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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October 17, 2007
07-42

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS I
___________________________________
PRODUCT
VEP America's Best Raisins, Net Wt. 7 oz. (200 gms). The raisins are packaged in a flexible, plastic bag, Recall # F-004-8
CODE
Uncoded
RECALLING FIRM/MANUFACTURER
VEP International Inc., Brooklyn, NY, by Consumer Alert and telephone on August 9, 2007. Firm initiated recall is complete.
REASON
The product contained undeclared sulfites (496 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Brooklyn, NY
___________________________________
PRODUCT
a) Frango Cheggs brand Mint Chegg. UPC 2179500565, Recall # F-005-8;
b) Frango Cheggs brand Double Chocolate Chegg, UPC 2179500566,
    Recall # F-006-8;
c) Frango Cheggs brand Marshmallow Chegg, UPC 2179500567,
    Recall # F-007-8;
d) Frango Cheggs brand Peanut Butter Chegg, UPC 2179500568,
    Recall # F-008-8;
e) Frango Cheggs brand Caramel Chegg, Recall # F-009-8;
f) Frango Cheggs brand Toffee Crunch Chegg, UPC 2179500570,
    Recall # F-010-8;
CODE
All product lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Federated Department Stores, Cincinnati, OH, by joint press release with Harry London Candies on March 23, 2007.
Manufacturer: Macy's Candy Kitchen, Minneapolis, MN. Firm initiated recall is ongoing.
REASON
Candy products contain undeclared icing ingredients including egg whites and colors – FD&C Red #40, Yellow #6 & Blue #2.
VOLUME OF PRODUCT IN COMMERCE
4,683
DISTRIBUTION
IL, IN, MI, MN, OH, ND, SD, and WI
___________________________________
PRODUCT
a) NISSIN Cup Noodles with Shrimp, Net Wt. 2.25 oz. The product is shipped
    12 units per case/110 cases per pallet. UPC number 70662-03002-8,
    Recall # F-012-8;
b) Nissin Original Chow Mein Shrimp, Net Wt. 4 oz. The product is shipped
    8 units per case/98 cases per pallet, UPC number 70662- 08722-0,
    Recall # F-013-8;
c) Great Value Instant Shrimp and Vegetables, Net Wt. 2.25 oz. The product is
    shipped 12 units per case/110 cases per pallet, UPC number 78742-14212-8,
    Recall # F-014-8;
d) Thrifty Maid with Shrimp Oriental Noodles with Vegetables, Net Wt. 2.25 oz.
     The product is shipped 12 units per case/110 cases per pallet. UPC number
     21140-21769-1, Recall F-015-8;
e) Jehling Ramen Noodle Soup Cup with Shrimp and Vegetables, Net Wt. 2.25 oz.
    The product is shipped 12 units per case/110 cases per pallet. UPC number
    41498-12386-4, Recall # F-016-8
CODE
a) Lot numbers are printed on the packages at the time of production, according to the
    format and code for each product. The recall is underway on all production of the
    shrimp cup of noodle products with production dates after 1/1/06 (production code
    010107WS or 010107CS) through 7/17/07 (production code 071708WS or
    071708CS). The date codes are used to show the product Best By date;
b) Lot numbers are printed on the packages at the time of production, according to the
    format and code for each product. The recall is underway on all production of the
    shrimp chow Mein products with production dates after 1/1/06 (production code
    010107WS or 010107CS) through 7/17/07 (production code 071708WS or
    071708CS). The date codes are used to show the product Best By date;
c) Lot numbers are printed on the packages at the time of production, according
    to the format and code for each product. The recall is underway on all production
    of the shrimp cup of noodle products with production dates after 1/1/06
    (production code 010107WS or 010107CS) through 7/17/07 (production code
    071708WS or 071708CS). The date codes are used to show the product Best
    By date.
d) Lot numbers are printed on the packages at the time of production, according
    to the format and code for each product. The recall is underway on all production
    of the shrimp cup of noodle products with production dates after 1/1/06
    (production code 010107WS or 010107CS) through 7/17/07 (production code
    071708WS or 071708CS). The date codes are used to show the product Best
    By date.
e) Lot numbers are printed on the packages at the time of production, according
    to the format and code for each product. The recall is underway on All production
    of the shrimp cup of noodle products with production dates after 1/1/06
    (production code 010107WS or 010107CS) through 7/17/07 (production code
    071708WS or 071708CS). The date codes are used to show the product Best By
    date.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nissin Foods Co., Inc., USA, Gardena, CA, by press release on July 20, 2007 followed by letter, fax and telephone.
