    SKU 370549. Units sold as individual stock items. Diameter is 12 inches, height is 11
    inches. Recall # F-133-8
CODE
SKU #’s only
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cost Plus, Inc., Oakland, CA, by press release on August 3, 2007.
Manufacturer: Lucky Enamelware Factory Ltd, Taishan, China (Mainland). Firm initiated recall is ongoing.
REASON
Spigots of beverage containers leach lead.
VOLUME OF PRODUCT IN COMMERCE
12,592 total units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Kroger's Light Caesar Salad Dressing, UPC # 0 11110-717658, Recall # F-134-8
CODE
Sell By May 09 08 SA7221
RECALLING FIRM/MANUFACTURER
Kroger Co, Cincinnati, OH, by press release on November 8, 2007. Firm initiated recall is ongoing.
REASON
The salad dressing is being recalled because it contains undeclared milk, eggs, and anchovies. People who have an allergy or severe sensitivity to milk, eggs, or anchovies run the risk of serious or life-threatening allergic reaction if they consume these products.
VOLUME OF PRODUCT IN COMMERCE
8,510 Cases
DISTRIBUTION
IN, TN and KS
___________________________________
PRODUCT 
Liquid Whole Egg packaged in 3,600-lb stainless steel totes and 30-lb plastic pails, Recall # F-135-8
CODE
Lot # 2957-5, produced October 22, 2007
RECALLING FIRM/MANUFACTURER
Hi Point, Los Angeles, CA, by telephone on November 1, 2007 and by letter on November 12, 2007. Firm initiated recall is complete.
REASON
Product is contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
12,600 lbs (2 X 3,600 lb stainless steel totes; 180 X 30 lb plastic pails)
DISTRIBUTION
CA
___________________________________
PRODUCT 
Lay's Classic Potato Chips, 1.5 oz. Bags, Recall # F-136-8
CODE
Recalled product has a fresh date of February 12 with an 11 digit code number of 12923230985 (time stamp between 06:00 and 08:00)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Frito Lay, Inc, Plano, TX, by press release on December 10, 2007.
Manufacturer: Frito Lay Inc, Irving, TX. Firm initiated recall is ongoing.  
REASON
Undeclared milk; bags labeled as Lay's Classic Potato Chips actually contained Lay's Cheddar & Sour Cream flavored potato chips, which contain milk derived ingredients not included on the label of the Classic flavor packages.
VOLUME OF PRODUCT IN COMMERCE
2,460 bags
DISTRIBUTION
TX
___________________________________
PRODUCT
MAIZTECA MEXICAN BREAD, Net Wt. 1.5 lbs. --- Ingredients: Flour, Vegetable Shortening, Sugar, Eggs, Cinnamon, Water, Yeast, FD & C Red # 40, Red #3, Yellow #5, Blue #1, Recall # F-150-8
CODE
No codes
RECALLING FIRM/MANUFACTURER
215 Washington St. Foods, Inc., Newburgh, NY, by “consumer alert” on October 25, 2006. NY initiated recall is complete.
REASON
The product contained undeclared milk based on sampling, analysis, and inspectional findings by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
16 cases (6 - 1.5 lbs. bags per case)
DISTRIBUTION
NY

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II

___________________________________
PRODUCT 
Wegmans Bouillabaisse Seafood Sauce, Net Wt 8 oz. (227 g), UPC 77890 22746, Recall # F-139-8
CODE
"Use By" date up to and including 12/24/07;
RECALLING FIRM/MANUFACTURER
Wegmans Food Markets, Rochester, NY, by press release on December 12, 2007. Firm initiated recall is ongoing
REASON
The product contains undeclared wheat (from shrimp base ingredients). Wegmans discovered the error during a label review.
VOLUME OF PRODUCT IN COMMERCE
2841 units
DISTRIBUTION
NY, PA, NJ, VA and MD
___________________________________
PRODUCT 
Wegmans Bakery Wreath Kuchen, Net Wt 14 oz, 397 g, UPC 77890 92163,
Recall # F-140-8
CODE
"Best if Used By" date up to and including 12/12;
RECALLING FIRM/MANUFACTURER
Wegmans Food Markets, Rochester, NY, by telephone on December 6, 2007. Firm initiated recall is ongoing.
REASON
Containers of wreath kuchen contain pecans as a topping which are visible, and the pecans were not included on the ingredient label. This was discovered by a store employee.
VOLUME OF PRODUCT IN COMMERCE
3,909 units
DISTRIBUTION
NY, PA, NJ, VA and MD

