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U.S. Department of Health and Human Services

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Enforcement Report for March 5, 2008

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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March 5, 2008
08-10

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I

___________________________________
PRODUCT
a) Kroger Smoked Salmon Dip, net wt 7.5 oz (212 g) and 32 oz, and Smoked Salmon
    Dip, Net Wt. 32 oz. (907.2 g), Recall # F-205-8;
b) Kroger Cajun Style Smoked Salmon Dip, net wt 7.5 oz (212 g), Recall # F-206-8;
c) Kroger Southern Style Crab Dip, net wt 7.5 oz (212 g), Recall # F-207-8;
d) Kroger Sun Dried Tomato Crab Dip, net wt 7.5 oz (212 g), Recall # F-208-8;
e) Kroger Chipotle Smoked Salmon Dip, net wt 7.5 oz (212 g), and Chipotle Smoked
    Salmon Dip, Net Wt. 32 oz (907.2 g), Recall # F-209-8
CODE
a) 7.5oz Use by dates: 04NOV2007A LN3 and 04NOV2007B LN3, 11NOV2007A LN3,
    11NOV2007B LN3, 18NOV2007A LN3, 18NOV2007B LN3, 25NOV2007A LN3,
    25NOV2007B LN3, 02 DEC2007A LN3, 02DEC2007B LN3, 09DEC2007A LN3,
    09DEC2007B LN3, 16 DEC2007A LN3, 16DEC2007B LN3, 23DEC2007A LN3;
    32oz, Use by date: 18NOV2007A LN3;
b) Use by dates: 04NOV2007A LN3, 04NOV2007B LN3, 11NOV2007A LN3,
    11NOV2007B LN3, 25NOV2007A LN3, 25NOV2007B LN3, 02DEC2007A LN3,
    02DEC2007B LN3, 09DEC2007A LN3, 09DEC2007B LN3, 16DEC2007A LN3,
    16DEC2007B LN3, 23DEC2007A LN3;
c) Use by dates: 04NOV2007A LN3 and 04NOV2007B LN3;
d) Use by date: 24OCT2007A LN3;
e) 7.5oz, Use by date: 11NOV2007A LN3, 11NOV2007B LN3, 19NOV2007A LN3,
    19NOV2007B LN3, 02DEC2007A LN3, 02DEC2007B LN3, 10DEC2007A LN3,
    10DEC2007B LN3, 16EC2007A LN3; 32oz, Use by date: 19NOV2007A LN3
RECALLING FIRM/MANUFACTURER
House Of Thaller Inc., Knoxville, TN, by telephone on October 28, 2007 and by fax on October 29, 2007. Firm initiated recall is complete.
REASON
These products were contaminated with Listeria monocytogenes based on the state of Georgia's and the FDA laboratory's analysis.
VOLUME OF PRODUCT IN COMMERCE
13,455 pounds
DISTRIBUTION
TN
___________________________________
PRODUCT
a) Sweetwater Valley Farms Southern Cheddar Jack Volunteer Special Cheese, 7, 10
    and 15 oz, and 5 lb blocks, Recall # F-210-8;
b) Sweetwater Valley Farms Tennessee Aged Southern Sharp Cheddar Cheese, 7, 10
    and 15 oz bars, Recall # F-211-8;
c) Sweetwater Valley Farms Tennessee Aged Southern Mild Cheddar Cheese, 7, 10
    and 15 oz bars, Recall # F-212-8
CODE
a) Lot No. 539;
b) and c) Lot No. 604
RECALLING FIRM/MANUFACTURER
Sweetwater Valley Farm, Philadelphia, TN, by telephone on November 17, 2007, press  release on November 21, 2007 and by telephone and fax on November 28, 2007. Firm initiated recall is complete.
REASON
This product was contaminated with Listeria monocytogenes based on the Tennessee Department of Agriculture’s analysis.
VOLUME OF PRODUCT IN COMMERCE
2,813 pounds
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Harry and David Moose Munch Milk & Dark Chocolate White Chocolate Macadamia
    Confection in clear round tub with clear plastic lid and shrink wrapped. Top label
    states "HARRY & DAVID MOOSE MUNCH MILK & DARK CHOCOLATE
    WHITE CHOCOLATE MACADAMIA NET WT 1 lb 10 oz. Label on side of
    container states "MILK CHOCOLATE CARAMEL, DARK CHOCOLATE,
    Recall # F-213-8;
b) Harry and David Moose Munch Peanut Butter, Milk Chocolate, Macadamia Nut
    Confection in clear round tub with clear plastic lid and shrink wrapped. Top label
    states "HARRY & DAVID MOOSE MUNCH PEANUT BUTTER, MILK
    CHOCOLATE, MACADAMIA NUT NET WT 1 lb 10 oz. Label on side of container
    states "MILK CHOCOLATE CARAMEL, DARK CHOCOLATE, Recall # F-214-8
CODE
a) Lot codes: 304 NXXX NN:NN, 305 NXXX NN:NN, 306 NXXX NN:NN,
    307 NXXX NN:NN;
b) Lot codes: 264 NXXX NN:NN, 265 NXXX NN:NN or 266 NXXX NN:NN.
    The X represents a letter and N represents a number
RECALLING FIRM/MANUFACTURER
Bear Creek Operations, Inc. DBA Harry and David's, Medford, OR, by e-mail on November 20, 2007 and by e-mail and press release on November 21, 2007. Firm initiated recall is complete.
REASON
The label on the side of the products is for a different product; Harry and David brand Milk Chocolate Caramel, Dark Chocolate Confection, and fails to list macadamia nuts and peanuts as ingredients.