Manufacturer: Nissin Foods USA, Co., Inc., Lancaster, PA. Firm initiated recall is ongoing.
REASON
The product contains undeclared cod and lobster.
VOLUME OF PRODUCT IN COMMERCE
16,497,995 cases
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS II
___________________________________
PRODUCT
Live Pacific Oysters (in the Shell) Sol Azul Brand, in cardboard shipping cases. Each shipping case weighted approx. 10 kilos and held 5 – 10 dozen oysters (based on oyster size), Recall # F-002-8
CODE
Lot: 140807
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sol Azul USA, Inc., Bonita, CA, by telephone on August 17, 2007 and by visit and letter on August 18, 2007.
Manufacturer: Sol Azul Oyster Packaging Plant, San Ignacio, Mexico. Firm initiated recall is complete.
REASON
Product was held at an elevated temperature for an extended period of time.
VOLUME OF PRODUCT IN COMMERCE
119 cases
DISTRIBUTION
CA
___________________________________
PRODUCT
Golden Boy Frozen Fish, Frozen Silver Barb/Ta-Pian/Ca Me Vinh; Ingredients: Silver Barb; Keep Frozen Store at or below Minus 18 degrees C; Product of Vietnam; Individually wrapped fish, to be sold by weight, in 33 lb. cases, Recall # F-011-8
CODE
Item #FF84062, All product shipped after March 1, 2007.
RECALLING FIRM/MANUFACTURER
Lien Hoa Food Corp., Chicago, IL, by telephone on July 2, 2007and by letter dated September 18, 2007. Firm initiated recall is ongoing.
REASON
The Silver Barb Fish was found to be contaminated with Enrofloxacin, a fluoroquinolone antibiotic that is not approved for aquaculture use.
VOLUME OF PRODUCT IN COMMERCE
12 cases
DISTRIBUTION
IN, KY, MI, NC, and WI

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS III

PRODUCT
Minute Maid® Fruit Punch, 3% Fruit Juice, Product is packed in 20 oz. and 1 liter PET containers, Recall # F-003-8
CODE
Best if used by date on and before FEB2508
RECALLING FIRM/MANUFACTURER
Recalling Firm: The Coca-Cola Company (Corporate Offices), Atlanta, GA, by email on September 6, 2007.
Manufacturer: Coca Cola Bottling Company of North Texas, Abilene, TX. Firm initiated recall is ongoing.
REASON
Specified preservative levels may fail to prevent against spoilage by mold.
VOLUME OF PRODUCT IN COMMERCE
57,736 cases
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
FazaClo (clozapine, USP) Orally Disintegrating Tablets 100 mg, each tablet packaged in a child-resistant blister, 100 tablets per box, NDC 68322-002-04, RX, Recall # D-003-2008
CODE
Lot: 370522
RECALLING FIRM/MANUFACTURER
Recalling Firm: Azur Pharma, Inc., Exton, PA, by letters on September 19, and September 27, 2007.
Manufacturer: Catalent Pharma Solutions, LLC, Woodstock, IL. Firm initiated recall is ongoing.
REASON
Mispacked. Non child-resistant blister packages were packaged in boxes labeled as child-resistant.
VOLUME OF PRODUCT IN COMMERCE
2,748/100 count boxes
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
Panadol 500 mg Extra Strength Tablets, 60 ct. cartons, Rx only, Recall # D-001-2008
CODE
Lot: PA019CB1; Exp Date: 11/15/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Glaxo SmithKline, Parsippany, NJ, by letters on September 2, 2007.
Manufacturer: Glaxo Smithkline, Dungarven, Ireland. Firm initiated recall is ongoing.
REASON
Mispacked: Panadol 500 ES Caplets 50 ct. bottles were incorrectly packaged in Panadol 500 ES Tablet 60 Ct. Cartons.