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS III

___________________________________
PRODUCT 
a) Success® Rice Ready to Serve Natural Whole Grain Brown Rice; 8.8 oz. (250g);
    packaged two 125g containers per carton, Product of Spain; Recall # F-137-8;
b) Success® Rice Ready to Serve Natural Whole Grain White Rice; 8.8 oz. (250g);
    packaged two 125g containers per carton, Product of Spain; Recall # F-138-8
CODE
All production codes
RECALLING FIRM/MANUFACTURER
Riviana Foods Inc, Houston, TX, by e-mail on October 25, 2007. Firm initiated recall is ongoing.  
REASON
Mislabeled; Sodium underdeclared on the Nutrition Facts panel.    
VOLUME OF PRODUCT IN COMMERCE
238,048 cases (8 units per case).
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
a)Kitchen Blend® Gourmet Style ADOBO CON SAZON, Net Wt. 13 oz. 368.5 gm,
    UPC 0 77636 99109 5; Recall # F-141-8;
b) Kitchen Blend® Gourmet Style ADOBO CON SAZON NO PEPPER (SIN
    PIMIENTA), Net Wt. 13 oz. 368.5 g, UPC 0 77636 99115 6; Recall # F-142-8;
c) Kitchen Blend® Gourmet Style SEASONING SALT EXTRA HOT SAZON,
    Net Wt. 13 oz. 368.5 g, UPC 0 77636 99575 8; Recall # F-143-8
CODE
All products on the market at time of recall initiation
RECALLING FIRM/MANUFACTURER
La Flor Products Co., Inc., Hauppauge, NY, by letter on November 29, 2007. Firm initiated recall is ongoing.
REASON
Labeling of the product lacked an ingredient statement and contained incorrect information in the Nutrition Facts Panel. The Nutrition Facts Panel declares Sodium 0mg (0%) but the product actually contains 380 mg Sodium.  
VOLUME OF PRODUCT IN COMMERCE
2343 cases (12 -13 oz. bottles per case)
DISTRIBUTION
NY
___________________________________
PRODUCT 
a) Gladder's Gourmet Fudge Chocolate Chip (Raw, Pre-portioned Cookie Dough),
    Net Wt. 18 Lbs. /216 ct, Recall # F-144-8;
b) Gladder's Gourmet Sugar Cookie (Raw, Pre-portioned Cookie Dough), Net Wt. 18
    Lbs. /216 ct, Recall # F-145-8;
c) Gladder's Gourmet Chocolate Chip (Raw, Pre-portioned Cookie Dough), Net Wt.
    18 Lbs. /216 ct, Product Code 1110; also Net Wt. 18 Lbs. /96 ct, Product Code 1610,
    Recall # F-146-8;
d) Gladder's Gourmet Pareve Chocolate Chip (Raw, Pre-portioned Cookie Dough),
    Net Wt. 18 Lbs. /216 ct, Recall # F-147-8;
e) Gladder's Gourmet Elegance Double Fudge Pecan (Raw, Pre-portioned Cookie
    Dough), Net Wt. 16 Lbs. /64 ct, Recall # F-148-8
CODE
a) Lot #10/11/07, Case #0569-0819 / 16:14 - 18:20;
b) Lot #10/11/07, Case #0148-0288 / 11:44 - 13:14;
c) Lot #10/11/07, Case #0404-0529 / 14:16 - 15:29;
    Lot #10/11/07, Case #0530-0568 / 15:40 - 16:11;
d) Lot #10/11/07, Case #0289-0483 / 13:15 - 14:08;
e) Lot #10/11/07, Case #0820-0859 / 18:24 - 18:50
RECALLING FIRM/MANUFACTURER
Gladders Gourmet Cookie, Inc, Lockhart, TX, by e-mail on November 21, 2007. Firm initiated recall is ongoing.
REASON
Product may contain foreign material.
VOLUME OF PRODUCT IN COMMERCE
966 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Girl Scouts, Whole Cashews, Net Wt. 10 oz. (283g). Recall # F-149-8
CODE
7268A9 or 7268B9 on the second line of the code printed on the bottom of the can.
RECALLING FIRM/MANUFACTURER
Ashdon Farms, Waukesha, WI, by e-mail on November 9, 2007. Firm initiated recall is ongoing.
REASON
Ashdon Farms is voluntarily recalling 10 oz Girl Scout Cashews (item GS-018) packed in pop-top cans with the code dates of 7268A9 and 7268B9 because the firm has received a small number of complaints regarding pieces of metal in the product.
VOLUME OF PRODUCT IN COMMERCE
5272 cases, 12 cans per case
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III

