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U.S. Department of Health and Human Services

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Enforcement Report for February 6, 2008

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

February 6, 2008
08-06

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I

___________________________________
PRODUCT 
Lochmead Farms Chocolate Country Fresh Premium Ice Cream Half Gallon in round cardboard carton. Recall # F-102-8
CODE
Code of June 22, 2008 stamped on the bottom of the container.
RECALLING FIRM/MANUFACTURER
Lochmead Dairy Inc, Junction City, OR, by e-mail on October 11, 2007 and by press release on October 15, 2007. Firm initiated recall is complete.
REASON
Some containers labeled as Chocolate Ice Cream actually contain a different flavor, Rocky Road Ice Cream, which has almonds. The label of the Chocolate Ice Cream does not list almonds as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
952 half gallon containers
DISTRIBUTION
OR
___________________________________
PRODUCT 
Back to Nature Sesame Ginger Rice Thins, Lightly Crisped Baked Crackers; Net Wt. 4 Oz box, 12 boxes per case; package UPC 7 59283 10013 5, case UPC 07-59283-10013-00, Recall # F-163-8
CODE
"Best When Used By" 22FEB2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kraft Foods, Inc., Northfield, IL, by press release on December 10, 2007.
Manufacturer: TH Foods Inc, Loves Park, IL. Firm initiated recall is ongoing.
REASON
Some packages labeled as Sesame Ginger Rice Thins actually contain a different product, Loblaw brand Sour Cream and Onion Chips, which contain milk. The label of the Back to Nature Sesame Ginger Rice Thins does not list milk as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
1,150 cases
DISTRIBUTION
Nationwide and Bermuda

___________________________________
PRODUCT 
Heartland All Natural Graham Pie Crust, Net Wt. 6 oz (170 g), Recall # F-167-8
CODE
BEST BY: 10 27 08 1 or BEST BY: 10 27 08 3
RECALLING FIRM/MANUFACTURER
Blue Planet Foods, Inc., Collegedale, TN, by telephone with email follow-up beginning  on November 16, 2007 and press release on November 19, 2007. Firm initiated recall is complete.
REASON
Some containers labeled as Graham Pie Crust actually contains a different product, Granola Pie Crust, which contains milk, almonds, and coconut. The label of the Graham Pie Crust does not list these ingredients.
VOLUME OF PRODUCT IN COMMERCE
9,732 units
DISTRIBUTION
FL, IL, CA, GA, AL, TX
___________________________________

PRODUCT 
Ranch Peppercorn Cheddar Cheese Curds, SINCE 1995, Farm Fresh, Heritage Cheese brand, 8 oz. (227g), UPC 7 10875 11117 5, and 16 oz. packages. Pride of New York. Keep Refrigerated. Actual ingredients: Cultured pasteurized milk, salt, enzymes, cracked peppercorn, Buttermilk Ranch Dressing (soybean oil, water, buttermilk, vinegar, corn syrup, egg yolk, buttermilk solids (milk), salt, and contains less than 2% of: onion, monosodium glutamate, garlic, xanthan gum, lactic acid, polysorbate 60, potassium sorbate as a preservative, phosphoric acid, propylene glycol alginate, spices), Recall # F-168-8
CODE
All Sell By Dates up to and including December 19, 2007
RECALLING FIRM/MANUFACTURER
Heritage Cheese LLC., Heuvelton, NY, by letter and telephone on November 30, 2007.
Firm initiated recall is complete.
REASON
The product contains undeclared eggs based on inspectional findings by New York State Department of Agriculture & Markets' Division of Milk Control and Dairy Services.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
NY
___________________________________
PRODUCT 
Cedarlane brand Low Fat Beans, Rice & Cheese Style Burrito, made with Organic Beans, Rice & Tortilla, packaged as individually wrapped 6 oz burritos as well as 48 oz cartons containing eight individually wrapped 6 oz burritos. Box UPC 0 38794 34901 2; individual unit UPC code is 0 38794 34777 3, Recall # F-169-8
CODE
Cartons are coded "062808A" through "082908A". Individual units are coded "062808A" through "082908A".
RECALLING FIRM/MANUFACTURER
Cedarlane Natural Foods Inc., Carson, CA, by press release on December 12, 2007, e-mail on or about December 14, 2007 and by letter beginning December 17, 2007. Firm  initiated recall is complete.
REASON
Casein, a milk protein, was not listed as an ingredient on the label of the individually wrapped burritos.
VOLUME OF PRODUCT IN COMMERCE
19,884 cartons / 12 burritos; 24,783 cartons / 6 boxes / 8 burritos
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
a) UNI-PRESIDENT RED BEAN ICE BAR 6/6/3 FL OZ, UPC 4 710608 813600
(NOTE: OUTER CARTON LABELED AS RED BEAN FLAVOR ICE BARS & INNER BOX AND PACKAGE LABELED AS UNI-PRESIDENT RED BEAN ICE BAR ), Recall # F-179-8;
b) UNI-PRESIDENT RED BEAN & JELLY ICE CREAM BAR 6/6/2.83 FL OZ, UPC 4 710088 070968 (NOTE: OUTER CARTON LABELED AS RED BEAN TAPIOCA FLAVOR ICE BARS & INNER BOX AND PACKAGE LABELED AS UNI-PRESIDENT RED BEAN & JELLY ICE CREAM BAR ), Recall # F-180-8;
CODE
UPC codes only
RECALLING FIRM/MANUFACTURER
Recalling Firm: President Global Corporation, Buena Park, CA, by Press Release on November 28, 2007 and by letters on November 29 – November 30, 2007.
Manufacturer: Uni Presient Ent Corp., Tainan, Taiwan. Firm initiated recall is ongoing.
REASON
Product contains undeclared skim milk.
VOLUME OF PRODUCT IN COMMERCE
1807 cartons (6 bx/ct, 6 bars/bx)
DISTRIBUTION
CA

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II

___________________________________
PRODUCT
a) Thirst Extinguisher Cocktail shaker used to mix drinks. Product is silver plated and
    shaped like the end of a fire hose. Sold in a box that states the name of the product
    and the firm name Authentic Models. Item CS001, Recall # F-171-8;
b) Fire Extinguisher Cocktail shaker used to mix drinks. Product is silver plated and
    shaped like a fire extinguisher. Sold in a box that states product name and firm name
    Authentic Models. Item number CS002, Recall # F-172-8;
c) Joy Bell Cocktail Shaker used to mix drinks. Product is silver plated and shaped like a
    bell. Product sold in a box labeled with product name and name of firm Authentic
    Models. Item number CS003, Recall # F-173-8;
d) Dumbbell Cocktail Shaker used to mix drinks. Product is silver plated and shaped like
    a dumbbell and is sold in a box labeled with product name and the firm name
    Authentic Models. Item number CS004, Recall # F-174-8;
e) Lighthouse Cocktail Shaker used to mix drinks. Product is silver plated and shaped
    like a lighthouse. It is sold in a box containing product name and name of firm
    Authentic Models. Item number CS010, Recall # F-175-8
CODE
Product not coded
RECALLING FIRM/MANUFACTURER
Recalling Firm: Authentic Models, Eugene, OR, by e-mail on November 16, 2007 and by letters dated 1/3/08 and January 14, 2008
Manufacturer: Sparks Enterprises, Baradari Moradabad, India. Firm initiated recall is ongoing.
REASON
Cocktail shakers contain leachable lead from lead solder.
VOLUME OF PRODUCT IN COMMERCE
1,237 Thirst Extinguishers; 4,590 Fire Extinguishers; 1,112 Joy Bell; 654 Dumbbell; and 3,840 Lighthouse
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) 44 ounce Green Feudo Pitchers (also referred to as Romano Pitchers), SKU 4410,
    Style B18. All Green Feudo Pitchers purchased under Purchase Order number 1805.
    Items may have been purchased as a matching set of 1 pitcher and 4 tumblers having
    SKU 4701, Recall # F-176-8;
b) 14 ounce Green Feudo Tumblers (also known as Romano Tumblers) IL Nodo
    Ceramiche SRL, SKU 4411, Style B10. Items may have been purchased as a
    matching set of 1 pitcher and 4 tumblers having SKU 4701, Recall # F-177-8;
c) Set including one 44 ounce Green Feudo Pitcher (also referred to as Romano Pitcher)
    and four 14 ounce Green Feudo Tumblers (also referred to as Romano Tumblers),
    SKU 4701; Purchase Order number 1805, Recall # F-178-8
CODE
All tumblers distributed under Purchase Order number 1805.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Napa Style Inc., Napa, CA, by telephone on August 15, 2007 followed by letter dated November 2, 2007 and by press release on November 9, 2007.
Manufacturer: IL Nodo Ceramiche SRL, Fibbiana/Montelupo (FI), Italy. Firm initiated recall is ongoing.
REASON
Ceramicware items contain leachable lead in excess of CPG 545.450 guidelines..
VOLUME OF PRODUCT IN COMMERCE
60 pitchers and 155 tumblers
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________