VOLUME OF PRODUCT IN COMMERCE
3,425 bottles
DISTRIBUTION
PR
___________________________________
PRODUCT
Testosterone Cypionate, USP, CIII, packed in 5 grams, 25 grams, 100 grams, 500 grams, 1 kilogram bottles; NDC #s: 38779-0164-3 (5 grams), 38779-0164-4 (25 grams), 38779-0164-5 (100 grams), 38779-0164-8 (500 grams), 38779-0164-9 (1 kilograms) --- For Prescription Compounding. Product is a white or creamy white, crystalline powder, odorless or has a slight odor, and is stable in air, Recall # D-002-2008
CODE
Lot 20060901M and 20060901M/x (whereby x represents a letter), exp. 08/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medisca Inc., Plattsburgh, NY, by letters dated September 10, 2007.
Manufacturer: Zhejiang Xianju Chemical Pharmaceutical Factory, Chengguan, Xianju,
China (Mainland). Firm initiated recall is ongoing.
REASON
Failed USP limit for Free Cyclopentanepropionic Acid.
VOLUME OF PRODUCT IN COMMERCE
44,825 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Sudafed PE Nighttime Nasal Decongestant Tablets (Diphenhydramine
    HCl 25 mg and Phenylephrine HCl 10 mg), 12-tablet carton,
    NDC 0501-2914-12, Recall # D-006-2008;
b) Benadryl-D Allergy & Sinus Antihistamine, Nasal Decongestant Tablets
    (Diphenhydramine HCl 25 mg and Phenylephrine HCl 10 mg), 24-tablet
    cartons or trays and 3-24 tablet club cartons, Recall # D-007-2008
CODE
a) Lot 6HB0165;
b) Lots: 6HB0001, 6NB0472, 00837LLN10, 02827LLD04, 01917LLD06,
    01917LLN06, 01917LLN06A, 02217LLD06, 02217LLN06, 02317LLN06, and
    02317LLD06
RECALLING FIRM/MANUFACTURER
Recalling Firm: McNeil Consumer Healthcare, Div of McNeil-PPC, Inc., Fort Washington, PA, by letter pm/about September 10, 2007.
Manufacturer: Leiner Health Products, Llc, Wilson, NC. Firm initiated recall is ongoing.
REASON
Product failed specification for dosage uniformity and may contain some tablets with lower dose than label amount.
VOLUME OF PRODUCT IN COMMERCE
176,444 packages
DISTRIBUTION
Nationwide and PR

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0004-08;
b) Fresh Frozen Plasma, Recall # B-0005-08
CODE
a) and b) Units: 30GH04390
RECALLING FIRM/MANUFACTURER
American Red Cross, Northeastern, Ashley, PA, by letter dated May 25, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of hepatitis exposure, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0010-08
CODE
Unit: 318646200
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on September 1, 2005.
Manufacturer: Blood Systems Inc/dba United Blood Services, Tupelo, MS. Firm initiated recall is complete.
REASON
Blood product, labeled with an incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0030-08;
b) Plasma, Recall # B-0031-08
CODE
a) and b) Unit: 19LS06714
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by letter and email dated December 2, 2005, and follow-up email dated February 2, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who resided in a HIV Group O risk area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN & NC
___________________________________
PRODUCT
a) Packed Red Blood Cells, Recall # B-0032-08;
b) Red Blood Cells for Manufacturing, Recall # B-0033-08;
c) Recovered Plasma, Recall # B-0034-08;
d) Fresh Frozen Plasma, Recall # B-0035-08
CODE
a) Units: 55R96437 and 55S86094;
b) Unit: 55S73527;
c) Units: 55S73527, and 55R96437;
d) Unit: 55S86094
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR , by telephone on December 6, 2006 and letter dated December 20, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 components
DISTRIBUTION
TX, AR, and CA
___________________________________
PRODUCT
Granulocytes, Recall # B-0039-08
CODE
Unit: LP02260
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by fax on June 16, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0048-08
CODE
Units: 5609800 and 7119735
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Alexandria, LA, by facsimile on July 28, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0058-08
CODE
Unit: 017FP08999
RECALLING FIRM/MANUFACTURER
The American National Red Cross, North Central Region, Saint Paul, MN, by telephone on December 8, 2004. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may compromise the sterility of the product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN

___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0059-08
CODE
Units: 17FS34587 (split unit), 17FS34588, 17FS34589 (split unit), 17FS34591 (split unit), 17FS34592 (split unit)
RECALLING FIRM/MANUFACTURER
The American National Red Cross, North Central Region, Saint Paul, MN, by telephone on September 10, 2004 and by letter dated September 21, 2004. Firm initiated recall is complete.