___________________________________
PRODUCT
Primidone Tablets, USP, 50 mg, 100-tablet bottles, Rx Only, NDC 0603-5371-21, Recall # D-082-2008
CODE
Lot T055A07A, exp. 01/09
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals LLC, Huntsville, AL, by letter on December 14, 2007. Firm initiated recall is ongoing.
REASON
Product failed potency specification at 3-month stability test point.
VOLUME OF PRODUCT IN COMMERCE
16,606 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS II

___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0183-08
CODE
 Unit: 4770940
RECALLING FIRM/MANUFACTURER
Recalling Firm: Oklahoma Blood Institute - Sylvan N Goldman Center, Oklahoma City, OK, by fax on October 3, 2006.
Manufacturer: Southwest Oklahoma Blood Institute, Lawton, OK. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0402-08
CODE
Unit: LC66239
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by fax on June 13, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0403-08
CODE
Units: FS09662; LC57976; LC53857
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by fax on March 29, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who visited a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
WI
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0405-08
CODE
Unit: 9847586
RECALLING FIRM/MANUFACTURER
 Lifesource, Glenview, IL by telephone on May 4, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who emigrated from a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
___________________________________
PRODUCT
SoftBank II Software Versions 23.x, 22.x, 21.x, and 19.x. Report Unique Identifier: 1058332-04/10/2006-014C, Recall # B-0503-08
CODE
Sofware Versions 23.x, 22.x, 21.x, and 19.x
RECALLING FIRM/MANUFACTURER
SCC Soft Computer, Clearwater, FL, by firm’s task management system and telephone on April 2, 2003. Firm initiated recall is complete.
REASON
Software with a glitch or defect, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1,059 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Softbank II Software Version 23.1 with database Management System Interface. Report Unique Identifier: 1058332-04/07/2006-011-C, Recall # B-0504-08
CODE
Software Version 23.1
RECALLING FIRM/MANUFACTURER
SCC Soft Computer, Clearwater, FL, by e-mail on May 9, 2005. Firm initiated recall is complete.
REASON
Software with a glitch or defect, was distributed.
VOLUME OF PRODUCT IN COMMERCE
76 units
DISTRIBUTION
Nationwide and Canada

___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0536-08
CODE
Unit: 72C417412
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by facsimile on July 28, 2007. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0538-08;
b) Recovered Plasma, Recall # B-0539-08
CODE
a) and b) Unit: 2122287
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter on June 8, 2006 and e-mail on May 23, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported testing positive for Hepatitis B antibody, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN and Switzerland
___________________________________
PRODUCT 
Red Blood Cells, Recall # B-0540-08
CODE
Unit: 04K569439
RECALLING FIRM/MANUFACTURER
 LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on August 16, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported testing positive for Hepatitis B antibody, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0542-08
CODE
Unit: 1968503
RECALLING FIRM/MANUFACTURER
 Carter BloodCare, Bedford, TX, by telephone on June 23, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0543-08
CODE
Unit: 0311769
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Piedmont, SC, by facsimile and e-mail on July 5, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor taking the medication Avodart, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC and Switzerland
___________________________________
PRODUCT 
Source Plasma, Recall # B-0551-08
CODE
Units: 350036994; 350039186
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biomat USA, Inc., City of Industry, CA., by fax on March 20, 2006.
Manufacturer: Biomat USA, Inc., McAllen, TX. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Barcelona, Spain

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS III

___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0404-08
CODE
Units: 2710885; 2710876; 2710882; 2710883
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone on May 25, 2006 and follow-up fax on June 7, 2006. Firm initiated recall is complete.
REASON
Blood product, documented as being out of controlled storage for more than 30 minutes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
TN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0537-08
CODE
Unit: 71S393388
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Birmingham Region, Birmingham, AL, by facsimile on July 18, 2006. Firm initiated recall is complete.
REASON
Blood product, manufactured without additive solution, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0541-08
CODE
Units: 71S624379 Part A; 71S624379 Part B
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Montgomery Region, Montgomery, AL, by facsimile on June 12, 2006. Firm initiated recall is complete.
REASON
Leukoreduced products that had WBC counts performed using samples that exceeded time frame requirements for analysis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0544-08
CODE
Unit: 0311769
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Piedmont, SC, by facsimile and e-mail on July 5, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor taking the medication Avodart, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC and Switzerland

___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0552-08
CODE
Units: 4452503; 4452486 (split unit)
RECALLING FIRM/MANUFACTURER
Lifesource, Glenview, IL, by telephone on April 12, 2007. Firm initiated recall is complete.
REASON
Blood products, stored at an unacceptable temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
IL