VOLUME OF PRODUCT IN COMMERCE
Milk & Dark Chocolate White Chocolate Macadamia – 5,880 tubs; Peanut Butter, Milk Chocolate, Macadamia Nut – 4,392 tubs
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
GOLDEN LION brand Dried Hylocereus Undatus Brltt, NET WT: 6oz, UPC 7 34765 04361 2. (The labeled handling instructions refers to this product as a fungus, NYSDAM has this as a Dried Natural Herb), Recall # F-215-8
CODE
No code.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blooming Import Inc., Brooklyn, NY, by press release and letters on December 3, 2007.
Manufacturer: TAISHAN CITY DAXIN FOODCO, LTD, Shiubu Town, TAISHAN, China. NY initiated recall is complete.
REASON
The product contained undeclared sulfites (259.5ppm) based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
25 cases (50 - 6 oz. bags per case)
DISTRIBUTION
NY
___________________________________
PRODUCT
Sun Kee Ching Po Leung (soup mix) Nt. Wt. 5 oz, Recall # F-216-8
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Prosperity Resources International Inc., Irvington, NJ, by letter on December 11, 2007 and by telephone on December 12, 2007.
Manufacturer: Yau Luk Hong, Ping Shan, Hong Kong. NY initiated recall is complete.
REASON
New York State Department of Agriculture and Market randomly sampled product and found it to contain sulfites, which are not declared on the label
VOLUME OF PRODUCT IN COMMERCE
99 cartons (100 x 5 oz. per carton)
DISTRIBUTION
MD, IL, MI, NJ, NY, OH, PA and VA

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________
PRODUCT
Alprazolam Extended-Release Tablets, 3mg, Rx only, packaged in 60 count plastic (HDPE) bottles, NDC 0185-0198-60, Catalog Number: 0198-60, Recall # D-166-2008
CODE
Lot number: MK070099
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sandoz, Inc., Princeton, NJ, by letter on February 15, 2008.
Manufacturer: Sandoz, Inc., Wilson, NC. Firm initiated recall is ongoing.  
REASON
Failed Dissolution Specification (6 month stability)
VOLUME OF PRODUCT IN COMMERCE
1,566 bottles (60 count)
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS II

___________________________________
PRODUCT
Cryoprecipitated AHF Irradiated, Recall # B-0779-08
CODE
Units: 0365414; 0378815; 0378830; 0398735; 0366520; 0365427; 0401026; 0378828
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on October 30, 2006.  Firm initiated recall is complete.
REASON
Cryoprecipitated AHF units, not processed and re-frozen within one hour, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
LA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0845-08
CODE
Unit: 033GF86054
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Farmington, CT, by facsimile, electronic mail and letter on August 3, 2007. 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
CT
___________________________________
PRODUCT
Platelets, Recall # B-0952-08
CODE
Unit: 0390365
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on January 15, 2007 and by letter on January 22, 2007.  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
LA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0954-08
CODE
Units: 7086250(1) and 7086250(2)
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by facsimile on January 21, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who traveled to malarial endemic areas, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Source Plasma, Recall # B-0973-08
CODE
Unit: 386026885
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Waukegan, IL, by facsimile on May 24, 2007 and June 1, 2007. Firm initiated recall is complete.
REASON
Blood product, which tested negative for Hepatitis B, but was collected from a donor who subsequently tested positive for Hepatitis B surface antigen (HbsAg), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0978-08
CODE
Unit: 2710000
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by facsimile on May 27, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS III

___________________________________
PRODUCT
Recovered Plasma, Recall # B-0846-08
CODE
Unit: 033GF86054
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Farmington, CT, by facsimile, electronic mail and letter on August 3, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0951-08
CODE
Units: 033GC04426 Part1, 033GC04426 Part2; 033GX00978 Part1; 033GX00978 Part2; 033GX00984 Part1; 033GX00984 Part2; 033GX01030 Part1; 033GX01030 Part2
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Farmington, CT, by telephone and letter on May 11, 2007. Firm initiated recall is complete.
REASON
Blood products, prepared without the appropriate amount of additive solution (ADSOL), were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
NY, MA, CT
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0953-08
CODE
Unit: 0357016
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on July 24, 2007. Firm initiated recall is complete.
REASON
Blood product, which was out of controlled storage for more than 30 minutes during leukoreduction, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0955-08
CODE
Units: I3015681, I3011999
RECALLING FIRM/MANUFACTURER
Community Blood Center of Greater Kansas City, Kansas City, MO, by telephone on October 15, 2007. Firm initiated recall is complete.
REASON
Blood products, which were labeled with incorrect expiration dates, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MO

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II

___________________________________
PRODUCT
American Medical Systems, Inc., (AMS) GreenLight HPS Fiber Optic (ADDStat) Part Number 0010-2090B. Fiber optic laser for treatment of BPH (Benign Prostatic Hyperplasia), Recall # Z-0131-2008
CODE
Lot Numbers 705 N and 706 E
RECALLING FIRM/MANUFACTURER
AMS Innovative Center - San Jose, San Jose, CA, by letters. Firm initiated recall is ongoing.
REASON
Control knob break: The knob used to finely control the direction of the laser energy may break.
VOLUME OF PRODUCT IN COMMERCE
611 units
DISTRIBUTION
Nationwide and Singapore
___________________________________
PRODUCT
Smiths Medical CADD-Sentry Pro Medication Safety Software – electronic pump protocol programming software – Administrator REF 21-6275-51 RX only, Recall # Z-0134-2008
CODE
Software Version B
RECALLING FIRM/MANUFACTURER
Smiths Medical MD, Inc., Saint Paul, MN, by visit between August 14 and 31, 2007. Firm initiated recall is ongoing.