PRODUCT 
Simvastatin Tablets USP, 20 mg, 1,000-tablet bottle, Rx only, NDC 0093-7154-10, Recall # D-097-2008
CODE
Lot 02S179, exp 8/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, North Wales, PA, by letter on December 28, 2007.
Manufacturer: Teva Pharmaceutical Industries, Har Hozvim, Jerusalem, Israel. Firm initiated recall is ongoing.
REASON
Product may contain some Carvedilol 25 mg tablets.
VOLUME OF PRODUCT IN COMMERCE
1,447 bottles/1,000-tablet bottles
DISTRIBUTION
IL, NJ, and NV

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III

___________________________________
PRODUCT
IVAX Aspirin Tablets, 81 mg, enteric coated, 100-tablet unit dose package, OTC, NDC 0182-8217-89, Recall # D-096-2008
CODE
Lot 067210
RECALLING FIRM/MANUFACTURER
Recalling Firm: Amerisource Health Services Corp, Columbus, OH, by e-mail and letter WHEN.
Manufacturer: Time-Cap Labs, Farmingdale, NY. Firm initiated recall is ongoing.
REASON
Product fails assay and impurity specifications.
VOLUME OF PRODUCT IN COMMERCE
11/100-unit dose packages
DISTRIBUTION
GA

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS II

___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0359-08
CODE
Units: 71X453741 (split product); 71X22522X; and 71X153231 (split product)
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers - Montgomery Region, Montgomery, AL, by facsimile on May 12, 2006. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0411-08
CODE
Unit: LG55278
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., Providence, RI, by telephone and letter dated May 4, 2007. Firm initiated recall is complete.
REASON
Blood product, which tested positive for CMV, but was labeled as CMV-negative, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MA
___________________________________
PRODUCT
a) Platelets, Recall # B-0412-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0413-08
CODE
a) and b) Unit: 027GH13188
RECALLING FIRM/MANUFACTURER
ARC Greater Alleghenies, Johnstown, PA, by telephone on April 27, 2007 and by letter dated April 30, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who provided post donation information concerning a previous positive test for the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA, VA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0420-08
CODE
Recall # 12FL20065
RECALLING FIRM/MANUFACTURER
American Red Cross Carolinas Blood Services Region, Charlotte, NC, by letter on January 26, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0424-08
CODE
Unit: 55S55386
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR, by letter and electronic mail dated February 12, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a gender discrepancy on his registration card, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AR
__________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0429-08
CODE
Unit: 5977950
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated June 1, 2006. Firm initiated recall is complete.
REASON
Blood product, which was not manufactured in accordance with standard operating procedures (SOP), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced, Recall # B-0443-08
CODE
Unit: 3101389
RECALLING FIRM/MANUFACTURER
Indiana Blood Center, Indianapolis, IN, by telephone on June 17, 2007 and by letter dated July 18, 2007. Firm initiated recall is complete.
REASON
Blood product, which was possibly contaminated with Propionibacterium acnes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN
___________________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced, Recall # B-0444-08
CODE
Unit: 1542785
RECALLING FIRM/MANUFACTURER
Indiana Blood Center, Indianapolis, IN, by telephone on June 30, 2007 and by letter dated July 18, 2007. Firm initiated recall is complete.
REASON
Blood product, which was possibly contaminated with Bacillus species, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0592-08
CODE
Unit: 1223824
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter dated March 17, 2005. Firm initiated recall is complete.
REASON
Blood product, associated with a red cell component that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0609-08
CODE
Units: Y86111; Y85226; Y85234; Y86109; Y90369
RECALLING FIRM/MANUFACTURER
Blood Assurance Inc., Chattanooga, TN, by fax on June 20, 2006. Firm initiated recall is complete.
REASON
Blood products, leukoreduced more than 72 hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
TN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0617-08
CODE
Units: 314872599; 314872601
RECALLING FIRM/MANUFACTURER
Blood Systems Inc/dba United Blood Services, Tupelo, MS, by telephone on January 18, 2007. Firm initiated recall is complete.
REASON
Blood components, processed from Whole Blood more than 8 hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MS
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0678-08
CODE
Unit: 71X489040
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on September 30, 2006. Firm initiated recall is complete.
REASON
Blood product, stored in insufficient volume of plasma, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0679-08
CODE
Unit: 22FR03446
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by letter and e-mail 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
NJ
___________________________________
PRODUCT
a) Fresh Frozen Plasma, Recall # B-0681-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0682-08;
c) Platelets Leukocytes Reduced, Recall # B-0683-08
CODE
a) b) and c) Unit: 22FX36274
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by letters dated July 6, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NJ and PA
___________________________________
PRODUCT
a) Platelets, Recall # B-0685-08;
b) Fresh Frozen Plasma, Recall # B-0686-05
CODE
a) and b) Unit: 1251177
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter dated January 31, 2005. Firm initiated recall is complete.
REASON
Blood products, associated with a red cell component that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-689-08
CODE
Unit: 22KV55764
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by fax and e-mail on August 1, 2007 and by letters dated August 7, 2007 and September 6, 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
PA
___________________________________
PRODUCT
a) Fresh Frozen Plasma, Recall # B-0691-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0692-08
CODE
a) and b) Unit: 311311929
RECALLING FIRM/MANUFACTURER
Blood Systems Inc/dba United Blood Services, Tupelo, MS, by letter dated April 17, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MS
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0693-08
CODE
Unit: 12KW19239 (Part 2)
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Carolinas Region, Charlotte, NC, by telephone on July 30, 2007 and by letter dated September 18, 2007.
Manufacturer: American Red Cross Blood Services, Carolinas Region, Winston Salem, NC. Firm initiated recall is complete.
REASON
Blood product, with a low volume, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0695-08
CODE
Unit: 72C165437
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by telephone on August 14, 2007. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0696-08
CODE
Units: 012KY21842 (2 units)
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Carolinas Blood Services, Region, Charlotte, NC, by telephone on May 23, 2007 and by letters dated June 1, 2007, July 8, and July 25, 2007.
Manufacturer: American Red Cross Blood Services, Carolinas Region, Winston Salem, NC. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0698-08
CODE
Unit: 12GE87785
RECALLING FIRM/MANUFACTURER
American Red Cross Carolinas Blood Services Region, Charlotte, NC, by telephone or electronic notification on September 20, 2007 and by letter dated October 1, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC

___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0699-08;
b) Fresh Frozen Plasma, Recall # B-0700-08
CODE
a) and b) Units: 012V44881, 012V43605
RECALLING FIRM/MANUFACTURER
American Red Cross Carolinas Blood Services Region, Charlotte, NC, by telephone on  August 29, 2007 and by letter dated September 2, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
AL, NC, TN
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0701-08;
b) Red Blood Cells Leukocytes Reduced, B-0702-08;
c) Red Blood Cells Irradiated, Recall # B-0703-08;
d) Red Blood Cells Leukocytes Reduced Irradiated, B-0704-08;
e) Platelets, Recall # B-0705-08;
f) Fresh Frozen Plasma, Recall # B-0706-08;
g) Plasma Frozen, Recall # B-0707-08
CODE
a) Units: 004J04673, 004S85007, and 004V49209;
b) Units: 004F15522, 004L66154, 004M26734, 004N15405, 004N19273,
    004S24510, 004V13091, and 004E86282;
c) Unit: 004R43548;
d) Units: 004R67018 and 004R80123;
e) Units: 004J04673, 004R67018, 004S24510, and 004E86282;
f) Units: 004N19273, 004R43548, and 004S24510;
g) Unit: 004M26734
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by the Logic system and facsimile on April 11, 2007 and April 20, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
22 units
DISTRIBUTION
MA, ME, NH, NY
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0710-08
CODE
Unit: 311393414
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc/dba United Blood Services, Tupelo, MS, by telephone on February 7, 2005.
Manufacturer: Blood Systems, Inc., Bedford, TX. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly tested for syphilis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MS
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0711-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0712-08;
c) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0713-08;
d) Fresh Frozen Plasma, Recall # B-0714-08
CODE
a) Unit: 41FQ11815;
b) Units: 41LN10799, 41FW42442, 41FQ11662, 41FQ11667, 41FQ11669,
    41LR94362, 41LR94364, 41LR94365, 41LP35846, 41LP35872, 41LP35878,
    41FR58587, 41FR58592, 41FR58600, 41LP35850, 41LP35852, 41LP35853,
    41LP35854, 41FR58605, 41FR58616, 41FR58620, 41FR58623, 41FR58626,
    41FY51235, 41FY51238, 41FY51241, 41FY51243, 41FY51250, 41FN66860,
    41FN66863, 41FN66868, 41FN66869, 41FN66890, 41FN66894, 41FN66900,
    41FN66904, 41FN66908, 41FQ11810, 41FQ11812, 41FQ11820, 41FQ11825,
    41FQ11837, and 41FQ11840;
c) Unit: 41FW42440;
d) Units: 41FN66863, 41FN66868, 41FN66894, 41FN66904, and 41FN66908
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, by telephone on August 8, 2005 and by letters dated August 25, 2005, August 29, 2005 and September 15, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
50 units
DISTRIBUTION
AL and MS
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0715-08
CODE
Unit: 012E70978
RECALLING FIRM/MANUFACTURER
American Red Cross Carolinas Blood Services Region, Charlotte, NC, by telephone on November 21, 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
NC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0716-08
CODE
Unit: 004KQ66949
RECALLING FIRM/MANUFACTURER
Recalling Firm: ARC Blood Services, New England Region, Dedham, MA, by letter dated August 17, 2007.
Manufacturer: AC/Manchester, NH, Manchester, NH. Firm initiated recall is complete.
REASON
Blood product collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NH
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0717-08
CODE
Unit: 2176342
RECALLING FIRM/MANUFACTURER
Central Jersey Blood Center, Shrewsbury, NJ, by facsimile on April 18, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt - Jakob disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Scotland
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0718-08
CODE
Unit: 4309184
RECALLING FIRM/MANUFACTURER
Central Jersey Blood Center, Shrewsbury, NJ, by facsimile on July 9, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt - Jakob disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Scotland
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0719-08
CODE
Unit: W045006021725
RECALLING FIRM/MANUFACTURER
Community Blood Center of Greater Kansas City, Kansas City, MO, by electronic notification on April 5, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0720-08;
b) Platelets, Recall # B-0721-08
CODE
Units: a) and b) 1251059
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter dated March 29, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MN
___________________________________
PRODUCT
a) Blood Cells Leukocytes Reduced, Recall # B-0722-08; 
b) Platelets Leukocytes Reduced, Recall # B-0723-08
ODE
a) and b) Units: 19GH76642, 19GH77675, 19LF27853, 19LF29189
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by letter dated June 13, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
TN, KY, PR
___________________________________
PRODUCT
Blood Cells Leukocytes Reduced, Recall # B-0724- 08
CODE
Units: W045006059874, W045006084874
RECALLING FIRM/MANUFACTURER
Community Blood Center of Greater Kansas City, Kansas City, MO, by telephone and by letter dated October 24, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
KS, MO
___________________________________
PRODUCT
a) Red Blood Cells (Apheresis), Recall # B-0725-08;
b) Platelets Pheresis Leukocytes Reduced, Recall # B-0726-08
CODE
a) Units: 004GC19062, 004GC22321;
b) Units: 004GC22321 (Parts 1 & 2), 004GC19106 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by facsimile and letters dated August 11, 2007.  Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
MA, NY
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0727-08
CODE
Units: 197533008 (2 units)
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Reno, NV, by letter dated October 12, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who lived in an area with increased risk for human immunodeficiency virus (HIV) Group O, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NV
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0728-08
CODE
Units: 012GH34518, 12KQ56982
RECALLING FIRM/MANUFACTURER
American Red Cross Carolinas Blood Services Region, Charlotte, NC, by telephone on September 28, 2006 and by letter dated October 6, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA and NC
___________________________________
PRODUCT
Platelets, Recall # B-0734-08
CODE
Unit: 1239471
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter dated December 22, 2004. Firm initiated recall is complete.
REASON
Blood product, associated with a red cell unit that contained a clot, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0735-08
CODE
Unit: 1266160
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter dated March 8, 2005. Firm initiated recall is complete.
REASON
Blood product, associated with a red cell unit that contained a clot, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0736-08
CODE
Unit: 1272308
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter dated March 29, 2005. Firm initiated recall is complete.
REASON
Blood product, associated with a red cell unit that contained a clot, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0738-08
CODE
Unit: LL67342
RECALLING FIRM/MANUFACTURER
Rhode Island Blood Center, Providence, RI, by letter dated September 18, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0739-08
CODE
Unit: LG58930
RECALLING FIRM/MANUFACTURER
Rhode Island Blood Center, Providence, RI, by letter on September 27, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
RI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0740-08
CODE
Unit: LM43626
RECALLING FIRM/MANUFACTURER
Rhode Island Blood Center, Providence, RI, by telephone on September 22, 2007 and follow up letter on September 26, 2007. Firm initiated recall is complete.
REASON
Blood product, prepared without the appropriate amount of additive (Adsol), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
RI
___________________________________
PRODUCT
Source Plasma, Recall # B-0748-08
CODE
Units: 0370129450, 0370129889, 0370130601, 0370131169, 0370131770, 0370132516, 0370133554, 0370134046, 0370151229, and 0370151765
RECALLING FIRM/MANUFACTURER
Biomat USA Inc., Toledo, OH, by facsimile on July 26, 2006. Firm initiated recall is complete.
 REASON
Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
Spain and CA