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II

___________________________________
PRODUCT
a) Siemens, ACUSON Antares, Ultrasound System (Standard and Premium Edition),
    5.0 Systems with software version 200.0.054, P/N: 10032747 and 10032746
    standard, 10032746, 10037591, and 10038202 for premium edition,
    Recall # Z-0297-2008;
b) Siemens, SONOLINE Antares Ultrasound System, 5.0 Systems with software
    version 200.0.054, P/N 05936518 and 10037593, Recall # Z-0298-2008
CODE
a) Serial numbers : 114792, 114819, 114822, 114827, 114829, 114839, 114843, 114844, 114845, 114846, 114847, 114848, 114849, 114851, 114859, 114860, 114861, 114863, 114864, 114871, 117874, 114876, 114880, 114881, 114882, 114885, 114890, 114891, 114894, 114895, 114909, 114910, 114912, 114918, 114921, 114927, 114928, 114930, 114931, 114935, 114941, 114944, 114947, 114948, 114949, 114953, 114957, 114958, 114959, 114960, 114962, 114963, 114971, 114977, 114978, 114730, 114735, 114745, 114761, 114781, 114785, 114826, 114865, 114868, 114869, 114896, 114936, 5000, 5001, 112919, 112925, 112971, 112980, 112981, 112984, 112989, 112992, 113005, 113009, 113013, 113015, 113037, 113040, 113041, 113042, 113045, 113048, 113051, 113052, 113053, 113055, 113058, 113061, 113067, 113068, 113075, 113076, 113079, 113080, 113101, 113102, 113105, 113143, 113145, 113147, 113204, 113225, 113257, 113259, 113302, 113407, 113411, 113414, 113462, 113469, 113566, 113682, 113706, 113715, 113759, 113767, 113803, 113825, 113826, 113827, 113828, 113829, 113831, 113832, 113834, 113835, 113841, 113843, 113846, 113847, 113848, 113849, 113850, 113851, 113852, 113856, 113863, 113873, 113900, 113917, 113921, 113945, 113947, 113950, 113957, 113980, 113986, 114014, 114043, 114052, 114061, 114164, 114172, 114176, 114186, 114233, 114254, 114255, 114271, 114274, 114313, 114351, 114356, 114363, 114406, 114461, 114474, 114475, 114481, 114482, 114493, 114536, 114573, 114583, 114584, 114590, 114596, 114587, 114602, 114612, 114614, 114616, 114617, 114621, 114640, 114644, 114647, 114652, 114655, 114661, 114665, 114669, 114671, 114675, 114687, 114690, 114694, 114699, 114703, 114706, 114716, 114721, 114728, 114734, 114732, 114740, 114742, 114743, 114744, 114749, 114751, 114753, 114754, 114755, 114757, 114759, 114760, 114762, 114764, 114768, 114770, 114771, 114773, 114775, 114777, 114782, 114789, 114790, 114791, 114792, 114793, 114794, 114796, 114799, 114802, 114805, 114807, 114808, 114809, 114810, 114811, 114813, 114818, 114819, 114820, 114821, 114822, 114825, 114827, 114828, 114829, 114831, 114833, 114834, 114835, 114836, 114838, 114842, 114843, 114844, 114844, 114845, 114846, 114847, 114848, 114849, 114850, 114851, 114853, 114857, 114859, 114860, 114861, 114863, 114864, 114866, 114870, 114873, 114878, 114886, 114899, 114901, 114908, 114914, 114916, 114920, 114926, 114937, 114939, 114940, 114943, 114945, 114950, 114955, 114973, 113322, 113904, 114228, 114415, 114524, 114528, 114566, 114568, 114623, 114630, 114632, 114635, 114636, 114645, 114646, 114651, 114672, 114685, 114717, 114723, 114724, 114725, 114726, 114727, 114729, 114733, 114736, 114737, 114739, 114741, 114746, 114747, 114748, 114750, 114752, 114758, 114769, 114765, 114766, 114767, 114779, 114780, 114783, 114784, 114786, 114788, 114795, 114797, 114798, 114800, 114801, 114803, 114804, 114806, 114812, 114814, 114816, 114823, 114824, 114830, 114832, 114837, 114840, 114841, 114852, 114854, 114855, 114858, 114862, 114867, 114868, 114869, 114872, 114875, 114877, 114879, 114887, 114888, 114889, 114892, 114893, 114897, 114898, 114900, 114902, 114903, 114904, 114905, 114907, 114911, 114913, 114915, 114919, 114922, 114923, 114924, 114925, 114929, 114933, 113249001, 113344001, 113458001, 113593001, 113731001, 113887001, and 113159001;