REASON
Blood products, lacking assurance of sterility, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
MD, DC, ME, NH, MA, and VA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0080-08
CODE
Units: 184281394 and 184284512
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Scottsdale, AZ, by letter on March 12, 2007.
Manufacturer: Blood Systems, Inc., Cheyenne, WY. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WY
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0081-08
CODE
Unit: 19GE22811
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by telephone on December 14, 2006. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of plasma that exhibited hemolysis was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0085-08
CODE
Unit: 003E64866
RECALLING FIRM/MANUFACTURER
American National Red Cross, Douglasville, GA, by letter and fax dated January 4, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from donors whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Irradiated, Recall # B-0089-08
CODE
Unit: 040LF11663
RECALLING FIRM/MANUFACTURER
American National Red Cross Heart of American Region, Peoria, IL, by telephone on April 26, 2007. Firm initiated recall is complete.
REASON
Blood product, with incomplete documentation of the irradiation process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-0007-08
CODE
Units: FC2012232A, FC2012232B
RECALLING FIRM/MANUFACTURER
Community Blood Council of New Jersey, Inc., Trenton, NJ, by facsimile on August 24, 2005. Firm initiated recall is complete.
REASON
Blood products, collected using an expired blood collection set, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ
___________________________________
PRODUCT
Red Blood Cells Apheresis, Leukocytes Reduced, Recall # B-0009-08
CODE
Units: 318109417 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on October 6, 2006.
Manufacturer: Blood Systems, Inc/dba United Blood Services, Tupelo, MS. Firm initiated recall is complete.
REASON
Blood products, for which documentation of the apheresis procedure was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MS
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Irradiated, Recall # B-0011-08
CODE
Units: 203161787, 203167079, 203167080, 203168428
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on July 14, 2006.
Manufacturer: Blood Systems, Inc., Lafayette, LA. Firm initiated recall is complete.
REASON
Blood products, labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
LA
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0086-08
CODE
Unit: 003E64866
RECALLING FIRM/MANUFACTURER
American National Red Cross, Douglasville, GA, by letter and fax dated January 4, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from donors whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0100-08
CODE
Unit: 9058245 (split unit)
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Piedmont, SC, by telephone on September 2, 2006. Firm initiated recall is complete.
REASON
Blood products, which were identified as being contaminated by the BacT/ALERT system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC and SC

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
a) EPIK® KNEE SYSTEM Angled Insert Impactor LM/RL; Catalog #801-03-051
Rev. A; non-sterile; knee prosthesis instrument, Recall # Z-0009-2008;
b) EPIK® KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052
Rev. A; non-sterile; knee prosthesis instrument, Recall # Z-0010-2008
CODE
All lots
RECALLING FIRM/MANUFACTURER
Encore Medical, Lp, Austin, TX, by letter on August 9, 2007. Firm initiated recall is ongoing.
REASON
Angled Insert Impactor may scratch Tibial Insert on the articulating surface, causing increased wear at the damaged site.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
CA, FL, and MD
___________________________________
PRODUCT
Brain Heart Infusion Agar (BHIA) + Vancomycin 6 MCG/ML Microbiological media plates. PML's catalog #P1174, Recall # Z-0011-2008
CODE
LOT CODES: 75707-1, 75975-1, 76285-1, 235823-1, 236361-1, 236916-1, 237354-1, 237378-1, 237917-1
RECALLING FIRM/MANUFACTURER
Pml Microbiologicals, Inc., Wilsonville, OR, by telephone and fax on August 17, 2007. Firm initiated recall is ongoing.
REASON
Marketed a regulated product without a 510(k).