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS III

___________________________________
PRODUCT
Recovered Plasma, Recall # B-0425-08
CODE
Unit: 55S55386
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR, by letter and electronic mail dated February 12, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a gender discrepancy on his registration card, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AR, CA
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0445-08
CODE
Unit: 004GE03469 (2 units)
RECALLING FIRM/MANUFACTURER
Recalling Firm: ARC Blood Services, New England Region, Dedham, MA, by letter dated March 5, 2007.
Manufacturer: The American National Red Cross ARC Blood Service New England Region, Worcester, MA. Firm initiated recall is complete.
REASON
Blood products, for which the sterility may have been compromised, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MA
___________________________________
PRODUCT
Blood Grouping Reagent anti-Le(a) (LE1) (Murine Monoclonal) BioClone 2.0. for tube test; Qualitative Test for recognition of the Le(a) (LE1) antigen on human Red Blood Cells. for in vitro diagnostic use; Meets FDA Potency requirements. Ortho Clinical Diagnostics, Recall # B-0446-08
CODE
DOMESTIC: Product code 715280; LAB129A; exp. 03/10/08; LAB130A; exp 06/29/08; LAB131A; exp. 12/27/08;
INTERNATIONAL: Product Code 6901859; LAB129AX; exp. 3/10/08; LAB130AX; exp/ 06/29/08: LAB131AX; exp. 12/27/08
RECALLING FIRM/MANUFACTURER
Ortho Clinical Diagnostics Inc., Raritan, NJ, by letter on October 30 and November 2, 2007. Firm initiated recall is complete.
REASON
Reagent Anti Le(a) BioClone 2.0, with reports of weakened reactivity or false negative reaction when using specific lots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2,851 kits
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Panoscreen 3.10mL vial, Reagent Red Blood Cells, Recall # B-0482-08
CODE
Lot number 03954, Expiration 2006-03-17
RECALLING FIRM/MANUFACTURER
Immucor, Inc., Norcross, GA, by letter and fax on/about March 8, 2006. Firm initiated recall is complete.
REASON
Blood Bank reagent screening cells, which may produce unexpected positive reactions at the Anti-Human Globulin phase of testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
256 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0607-08
CODE
Unit: 019FZ18167
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by fax on May 16, 2006. Firm initiated recall is complete.
REASON
Blood product, incorrectly identified as negative for the e antigen, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0615-08
CODE
Unit: 71R422631
RECALLING FIRM/MANUFACTURER
Lifesouth Community Blood Centers Inc., Birmingham Region, Birmingham, AL, by fax on December 9, 2005. Firm initiated recall is complete.
REASON
Blood component, processed from Whole Blood more than 8 hours after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0676-08
CODE
Unit: 5421874
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, Inc., Long Island City, NY, by telephone and letter on January 4, 2006 and facsimile on January 11, 2006.
Manufacturer: New York Blood Center, Inc., Westbury, NY. 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
NY
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0680-08
CODE
Unit: 22FR03446
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by letter and e-mail 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, Recall # B-0684-08
CODE
Unit: 1299403
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter dated July 15, 2005. Firm initiated recall is complete.
REASON
Blood product, associated with a plasma component that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN
___________________________________
PRODUCT
a) Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated Recall # B-0687-08;
b) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0688-08
CODE
a) Unit: 230087183;
b) Units: 230086401; 230087002; 230086022; 163850358; 163850354
RECALLING FIRM/MANUFACTURER
Blood Systems Inc/dba United Blood Services, Meridian, MS, by letter dated September 28, 2005. Firm initiated recall is complete.
REASON
Blood product, documented as being out of controlled storage for more than 30 minutes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
MS
_______________________________
PRODUCT
Recovered Plasma, Recall # B-690-08
CODE
Unit: 22KV55764
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by fax and e-mail on August 1, 2007 and by letter dated August 7, 2007 and September 6, 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
Switzerland
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0694-08
CODE
Unit: 49KK03476
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross SW Region – HT, Tulsa, OK, by telephone on October 14, 2005.
Manufacturer: American Red Cross Blood Services, SW Region, College Station, TX. 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
TX
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0697-08
CODE
Unit: 12GE87785
RECALLING FIRM/MANUFACTURER
American Red Cross Carolinas Blood Services Region, Charlotte, NC, by telephone or electronic notification on September 20, 2007 and by letter dated October 1, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC and CA
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0708-08
CODE
Unit: 1311085
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by telephone on June 6, 2005. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which an associated blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0709-08
CODE
Unit: 1271692
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter dated June 21, 2005. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which an associated blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0733-08
CODE
Unit: 71T69176X
RECALLING FIRM/MANUFACTURER
Lifesouth Community Blood Centers Inc., Birmingham Region, Birmingham, AL, by telephone on October 13, 2006. Firm initiated recall is complete.
REASON
Blood product, which was labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0737-08
CODE
Unit: 041FY46336
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by telephone on November 22, 2004 and by letter on November 23, 2004.
Manufacturer: American Red Cross Blood Services, Montgomery, AL. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom there was no documentation on the donor record of an arm inspection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0747-08
CODE
Unit: 1260256
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter and telephone on January 14, 2005. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which an associated blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS I

___________________________________
PRODUCT
a) Sierra Pre-Filled, Heparin Lock Flush Solution USP, 100 units/ml in 0.9% Sodium
    Chloride 120/Case, Catalog #1003-01, NDC #64054-1003-01, 3 mL Fill in a 12mL
    Syringe, For Single Use only, Sterile Solution Pathway, For IV Flush,
    Recall # Z-0827-2008;
b) Sierra Pre-Filled, Heparin Lock Flush Solution USP, 100 units/ml in 0.9% Sodium
    Chloride 120/Case, Catalog #1003-02, NDC #64054-1003-02, 5 mL Fill in a 12mL
    Syringe, For Single Use only, Sterile Solution Pathway, For IV Flush,
    Recall # Z-0828-2008;
c) B. Braun, Heparin Lock Flush Solution USP, 100 units/ml, 120/Case, Ref #513611,
    NDC #64054-1003-01, 3 mL Fill in a 12mL Syringe, For Single Use only, Sterile
    Solution Pathway, For IV Flush, Recall # Z-0829-2008;
d) Braun, Heparin Lock Flush Solution USP, 100 units/ml, 120/Case, Ref #513612,
    NDC #64054-1003-02, 5 mL Fill in a 12mL Syringe, For Single Use only, Sterile
    Solution Pathway, For IV Flush, Recall # Z-0830-2008;
e) Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0903-12, NDC #64054-0903-2,
    3 mL Fill in a 12mL Syringe, 0.9% Sodium Chloride Injection USP, 120/Case, For
    Single Use only, Sterile Solution Pathway, For IV Flush, Recall # Z-0831-2008;
f) Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0905-12, NDC #64054-0905-2,
    5 mL Fill in a 12mL Syringe, 0.9% Sodium Chloride Injection USP, 120/Case, For
    Single Use Only, Rx only, Sterile Solution Pathway, For IV Flush, Recall # Z-0832-
    2008;
g) Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0910-12, NDC #64054-0910-2,
    10 mL Fill in a 12mL Syringe, 0.9% Sodium Chloride Injection USP, 120/Case, For
    Single Use only, Sterile Solution Pathway, For IV Flush, Recall # Z-0833-2008;
h) B. Braun, Normal Saline IV Flush, REF #513584, NDC 64054-0903-2, 3 mL fill in a
    12mL syringe, 120/Case, Single Use Only, Rx Only, Recall # Z-0834-2008;
i) B. Braun, Normal Saline IV Flush, REF #513586, NDC 64054-0905-02, 5 mL fill in a
    12mL syringe, 120/Case, Single Use Only, Rx Only, Recall # Z-0835-2008;
j) B. Braun, Normal Saline IV Flush, REF #513587, NDC 64054-0910-2, 10 mL fill in a
    12mL syringe, 120/Case, Single Use Only, Rx Only, Recall # Z-0836-2008;
k) Sierra Pre-Filled, Heparin Lock Flush Solution USP, 10 units/ml, Catalog #3005-02,
    NDC #64054-3005-02, 5mL Fill in a 12mL Syringe, 120/Case, For Single Use only,
    Sterile Solution Pathway, For IV Flush, Recall # Z-0837-2008;
l) B. Braun, Heparin Lock Flush Solution USP, 10 units/ml, Ref #513610, NDC #64054-
   3005-02, 5mL Fill in a 12mL Syringe, 120/Case, For Single Use only, Sterile Solution
    Pathway, For IV Flush, Recall # Z-0838-2008;
m) Sierra Pre-Filled, Heparin Lock Flush Solution USP, 10 units/ml, Catalog #3003-02,
    NDC #64054-3003-02, 3mL Fill in a 12mL Syringe, 120/Case, For Single Use only,
    Sterile Solution Pathway, For IV Flush, Recall # Z-0839-2008;
n) Sierra Pre-Filled, Heparin Lock Flush Solution USP, 10 units/ml, Catalog #3003-06,
    NDC #64054-3003-06, 3mL Fill in a 6mL Syringe, 120/Case, For Single Use only,
    Sterile Solution Pathway, For IV Flush, Recall # Z-0840-2008;
o) Sierra Pre-Filled, Heparin Lock Flush Solution USP, 10 units/ml, Catalog #3005-06,
    NDC #64054-3005-06, 5mL Fill in a 6mL Syringe, 120/Case, For Single Use only,
    Sterile Solution Pathway, For IV Flush, Recall # Z-0841-2008;
CODE
All lots
RECALLING FIRM/MANUFACTURER
AM2 PAT Inc., Angier, NC, by telephone on or about January 17, 2008 and by press release on January 17, 2008. Firm initiated recall is ongoing.
REASON
Lack of assurance of sterility by manufacturer.
VOLUME OF PRODUCT IN COMMERCE
618 cases
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II