REASON
Incorrect dosage possible: A software anomaly in the CADD-Sentry Pro Administrator software (version B) where the values of a weight based protocol go to zero or round up to the next higher hundredths place, even if Administrator displayed the values correctly at data entry.
VOLUME OF PRODUCT IN COMMERCE
3 CD-Rom’s
DISTRIBUTION
UT, MD, CO
___________________________________
PRODUCT
a) TENET Medical Engineering Wrist Stabilization Kit, Small; REF (Part) # 7691;
    Sterile, Recall # Z-0577-2008;
b) TENET Medical Engineering Wrist Stabilization Kit, Medium; REF (Part) # 7692;
    Sterile, Recall # Z-0578-2008;
c) TENET Medical Engineering Wrist Stabilization Kit, Large; REF (Part) # 7693;
    Sterile, Recall # Z-0579-2008
CODE
a), b), and c) Lot Number: 20060605
RECALLING FIRM/MANUFACTURER
Tenet Medical Engineering, Inc., Calgary, Canada, by letter on November 23, 2007. Firm initiated recall is ongoing.
REASON
Sterility compromised: Sterility seals on some of the firm’s wrist stabilization kit pouches may be compromised.
VOLUME OF PRODUCT IN COMMERCE
820 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Orthofix TrueLok External Ring Fixation System, Telescopic Linear Distractor, 150mm; Catalog Number: 50-1015, Recall # Z-0674-2008
CODE
Lot number: 2664-01
RECALLING FIRM/MANUFACTURER
Orthofix, Inc., Mckinney, TX, by telephone starting on September 28, 2007. Firm initiated recall is ongoing.
REASON
Markings reversed: Graduated markings on telescoping bone distractors were reversed, causing the distractors to compress rather than distract the treatment site when adjusted.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Stryker Modular Replacement System Curved Cemented Stem; MRS SM Curved
    Femoral Stem 10x102; Catalog Number: 6485-3-300; Recall # Z-0917-2008;
b) Stryker Modular Replacement System Curved Cemented Stem; MRS Small Curved
    Femoral Stem 8x102; Catalog Number 6485-3-308; Recall # Z-0918-2008;
c) Stryker Modular Replacement System Curved Cemented Stem; MRS Small Curved
    Femoral Stem 9 x 102; Catalog Number: 6485-3-309; Recall # Z-0919-2008;
d) Stryker Modular Replacement System Curved Cemented Stem; MRS 11mmx203mm
    femoral stem. Catalog Number: 6485-3-311; Recall # Z-0920-2008;
e) Stryker Modular Replacement System Curved Cemented Stem; MRS 12mmx203
    Femoral Stem; Catalog Number: 6485-3-313; Recall Z-0921-2008;
f) Stryker Modular Replacement System Curved Cemented Stem; MRS 15mmx203mm
    Femoral Stem; Catalog Number: 6485-3-315; Recall # Z-0922-2008;
g) Stryker Modular Replacement System Curved Cemented Stem; MRS 17mmx203
    Femoral Stem; Catalog Number 6485-3-317; Recall # Z-0923-2008;
h) Stryker Modular Replacement System Curved Cemented Stem; MRS 11x127
    Curved Femoral Stem; Catalog Number: 6485-3-711; Recall # Z-0924-2008;
i) Stryker Modular Replacement System Curved Cemented Stem; MRS 13x127
    Curved Femoral Stem; Catalog Number: 6485-3-713; Recall # Z-0925-2008;
j) Stryker Modular Replacement System Curved Cemented Stem; MRS 15x127 Curved
    Femoral Stem; Catalog Number: 6485-3-715; Recall # Z-0926-2008;
k) Stryker Modular Replacement System Curved Cemented Stem; MRS 17x127 Curved
    Femoral Stem; Catalog Number: 6485-3-717; Recall # Z-0927-2008
CODE
a) Lot Codes: TEC023A, TEC023B, TEC082;
b) Lot Codes: LCDBP, TEC024A, TEC024B, TEC080A, TEC080C;
c) Lot code TEC025A;
d) Lot Codes: LCDAR, TEC009A, TEC009B, TEC009B1, TEC009C, TEC017A,
    TEC017B, TEC017C, TEC121, TEC122, TEC123, TEC124, TEC125, TEC125A,
    TEC126, TEC127, TEC246, TEC246A, TEC246A1, TEC246B, TECO17A,
    TECO17B, TECO17B1, TECO172B2, TECO17B3;
e) Lot codes: LCDAS, LPF008, SCAN, TEC018B, TEC018C, TEC128, TEC129,
    TEC130, TEC131, TEC247, TEC247A, TEC247B, TECO18A, TECO18B;
f) Lot codes: D6TEBR, D6TECR, LCDAT, TEC019A, TEC019A1, TEC019E,
    TEC132A, TEC133, TEC134, TEC135, TEC136,
g) Lot codes: LCCAS, LCCAS10, LCCAS11, LCCAS3, LCCAS9, LCDAU, LCDAU11,
    LCDAU13, LCDAU5, LCDAU6, LCDAU7, LCDAU9, TEC138A, TEC139,
    TEC140, TEC249B;
h) Lot code: LCDCD, TEC010, TEC010A, TEC010A2, TEC026A, TEC026B,
    TEC026C, TEC026C1, TEC054B, TEC054D, TEC054E, TEC086A, TEC086A1,
    TEC086A2, TEC086A3, TEC086A4, TEC086B, TEC086C, TEC086F, TEC086H,
    TEC086I, TEC086J, TEC086J1, TEC256, TEC300B, TEC300D;
i) Lot Codes: LCDCE, LCDE1, TEC027, TEC055, TEC055B, TEC055C, TEC087,
    TEC087A, TEC087A1, TEC087B, TEC087B1, TEC087C, TEC087D, TEC097E,
    TEC257, TEC283A;
j) Lot Codes: LCDCF, TEC056A, TEC056B, TEC088B, TEC088B1, TEC088C,
    TEC088E, TEC088H, TEC141, TEC142, TEC258, TEC338;
k) Lot Codes: LCDCH, TEC029A, TEC057A, TEC089B, TEC089C, TEC089D,
    TEC089E, TEC089E2, TEC089F, TEC089G, TEC089G1, TEC089H1, TEC089I1,
    TEC144, TEC145, TE 259, TEC301
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Orthopaedi, Mahwah, NJ, by letters on November 26, 2007.
