• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Enforcement Report for November 15, 2006

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.

November 15, 2006
06-46

 

RECALLS AND FIELD CORRECTIONS: FOOD and COSMETICS -- CLASS II

______________________________
PRODUCT
Fillets of Anchovies in Olive Oil, metal cans, net wt. 2 oz. Anchovies are a product of Chile, Recall # F-051-7
CODE
G.01.11
RECALLING FIRM/MANUFACTURER
Recalling Firm: The Napoleon Co., Bellevue, WA, by telephone and letters on September 22, 2006.
Manufacturer: K Y C Seafood's Limitada, Arica, Chile. Firm initiated recall is complete.
REASON
Product contains high levels of histamine - above 1400ppm.
VOLUME OF PRODUCT IN COMMERCE
36 cases/100/2 oz. cans
DISTRIBUTION
AK, CA, WA, FL, KY, and OR

______________________________
PRODUCT
Bueno Corn Tortillas, Authentic Stone Ground, Packaged in 1, 3, 10 dozen packages and in precut tortillas for chips 25 lb. box, Recall # F-052-7
CODE
Lots: 2676 and 2686
RECALLING FIRM/MANUFACTURER
El Encanto, Inc., Albuquerque, NM, by telephone on September 25, 2006. Firm initiated recall is ongoing.
REASON
Corn tortillas contain undeclared wheat flour.
VOLUME OF PRODUCT IN COMMERCE
200 cases
DISTRIBUTION
NM, and CO

______________________________
PRODUCT
a) Similac Alimentum Advance Ready-to-Feed 32 oz. Plastic Bottle,
UPC #070074-57513-1, Recall # F-053-7;
b) Similac Advance Ready-to-Feed 32 oz. Plastic Bottle, UPC #070074-55962-3,
Recall # F-054-7;
c) Similac Advance Ready-to-Feed Hospital Discharge Kit Coded with, Item #58986.
The lot number for these discharge kits can be found on the back of the bear tag
attached to the kit, Recall # F-055-7
CODE
a) Lot: #401895V, Use by Date 1-May 2007;
b) Lot: #40177RH, use by 1 November 2007 and Lot #40172RH, use by 1 November 2007;
c) Lot: #41699D5, Use by Date 1 Nov 2007
RECALLING FIRM/MANUFACTURER
Ross Products Division Abbott Laboratories, Columbus, OH, by press release on September 15, 2006, and by telephone on September 18, 2006. Firm initiated recall is ongoing.
REASON
Some bottles within the recalled lots potentially not meeting the label claim for Vitamin C.
VOLUME OF PRODUCT IN COMMERCE
49438/32 oz cans and 1775 kits/32 oz cans
DISTRIBUTION
Nationwide, PR, and Guam

______________________________
PRODUCT
Palmer's Baby Butter Massage Lotion, Item #4046 and #4046RQ. Each 400 ml (13.5 fl. oz.) HDPE bottle with a pump dispenser is labeled Palmer's Cocoa Butter formula with Vitamin E. Gently Moisturizes Baby's Sensitive Skin. Moisturize, soften and soothe baby's delicate skin with this unique blend of pure Cocoa Butter, Vitamin E and rich emollients. Ingredients: Water, Isopropyl Palmitate, Dimethicone, Glycerine, Theobroma Cacao Seed Butter, Stearic Acid, Propylene Glycol, Bentonite, Lanolin Alcohol, Glyceryl Stearate, PEG 100 Strearate, Tocopheryl Acetae, Aloe Barbadensis Leaf Powder, Cetearyl Alcohol, Diazolidinyl Urea, Fragrance, Methylparaben, Benzyl Alcohol. Coumarin, Propylparaben, Recall # F-056-7
CODE
Lots: L5362A, L5362B, and L5363A
RECALLING FIRM/MANUFACTURER
Recalling Firm: E T Browne Drug Co. Inc., Englewood Cliffs, NJ, by letters and email on September 15, 2006 and September 18, 2006.
Manufacturer: Hayward Laboratories, Inc., East Stroudsburg, PA. Firm initiated recall is ongoing.
REASON
Product is contaminated with Enterobacter gergoviae.
VOLUME OF PRODUCT IN COMMERCE
26,052 bottles
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: FOOD and COSMETICS -- CLASS III

______________________________
PRODUCT
a) Minute Maid® 100% Apple Juice From Concentrate with Added Ingredients,
6.75 FL. OZ (200mL), 100% Apple Juice, contains Pure Filtered Water,
Concentrated Apple Juice, Calcium Citrate (Calcium Source), Vitamin C
(Ascorbic Acid). Product is packed in juice boxes (10 packs), Recall # F-057-7;
b) b) Minute Maid®, 100% Vitamin C, 100% Pure Apple Juice. From Concentrate with
Added Ingredients, 6.75 FL.OZ (200 mL), Contains Pure Filtered Water, Concentrated
Apple Juice, Less Thank 2% of Each: Vitamin C (Ascorbic Acid), Calcium Citrate
(Calcium Source). Product is packed in juice boxes (10 packs), Recall # F-058-7;
CODE
a) Primary Code: JUL0207PWA, XXXX CT349YY; Secondary Code: 10PKAPPLE JUICE0500,
XXXXJUL0207WIJ T16497B (Where A=Initials ''I'' or ''J'' for filler designation;
YY=Filler operator's initials; XXXX= Military Time. Affected product time frame is from
0157 to 0418;
b) Primary Code: JUL0207PWA, XXXX CT349YY; Secondary Code: 10PKAPPLE JUICE0500,
XXXXJUL0207WIJ T16497B (Where A=Initials ''I'' or ''J'' for filler designation;
YY=Filler operator's initials; XXXX= Military Time. Affected product time frame is from 0157
to 0418 and Code: MAR2107PWA, XXXXCT349YY, Where A=''A'', ''B'' ''C'' or ''D'' filler
designation; YY= Filler operator's initials; XXXX= Military Time. Affected product timeframe
is from 0157 to 0418;
RECALLING FIRM/MANUFACTURER
Recalling Firm: The Coca-Cola Company (Corporate Offices), Atlanta GA, by telephone, fax, and email beginning on October 24, 2006.
Manufacturer: Coca Cola North America, Paw Paw, MI. Firm initiated recall is ongoing.
REASON
Beverages labeled as 100% apple juice are misbranded in that they may contain small amounts of high fructose corn syrup (HFCS).
VOLUME OF PRODUCT IN COMMERCE
3,500 cases (40 units per case)
DISTRIBUTION
CT, IN, MA, NJ, NY, and PA