___________________________________
PRODUCT
Philips Page Writer Touch Cardiograph, Model: 860284, Recall # Z-0124-2008
CODE
Serial Numbers: US10603477 US60711180 US70711234 US80711276 US80711348 US80711386 US80711459 US10603478 US60711181 US70711235 US80711283 US80711349 US80711387 US80711460 US10603491 US60711182 US70711236 US80711284 US80711350 US80711388 US80711461 US10603493 US60711183 US70711241 US80711285 US80711351 US80711389 US80711462 US10603494 US60711184 US80503039 US80711286 US80711352 US80711390 US80711463 US10603495 US60711185 US80503049 US80711287 US80711353 US80711391 US90503082 US10603496 US60711186 US80711244 US80711288 US80711354 US80711392 US90503117 US10603497 US70711197 US80711245 US80711289 US80711355 US80711393 US90503119 US10603498 US70711199 US80711246 US80711290 US80711356 US80711394 US90503120 US10603499 US70711201 US80711247 US80711291 US80711357 US80711395 US90503121 US10603530 US70711205 US80711248 US80711292 US80711358 US80711396 US90503126 US10710463 US70711207 US80711249 US80711293 US80711359 US80711398 US90503127 US10710464 US70711208 US80711250 US80711294 US80711360 US80711399 US90503128 US10710465 US70711209 US80711251 US80711295 US80711361 US80711400 US90503129 US50502760 US70711210 US80711252 US80711296 US80711362 US80711402 US90503143 US50710968 US70711211 US80711253 US80711297 US80711363 US80711403 US90503148 US60502824 US70711212 US80711254 US80711298 US80711364 US80711404 US90503149 US60502825 US70711213 US80711255 US80711299 US80711365 US80711405 US90503150 US60502826 US70711214 US80711256 US80711300 US80711366 US80711406 US90503151 US60711064 US70711215 US80711257 US80711301 US80711367 US80711407 US90503152 US60711065 US70711216 US80711258 US80711302 US80711368 US80711408 US90503153 US60711067 US70711217 US80711259 US80711303 US80711369 US80711409 US90503154 US60711068 US70711218 US80711260 US80711304 US80711370 US80711411 US90503155 US60711070 US70711219 US80711261 US80711305 US80711371 US80711412 US90503156 US60711071 US70711220 US80711262 US80711306 US80711372 US80711413 US90503157 US60711073 US70711221 US80711263 US80711307 US80711373 US80711416 US90503158 US60711074 US70711222 US80711264 US80711308 US80711374 US80711417 US90503159 US60711075 US70711223 US80711265 US80711309 US80711375 US80711418 USD0301315 US60711076 US70711224 US80711266 US80711310 US80711376 US80711419 USD0610313 US60711077 US70711225 US80711267 US80711339 US80711377 US80711420 USN0301134 US60711078 US70711226 US80711268 US80711340 US80711378 US80711421 USN0400155 US60711079 US70711227 US80711269 US80711341 US80711379 US80711422 USN0402121 US60711080 US70711228 US80711270 US80711342 US80711380 US80711431 USN0402126 US60711081 US70711229 US80711271 US80711343 US80711381 US80711439 USN0402127 US60711176 US70711230 US80711272 US80711344 US80711382 US80711440 USN0402128 US60711177 US70711231 US80711273 US80711345 US80711383 US80711455 USN0402129 US60711178 US70711232 US80711274 US80711346 US80711384 US80711457 USN0610295 US60711179 US70711233 US80711275 US80711347 US80711385 US80711458 USO0610104
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Andover, MA, by letter dated September 12, 2007. Firm initiated recall is ongoing.
REASON
Incorrect display: When using the 16 lead Patient Interface Module (PIM), lead tracings of V3R and V4R are reversed in the extended lead modes of Pediatric and Balanced.
VOLUME OF PRODUCT IN COMMERCE
266 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Siemans Simview 3000 Cassette Holder Electronic Imaging device (Image Identifier),
    with CT Part No: 19 57-161 or without CT Part No. 19 57 153, Recall # Z-0281-2008;
b) Siemans Simview NT Cassette Holder Electronic Imaging Device (Image Identifier)
    Part No. 54 96 992,  Recall # Z-0282-2008;
c) Siemans Simview NT Cassette Holder Electronic Imaging Device (Image Identifier)
    with CT, Part No: 54 96 984; Recall # Z-0283-2008;
d) Siemans Simview NT Cassette Holder Electronic Imaging Device (Image Identifier)
    with IDI, Part No: 54 97 016, Recall # Z-0284-2008;
e) Siemans Mevasim, with patient table, Part No: 44 81 586, and without patient table
    Part No: 44-81-669, Recall # Z-0285-2008
CODE
a) Serial Numbers: 4164, 4062, 4114, 4037, 4155, 4125, 4180, 4096, 4064, 4107, 4145,
    4144, 4143, 4081, 4172, 4152, 4090, 4161, 4181, 4093, 4066, 4054, 4091, 4068,
    4128, 4179, 4019, 4023, 4117, 4094, 4015, 4083, 4174, 4074, 4082, 4011, 4078,
    4034, 4063, 4025, 4171, 4086, , 4134, 4029, 4002, 4003, 4004, 4027, 4053, 4061,
    4118, 4123, 4124, 4008, 4009, 4010, 4014, 4016, 4017, 4021, 4022, 4024, 4026,
    4031, 4032, 4035, 4043, 4059, 4072, 4075, 4076, 4078, 4085, 4087, 4092, 4095,
    4098, 4102, 4104, 4105, 4108, 4109, 4110, 4111, 4112, 4115, 4116, 4130, 4136,
    4142, 4150, 4153, 4156, 4173, 70001004511, 40000296842, 4099, 4147, 4100,
    4154, 4044, 4119, 4121, 4122, 4131, 4139, 4185, 4020, 4030, 4036, 4079, 4135,
    4167, 4077, 4039, 4071, 4120, 41514127, 4176, 4097, 4049, 4046, 4070, 4084,
    4138, 4160, 4165, 4028, 4042, 4101, 410, 4158, 4045, 4065, 4060, 4088, 4177,
    4073, 4113, 4175, 4141, 4040, 4137, and 4052;
b) Serial Numbers: 6032, 6005, 6068, 6035, 6046, 6012, 6080, 6019, 6029, 6021,
    6024, 6025, 6053, 6060, 6015, 6059, 6002, 6004, 6007, 6011, 6014, 6023, 6030,
    6042, 6049, 6062, 4190, 6033, 6039, 6061, 6086, 6056, 6028, 3654, 6020, 6069,
    6085, 6088, 6095, 6103, 6104, 6070, 6099-1, 6048, 6006, 1236, 6092, and 6054;
c) Serial Numbers: 6013, 6003, 6078, and 6676;
d) Serial Numbers: 6018, 6001, 6008, 6067, 6037, 6038, 6059, 6041, 6047, 6017, 6027,
    6036, 6040, 6050, 1256, 6082, 6056, 6064, 6083, 6034, 6044, 6055, 6058, 6028,
    6090, 6105, 2255, 6079, 6089, 6073, 6052, 6077, 6072, and 6066
e) All Serial Numbers (1182 and higher): 1501, 1516, 1213, 1225, 1200, 1518, 1201,
    1520, 1246, 1228, 1197, 1202, 1224, 1231, 1191, 1184, and 1506, "MEVASIM",
    Serial Numbers (1182 and higher): 1204, 1192, 1216, 1502, 1230, 1220, 1209, 1233,