Manufacturer: Stryker Orthopaedi, Limerick, Ireland. Firm initiated recall is ongoing.
REASON
Curvature Discrepancy: The radius of curvature may be out of specification to varying degrees causing a discrepancy in the stem curvature between trials and implants.
VOLUME OF PRODUCT IN COMMERCE
803 units
DISTRIBUTION
Nationwide
_____________________________________
PRODUCT
a) Abbott TDx/TDxFLx Gentamicin Reagent - Is a reagent for in vitro diagnostic use.
    This reagent system is composed of one bottle of gentamicin antiserum, one bottle of
    gentamicin flourescein tracer and one bottle of pretreatment solution; List # 9512-60,
    Recall # Z-0928-2008;
b) Abbott TDx/TDxFLx Gentamicin Wedge Reagent - Is a reagent for in vitro
    diagnostic use. This reagent system is composed of one bottle of gentamicin
    antiserum, one bottle of gentamicin flourescein tracer and one bottle of
    pretreatment solution; List # 9512-85,  Recall # Recall # Z-0929-2008;
c) Abbott AxSYM Gentamicin Reagent - Is a reagent for in vitro diagnostic use.
    This reagent system is composed of one bottle of gentamicin antiserum, one bottle of
    pretreatment solution and one bottle of gentamicin flourescein tracer; List # 7A65-20;
    Recall # Z-0930-2008
CODE
a) Lot # 51187Q100 Exp Date: 09/17/08;
b) Lot # 51189Q100 Exp Date 09/17/08;
c) Lots # 53190Q100 Exp Date 04/12/08 and Lot # 53190Q101 Exp Date 04/12/08
RECALLING FIRM/MANUFACTURER
Abbott Diagnostic International, Ltd., Barceloneta, PR, by letters on October 26, 2007.
Firm initiated recall is ongoing.
REASON
Incorrect Results -- Through evaluation of stability, Abbott have found a decrease in the calibrator A to F span with these reagents lots, which may produce the following results: Printed Error Code "SPAN LESS THAN MIN SPAN" - Controls out of range. When a control is out of range, patient results should not be reported.
VOLUME OF PRODUCT IN COMMERCE
5,186 kits
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Advanced Bionics Precision Implantable Pulse Generator Kit, Model Number:
    SC-1110 with firmware version prior to Revision 3.02, Recall # Z-0960-2008;
b) Advanced Bionics Precision Implantable Pulse Generator Kit, Model Number:
    SC-1100 with firmware version prior to Revision 3.02, Recall # Z-0961-2008
CODE
a) Serial Numbers: 101507 163647 810125 701550 702047 802266 165125 165187 701799 11043 11702 100101 165271 802245 164445 163077 103643 103739 165066 164048 701001 160570 165819 165633 160654 164541 164632 164909 11673 101843 100872 102147 102364 160487 102641 102825 102874 163838 164115 164752 164891 164994 165079 165099 165106 165180 165198 165212 165225 165272 165317 165320 165361 165407 165525 163504 165704 165715 166263 102994 103274 162192 802631 103205 103301 160353 165037 165249 165286 103207 162774 164339 164573 164586 16007 100091 163571 802377 164932 164957 165176 161716 165152 165948 166041 800670 164896 701092 161856 164302 164319 102683 164342 165057 165105 10024 11000 11001 11006 11016 11025 11040 11041 11044 11045 11048 11049 11050 11051 11052 11054 11057 11058 11060 11061 11063 11064 11067 11070 11071 11072 11074 11077 11078 11083 11093 11122 11133 11160 11161 11162 11163 11164 11165 11166 11167 11168 11169 11170 11171 11172 11174 11175 11177 11179 11180 11181 11182 11184 11185 11186 11187 11190 11191 11192 11193 11194 11195 11196 11197 11198 11200 11201 11202 11203 11204 11205 11206 11208 11209 11210 11211 11213 11214 11216 11218 11219 11220 11222 11223 11224 11225 11226 11227 11228 11229 11230 11231 11232 11233 11234 11235 11236 11237 11238 11239 11240 11241 11242 11243 11244 11245 11246 11247 11248 11249 11250 11251 11252 11253 11255 11257 11258 11259 11260 11262 11263 11264 11265 11266 11268 11269 11270 11272 11273 11274 11275 11277 11278 11279 11280 11281 11282 11283 11285 11286 11287 11288 