b) Serial Numbers: 111259, 111264, 111287, 111514, 112013, 112207, 111459, 112730, 113048, 113052, 113053, 113058, 113068, 113075, 113105, 113257, 113259, 113462, 113682, 113759, 113831, 113832, 113841, 113846, 113849, 113850, 113851, 113852, 113854, 113856, 113863, 113945, 113957, 114271, 114274, 114474, 114482, 114583, 114590, 114597, 114644, 114655, 114661, 114687, 114690, 114699, 114703, 114706, 114716, 114749, 114753, 114754, 114760, 114768, 114770, 114771, 114773, 114777, 114782, 114787, 114790, 111259, 111264, 111287, 111514, 111786, 112013, 112207, 111459, 112730, 111552001, 112697001, 10188001, 10566001, 10604001, 111249001, 111552001, 111901001, 111901002, 111994001, 112029001, 112083001, 112178001, 112182001, 112256001, 112306001, 112384001, 112407001, 112697001, 112713001, 112776001, and 113159001
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View, CA, by letter on July 10, 2007. Firm initiated recall is ongoing.
REASON
Image errors: A software problem results in on-screen indications (graphics) that lead the user to believe that the patient's right and left and the transducer orientation are oriented the same. This is not the case and the actual patient's right and left are reversed from the on-screen indicators.
VOLUME OF PRODUCT IN COMMERCE
418 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
ARCHITECT i System Assay CD-ROM - WW (excluding USA accounts), Versions prior to Version 24.0; for use on the ARCHITECT i System; List Number (LN) 6E59, Recall # Z-0299-2008
CODE
LIst 6E59, Versions 22.0 and below, Assay CD-ROM Lot Numbers: 34664P100, 34708P100, 49130P100, 49131P100, 50450P100, 54701P100, 50449P100, 52151P100, 54692P100
RECALLING FIRM/MANUFACTURER
Abbott Laboratories MPG, Abbott Park IL, by letter dated September 18, 2007. Firm initiated recall is ongoing.
REASON
The lower limit flag for auto-dilution protocol 3 (amniotic fluid) was set too low (15 ng/mL) for the ARCHITECT AFP assay file for the ARCHITECT AFP non-U.S. product. The assay labeling indicates that the limit flag should be set no lower than 20 ng/mL
VOLUME OF PRODUCT IN COMMERCE
2,490 units
DISTRIBUTION
Internationally
___________________________________
PRODUCT 
Ventana Medical System's Symphony Staining System, KPA, Model #: 2200000, Catalog #: 900-SYM1 & 900-SYM3, Recall # Z-0300-2008
CODE
Serial Numbers: 910006-910011, 910013-910016, 910019, 910020, 910022, 910023, 910029, 910031-910033, 910036, 910049, 910053, 910054, 910056, 910057, and 910060
RECALLING FIRM/MANUFACTURER
Ventana Medical Systems Inc, Tucson, AZ, by visit beginning September 6, 2007. Firm initiated recall is ongoing.
REASON
Devices released prior to full testing; during internal testing it was discovered that the configuration of the Symphony instrument during Hi pot testing procedures does not completely evaluate all components in the test loop.
VOLUME OF PRODUCT IN COMMERCE
45 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Toshiba Aplio XG Diagnostic Ultrasound System, Model: SSA-790A with version 1.1 software, Recall # Z-0305-2008
CODE
Serial Numbers: 99B0752571, 99B0752572, 99B06Z2073, 99B06Z2102, 99B06Z2107, 99B0722268, 99B0722269, 99B0722270, 99B0722271, 99B0722272, 99B0732349, 99B0732350, 99B0732351, 99B0732352, 99B0732353, 99B0732354, 99B0722208, 99B0722250, 99B0752531, 99B0752532, 99B06Z2072, 99B0752508, 99B0752509, 99B0752510, 99B0752511, 99B0722251, 99B06Z2071, 99B0722206, 99B0722207, 99B0722204, 99B0752524, 99B0752525, 99B0732355, 99B0742413, 99B0742414, 99B0742415, 99B0742416, 99B0742417, 99B0722203, 99B06Z2062, 99B0722201, 99B0712171, 99B0722254, 99B0752507, 99B06Z2064, 99B06Z2104, 99B0712169, 99B0712172, 99B0722202, 99B0752570, 99B0752562, 99B0752563, 99B0752564, 99B0752565, 99B06Z2103, 99B0752523, 99B0752550, 99B06Z2074, 99B0712173, 99B0712174, 99B06Z2059, 99B0752551, 99B0752561, 99B06Z2108, 99B0752549, 99B0722205, 99B0752547, 99B0712168, 99B0722253, 99B06Y2048, 99B06Y2049, 99B06Y2051, 99B06Z2058, 99B06Z2067, 99B06Z2110, 99B06Z2116, 99B06Z2057, 99B06Z2088, 99B06Z2105, 99B06Z2111, 99B06Z2115, 99B0722252, 99B06Z2063, 99B06Z2065, 99B06Z2066, 99B06Z2090, 99B06Z2101, 99B06Z2113, 99B0712170, 99B06Z2060, 99B06Z2068, 99B06Z2070, 99B06Z2106, 99B0752548, 99B06Z2089, 99B06Z2091, 99B06Z2092, 99B06Y2050, 99B06Z2055, 99B06Z2056, 99B06Z2061, 99B06Z2069, 99B06Z2075, 99B06Z2109, 99B06Z2112, and 99B06Z2114
RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Med Sys Inc., Tustin, CA, by letters beginning on October 2, 2007.