    1510, 1241, 1194, 1514, 1523, 1212, 1222, 1252, 2012, 2010-335-217, 1249,
    4000296842, S1144, 01069H400, 1503, 1517, 1251, 1238, 1274, 1509, and 1519
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Concord, CA, by letter on February 27, 2007. Firm initiated recall is ongoing.
REASON
Loose Mounting Screws -- Cassette holder may become loose and result in the device dislodging and colliding with the patient.
VOLUME OF PRODUCT IN COMMERCE
287 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Philips Medical Systems, GEMINI TF 16 & 64 slice PET/CT Systems, diagnostic
    imaging systems for fixed or mobile installations that combine Positron Emission
    Tomography (PET) and X-ray Computed Tomography (CT) systems, Gemini TF
    Product Numbers/Manufacturer Numbers: TF 64 slice: 4535 679 94741, TF 16 slice:
    4535 679 83931. Catalog Numbers: TF 64 slice: 882471, TF 16 slice: 882470,
    Recall # Z-0461-2008;
b) Philips Medical Systems, GEMINI GXL 6, 10, & 16 slice PET/CT Systems,
    diagnostic imaging systems for fixed or mobile installations that combine Positron
    Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
    Gemini GXL Product Numbers/Manufacturer Numbers: 16 slice: 4535 679 71891,
    10 slice: 4535 679 75681, 6 slice: 4535 679 75691. Catalog Numbers: 16 slice:
    882410, 10 slice: 882400, 6 slice: 882390. Recall # Z-0462-2008
CODE
a) Serial Numbers: 7001-7058, 7062, 7064, and 7066;
b) Serial Numbers: 4034-4159
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated May 30, 2007. Firm initiated recall is ongoing.
REASON
Artifacts: Artifacts may appear in some images from head scans on the CT subsystem of the GEMINI PET/CT system. Reading images with these artifacts may lead to misdiagnosis or improper treatment.
VOLUME OF PRODUCT IN COMMERCE
187 Systems
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Hallmark Anterior Cervical Plate System: Primary Bone Screw, Semi Constrained, REF # 62-3140,14mm; (The Hallmark Anterior Cervical Plate Systems consists of an assortment of implantable titanium alloy plates and bone screws that are provided non-sterile), Recall # Z-0478-2008
CODE
All Lots (Primary semi-contained rescue Screws: P/N's 62-3100 through 62-3180 and rescue simi-constrained bone screws P/N's 62-4100- 62-4180)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blackstone Medical, Inc., Wayne, NJ, by telephone, e-mail and fax On May 8, 2006.
Manufacturer: Blackstone Medical Inc., Springfield, MA. Firm initiated recall is complete.
REASON
Incomplete Design Validation: the laser marking on the head of the screw lacked complete process qualification
VOLUME OF PRODUCT IN COMMERCE
1,991 systems
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Vital Images ViTALConnect, Version 4.0 and 4.1, PET/CT Visualization option. (A web-based medical diagnostic tool that allows physicians to use PCs or notebook computers to gain remote access to 2D, 3D, and 4D advanced visualization. The software enables users to measure, rotate, and analyze images), Recall # Z-0520-2008
CODE
Versions 4.0 and 4.1 (PET/CT Visualization option in VITALConnent)
RECALLING FIRM/MANUFACTURER
Vital Images, Inc., Plymouth, MN, by telephone on November 7/8, 2008 and by letter November 8, 2007. Firm initiated recall is ongoing.
REASON
Standard Uptake Values (SUV) display/update problems; in the way Standard Uptake Values (SUV) are displayed in 3D/MPR views. The problem arises when a user draws a selected region of interest in order to calculate the SUV statistics of the region. If the user then changes the slice shown by scrolling through additional slices, the original SUV measurements will remain on the screen and do not update with new values for the current slice.
VOLUME OF PRODUCT IN COMMERCE
18 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) life+cel Replacement Battery for Cardiac Science Powerheart AED G3 OEM P/N:
    9146-001, Lithium Sulfur Dioxide, Part # 7L877, Voltage 12V, 7.5 amps;
    Recall #Z-0521-2008;
b) life+cel, Replacement battery for Cardiac Science FirstSave Survivalink; OEM
    P/N: 9141-001, Part #: 2L561, Lithium Sulfur Dioxide, Voltage 12V, 7.5 amps.,
    Recall # Z-0522-2008
CODE
All Serial Numbers
RECALLING FIRM/MANUFACTURER
Exocomm Tech Group, Cumming, GA, by letter on September 3, 2007 and October 25, 2007. Firm initiated recall is ongoing.
REASON
Marketed without a 510K
VOLUME OF PRODUCT IN COMMERCE
266 batteries Part # 2L561; 46 batteries Part # 7L877
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Baxter RenalSoft v.2.0 Patient Management Software Suite - HD Module;
    clinical data management software, Recall # Z-0527-2008;
b) Baxter Renal Software Suite v.3.0 and v.3.1 - Renal Link HD Module; clinical data
    management software; Recall # Z-0528-2008
CODE
a) Serial Numbers 17023766 to 17026503;
b) All Serial Numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Renal Division, McGraw Park, IL, by letter, dated November 14, 2007.
Manufacturer: Baxter Healthcare Corporation, Largo, FL. Firm initiated recall is ongoing.
REASON
Pre-Treatment/Post-Treatment Report errors: 1) The Heparin Bolus Value is displayed on Pre and Post Treatment Reports for patients with "No Heparin" orders (RenalSoft v2.0, Renal Software Suite v.3.0 and v.3.1), and 2) Withheld Medications are incorrectly displayed as Administered on the Pre-Treatment report (RenalSoft v.2.0 only).
VOLUME OF PRODUCT IN COMMERCE
73 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Varian Real-Time Position Management System (RPM), A Respiratory Gating System; Version 1.7.3, All Models, Recall # Z-0554-2008
CODE
Serial Number: H502244, H502211, H502203, H502183, H502179, H502178, H502169, H502167, H502166, H502154, H502152, H502138, H502137, H502136, H502133, H502132, H502131, H502130, H502126, H502121, H502119, H502118, H502117, H502116, H502112, H502110, H502107, H502104, H502103, H502102, H502096, H502060, H502057, H502045, H502002, H501999, H501983, H501930, H501907, H501904, H501869, H501838, H501577, H501412, H501367, H501329, H501325, H501306, H501290, H501259, H501246, H501222, H501214, H502051, H502067, H500395, H500406, H500853, and H502066