11289 11290 11291 11293 11295 11296 11297 11298 11299 11300 11301 11302 11304 11305 11306 11307 11308 11309 11310 11311 11313 11314 11316 11319 11320 11321 11322 11324 11325 11327 11328 11329 11330 11331 11333 11334 11335 11337 11339 11340 11341 11342 11343 11344 11347 11348 11349 11350 11352 11353 11354 11358 11359 11360 11364 11365 11366 11369 11371 11372 11374 11375 11377 11379 11380 11381 11383 11384 11385 11386 11387 11388 11390 11393 11394 11395 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810044 810047 810049 810050 810051 810053 810054 810057 810058 810061 810066 810069 810070 810071 810079 810080 810083 810084 810085 810087 810090 810091 810092 810094 810095 810097 810098 810100 810102 810103 810112 810115 810117 810119 810120 810121 810122 810123 810127 810129 810131 810132 810135 810136;

b) Serial Numbers: 367 379 408 418 429 432 435 436 438 462 467 473 490 601 608 625 636 655 660 661 666 667 671 679 681 683 685 691 696 712 715 719 724 731 732 734 744 745 748 770 1011 1012 1015 1016 1017 1022 1024 1027 1030 1035 1038 1044 1046 1048 1051 1053 1056 1065 1066 1068 1076 1077 1079 1083 1085 1090 1091 1093 1094 1095 1096 1102 1103 1105 1108 1111 1115 1117 1121 1129 1131 1141 1142 1146 1149 1153 1154 1158 1159 1161 1164 1167 1168 1169 1170 1171 1177 1179 1180 1185 1186 1188 1190 1191 1213 1214 1218 1219 1220 1221 1222 1224 1225 1226 1231 1232 1233 1237 1238 1240 1241 1242 1245 1246 1257 1266 1267 1269 1272 1273 1274 1277 1280 1283 1285 1286 1401 1403 1404 1406 1408 1409 1412 1413 1414 1416 1420 1421 1426 1428 1429 1431 1432 1435 1437 1443 1444 1445 1446 1447 1448 1451 1458 1459 1464 1500 1502 1503 1508 1509 1511 1512 1513 1517 1519 1522 1526 1527 1528 1529 1530 1532 1535 1536 1541 1545 1550 1552 1554 1556 1558 1561 1563 1565 1566 1567 1568 1575 1578 1582 1583 1586 1587 1589 1593 1595 1596 1602 1605 1606 1608 1612 1613 1617 1620 1621 1622 1627 1630 1633 1634 1635 1637 1638 1639 1643 1645 1646 1647 1649 1650 1653 1654 1656 1659 1660 1661 1662 1665 1669 1670 1673 1682 1685 1686 1693 1696 1697 1698 1699 1706 1710 1711 1712 1713 1714 1715 1716 1718 1723 1731 1733 1739 1743 1744 1745 1746 1748 1749 1753 1756 1757 1758 1759 1763 1765 1767 1768 1769 1771 1774 1777 1779 1782 1783 1785 1786 1790 1791 1792 1794 1795 1796 1801 1806 1807 1808 1811 1812 1818 1819 1822 1825 1828 1831 1835 1836 1838 1839 1844 1845 1853 1855 1869 1871 1874 1878 1886 1893 1894 1896 1898 1899 2001 2003 2004 2005 2007 2011 2013 2015 2016 2018 2022 2024 2025 2027 2028 2031 2033 2034 2037 2040 2041 2042 2044 2046 2048 2054 2056 2057 2058 2061 2065 2066 2067 2070 2071 2072 2073 2075 2081 2083 2092 2094 2098 2102 2109 2111 2119 2124 2127 2132 2134 2138 2142 2150 2153 2158 2160 2163 2167 2168 2177 2178 2180 2182 2185 2191 2192 2199 2209 2212 2215 2221 2224 2238 2241 2242 2243 2246 2249 2251 2252 2257 2260 2262 2265 2268 2271 2275 2277 2278 2279 2283 2284 2285 2289 2291 2294 2295 2296 2299 2301 2305 2307 2311 2314 2317 2321 2328 2329 2334 2344 2346 2348 2352 2353 2363 2367 2368 2372 2376 2377 2378 2379 2380 2382 2387 2390 2391 2394 2397 2398 2401 2402 2403 2406 2408 2411 2412 2413 2418 2419 2425 2427 2430 2433 2437 2439 2441 2443 2445 2449 2452 2455 2457 2459 2460 2461 2466 2470 2473 2474 2475 2476 2488 2489 2496 2497 2498 2501 2502 2508 2513 2519 2521 2522 2523 2529 2531 2532 2545 2547 2548 2550 2556 2559 2562 2566 2575 2577 2582 2588 2591 2594 2596 2602 2603 2604 2610 2611 2619 2621 2630 2631 2632 2633 2637 2640 2646 2647 2648 2661 2665 2680 2681 2682 2684 2689 2694 2695 2698 2699 2706 2718 2723 2725 2726 2727 2728 2737 2739 2745 2746 2749 2752 2753 2766 2768 2777 2785 2805 2815 2819 2826 2827 2828 2840 2843 2844 2845 2848 2853 2854 2855 2857 2859 4156 4167 4172
RECALLING FIRM/MANUFACTURER
Advanced Bionics Corp., Sylmar CA, by letter on October 5, 2007. Firm initiated recall is ongoing.