______________________________
PRODUCT
Caffeine Free, Diet Coke, 12 oz. cans. Product is packed 12 cans per wrap and 6 cans per carrier, Recall # F-059-7.
CODE
DEC2506HWD/05533
RECALLING FIRM/MANUFACTURER
Recalling Firm: Coca Cola Enterprises, Inc., Atlanta, GA, by visit and letter beginning on October 24, 2006.
Manufacturer: Coca Cola Bottling Co., Hollywood, FL. Firm initiated recall is ongoing.
REASON
Product labeled as Caffeine Free, Diet Coke actually contains caffeinated and sugared Cherry Coke.
VOLUME OF PRODUCT IN COMMERCE
3,413 cases
DISTRIBUTION
FL

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

______________________________
PRODUCT
Amantadine Hydrochloride Capsules, USP, 100mg, packaged in 100 and 500 count bottles, Recall # D-395-7
CODE
Batch #215103, Expiration 10/07 (bottles of 500). Batch #215105, Expiration 10/07 (bottles of 500). Batch #223755, Expiration 03/07 (bottles of 100).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Upsher Smith Laboratories, Inc., Maple Grove, MN, by letters on August 7, 2006.
Manufacturer: Banner Pharmacaps, Inc., High Point, NC. Firm initiated recall is ongoing.
REASON
Failed USP Test Requirements for Content Uniformity.
VOLUME OF PRODUCT IN COMMERCE
1,497 bottles/#215103; 956 bottles/#215105; 6,097 bottles/#223755
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Derma 50 Wound Care Ointment, Emu Oil, 2 oz. jar, Recall # D-397-7
CODE
Lot: 3/16/06
RECALLING FIRM/MANUFACTURER
Recalling Firm: Purple Emu/PEL Naturals, Woxall, PA, by telephone on September 8, 2006, and by letters on September 29, 2006.
Manufacturer: Iren Corp., Union Dale, PA. Firm initiated recall is ongoing.
REASON
Undeclared Sulfur
VOLUME OF PRODUCT IN COMMERCE
255 bottles
DISTRIBUTION
Nationwide, UK, Canada, and England

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

______________________________
PRODUCT
Precedex® (Dexmedetomidine Hydrochloride) Injection, Equivalent to 100 mcg/mL Dexmedetomidine base, 2 mL single-dose vial, Rx only, NDC 0409-1638-02, Recall # D-392-7
CODE
Lots: 37-483-DK and 38-481-DK
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira, Inc, Lake Forest, IL, by letter on August 23, 2006.
Manufacturer: Hospira, Inc, Rocky Mount, NC. Firm initiated recall is ongoing.
REASON
Degradation impurities may exceed specification over shelf life.
VOLUME OF PRODUCT IN COMMERCE
142,925 units
DISTRIBUTION
Nationwide and Dominica Republic

______________________________
PRODUCT
Metoclopramide USP Tablet, 5mg, NDC 61392-557-30, NDC 61392-557-30 The medication is distributed in 30 count boxes containing single tablet unit dose strips, Recall # D-394-7
CODE
Lot Code: C41955A30, Expiration Date: 03/31/2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Heartland Repack Services LLC, Toledo, OH, by letter on October 11, 2006.
Manufacturer: Pliva, Inc., East Hanover, NJ. Firm initiated recall is ongoing.
REASON
Broken Tablets
VOLUME OF PRODUCT IN COMMERCE
8,669/30 count boxes
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Akineton® (biperiden hydrochloride) tablets, 2 mg, 100 tablet bottles, Rx only, NDC 49884-693-01, Recall # D-396-7
CODE
Lot: 04AKT21001, exp. 03/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, Abbott Park, IL, by letter on September 12, 2006.
Manufacturer: Abbott Laboratories, Whippany, NJ. Firm initiated recall is ongoing.
REASON
Product does not meet potency specifications throughout shelf life.
VOLUME OF PRODUCT IN COMMERCE
9,020/100 tablet bottles
DISTRIBUTION
Nationwide and PR

______________________________
PRODUCT
Fougera® CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM USP 1%/0.05% (base), 15 gram and 45 gram tubes, Rx only, NDC 0168-0258-15 (15 grams) and NDC 0168-0258-46 (46 grams), Recall # D-398-7.
CODE
15 gram lot: T244 (exp. date 8/07); 45 gram lots: S969 (exp. date 6/07) and U268 (exp. date 1/08).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Altana Inc., Melville, NY, by letters dated October 25, 2006.
Manufacturer: Altana, Inc., Hicksville, NY. Firm initiated recall is ongoing.
REASON
Subpotent (betamethasone dipropionate)
VOLUME OF PRODUCT IN COMMERCE
125,836/15 gram tubes; 85,254/45 gram tubes
DISTRIBUTION
Nationwide, PR, and Guam

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

______________________________
PRODUCT
a) Red Blood Cells, Leukocyte Reduced, Recall # B-0086-7;
b) Fresh Frozen Plasma, Recall # B-0087-7
CODE
a) and b) Unit: LC29072
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on May 26, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the drug Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0185-7
CODE
Unit: 71X308036
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Brooksville, FL, by facsimile on April 21, 2006. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

______________________________
PRODUCT
Platelets Pheresis, Recall # B-0221-7
CODE
Unit: 1038424 (split)
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on February 17, 2004.
Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA and SC