Manufacturer: Toshiba Corp. Medical Engineering Ctr., Nasu Works, Tochigi, Japan. Firm initiated recall is ongoing.
REASON
Panel Lock-up: When using dynamic image acquisition modes the panel may lock up, if the operator attempts to perform a still image capture. If the panel locks up the system will have to be rebooted to continue the examination which may cause a delay in completion of the patient examination.
VOLUME OF PRODUCT IN COMMERCE
69 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) VariLift Bone Plug w/ End Cap; 14mm Dia, 24mm long; Ref #: CEA1-14-24-BP;
    Sterile, Recall # Z-0306-2008;
 b) VariLift Bone Plug w/ End Cap; 16mm Dia, 24mm long; Ref #: CEA1-16-24-BP;
     Sterile, Recall # Z-0307-2008;
c) VariLift Bone Plug w/ End Cap; 18mm Dia, 24mm long; Ref #: CEA1-18-24-BP;
    Sterile, Recall # Z-0308-2008; 
d) VariLift Bone Plug w/ End Cap; 11mm Dia, 24mm long; Ref #: CIE1-11-24-BP;
    Sterile, Recall # Z-0309-2008;
e) VariLift Bone Plug w/ End Cap; 13mm Dia, 24mm long; Ref #: CIE1-13-24-BP;
    Sterile, Recall # Z-0310-2008;
f) VariLift Bone Plug w/ End Cap; 15mm Dia, 24mm long; Ref #: CIE1-15-24-BP;
    Sterile, Recall # Z-0311-2008;
CODE
a) Lot #: U101;
b) Lot #: U102;
c) Lot #: U103 and U171;
d) Lot #: 122CIE1-11-24-BP, 2245, 2250, 2260, 2535, 2545, 2940, U051, U748
    and W657;
e) Lot #: 2945, Y299, Y301, 2235, 2240, 2565, 1.0186C and 1.0278B;
f) Lot #: 122CIE1-15-24-BP, 291C, T179, T184, T412, T416, T425, 2950,
    53845879, 53852082, X117 and X118
RECALLING FIRM/MANUFACTURER
Encore Medical Lp, Austin, TX, by letter on September 19, 2007. Firm initiated recall is ongoing.
REASON
Device marketed without label warning required in the device's 510(k) approval letter. (In part-Warning: This device is not intended for any spinal indications.....)
VOLUME OF PRODUCT IN COMMERCE
175 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Transilluminator, Model BFO-150, a Fiber Optic Light Source (Illuminator), available in 2 voltages: 115v for USA users & 220v for foreign countries, Recall # Z-0320-2008
CODE
All Serial Numbers on the market
RECALLING FIRM/MANUFACTURER
Chiu Technical Corp., Kings Park, NY, by letter on November 9, 2007. Firm initiated recall is ongoing.
REASON
Device was marketed without a 510(k).
VOLUME OF PRODUCT IN COMMERCE
191 units
DISTRIBUTION
Nationwide, Canada and India
___________________________________
PRODUCT
a) Dale 240 Blue (Adults) Trachestomy Tube Holder, Product Number: H84102401,
    Recall # Z-0446-2008;
b) Dale 242 Blue (Neonate, Infants and Small Children) Trachestomy Tube Holder,
    Product Number: H84102421, Recall # Z-0447-2008
CODE
All lots
RECALLING FIRM/MANUFACTURER
Dale Medical Products, Inc., Plainville, MA, by letter dated September 27, 2007. Firm initiated recall is ongoing.
REASON
Revised Labeling: Instructions For use: "Do not trim fastener hook tabs." Trimming can cause tabs to disengage at the trach plate.
VOLUME OF PRODUCT IN COMMERCE
665,000 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Disposable Angled MVR Blade (23 gauge/0.6mm), REF/Item Code: 1282D0.6,
    Recall # Z-0485-2008;
2) PremierEdge, MICROSURGICAL KNIFE, 1.2mm, Sideport Knife, REF/Item Code:
    PE 3012, Recall # Z-0486-2008;
3) PremierEdge, Bulk Microsurgical Knife. 1.2mm, Sideport Knife, Item Code B-
    PE3012, Recall # Z-0487-2008;
4) PremierEdge, Bulk Microsurgical Knife, 3.0mm Slit Knife, Item Code B-PE3830,
    Recall # Z-0488-2008;
5) Eyemaxx your choice!, Microsurgical Knife 3.0mm Slit Knife, REF/Item Code:
    MX2030, MADE IN USA, Recall # Z-0489-2008;
6) PremierEdge, MICROSURGICAL KNIFE,15 DEGREES STAB KNIFE, REF/Item
    Code: PE 3015, Recall # Z-0490-2008;
7) PremierEdge, MICROSURGICAL KNIFE, 30 DEGREES STAB KNIFE, REF/item
    Code: PE 3030, Recall # Z-0491-2008;
8) PremierEdge MICROSURGICAL KNIFE, 45 DEGREES STAB KNIFE, REF/Item
    Code: PE 3045, Recall # Z-0492-2008;
9) PremierEdge MICROSURGICAL KNIFE, 2.5mm Clear Cornea Knife, REF/Item
      Code: PE 3125; Recall # Z-0493-2008;
10) PremierEdge MICROSURGICAL KNIFE, 2.85mm Clear Cornea Knife, Item