REASON
Incorrect Data -- Corruption of internal memory component results in an inability for the physician to reprogram the IPG with firmware version prior to Revision 3.02. When this occurs, the IPG will report an error code of "10h0" or "00h0" through the Remote Control. Under this condition, the IPG will cease to log in some data that could be used for informational purposes. ** It should be noted that there is no effect to the actual functionality of the IPG.**
VOLUME OF PRODUCT IN COMMERCE
Over 12,000 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) BHM Medical Scales, 800 lb. scale weight limit; Part Number 700.00510. These
    scales were sold for installation on or as a component of the following patient lifts:
    a): Part Number: 88570101, Ergolift 600 BAL. Wide Opening Patient Lift;
    Part Number : ERGOLIFT-600+SC, Ergolift 600 Lbs with Scale Patient Lift;
    Part Number: ERGOLIFT-2 + SC, Ergolift 400 Lbs with Scale Patient Lift;
    b) Part Number : 700.05610.06, Hoyer-600 Spreader Bar with Scale;
    Part Number: 9600102.06, Hoyer-600 Sunrise Patient Lifter with Scale,  
    Model HPL-600WBSC; Part Number: 9600132.06, Hoyer-600 Wide Opening
    Patient Lifter with Scale, Recall #  Z-1135-2008;
b) BHM Medical Scales, 1000 lb. scales weight limit; Part Number 700.00525;
    These scales were sold for installation on the Model V10 and Model Maxisky fixed
    ceiling lifts. Part 700.00525, Recall # Z-1136-2008
CODE
 a) Part Number 700.00510, a) Serial Numbers :ERSC-3044, ERSC-3060, ERSC-5318,
    ERSC-5323, ERSC-5324, ERSC-5907, ERSC-5967, ERSC-6032, ERSC-6073,
    ERSC-6232, ERSC-6316, ERSC-6326, ERSC-6354, ERSC-6355, ERSC-6357,
    ERSC-6365, ERSC-6372, ERSC-6532, ERSC-6703, ERSC-6716, ERSC-6717,
    ERSC-6719, ERSC-7024, ERSC-7025, ERSC-7060, ERSC-7064, ERSC-7347,
    ERSC-7351, ERSC-7532, ERSC-7551, ERSC-7553, ERSC-7554, ERSC-7555,
    ERSC-7556, ERSC-7559, ERSC-7560, ERSC-7561, ERSC-7562, ERSC-7565,
    ERSC-7566, ERSC-7567, ERSC-7614, ERSC-7617, ERSC-7623, ERSC-7625,
    ERSC-7665, ERSC-7709, ERSC-8487, ERSC-8488, ERSC-8492, ERSC-8498,
    ERSC-8500, ERSC-8501, ERSC-8503, ERSC-8509, ERSC-8561, ERSC-8565,
    ERSC-8632, ERSC-8634, ERSC-8635, ERSC-8638, ERSC-8644, ERSC-8648,
    ERSC-8658, ERSC-8675, ERSC-8834, ERSC-8848, ERSC-8874, ERSC-8883,
    ERSC-8886, ERSC-8887, ERSC-8890, ERSC-8894, ERSC-8896, ERSC-8899,
    ERSC-8900, ERSC-8918, ERSC-8920, ERSC-8921, ERSC-8923, ERSC-8924,
    ERSC-8925, ERSC-8927, ERSC-8992, ERSC-9348, and ERSC-9361;
    a) Part Number 88570101, Serial Numbers: 885-0100. 885-0104, 885-0105,
    885-0139, 885-0210, 885-0211, 885-0218, 885-0219, 885-0220, 885-0266,
    885-0267, 885-0269, 885-0273, 885-0275, and 885-2676;
    Part Number ERGOLIFT-600+SC, Serial Numbers: ER600-1402, ER600-1406,
    ER600-1435, ER600-1436, ER600-1437, ER600-1438, ER600-1460, ER600-1475,
    ER600-1476, ER600-1477, ER600-1478, ER600-1479, ER600-1480, ER600-1481,
    ER600-1483, ER600-1484, ER600-1485, ER600-1486, ER600-1515, ER600-1517,
    ER600-1594, ER600-1671, ER600-1672, ER600-1673, ER600-1674, ER600-1675,
    ER600-1676, ER600-1677, ER600-1721, ER600-1722, ER600-1724, ER600-1803,
    ER600-1988, ER600-1989, ER600-1990, ER600-1991, ER600-1992, and ER600-
    2070;
    Part Number ERGOLIFT-2 + SC, Serial Numbers: ERLI-1471, ERLI-1472, ERLI-
    1473, ERLI-1474, ERLI-3046, ERLI-3144, ERLI-3145, ERLI-3146, ERLI-3232,
    ERLI-3271, ERLI-3390, ERLI-3391, ERLI-3392, ERLI-3398, ERLI-3436, ERLI-
    3466, ERLI-3471, ERLI-3496, ERLI-3508, and ERLI-3526;
    b) Part Number 700.05610.06, Serial numbers: 5427, 5428, 5639, 5640, 5641, 5642,
    5644, 5645, 5646, 5647, 5657, 5658, 5913, 5915, 5916, 5917, 5918, 5919, 5920,
    5962, 5985, 5986, 5987, 5988, 5989, 5990, 5991, 5992, 5993, 5994, 5995, 5996,
    5997, 5998, 5999, 6000, 6001, 6002, 6003, 6004, 6005, 6006, 6007, 6008, 6009,
    6010, 6011, 6013, 6014, 6015, 6016, 6017, 6020, 6042, 6045, 6046, 6050, 6053,
    6054, 6056, 6099, 6100, 6101, 6102, 6103, 6104, 6105, 6106, 6107, 6108, 6109,
    6110, 6111, 6112, 6113, 6114, 6115, 6116, 6119, 6120, 6123, 6129, 6135, 6136,
    6137, 6138, 6139, 6140, 6141, 6142, 6143, 6144, 6145, 6146, 6147, 6148, 6149,
    6150, 6151, 6152, 8424, 8425, 8426, 8427, 8428, 8429, 8433, 8434, 8435, 8436
    8437, 8438, 8439, 8440, 8441, 8460, 8461, 8462, 8463, 8464, 8465, 8466, 8467,