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0222-7
CODE
Unit: 71X383190
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Brooksville, FL, by telephone on March 10, 2006. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

______________________________
PRODUCT
Red Blood Cells, Recall # B-0223-7
CODE
Units: 71P675257, 71Q028316, and 71Q867855
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Brooksville, FL, by facsimile on April 29, 2006. 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
3 units
DISTRIBUTION
FL

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0224-7;
b) Red Blood Cells, Apheresis, Recall # B-0225-7;
c) Platelets, Recall # B-0226-7;
d) Platelets, Irradiated, Recall # B-0227-7
CODE
a) Units: L22560 and L23663;
b) Units: L24646 (split units);
c) Unit: L23663;
d) Unit: L22560
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter on September 16, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
VA

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0244-7
CODE
Unit: 29KY26570
RECALLING FIRM/MANUFACTURER
American National Red Cross, Mid-Atlantic Region, Norfolk, VA, by telephone on July 5, 2005 and by letter dated July 6, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not have a hematocrit test during the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA
_____________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0247-7
CODE
Unit: 71X279927
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on September 13, 2005.
Manufacturer: LifeSouth Community Blood Centers, Inc., Birmingham, AL. Firm initiated recall is complete.
REASON
Platelets Pheresis, with an unacceptably low volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL

______________________________
PRODUCT
Source Plasma, Recall # B-0253-7
CODE
Units: 68615598, 68611057
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Duluth, MN, by facsimile on December 20, 2002. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob Disease (CJD) and variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA

______________________________
PRODUCT
a) Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-0254-7;
b) Platelets Pheresis, Leukocytes Reduced, Recall # B-0255-7;
c) Fresh Frozen Plasma Pheresis, Recall # B-0256-7
CODE
a), b), and c) Unit: 16458-5185
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on July 10, 2004.
Manufacturer: Blood Systems, Inc., dba United Blood Services, Meridian, MA, Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Corynebacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
MS

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0262-7;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0263-7
CODE
a) Units: 9016659 and 9014813;
b) Unit: 9014308
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on August 5, 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
3 units
DISTRIBUTION
CO and IL

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0264-7
CODE
Unit: 9150685
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on August 10, 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
TN

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0265-7
CODE
Units: 9150583, 9044563, and 6671207
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on August 22, 2005. Firm initiated recall is complete.
REASON
Blood products, which was collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CO, and FL

______________________________
PRODUCT
Platelets Pheresis, Recall # B-0266-7
CODE
Unit: 3811179 (split)
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on February 7, 2005 and by letter dated March 1, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had engaged in high risk behavior activities, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MS

______________________________
PRODUCT
Red Blood Cells, Recall # B-0307-7
CODE
Unit: 9977993
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone and electronic mail on May 2, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA and Switzerland

______________________________
PRODUCT
Red Blood Cells, Recall # B-0309-7
CODE
Unit: 0228954
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone and electronic mail on June 10, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA

______________________________
PRODUCT
Red Blood Cells, Recall # B-0310-7
CODE
Unit: 0239281
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone and electronic mail on June 24, 2005. Firm initiated recall is complete.
REASON
Blood product, manufactured from a unit of Whole Blood that was designated as a low volume collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0311-7;
b) Fresh Frozen Plasma, Recall # B-0312-7
CODE
a) and b) Unit: H81780
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by telephone on November 19, 2005 and by letters on December 28, 2005 and February 16, 2006. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor with a history of hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0313-7
CODE
Unit: 29FK62341
RECALLING FIRM/MANUFACTURER
American National Red Cross, Mid-Atlantic Region, Norfolk, VA, by telephone on December 2, 2005 and by letter dated December 6, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA

______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0314-7
CODE
Unit: H94616
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter on September 21, 2005. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of clotted red blood cells, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0319-7
CODE
Unit: 7685031
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Beaumont, TX, by telephone on January 6, 2005. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0320-7
CODE
Unit: 3795586
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Beaumont, TX, by facsimile on April 28, 2005. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

______________________________
PRODUCT
Platelets, Recall # B-0341-7
CODE
Unit: 3799972
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Beaumont, TX, by facsimile on May 16, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had taken aspirin or an aspirin product within three days of the donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0342-7
CODE
Units: 4035970 and 7685655
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Beaumont, TX, by facsimile on September 15, 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
TX

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0343-7
CODE
Units: 3798480 and 3799980
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Beaumont, TX, by facsimile on May18, 2005. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0344-7;
b) Platelets, Recall # B-0345-7
CODE
a) and b) Unit: 4037174
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Beaumont, TX, by letter on October 4, 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
MI

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0346-7;
CODE
Unit: 3796693
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Beaumont, TX, by letter on September 15, 2005. Firm initiated recall is complete.
REASON
Blood product, which were collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

______________________________
PRODUCT
Platelets, Leukocytes Reduced, Recall # B-0186-7
CODE
Unit: 16GQ28697
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Columbus, OH, by telephone on April 4, 2006 and by letter dated April 6, 2006. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH

______________________________
PRODUCT
Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-0242-7
CODE
Units: 16374-8427 (split)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated March 19, 2004.
Manufacturer: Blood Systems, Inc., dba United Blood Services, Meridian, MA, Firm initiated recall is complete.
REASON
Blood products, for which documentation of an abnormal alarm during apheresis collection was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MS

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0248-7
CODE
Unit: 53LF81748
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by telephone on December 5, 2005 and letter dated December 9, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for Leishmaniasis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0257-7
CODE
Units: 71X277203 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Centers, Inc., Gainesville, FL, by facsimile on June 16, 2005.
Manufacturer: LifeSouth Community Centers, Inc., Birmingham, AL. Firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with coagulase negative Staphylococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL

______________________________
PRODUCT
Recovered Plasma, Recall # B-0308-7
CODE
Unit: 9977993
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone and electronic mail on May 2, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA and Switzerland