      Code/ REF: PE 3128, Recall # Z-0494-2008;
11) PremierEdge MICROSURGICAL KNIFE, 3.0mm Clear Cornea Knife, Item
      Code/REF: PE 3130; Recall # Z-0495-2008;
12) PremierEdge MICROSURGICAL KNIFE, 3.2mm Clear Cornea Knife, Item
      Code/REF: PE 3132; Recall # Z-0496-2008;
13) PremierEdge MICROSURGICAL KNIFE, 2.65mm Clear Cornea Knife - Parallel
      Sides, Item Code/REF: PE 3226; Recall # Recall # Z-0497-2008;
14) PremierEdge MICROSURGICAL KNIFE, 2.85mm Clear Cornea Knife - Parallel
      Sides, Item Code/REF: PE 3228, Recall # Z-0498-2008;
15) PremierEdge MICROSURGICAL KNIFE, 3.0mm Clear Cornea Knife - Parallel
      Sides, Item Code/REF: PE 3230, Recall # Z-0499-2008;
16) PremierEdge MICROSURGICAL KNIFE, 2.5-3.0mm Clear Cornea Knife –
      Trapezoid, Item Code/REF: PE 3302, Recall # Z-0500-2008;
17) PremierEdge MICROSURGICAL KNIFE, 3.2mm Implant Knife, Item Code/REF:
      PE 3432, Recall # Z-0501-2008;
18) PremierEdge MICROSURGICAL KNIFE, 3.5mm Implant Knife, Item Code/REF:
      PE 3435, Recall # Z-0502-2008;
19) PremierEdge MICROSURGICAL KNIFE ,4.0mm Implant Knife, Item Code/REF:
      PE 3440; Recall # Z-0503-2008;
20) PremierEdge MICROSURGICAL KNIFE, 23g MVR Knife, Item Code/REF:
      PE3523, Recall # Z-0504-2008;
21) PremierEdge MICROSURGICAL KNIFE, 3.0mm Round, Tunnel Knife, Item
      Code/REF: PE 3630, Recall # Z-0505-2008;
22) PremierEdge MICROSURGICAL KNIFE, 2.0mm Angled Crescent Tunnel Knife,
      Angled, Item Code/REF: PE 3720A; Recall # Z-0506-2008;
23) PremierEdge MICROSURGICAL KNIFE, 2.65mm Slit Knife, Item Code/REF:
      PE 3826; Recall # Z-0507-2008;
24) PremierEdge MICROSURGICAL KNIFE, 2.75mm Slit Knife, Item Code/REF:
      PE 3827; Recall # Z-0508-2008;
25) PremierEdge MICROSURGICAL KNIFE, 2.85mm Slit Knife, Item Code/REF:
      PE 3828; Recall # Z-0509-2008;
26) PremierEdge MICROSURGICAL KNIFE, 3.0mm Slit Knife, Item Code/REF:
      PE 3830; Recall # Z-0510-2008;
27) PremierEdge MICROSURGICAL KNIFE, 3.0mm Slit Knife - Straight Item
      Code/REF: PE 3830S; Recall # Z-0511-2008;
28) PremierEdge MICROSURGICAL KNIFE, 3.2mm Slit Knife; Item Code/REF:
      PE 3832; Recall # Z-0512-2008;
29) PremierEdge MICROSURGICAL KNIFE, 2.4mm Thin Slit Knife, Item Code/REF:
      PE 4824-TL; Recall # Z-0513-2008;
30) PremierEdge MICROSURGICAL KNIFE, 2.75mm Thin Slit Knife, Item Code/REF:
      PE4827-TL; Recall # Z-0514-2008;
31) PremierEdge MICROSURGICAL KNIFE , 2.85mm Thin Slit Knife, Item Code/REF:
      PE4828-TL; Recall # Z-0515-2008;
32) PremierEdge MICROSURGICAL KNIFE, 3.0mm Thin Slit Knife, Item Code/REF:
       PE4830-TL; Recall # Z-0516-2008
CODE
  1) Lot No: DK1106H, DK0107L, DK0407G, and DK0407O;
  2) Lot No.: DK0407A, and DK0407B;
  3) Lot No.: DK0207Q, DK0307I, DK0407M, DK0507R;
  4) Lot No: DK0407H;
  5) Lot No.: DK1206U;
  6) Lot No.: DK1106M, DK1106T, and DK0207R;
  7) Lot No: DK0207S;
  8) Lot No: DK0207T, DK0307M, and DK0507A;
  9) Lot No: DK1106X;
10) Lot No: DK0207V and DK0307N;
11) Lot No: DK1106Z and DK0107Q;
12) Lot No: DK0107R;
13) Lot No: DK0107S, DK0207X, DK0307A and DK0107AG;
14) Lot No: DK0307O and DK0407K;
15) Lot No: DK0207AA;
16) Lot No: DK0307AJ;
17) Lot No: DK0107U and DK0207AB;
18) Lot No: DK0107V, DK0207E and DK0507V;
19) Lot No: DK0307B and DK0407C;
20) Lot No: DK0307AH;
21) Lot No: DK1106P and DK0207AC;
22) Lot No: DK0107AA, DK0207H, DK0207AD and DK0307E;
23) Lot No: DK1106I, DK0107AB, and DK0107AK;
24) Lot No: DK1106N, DK1106AG, DK0207AF and DK0307T;
25) Lot No: DK0107AC, DK0207K, DK0207AG, DK0307G, DK0307U, and
      DK0507AD;
26) Lot No: DK1106J, DK0207M, DK0207AH, DK0307H, DK0407L, and DK0507E;
27) Lot Code: DK0107AD and DK0207N;
28) Lot No: DK1106Q;
29) Lot No: DK0307AI;
30) Lot Code: DK0507G and DK0507AE;
31) Lot Code: DK0407D;
32) Lot No: DK0407E
RECALLING FIRM/MANUFACTURER
Oasis Medical Inc, Glendora, CA, by letter dated July 18, 2007. Firm initiated recall is ongoing.
REASON
Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL.
VOLUME OF PRODUCT IN COMMERCE
28,319 individual knives
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS III