VOLUME OF PRODUCT IN COMMERCE
2,245 plates
DISTRIBUTION
Nationwide, PR, and Canada
___________________________________
PRODUCT
Brain Heart Infusion Agar labeled BHIA + Vancomycin 6 MCG/ML for screening for Vancomycin Resistant Enterococc, Catalog #P1174, Recall # Z-0014-2008
CODE
Lots: 229957-1 and 229958-1
RECALLING FIRM/MANUFACTURER
Pml Microbiologicals, Inc., Wilsonville, OR, by telephone and fax on April 23, 2007. Firm initiated recall is ongoing.
REASON
Plates manufactured without vancomycin. Possibility for false resistant results.
VOLUME OF PRODUCT IN COMMERCE
640 plates
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Medtronic InterStim II INS Model 3058 with N'Vision InterStim-B Software supplied on the Model 8870 Version MMB_01/NNB_01 N'Vision with a Clinican Programmer Model 8840. Implantable Neurostimulator for Urinary Control. Catalog # 8870MM01 & 8870NNB01, Recall # Z-0037-2008
CODE
All serial numbers within above catalog/model numbers
RECALLING FIRM/MANUFACTURER
Medtronic Neurological, Minneapolis, MN, by letter beginning on July 11, 2007. Firm initiated recall is ongoing.
REASON
A software issue may cause a lower than expected battery capacity estimate when evaluating an InterStim II Implantable Neurostimulator (model 3058) with an N'Vision Clinician Programmer(Model 8840) before implant .
VOLUME OF PRODUCT IN COMMERCE
1,885 units
DISTRIBUTION
Nationwide and the Netherlands
___________________________________
PRODUCT
Pump waste tube for blood gas analysis kit. One yellowish/white rubber tube per plastic bag. Used on ABL800 Flex Series blood gas analyzers, Recall # Z-0038-2008
CODE
Serial #905-671, 902-754
RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America Inc., Westlake, OH, by telephone call or service representative visit beginning July 18, 2007.
Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is ongoing.
REASON
Tube may break. The firm discovered that the yellowish/white tubes used in their blood gas analyzers (ABL800 Flex Series) were manufactured incorrectly. These tubes have the potential to break off at the black plastic connectors. The breakage may occur during the installation of the tubes or after a short time in use.
VOLUME OF PRODUCT IN COMMERCE
189 pieces
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
STA Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic, Recall # Z-0039-2008
CODE
BT7 7016065; BT7 7016067; BT7 7016068; BT7 7016072; BT7 7016074; BT7 7016075; BT8 7016076; BT7 7016078; BT7 7017080; BT7 7016090; BT7 7016091; BT8 7026119; BT8 7026126; BT8 7026127; BT8 7026128; BT8 7026130; BT7 7026134; BT7 7026135; BT7 7026140; BT8 7026146; BT8 7026147; BT8 7026148; BT8 7026149; BT8 7026150; BT7 7026151; BT7 7026152; BT7 7026153; BT7 7026154; BT7 7026155; BT7 7026156; BT7 7026157; BT7 7036164; BT7 7036166; BT7 7036167; BT7 7036168; BT7 7036177; BT7 7036192
RECALLING FIRM/MANUFACTURER
Recalling Firm: Diagnostica Stago, Inc., Parsippany, NJ, by letters on July 30, 2007.
Manufacturer: Diagnostica Stago - Taverny Site, Taverny, France. Firm initiated recall is ongoing.
REASON
Incorrect results. Internal investigation determined the presence of a defective measurement head which can impact the results of clotting tests by either yielding no result or rendering an error message.
VOLUME OF PRODUCT IN COMMERCE
41 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Medtronic InterStim INS (Model 3023) with N’Vision Inter Stim-B software supplied on the Model 8870 Version MMB_01/NNB_01 with N’Vision Clinician Programmer Model 8840 or InterStim iCon Patient Programmer Model 3037. Implantable Neurostimulator for Urinary Control, Recall # Z-0040-2007-8
CODE
All serial numbers within above catalog/model numbers
RECALLING FIRM/MANUFACTURER
Medtronic Neurological, Minneapolis, MN, by letters beginning on July 11, 2007. Firm initiated recall is ongoing.