______________________________
PRODUCT
a) Red Blood Cells, Recall # B- 0315-7;
b) Platelets, Recall # B-0316-7;
c) Fresh Frozen Plasma, Recall # B-0317-7
CODE
a), b), and c) Unit: 9999463
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on June 27, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
LA

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0318-7
CODE
Unit: 5713905
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Beaumont, TX, by facsimile on January 26, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

CORRECTION
Recall # Z-0078-2007, listed in November 8, 2006, Enforcement Report should be listed as a Class III Recall.
_____________________________
PRODUCT
Z-0018-07
a) CSI® Daily Wear, soft (hydrophilic) contact lenses, Recall # Z-0018-2007;
b) CSI® Flexible Wear, soft (hydrophilic) contact lenses, Recall # Z-0019-2007;
c) CSI® Toric, soft (hydrophilic) contact lenses, Recall # Z-0020-2007
CODE
a) Polymer Lot #RM-309824, RM-309691, RM-309631, RM-309592, 03D0201, 03D1401, RM-309825, RM-309762;
b) Polymer Lot #RM-309824, RM-309691, RM-309631, RM-309592, 03D0201, 03D1401, RM-309825, RM-309762;
c) Polymer Lot #RM-309824, RM-309691, RM-309631, RM-309592, 03D0201, 03D1401, RM-309825, RM-309762
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ciba Vision Corp., Duluth, GA, by letter on September 13, 2006.
Manufacturer: Ciba Vision Puerto Rico, Inc., Cidra, PR. Firm initiated recall is ongoing.
REASON
Out of specification lens curve.
VOLUME OF PRODUCT IN COMMERCE
58,947 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
GE Healthcare-Datex-Ohmeda Aisys Anesthesia Delivery System with Aladin 2 cassettes, Recall # Z-0021-2007
CODE
Serial numbers: ANAK00115, ANAH00114, ANAH00115, ANAH00116, ANAH00117, ANAH00124, ANAH00126, ANAJ00100, ANAJ00101, ANAJ00102, ANAJ00103, ANAJ00104, ANAJ00105, ANAJ00106, ANAJ00107, ANAJ00108, ANAJ00109, ANAJ00110, ANAJ00111, ANAJ00112, ANAJ00113, ANAJ00114, ANAJ00115, ANAJ00116, ANAJ00117, ANAJ00118, ANAJ00119, ANAJ00120, ANAJ00121, ANAJ00122, ANAJ00123, ANAJ00124, ANAJ00125, ANAJ00126, ANAJ00127, ANAJ00128, ANAJ00129, ANAJ00131, ANAJ00132, ANAJ00133, ANAJ00134, ANAJ00135, ANAJ00136, ANAJ00137, ANAJ00138, ANAJ00139, ANAJ00140, ANAJ00141, ANAJ00142, ANAJ00143, ANAJ00144, ANAJ00145, ANAJ00146, ANAJ00147, ANAJ00148, ANAJ00149, ANAJ00150, ANAJ00151, ANAJ00152, ANAJ00153, ANAJ00154, ANAJ00155, ANAJ00156, ANAJ00157, ANAJ00158, ANAJ00159, ANAJ00160, ANAJ00161, ANAJ00162, ANAJ00163, ANAJ00164, ANAJ00165, ANAJ00166, ANAJ00167, ANAJ00168, ANAJ00169, ANAJ00170, ANAJ00171, ANAJ00172, ANAJ00173, ANAJ00174, ANAJ00175, ANAJ00176, ANAJ00177, ANAJ00178, ANAJ00179, ANAJ00180, ANAJ00181, ANAJ00182, ANAJ00183, ANAJ00184, ANAJ00185, ANAJ00186, ANAJ00187, ANAJ00188, ANAJ00189, ANAJ00190, ANAJ00191, ANAJ00192, ANAJ00193, ANAJ00194, ANAJ00195, ANAJ00195, ANAJ00196, ANAJ00197, ANAJ00198, ANAJ00199, ANAJ00200, ANAJ00201, ANAJ00202, ANAJ00203, ANAJ00204, ANAJ00205, ANAJ00206, ANAJ00207, ANAJ00208, ANAJ00209, ANAJ00210, ANAJ00211, ANAJ00212, ANAJ00213, ANAJ00214, ANAJ00215, ANAJ00216, ANAJ00217, ANAJ00218, ANAJ00219, ANAJ00220, ANAJ00221, ANAJ00222, ANAJ00223, ANAJ00224, ANAJ00225, ANAJ00226, ANAJ00227, ANAJ00228, ANAJ00229, ANAJ00230, ANAJ00231, ANAJ00232, ANAJ00233, ANAJ00234, ANAJ00235, ANAJ00236, ANAJ00237, ANAJ00238, ANAJ00239, ANAJ00240, ANAJ00241, ANAJ00242, ANAJ00243, ANAJ00244, ANAJ00245, ANAJ00246, ANAJ00247, ANAJ00248, ANAJ00249, ANAJ00250, ANAJ00251, ANAJ00252, ANAJ00253, ANAJ00254, ANAJ00255, ANAJ00256, ANAJ00257, ANAJ00258, ANAJ00259, ANAJ00260, ANAJ00261, ANAJ00262, ANAJ00263, ANAJ00264, ANAJ00265, ANAJ00266, ANAJ00267, ANAK00100, ANAK00101, ANAK00102, ANAK00103, ANAK00104, ANAK00105, ANAK00106, ANAK00107, ANAK00108, ANAK00109, ANAK00110, ANAK00111, ANAK00112, ANAK00113, ANAK00114, ANAK00116, ANAK00117, ANAK00118, ANAK00119, ANAK00120, ANAK00121, ANAK00122, ANAK00123, ANAK00124, ANAK00125, ANAK00126, ANAK00127, ANAK00128, ANAK00129, ANAK00130, ANAK00131, ANAK00132, ANAK00133, ANAK00134, ANAK00135, ANAK00136, ANAK00137, ANAK00138, ANAK00139, ANAK00140, ANAK00141, ANAK00142, ANAK00143, ANAK00144, ANAK00145, ANAK00146, ANAK00147, ANAK00148, ANAK00149, ANAK00150, ANAK00151, ANAK00152, ANAK00153, ANAK00154, ANAK00155, ANAK00156, ANAK00156, ANAK00157, ANAK00158, ANAK00159, ANAK00160, ANAK00161, ANAK00162, ANAK00163, ANAK00164, ANAK00165, ANAK00166, ANAK00167, ANAK00168, ANAK00169, ANAK00170, ANAK00171, ANAK00172, ANAK00173, ANAK00174, ANAK00175, ANAK00176, ANAK00177, ANAK00178, ANAK00179, ANAK00180, ANAK00181, ANAK00182, ANAK00183, ANAK00184, ANAK00185, ANAK00186, ANAK00187, ANAK00188, ANAK00189, ANAK00190, ANAK00191, ANAK00192, ANAK00193, ANAK00194, ANAK00195, ANAK00196, ANAK00197, ANAK00198, ANAK00199, ANAK00200, ANAK00201, ANAK00202, ANAK00203, ANAK00204, ANAK00205, ANAK00206, ANAK00207, ANAK00208, ANAK00209, ANAK00210, ANAK00211, ANAK00212, ANAK00213, ANAK00214, ANAK00215, ANAK00216, ANAK00217, ANAK00218, ANAK00219, ANAK00220, ANAK00221, ANAK00222, ANAK00223, ANAK00224, ANAK00225, ANAK00226, ANAK00227, ANAK00228, ANAK00229, ANAK00230, ANAK00231, ANAK00232, ANAK00233, ANAK00234, ANAK00235, ANAK00236, ANAK00237, ANAK00238, ANAK00239, ANAK00240, ANAK00241, ANAK00242, ANAK00243, ANAK00244, ANAK00245, ANAK00246, ANAK00247, ANAK00248, ANAK00249, ANAK00250, ANAK00251, ANAK00252, ANAK00253, ANAK00254, ANAK00255, ANAK00256, ANAK00257, ANAK00258, ANAK00259, ANAK00260, ANAK00261, ANAK00262, ANAK00263, ANAK00264, ANAK00265, ANAK00266, ANAK00267, ANAK00268, ANAK00269, ANAK00270, ANAK00271, ANAK00272, ANAK00273, ANAK00274, ANAK00275, ANAK00276, ANAK00277, ANAK00278, ANAK00279, ANAK00280, ANAK00281, ANAK00282, ANAK00283, ANAK00284, ANAK00285, ANAK00286, ANAK00287, ANAK00288, ANAK00289, ANAK00290, ANAK00291, ANAK00292, ANAK00293, ANAK00294, ANAK00295, ANAK00296, ANAK00297, ANAK00298, ANAK00299, ANAK00300, ANAK00301, ANAK00302, ANAK00303, ANAK00304, ANAK00305, ANAK00306, ANAK00307, ANAK00308, ANAK00309, ANAK00310, ANAK00311, ANAK00312, ANAK00313, ANAK00314, ANAK00315, ANAK00316, ANAK00317, ANAK00318, ANAK00319, ANAK00320, ANAK00321, ANAK00322, ANAK00323, ANAK00324, ANAK00325, ANAK00326, ANAK00327, ANAK00329, ANAK00330, ANAK00331, ANAK00332, ANAK00333, ANAK00334, ANAK00335, ANAK00336, ANAK00337, ANAK00338, ANAK00339, ANAK00340, ANAK00341, ANAK00342, ANAK00343, ANAK00344, ANAK00348, ANAK00349, ANAK00350, ANAK00351, ANAK00352, ANAK00353, ANAK00354, ANAK00355, ANAK00356, ANAK00357, ANAK00358, ANAK00359, ANAK00360, ANAK00361, ANAK00362, ANAK00363, ANAK00364, ANAK00365, ANAK00366, ANAK00367, ANAK00368, ANAK00369, ANAK00370, ANAK00371, ANAK00372, ANAK00373, ANAK00374, ANAK00375, ANAK00376, ANAK00377, ANAK00378, ANAK00379, ANAK00380, ANAK00381, ANAK00382, ANAK00383, ANAK00384, ANAK00385, ANAK00386, ANAK00387, ANAK00388, ANAK00389, ANAK00390, ANAK00391, ANAK00392, ANAK00393, ANAK00394, ANAK00395, ANAK00412, ANAK00413, ANAK00414, ANAK00415
RECALLING FIRM/MANUFACTURER
Datex -- Ohmeda, Inc., Madison, WI, by letters on August 10, 2006. Firm initiated recall is ongoing.
REASON
Vaporizer shutdown with alarm-An intermittent leak in the Aladin 2 cassette/Aisys pneumatic interface (valves) may occur that will invoke an alarm state. When this occurs 'Vaporizer Failure' will appear on the Aisys main display, with an accompanying audible alarm. Delivery of anesthetic Agent is halted; gas flow and ventilation are not affected.
VOLUME OF PRODUCT IN COMMERCE
471 units
DISTRIBUTION
Nationwide, Mexico, and Canada