    8468, and 8469;
    Part Number 9600102.06, Serial Numbers: ER600-1330, ER600-1331, ER600-1332,
    ER600-1333, ER600-1334, ER600-1335, ER600-1336, ER600-1337, ER600-1338,
    ER600-1339, ER600-1377, ER600-1379, ER600-1380, ER600-1381, ER600-1382,
    ER600-1383, ER600-1384, ER600-1561, ER600-1562, ER600-1563, ER600-1564,
    ER600-1565, ER600-1566, ER600-1567, ER600-1568, ER600-1569, ER600-1570,
    ER600-1571, ER600-1572, ER600-1573, ER600-1574, ER600-1575, ER600-1576,
    ER600-1577, ER600-1578, ER600-1579, ER600-1580, ER600-1581, ER600-1582,
    ER600-1583, ER600-1584, ER600-1585, ER600-1586, ER600-1587, ER600-1588,
    ER600-1589, ER600-1590, ER600-1641, ER600-1642, ER600-1643, ER600-1644,   
    ER600-1645, ER600-1646, ER600-1647, ER600-1648, ER600-1649, ER600-1650,
    ER600-1651, ER600-1652, ER600-1653, ER600-1654, ER600-1655, ER600-1656,      
    ER600-1657, ER600-1658, ER600-1659, ER600-1660, ER600-1755, ER600-1756,
    ER600-1757, ER600-1758, ER600-1759, ER600-1760, ER600-1761, ER600-1762,     
    ER600-1763, ER600-1764, ER600-1765, ER600-1766, ER600-1767, ER600-1768,
    ER600-1769, ER600-1770, ER600-1771, ER600-1772, ER600-1773, ER600-1774,
    ER600-1854, ER600-1855, ER600-1856, ER600-1857, ER600-1858, ER600-1859,
    ER600-1860, ER600-1861, ER600-1862, ER600-1863, ER600-1864, ER600-1865,
    ER600-1866, ER600-1867, ER600-1868, ER600-1869, ER600-1870, ER600-1871,
    ER600-1872, ER600-1873, ER600-1874, ER600-1875, ER600-1876, ER600-1877,
    ER600-1878, ER600-1879, ER600-1880, ER600-1881, ER600-1882, ER600-1883,
    ER600-1948, ER600-1949, ER600-1950, ER600-1951, ER600-1952, ER600-1953,
    ER600-1954, ER600-1955, ER600-1956, ER600-1957, ER600-1958, ER600-1959,
    ER600-1960, ER600-1961, ER600-1962, ER600-1963, ER600-1964, ER600-1965,
    ER600-1966, ER600-1967, ER600-2014, ER600-2015, ER600-2016, ER600-2017,
    ER600-2018, ER600-2019, ER600-2020, ER600-2021, ER600-2022, ER600-2023,
    ER600-2024, ER600-2025, ER600-2026, ER600-2027, ER600-2028, ER600-2029,
    ER600-2030, ER600-2031, ER600-2032, and ER600-2033;
    Part Number 9600132.06, Serial Numbers: ER600-2146, ER600-2147, ER600-2148,
    ER600-2149, ER600-2150, ER600-2151, ER600-2154, ER600-2155, ER600-2156,
    ER600-2157, ER600-2158, ER600-2159, ER600-2160, ER600-2161, ER600-2162,
    ER600-2163, ER600-2164, ER600-2165, ER600-2166, ER600-2167, ER600-2168,
    ER600-2169, ER600-2170, ER600-2320, ER600-2321, ER600-2322, ER600-2323,
    ER600-2324, ER600-2325, ER600-2326, ER600-2327, ER600-2328, ER600-2329,
    ER600-2330, ER600-2331, ER600-2332, ER600-2333, ER600-2334, ER600-2335,
    ER600-2336, ER600-2337, ER600-2338, ER600-2339, ER600-2340, ER600-2341,
    ER600-2342, ER600-2343, ER600-2344, ER600-2345, ER600-2346, ER600-2347,
    ER600-2348, ER600-2349, ER600-2350, ER600-2351, ER600-2352, ER600-2353,
    ER600-2354, ER600-2355, ER600-2356, ER600-2357, ER600-2358, ER600-2359,
    ER600-2421, ER600-2422, ER600-2423, ER600-2424, ER600-2425, ER600-2426,
    ER600-2427, ER600-2428, ER600-2429, ER600-2430, ER600-2431, ER600-2432,
    ER600-2433, ER600-2434, ER600-2435, ER600-2436, ER600-2437, ER600-2438,
    ER600-2448, ER600-2449, ER600-2450, ER600-2451, ER600-2452, ER600-2453,
    ER600-2454, ER600-2455, ER600-2456, ER600-2457, ER600-2458, ER600-2459,
    ER600-2460, ER600-2461, ER600-2462, ER600-2463, ER600-2464, ER600-2465,
    ER600-2466, ER600-2467, ER600-2468, ER600-2469, ER600-2492, ER600-2493,
    ER600-2494, ER600-2495, ER600-2497, ER600-2498, ER600-2499, ER600-2500,
    ER600-2501, ER600-2502, ER600-2503, ER600-2504, ER600-2505, ER600-2506,
    ER600-2507, ER600-2508, ER600-2509, ER600-2510, ER600-2511, ER600-2512,
    ER600-2513, ER600-2514, ER600-2515, ER600-2516, ER600-2517, ER600-2518,
    ER600-2519, ER600-2520, ER600-2521, ER600-2522, ER600-2523, ER600-2524,   
    ER600-2525, ER600-2526, ER600-2527, ER600-2528, ER600-2529, ER600-2530,  
    ER600-2531, ER600-2532, ER600-2533, ER600-2534, ER600-2535, ER600-2536,
    ER600-2537, ER600-2538, ER600-2539, ER600-2540, ER600-2541, ER600-2542,
    ER600-2543, ER600-2544, ER600-2545, ER600-2546, ER600-2547, ER600-2548,
    ER600-2549, ER600-2550, ER600-2551, ER600-2552, ER600-2553, ER600-2554,
    ER600-2555, ER600-2556, ER600-2557, ER600-2558, ER600-2559, ER600-2560,