REASON
Software issue may cause false low battery alert to be displayed when interrogating an Interstim Implantable Neurostimulator (Model 3023) with an N’Vision Clinician Programmer (Model 8840), or with an Inter Stim iCon Patient Programmer (Model 3037).
VOLUME OF PRODUCT IN COMMERCE
1,885
DISTRIBUTION
Nationwide and the Netherlands
___________________________________
PRODUCT
Precision Implantable Pulse Generator (IPG), Model Number SC-110, Recall # Z-0055-2008
CODE
Serial Number 161767
RECALLING FIRM/MANUFACTURER
Advanced Bionics Corp., Sylmar, CA, by visit on August 3, 2007. Firm initiated recall is complete.
REASON
Mislabeled. Product labeled with the incorrect shelf-life information.
VOLUME OF PRODUCT IN COMMERCE
1 device
DISTRIBUTION
MD
___________________________________
PRODUCT
Angiomat Illumena Injector with Auxiliary Console, , Recall # Z-0056-2008
CODE
Lot #’s: 902040; 904045; and 902045Cl
RECALLING FIRM/MANUFACTURER
Mallinckrodt Inc., Cincinnati, OH, by letter on September 20, 2007. Firm initiated recall is ongoing.
REASON
Synchronization problems. Units that have both a main programmable console and an auxiliary programmable console, when simultaneously, injection parameters are programmed into the unit’s main console and the unit’s auxiliary consoles, mis-synchronization could occur resulting in a variance between the intended injection parameters (those programmed) and the actual parameters of the injection delivered to the patient.
VOLUME OF PRODUCT IN COMMERCE
176 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
ON-Q PainBuster with OnDemand (270 ml, 2 ml/hr + 5 ml bolus /60 min refill), Model PMB01, anesthetic/ narcotic medication pump. Recall # Z-0057-2008
CODE
6A4171 (exp. MAR 2009), 694133 (exp. FEB 2009), 654920 (exp. OCT 2008), 5A4732 (exp. MAR 2008), 584699 (exp. JAN 2008)
RECALLING FIRM/MANUFACTURER
I-Flow Corporation, Lake Forest, CA, by letter on March 27, 2007. Firm initiated recall is complete.
REASON
Misassembly: The ON-Q PainBuster PMB01 package may contain a Soaker catheter instead of a Non-Soaker catheter. As a result, the bolus button may remain latched in the down position which may cause the the device to deliver continuously at 7 ml/hr instead of 2 ml/hr.
VOLUME OF PRODUCT IN COMMERCE
2,582 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
___________________________________
PRODUCT
PEMView Software used with Naviscan PEM Flex Solo I and PEM Flex Solo II PET Scanner, for nuclear medicine imaging, Recall # Z-0041-2008
CODE
Serial numbers: C3, P1, P2, P3, P4, P5, P6, P7, P8, P10, P11, P12, P14, P002-B-070119-01, P002-B-070316-01, P002-B-070423-01, P002-B-070531-01, P002-B-070629-01, P002-B-070712-01
RECALLING FIRM/MANUFACTURER
Naviscan PET Systems, San Diego, CA, by telephone and letters on August 1 and 2, 2007 and August 16, 2007. Firm initiated recall is ongoing.
REASON
Naviscan has identified a potential safety issue with all versions of PEM View Software commonly used for analyzing patient images acquired on the PEMFIex product line. 1. The Positron Emission Mammography Standardized Uptake Value (PEMSUV) and distance measurements for the product mentioned above may be inaccurate if a zoomed image has been opened, measurement tools are used, and the applet remains open while subsequent measurements are being made on another applet (12 slice view). This software defect results in unreliable andlor inconsistent readings in the size, distance between lesions and mass measurement, which could result in the physician selecting inaccurate margins for surgery. 2. In addition, under these same circumstances the Region of Interest (ROI) numbering might not be sequential or multiple regions within the same image might have the same number. Duplicative numbering could result in confusion in definition of the region of interest. 3. When images, user defined as "Other," are acquired, the thumbnail image is mislabeled as "LCC" (Left Craniocaudal) while the caption contains the correct user-defined labeling. This thumbnail mislabeling could result in reader confusion in the body part being displayed.
VOLUME OF PRODUCT IN COMMERCE
19 units
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR OCTOBER 17, 2007

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