______________________________
PRODUCT
a) Enpath Lead Adapters, pacemaker lead adapter. Affects: 5 mm Bipolar, Model 501205;
6 mm Unipolar, Model 501204; 3.2 mm Low-Profile Bipolar Models 501206 and 501214.
All labeled Sterile, Recall # Z-0120-2007;
b) Angel Medical Systems Lead Adaptor system adapts a St. Jude Model 1488T
Bipolar Endocardial Lead to an AngelMed Guardian IMD; Part No. 0208-2100-001,
provided to Angel Medical Systems for International Clinical Studies; Sterile/ EO,
Single Use. Model LA-001, Recall # Z-0121-2007
CODE
a) Model 501204 - Lot W35696, Model 501205 - Lot # W39157,
Model 501206 - Lot #s W38997, W39457, W39156, W39389, W39687, W39665,
Model 501214 - Lot #s W38961, W39457, W39671, W39763, W40053, W40704, W41307;
b) Lot # W38932
RECALLING FIRM/MANUFACTURER
Enpath Medical, Inc., Minneapolis, MN, by telephone on July 7, and July 17, 2006 and by letters on July 10, and July 18, 2006. Firm initiated recall is ongoing.
REASON
The internal component (Connector Block) of the Lead Adapter used to secure a lead to the adapter has exhibited varying degrees of radial cracks that could cause a temporary intermittent electrical signal disruption if lateral tension is applied to device.
VOLUME OF PRODUCT IN COMMERCE
546 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) HydroCision SpineJet XL MIS 20 degree Handpieces, for cutting, ablation,
and removal of soft tissue, hard tissue, and bone. Catalog Number 58662,
Recall # Z-0123-2007;
b) Hydrocision SpineJet XL MIS 30 degree Handpieces, for cutting, ablation,
and removal of soft tissue, hard tissue, and bone. Catalog Number 58663,
Recall # Z-0124-2007
CODE
a) Lot: 75GF2531;
b) Lot: 75GF2530
RECALLING FIRM/MANUFACTURER
Hydrocision, Inc., Billerica, MA, by email on September 6, 2006. Firm initiated recall is complete.
REASON
Distal tip may become detached from the device.
VOLUME OF PRODUCT IN COMMERCE
40 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) DePuy Spine Bremer 3-D Halo Crown System, Product Code: 2923-01-100,
Recall # Z-0130-2007;
b) O Degree Slider Set, DePuy Spine Bremer Halo System, Product Code: 2923-01-010,
Recall # Z-0131-2007;
c) 12 Degree Slider Set, DePuy Spine Bremer Halo System, Product Code: 2923-01-020,
Recall # Z-0132-2007;
d) Small Halo Crown, DePuy Spine Bremer Halo System, Product Code: HT025,
Recall # Z-0133-2007;
e) Large Halo Crown, DePuy Spine Bremer Halo System, Product Code: HT026,
Recall # Z-0134-2007;
f) Small Halo Crown w/HI Skull pins, DePuy Spine Bremer Halo System, Product Code: HT025HI,
Recall # Z-0135-2007;
g) Large Halo Crown w/HI Skull pins, DePuy Spine Bremer Halo System, Product Code: HT026HI,
Recall # Z-0136-2007;
i) Adjustable Ring Traction Set, Size B, DePuy Spine Bremer Halo System, Product Code: HT001,
Recall # Z-0137-2007;
j) Adjustable Ring Traction Set, Size C, DePuy Spine Bremer Halo System, Product Code: HT002,
Recall # Z-0138-2007;
k) Small Pediatric Ring, DePuy Spine Bremer Halo System, Product Code: PT001,
Recall # Z-0139-2007;
l) Large Pediatric Ring, DePuy Spine Bremer Halo System, Product Code: PT002,
Recall # Z-0140-2007;
m) Standard Skull Ring, DePuy Spine Bremer Halo System, Product Code: AC007,
Recall # Z-0141-2007;
n) Skull pins w/torque, DePuy Spine Bremer Halo System, Product Code: AC014,
Recall # Z-0142-2007;
o) Extra Long Skull pins, DePuy Spine Bremer Halo System, Product Code: AC018,
Recall # Z-0143-2007;
p) HI Fix Skull pins, DePuy Spine Bremer Halo System, Product Code: AC020,
Recall # Z-0144-2007
CODE
All lot numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: DePuy Spine, Inc., Raynham, MA, by letter on October 10, 2006. Firm initiated recall is ongoing
REASON
Sterility of device is compromised due to loss of package integrity.
VOLUME OF PRODUCT IN COMMERCE
19,877 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
VITROSâ Chemistry Products GLU DT Slides GEN 56, REF (Catalog #) 153 2316, 25 slides per box. VITROSâ Chemistry Products GLU DT Slides quantitatively measure glucose (GLU) concentration in serum and plasma, Recall # Z-0151-2007
CODE
GEN 56
RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY, by letters dated September 27, 2006 and September 28, 2006. Firm initiated recall is ongoing.
REASON
Positively biased results when using the VITROSâ Chemistry Products GLU DT Slides GEN 56.
VOLUME OF PRODUCT IN COMMERCE
93,252 boxes (each box contains 25 slides)
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Hitachi Echelon Magnetic Resonance Imaging System, Recall # Z-0152-2007
CODE
Serial Number: V001. CTL coil component type = MR-CTL-150, N/N KH19636602
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hitachi Medical Systems America, Inc., Twinsburg, OH, by visit on August 14, 2006. Firm initiated recall is complete.
REASON
Component defect/overheating device; A malfunctioning decoupling circuit in the CTL coil caused high current flow and circuit overheating.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN

______________________________
PRODUCT
Precision Medical -- Easy Mate Portable Liquid Oxygen System (container), PM22010 Series, Model number: 2201, Recall # Z-0153-2007
CODE
Serial numbers: P002892 through P005116
RECALLING FIRM/MANUFACTURER
Precision Medical, Inc., Northampton, PA, by telephone on October 4, 2006. Firm initiated recall is ongoing.
REASON
Component assembly; the fill chuck is not assembled properly which may allow the device to come apart over time releasing its contents.
VOLUME OF PRODUCT IN COMMERCE
550 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Access Point Medical-Heavy Duty Rollator (rolling walker), Product Code: RL12010HD,
with seat, backrest, 8" wheels with locks, maximum capacity 400 lbs., and wire
basket, Recall # Z-0154-2007;
b) Access Point Medical-Heavy Duty Rollator with Curved Back (rolling walker),
Product Code: RL12011, with seat, curved backrest, 8" wheels with locks,
maximum capacity 400 lbs., and wire basket, Recall # Z-0155-2007
CODE
All Rollators of this model number
RECALLING FIRM/MANUFACTURER
Recalling Firm: Access Point Medical LLC, St. Louis, MO, by telephone on or about June 20, 2006.
Manufacturer: Danyang Changjiang Motorcycle, Danyang, China. Firm initiated recall is ongoing.
REASON
The fork component on the wheel of the Rollator can break due to the use of incorrect manufacturing material and/or molding processes.
VOLUME OF PRODUCT IN COMMERCE
Approximately 861 Rollators
DISTRIBUTION
Nationwide