    ER600-2561, ER600-2562, ER600-2563, ER600-2564, ER600-2565, ER600-2566,
    ER600-2567, ER600-2568, ER600-2569, ER600-2570, ER600-2571, ER600-2572,
    ER600-2573, ER600-2574, ER600-2575, ER600-2576, ER600-2577, ER600-2578,
    ER600-2579, ER600-2580, ER600-2581, ER600-2582, ER600-2583, ER600-2584,  
    ER600-2585, ER600-2586, ER600-2587, ER600-2588, ER600-2589, ER600-2590,
    ER600-2591, ER600-2592, ER600-2593, ER600-2594, ER600-2595, ER600-2596,
    ER600-2597, ER600-2598, ER600-2599, ER600-2600, ER600-2601, ER600-2602,
    ER600-2603, ER600-2604, ER600-2605, ER600-2606, ER600-2607, ER600-2608,
    ER600-2609, ER600-2610, ER600-2611, ER600-2612, ER600-2613, ER600-2614,
    ER600-2615, ER600-2616, ER600-2617, ER600-2618, ER600-2619, ER600-2620 ,   
    ER600-2621, ER600-2622, ER600-2623, ER600-2624, ER600-2625, ER600-2626,   
    ER600-2627, ER600-2628, ER600-2629, ER600-2630, ER600-2631, ER600-2632,
    ER600-2633, ER600-2634, ER600-2635, ER600-2636, ER600-2764, ER600-2765,   
    ER600-2766, ER600-2767, ER600-2768, ER600-2769, ER600-2770, ER600-2771,
    ER600-2772, ER600-2773, ER600-2774, ER600-2775, ER600-2776, ER600-2777,
    ER600-2778, ER600-2779, ER600-2780, ER600-2781, ER600-2782, ER600-2783,
    ER600-2784, ER600-2785, ER600-2786, ER600-2787, ER600-2788, ER600-2789,
    ER600-2790, ER600-2791, ER600-2792, ER600-2793, ER600-2794, ER600-2795,
    ER600-2818, ER600-2819, ER600-2820, ER600-2821, ER600-2822, ER600-2823,
    ER600-2824, ER600-2825, ER600-2826, ER600-2827, ER600-2838, ER600-2839,
    ER600-2840, ER600-2841, ER600-2842, ER600-2843, ER600-2844, ER600-2845,
    ER600-2846, ER600-2847, ER600-2848, ER600-2849, ER600-2850, ER600-2851,
    ER600-2852, ER600-2853, ER600-2854, ER600-2855, ER600-2856, ER600-2857,
    ER600-2858, ER600-2859, ER600-2882, ER600-2883, ER600-2884, ER600-2885,
    ER600-2886, ER600-2887, ER600-2888, ER600-2889, ER600-2910, ER600-2911,
    ER600-2912, ER600-2913, ER600-2914, ER600-2915, ER600-2916, ER600-2917,    
    ER600-2918, ER600-2919, ER600-2920, and ER600-2921;
b) Serial Numbers: ERSC-3064, ERSC-3065, ERSC-3066, ERSC-3068, ERSC-5858,
    ERSC-5859, ERSC-5860, ERSC-5861, ERSC-5864, ERSC-5866, ERSC-6765,
    ERSC-6767, ERSC-6768, ERSC-7729, ERSC-7742, ERSC-7769, ERSC-7776,
    ERSC-7779, ERSC-7780, ERSC-7781, ERSC-7784, ERSC-7787, ERSC-7789,
    ERSC-7790, ERSC-7791, and ERSC-8038
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arjo, Inc. Roselle, IL, by letters dated December 19, 2007. 
Manufacturer: B.H.M. Medical, Inc., Magog, Canada. Firm initiated recall is ongoing.
REASON
Unintended Hanger Bar Detachment: The locknut on the scales may loosen during use and allow the hanger bar assembly of the patient lift to detach and fall.
VOLUME OF PRODUCT IN COMMERCE
798 scales
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  VETERINARY MEDICINE - CLASS III

___________________________________
PRODUCT
Polydioxanone (PDO) Monofilament Synthetic Absorbable, Sterile Suture (Violet in Color), 0 3.5 metric NCP-1 30" (75 cm) 1/2 37mm cutting. Product was labeled for Veterinarian Use Only. Product is distributed under the following labels: Mono-Dox, brand; RXV ProPoly DS brand; Monovet brand; and Vedco brand; Product code M467, Recall # V-029-2008
CODE
Lot Number A0700810, EXP 2010-12
RECALLING FIRM/MANUFACTURER
C P Medical, Portland, OR, by letters dated March 20, 2007. Firm initiated recall is complete.
REASON
Package is labeled for a 37 mm 1/2 circle cutting needle, but may contain a 37 mm tapered needle.
VOLUME OF PRODUCT IN COMMERCE
878 boxes, each containing 12 packages
DISTRIBUTION
AZ, MI, MO, NE, NV, TX and Israel
___________________________________
PRODUCT
Dionne Foot Rot Treatment, Topical Antiseptic, containing Iodine 1% and Chloroxylenol 0.5%, packaged in 8-fl. oz., 16-fl. oz. (1 Pint), and 32-fl. oz. (1 Quart) containers, OTC, Recall # V-030-2008
CODE
Lot 7E14C, Exp. May 2009
RECALLING FIRM/MANUFACTURER
Qualis Group LLC, Des Moines, IA, by letters dated January 9, 2008 and fax and e-mail. Firm initiated recall is ongoing.
REASON
Iodine active ingredient failed stability testing (low).
VOLUME OF PRODUCT IN COMMERCE
96/8-fl. oz., 744/16-fl. oz., and 48/32-fl. oz. containers
DISTRIBUTION
IL, MO, WA, OK, NC, IA, TN, and SD

END OF ENFORCEMENT REPORT FOR MARCH 5, 2008

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