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc., Palo Alto, CA, by letter on September 26, 2007. Firm initiated recall is ongoing.
REASON
Erroneously Resetting: RPM System version 1.7.3, software failure can occur that affects the gated radiotherapy treatment when phase-based gating is used. RPM 1.7 erroneously resets the phase-based gating thresholds to system default during the treatment session, if the user accesses the Session options during the treatment session. This can lead to difference between the planned and delivered dose distribution for the treatment fraction accepted.
VOLUME OF PRODUCT IN COMMERCE
59 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Ethicon Endopath 5 mm Curved Dissector with Monopolar Cautery, Product Code: 5DCD, Recall # Z-0565-2008
CODE
Lot No: D4HZ9Y
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ethicon Endo-Surgery Inc., Cincinnati, OH, by letter on or about November 15, 2007.
Manufacturer: Ethicon Endo-Surgery, Inc. S.A. de C.V. Planta II, Ciudad Juarez, Chihuahua, Mexico. Firm initiated recall is ongoing.
REASON
Sterility (package integrity) compromised; damaged packaging may have compromised the sterility of the devices.
VOLUME OF PRODUCT IN COMMERCE
2,844 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Datascope CS 100 Intra-Aortic Balloon Pump and Datascope CS 300 Intra-Aortic Balloon Pump, Recall # Z-0567-2008
CODE
Serial Numbers: S805991-C2 S805993-C2 SA02504-C4 S806332-G2 S82934-H9 SA03941-F5 S82416-D9 S805969-C2 S806909-B3 S806924-B3 SA03395-A5 SA03407-A5 SI101373-H7 S805404-H1 S81758-K8 S807356-F3 S807013-C3 S806289-F2 S806308-G2 S806282-F2 S806306-G2 S806284-F2 S806292-F2 S806297-G2 SA04871-A6 S806286-F2 S806926-B3 S804246-J0 S805797-A2 S804934-D1 S806155-E2 SI101367-H7 SI100417-H7 S807506-J3 S807042-C3 S81471-I8 SA02801-G4 S8233778-E0 S82518-E9 S803467-B0 SA03469-B5 S806229-F2 S804255-J0 S806193-E2 S806025-D2 S806012-D2 S806019-D2 S806045-D2 S806017-D2 S806024-D2 S805992-C2 S806009-D2 S805581-I1 S82350-C9 S804783-B1 S804793-B1 S804799-B1 S806859-A3 SA01430-A4 SA01152-I3 SA01421-A4 SA01412-A4 S803857-F0 S803775-E0 SA02521-D4 SI01410-E7 S807446-G3 S807470-H3 S806225-F2 and S806259-F2 (These serial numbers do not differentiate between CS100 and CS300, just the board contained within.)
RECALLING FIRM/MANUFACTURER
Datascope Corp., Mahwah, NJ, by letters on November 19, 2007. Firm initiated recall is ongoing.
REASON
Defective Circuit Board -- A defect in the Printed Circuit Board's (PCB) in the CS 100 and CS300 Intra-Aortic Balloon Pump may cause the pump to exhibit intermittent malfunctions, which include failure to start-up or reset of the display screen during therapy.
VOLUME OF PRODUCT IN COMMERCE
101 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) da Vinci S Surgical System 8 mm instrument cannula, Part #: 420002-01,
    Recall # Z-0657-2008
b) da Vinci S Surgical System 8 mm Long instrument cannula, Part #:420004-01,
    Recall # Z-0658-2008;
c) da Vinci S Surgical System 5 mm instrument cannula, Part #: 420011-01,
    Recall # Z-0659-2008
CODE
a) Lot umbers SA054701, SA055201, SA 060803, SA061001, SA061301, SA062001,
    SA062502, SA62901, SA063302;
b) Lot numbers SA054702, SA060504, SA062801, SA062104;
c) Lot # SA061101
RECALLING FIRM/MANUFACTURER
Intuitive Surgical, Inc., Sunnyvale, CA, by letter on March 9, 2007. Firm initiated recall is ongoing.
REASON
Devices may have a ridge on the side of the cannula, which has the potential to abrade instrument shafts and generate black particulate matter.
VOLUME OF PRODUCT IN COMMERCE
896 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Spacelabs Medical, Ultraview Multigas Analyzer, Model 91518, Recall # Z-0660-2008
CODE
1518-000511, 1518-000512, 1518-000080, 1518-000079, 1518-000078, 1518-000077, 1518-000074, 1518-000073, 1518-000071, 1518-000072, 1518-000028, 1518-000086, 1518-000083, 1518-000048, 1518-000015, 1518-000012, 1518-000011, 1518-000009, 1518-000065, 1518-000020, 1518-000022, 1518-000066, 1518-000068, 1518-000492, 1518-000473, 1518-000476, 1518-000483, 1518-000482, 1518-000481, 1518-000480, 1518-000479, 1518-000478, 1518-000477, 1518-000474, 1518-000467, 1518-000472, 1518-000471, 1518-000470, 1518-000469, 1518-000468, 1518-000475, 1518-000634, 1518-000562, 1518-000588, 1518-000589, 1518-000590, 1518-000591, 1518-000592, 1518-000593, 1518-000594, 1518-000595, 1518-000602, 1518-000603, 1518-000609, 1518-000610, 1518-000587, 1518-000597, 1518-000574, 1518-000584, 1518-000561, 1518-000564, 1518-000563, 1518-000565, 1518-000566, 1518-000573, 1518-000575, 1518-000576, 1518-000577, 1518-000578, 1518-000582, 1518-000583, 1518-000567, 1518-000145, 1518-000144, 1518-000143, 1518-000142, 1518-000281, 1518-000286, 1518-000282, 1518-000283, 1518-000278, 1518-000285, 1518-000277, 1518-000276, 1518-000275, 1518-000280, 1518-000521, 1518-000522, 1518-000598, 1518-000119, 1518-000664, 1518-000659, 1518-000660, 1518-000661, 1518-000662, 1518-000663, 1518-000665, 1518-000667, 1518-000668, 1518-000658, 1518-000669, 1518-000666, 1518-000656, 1518-000655, 1518-000654, 1518-000653, 1518-000650, 1518-000649, 1518-000648, 1518-000647, 1518-000645, 1518-000635, 1518-000633, 1518-000657, 1518-000713, 1518-000709, 1518-000714, 1518-000712, 1518-000711, 1518-000710, 1518-000707, 1518-000706, 1518-000705, 1518-000704, 1518-000703, 1518-000708, 1518-000039, 1518-000059, 1518-000056, 1518-000053, 1518-000052, 1518-000051, 1518-000049, 1518-000041, 1518-000032, 1518-000047, 1518-000254, 1518-000257, 1518-000263, 1518-000265, 1518-000272, 1518-000273, 1518-000220, 1518-000672, 1518-000623, 1518-000622, 1518-000632, 1518-000631, 1518-000630, 1518-000629, 1518-000627, 1518-000626, 1518-000624, 1518-000613, 1518-000621, 1518-000606, 1518-000612, 