______________________________
PRODUCT
DermaStyle Chroma 2-blue and red light device indicated to be used in treating skin blemishes; portable home therapy, Recall # Z-0156-2007
CODE
All units sold before August 1, 2006.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lumiport, LLC, Provo, UT, by email or telephone beginning September 28, 2006.
Manufacturer: Ningbo Haishu Qualik Optoelectronics Corp., Ningbo, China. Firm initiated recall is ongoing.
REASON
Incorrect charger, batteries may overheat, catch fire or explode while being charged with the charger enclosed with the device.
VOLUME OF PRODUCT IN COMMERCE
2,480 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Jostra - HL-20 Heart Lung Integrated Perfusion System, Roller Pump Hand crank, Article # 923391, Recall # Z-0158-2007
CODE
S/Ns 100001 through 100240. Hand cranks shipped between the dates of 8/15/05 to 8/14/06 have the potential to be defective. Serial #s100155, 1025, 1026, 1032, 1331, 1332, 100011, 100015, 100016, 100017, 1272, 1417, 1480, 1500, 1653, 14031054, 14031055, 14031059, 14041074, 14041874, 100012, 100013, J14041874, 1584, 100108, 100109, 14041074, JOSTRA, 100009, 100010, 100130, 100131, 1625, 1626, 1627, 1628, 1629, 100135, 100136, 100137, 14031040, 14031068, 100188, 1019, 1020, 1021, 1295, 100021, 100022, 100116, 14031051, 14031052, 1507, 1508, 1509, 100017, 100219, 100220, 100221, 100222, 100223, 100224, 100225, 100226, 100227, 100228
RECALLING FIRM/MANUFACTURER
Recalling Firm: Maquet, Inc., Bridgewater, NJ, by letter on September 13, 2006.
Manufacturer: Maquet Critical Care AB, Solna, Sweden. Firm initiated recall is ongoing.
REASON
The hand crank necessary for the emergency manual operation of the pump is too wide diametrically to fit into the holes which they were designed to fill.
VOLUME OF PRODUCT IN COMMERCE
132 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Jostra HL-20 Heart Lung Machine - guiding pins, Recall # Z-0159-2007
CODE
All HL 20 systems Serial #s 1159,14031794,14031795, 14031796,14031797,14031798, 100155, 1345, 1363,1588, 14031765, 14031766, 1570, 1571,1593,1319,1320,1321,1322,14031774,14031775, 14031776, 1323,1324,1478,1479,14031067,14031069,10331385,1597,14021730,14031792,1459,1701,1512,1513,100035, 100036, 1034,1035, 14031045, 14031046, 14031047, 14031048, 1022,1023,1541,1559,100094,1025,1026,1032,1331,1332, 100011,100015,100016,100009,100063, 1668,1511, 1652, 1702,1454,1455, 1379,1380, 1381, 1272, 1417,1480, 1500, 1653, 14031054, 14031055,14031059, 14041074, 14041874, 1128, 1592, 100030, 100031, 100012, 100013, 1595, 1596, 14031039, 1510, 1105, 1433, 1434, 1456, 1457, 1577, 1578, 1579, 14021718, 14021719, 14041904, 100026, 14021706, 1420, 1421, 1398, 1418, 1598, J14041874,1584, 100108, 100109,14041074, JOSTRA, 1132, 100009, 100010,100130,100131, 1625, 1626, 1627, 1628, 1629, 100135, 100136, 100137, 1199, 1200, 1540, 1552, 1567, 1568, 1569, 1580, 1581, 1584, 1585, 1586, 14031040, 14031068, 14031761, 14031762, 1716, 100084, 14021716, 14041882, 100188, 1562, 1563, 100028, 100023, 14031831, 14031793, 1019, 1020, 1021, 1295, 100021, 100022, 14031777, 14031778, 14031779, 1523, 1524, 1017, 1442, 1443, 1465, 1466, 1635, 100116, 14031051, 14031052, 1507, 1508, 1509, 14031732, 100001, 100002, 100061, 100062, 14031734, 14031735, 14031736, 100017, 1483, 1481, 1482, 14031056, 14031057, 1535,1536, 1537, 1538, 1539, 1547, 1548, 1549, 1550, 1551, 14031060, 14031061, 14031062, 14031063, 100219,100220, 100221, 100222, 100223, 100224, 100225, 100226, 100227, 100228, 1642, 1643, 1494, 1666, 1667, 1618, 1619, 1517, 1518, 100027, 1345
RECALLING FIRM/MANUFACTURER
Recalling Firm: Maquet Inc, Bridgewater NJ, by letter on October 3, 2006.
Manufacturer: Maquet Critical Care AB, Solna, Sweden. Firm initiated recall is ongoing.
REASON
The HL-20's pump head on the roller pump has four pairs of tube guide rolls that keep the tube in place in the raceway and roll along the inserted tube as the pump head turns. If dirt and other particles accumulate in the tube guide rolls, they cannot roll smoothly and finally they can get stuck.
VOLUME OF PRODUCT IN COMMERCE
227 HL-20 base units with 545 single pumps
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Fusion OMNI ERCP Catheter, Recall # Z-0160-2007
CODE
Lot number: W2243511, Expiration date: 7/12/2009
RECALLING FIRM/MANUFACTURER
Cook Endoscopy, Winston Salem, NC, by letter on October 13, 2006. Firm initiated recall is ongoing.
REASON
Injection through the flush port of these ERCP catheters may be compromised due to omission of a manufacturing activity.
VOLUME OF PRODUCT IN COMMERCE
20 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) 1.5T HD Head Neck Spine Array, Model 2416329, for GE 1.5T Excite MR System,
Recall # Z-0163-2007;
b) 3.0T HD Head Neck Spine Array, Model 2415545, for GE 3.0T Excite MR System,
Recall # Z-0164-2007
CODE
a) Serial Numbers: 101, 201, 202, 203, 204, 205, 206, 207, 208, 308, 309, 310,
311, 312, 313, 314, 315, 316, 317, 318, 319, 320, 321, 322, 323, 324, 325,
326, 327, 328, and 329;
b) Serial Numbers: 101, 102, 201, 202, 203, 204, 205, 206, 207, 309, 310
RECALLING FIRM/MANUFACTURER
USA Instruments Inc., Aurora OH, by letters dated September 20, 2006 and October 13, 2006. Firm initiated recall is ongoing.
REASON
The firm determined that certain potential conditions for use of their medical device, outside of recommended practices, or operating manual descriptions, could result in a localized RF burn and/or electrical shock to a patient on which the device is being used.
VOLUME OF PRODUCT IN COMMERCE
42 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