___________________________________
PRODUCT
a) Extron Electronics OEM, CAB, DVI-Male to DVI-Female Cable Assembly (14 inch.);
    Part #: 43-111-01 (Stryker Part #: 0100-224-131); (These cables are commonly used
    with the Switchpoint Infinity II), Recall # Z-0302-2008;
b) Extron Electronics OEM, CAB, DVI-I to DVI (3ft.); Part #: 43-112-01 (Stryker
    Part #: 0100-224-108); (These cables are commonly used with the Switchpoint
    Infinity II), Recall # Z-0303-2008
CODE
All Lots and Serial Numbers shipped between Oct. 2006 and June 2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Communications, Flower Mound, TX, by letter on September 21, 2007.
Manufacturer: Extron Electronics, Anaheim, Ca. Firm initiated recall is ongoing.
REASON
Intermitten or Complete Loss of Signal: out-of-specification DVI cables causing intermitten or complete loss of signal on monitors used in surgery.
VOLUME OF PRODUCT IN COMMERCE
3,908 cables
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
Cepheid, Xpert GBS Assay Diagnostic Test Kit Part No: GXGBS-100N-10 (in foil pouch) for use with the GeneXpert DX System, Recall # Z-0376-2008
CODE
Lot Number: 1402
RECALLING FIRM/MANUFACTURER
Cepheid, Sunnyvale, CA, by letter on September 4, 2007. Firm initiated recall is ongoing.
REASON
Labeling Error: Some cartridges may be mislabeled as "Xpert EV" instead of "Xpert GBS". (The information embedded in the barcode label on the cartridge is correct for Xpert GBS and brings up the GBS assay definition file).
VOLUME OF PRODUCT IN COMMERCE
105 units
DISTRIBUTION
Nationwide and Internationally

END OF ENFORCEMENT REPORT FOR JANUARY 16, 2008

 

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