______________________________
PRODUCT
Michigan Instruments Thumper Mechanical CPR Device, Model 1007, Recall # Z-0119-2007
CODE
All units with a manual configuration (as opposed to a pneumatic configuration).
RECALLING FIRM/MANUFACTURER
Michigan Instruments, Inc., Grand Rapids, MI, by letter dated August 4, 2006. Firm initiated recall is ongoing.
REASON
Failure to initiate compressions when first turned on, if improperly shut down -- Operator Manual updated to include proper shut down procedures.
VOLUME OF PRODUCT IN COMMERCE
1,100 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) Sheridan Sher-I-Bronch Endobronchial Tube, Left-Sided, 37 Fr, 26 mm tracheal cuff,
19 mm bronchial cuff; a Rx, sterile, single use endobronchial tube with modified
tip for left bronchial intubation; catalog number (REF) 5-16037, Recall # Z-0125-2007;
b) Sheridan Preformed Uncuffed Oral Tracheal Tube, 3.0 mm; a Rx, sterile, single use
tracheal tube; catalog number (REF) 5-22006, Recall # Z-0126-2007;
c) Sheridan Preformed Cuffed Oral Tracheal Tube, 5.0 mm; a Rx, sterile, single use
tracheal tube; catalog number (REF) 5-22210, Recall # Z-0127-2007;
d) Sheridan Preformed Cuffed Nasal Tracheal Tube, 7.5 mm; a Rx, sterile, single use
tracheal tube; catalog number (REF) 5-22315, Recall # Z-0128-2007;
e) Sheridan T.T.X. Tracheal Tube Exchanger, Large Size for tracheal tube sizes 7.5 mm --
10.0 mm; a Rx, sterile, single use tracheal tube exchanger; catalog number (REF)
5-24006, Recall # Z-0129-2007
CODE
a) Lot number 1188199;
b) Lot number 1189038;
c) Lot number 1189023;
d) Lot number 1189026;
e) Lot number 1189037
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teleflex Medical, Bannockburn IL, letters dated September 27, 2006.
Manufacturer: Hudson RCI Tecate S.de R.L. de C.V., Teleflex Medical, Tecate, B.C., Mexico. Firm initiated recall is ongoing.
REASON
Biological indicator failed. Investigation eliminated all equipment and product related factors.
VOLUME OF PRODUCT IN COMMERCE
2,355 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Galileo Femoral Clamp TKR Slim, Model Number: SYS25 1226, Recall # Z-0149-2007
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Plus Orthopedics, USA, San Diego, CA, by telephone on June 27, 2006.
Manufacturer: Plus Orthopedics AG, Rotkreuz, Switzerland. Firm initiated recall is ongoing.
REASON
Possibility of pressure plate fractures/breakage.
VOLUME OF PRODUCT IN COMMERCE
31 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Home Access-Hepatitis C Check; At Home Telemedicine Test Service for Hepatitis C ; each kit is composed of an outer box, a shrink-wrapped inner box that contains the blood collection card with an unique PIN, the instructions for use and ''Frequently Asked Questions'', a polybag component that includes two lancets, one gauze pad, one adhesive bandage and one alcohol prep pad, a specimen return envelope and a prepaid return mailer either designated as U.S. first class or FedEx; UPC 0 83170 51000 5, Recall # Z-0150-2007
CODE
Lot 042715, exp May 2007; lot 042716, exp June 2007; lot 042717, exp June 2007; lot 042718, exp June 2007; lot 042719, exp August 2007; lot 042720, exp August 2007; lot 042721, exp August 2007; lot 042722, exp August 2007; lot 042723, exp October 2007; lot 042724, exp October 2007; lot 042725, exp October 2007; lot 042726, exp October 2007; lot 042727, exp October 2007; lot 052703, exp November 2007; lot 052704, exp November 2007; lot 052705, exp November 2007; lot 052706, exp November 2007; lot 052708, exp November 2007; lot 052709, exp January 2008
RECALLING FIRM/MANUFACTURER
Home Access Health Corp., Hoffman Estates, IL, by letters dated October 6, 2006. Firm initiated recall is ongoing.
REASON
Wrong Expiration Date; the kits were labeled with Expiration/Use By dates; that exceed the expiration dates of the sterile safety lancet component of the kit.
VOLUME OF PRODUCT IN COMMERCE
13,911 kits
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Angio-Seal Vascular Closure Device 6F VIP Platform, model 610130. The recalled product is the 6 French model size, Recall # Z-0157-2007
CODE
Lot: 1204437
RECALLING FIRM/MANUFACTURER
St. Jude Medical/Diag. Division, Minnetonka, MN, by letters on June 7, 2006. Firm initiated recall is complete.
REASON
The Angio Seal VIP 6F devices were incorrectly packaged with a 0.038" guidewire vs. the required 0.035" guidewire.
VOLUME OF PRODUCT IN COMMERCE
4,770 devices
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR November 15, 2006

###