1518-000614, 1518-000617, 1518-000625, 1518-000619, 1518-000604, 1518-000620, 1518-000611, 1518-000445, 1518-000448, 1518-000447, 1518-000446, 1518-000267, 1518-000271, 1518-000227, 1518-000646, 1518-000682, 1518-000558, 1518-000559, 1518-000556, 1518-000557, 1518-000560, 1518-000382, 1518-000393, 1518-000384, 1518-000394, 1518-000383, 1518-000691, 1518-000689, 1518-000690, 1518-000308, 1518-000309, 1518-000179, 1518-000165, 1518-000174, 1518-000177, 1518-000178, 1518-000180, 1518-000182, 1518-000184, 1518-000185, 1518-000188, 1518-000173, 1518-000186, 1518-000170, 1518-000166, 1518-000167, 1518-000164, 1518-000163, 1518-000162, 1518-000161, 1518-000160, 1518-000159, 1518-000158, 1518-000171, 1518-000216, 1518-000335, 1518-000340, 1518-000341, 1518-000342, 1518-000343, 1518-000332, 1518-000358, 1518-000353, 1518-000517, 1518-000520, 1518-000518, 1518-000516, 1518-000509, 1518-000506, 1518-000508, 1518-000519, 1518-000507, 1518-000515, 1518-000168, 1518-000266, 1518-000268, 1518-000312, 1518-000310, 1518-000311, 1518-000386, 1518-000387, 1518-000388, 1518-000540, 1518-000542, 1518-000541, 1518-000535, 1518-000538, 1518-000536, 1518-000539, 1518-000537, 1518-000581, 1518-000579, 1518-000729, 1518-000730, 1518-000671, 1518-000670, 1518-000046, 1518-000084, 1518-000081, 1518-000076, 1518-000075, 1518-000055, 1518-000030, 1518-000067, 1518-000398, 1518-000451, 1518-000370, 1518-000375, 1518-000374, 1518-000373, 1518-000371, 1518-000369, 1518-000368, 1518-000367, 1518-000361, 1518-000359, 1518-000372, 1518-000360, 1518-000366, 1518-000362, 1518-000363, 1518-000364, 1518-000365, 1518-000427, 1518-000434, 1518-000457, 1518-000450, 1518-000454, 1518-000616, 1518-000157, 1518-000155, 1518-000156, 1518-000738, 1518-000743, 1518-000742, 1518-000741, 1518-000739, 1518-000737, 1518-000736, 1518-000735, 1518-000734, 1518-000733, 1518-000732, 1518-000740, 1518-000452, 1518-000453, 1518-000489, 1518-000596, 1518-000608, 1518-000599, 1518-000600, 1518-000247, 1518-000529, 1518-000534, 1518-000533, 1518-000532, 1518-000531, 1518-000528, 1518-000527, 1518-000526, 1518-000525, 1518-000524, 1518-000523, 1518-000530, 1518-000435, 1518-000436, 1518-000125, 1518-000129, 1518-000130, 1518-000132, 1518-000462, 1518-000336, 1518-000337, 1518-000510, 1518-000605, 1517-000605, 1518-000683, 1518-000684, 1518-000195, 1518-000206, 1518-000205, 1518-000181, 1518-000203, 1518-000207, 1518-000200, 1518-000199, 1518-000198, 1518-000197, 1518-000196, 1518-000194, 1518-000193, 1518-000192, 1518-000191, 1518-000190, 1518-000189, 1518-000183, 1518-000175, 1518-000172, 1518-000187, 1518-000301, 1518-000304, 1518-000303, 1518-000215, 1518-000319, 1518-000400, 1518-000376, 1518-000317, 1518-000318, 1518-000322, 1518-000323, 1518-000325, 1518-000035, 1518-000009, 1518-000485, 1518-000002, 1518-000035, 1518-000033, 1518-000005, 1518-000006, 1518-000023, 1518-000062, 1518-000235, 1518-000238, 1518-000234, 1518-000232, 1518-000233, 1518-000231, 1518-000243, 1518-000440, 1518-000449, 1518-000685, 1518-000328, 1518-000324, 1518-000219, 1518-000217, 1518-000218, 1518-000331, 1518-000333, 1518-000334, 1518-000403, 1518-000404, 1518-000406, 1518-000402, 1518-000442, 1518-000443, 1518-000493, 1518-000503, 1518-000504, 1518-000502, 1518-000651, 1518-000652, 1518-000720, 1518-000721, 1518-000464, 1518-000465, 1518-000466, 1518-000488, 1518-000057, 1518-000048, 1518-000636, 1518-000637, 1518-000120, 1518-000124, 1518-000123, 1518-000121, 1518-000122, 1518-000038, 1518-000040, 1518-000043, 1518-000044, 1518-000050, 1518-000036, 1518-000013, 1518-000045, 1518-000029, 1518-000024, 1518-000016, 1518-000008, 1518-000003, 1518-000034, 1518-000019, 1518-000349, 1518-000354, 1518-000355, 1518-000389, 1518-000397, 1518-000399, 1518-000110, 1518-000111, 1518-000380, 1518-000264, 1518-000293, 1518-000292, 1518-000294, 1518-000295, 1518-000296, 1518-000297, 1518-000356, 1518-000357, 1518-000225, 1518-000245, 1518-000226, 1518-000223, 1518-000222, 1518-000228, 1518-000113, 1518-000114, 1518-000385, 1518-000313, 1518-000314, 1518-000112, 1518-000105, 1518-000102, 1518-000103, 1518-000458, 1518-000459, 1518-000460, 1518-000461, 1518-000463, 1518-000007, 1518-000001, 1518-000063, 1518-000061, 1518-000069, 1518-000070, 1518-000099, 1518-000100, 1518-000101, 1518-000134, 1518-000135, 1518-000136, 1518-000137, 1518-000344, 1518-000345, 1518-000455, 1518-000456, 1518-000496, 1518-000497, 1518-000495, 1518-000699, 1518-000701, 1518-000700, 1518-000697, 1518-000696, 1518-000695, 1518-000698, 1518-000702, 1518-000126, 1518-000128, 1518-000484, 1518-000487, 1518-000486, 1518-000116, 1518-000117, 1518-000118, 1518-000291, 1518-000688, 1518-000692, 1518-000693, 1518-000694, 1518-000339, 1518-000543, 1518-000544, 1518-000545, 1518-000580, 1518-000585, 1518-000586, 1518-000601, 1518-000607, 1518-000133, 1518-000139, 1518-000140, 1518-000141, 1518-000726, 1518-000727, 1518-000444, 1518-000209, 1518-000210, 1518-000211, 1518-000213, 1518-000299, 1518-000437, 1518-000438, 1518-000439, 1518-000302, 1518-000115, 1518-000138, 1518-000298, 1518-000628, 1518-000131, 1518-000262, 1518-000244, 1518-000248, 1518-000249, 1518-000252, 1518-000253, 1518-000255, 1518-000256, 1518-000258, 1518-000259, 1518-000261, 1518-000270, 1518-000236, 1518-000242, 1518-000260, 1518-000202, 1518-000241, 1518-000201, 1518-000204, 1518-000208, 1518-000212, 1518-000214, 1518-000229, 1518-000239, 1518-000237, 1518-000169, 1518-000240, 1518-000224, 1518-000176, 1518-000441, 1518-000548, 1518-000505, 1518-000686, 1518-000715, 1518-000716, 1518-000717, 1518-000718, 1518-000719, 1518-000230, 1518-000221, 1518-000570, 1518-000379, 1518-000390, 1518-000377, 1518-000378, 1518-000391, 1518-000395, 1518-000251, 1518-000554, 1518-000127, 1518-000728, 1518-000305, 1518-000082, 1518-000104, 1518-000106, 1518-000107, 1518-000108, 1518-000109, 1518-000037, 1518-000042, 1518-000054, 1518-000085, 1518-000088, 1518-000745, 1518-000744, 1518-000426, 1518-000422, 1518-000423, 1518-000421, 1518-000424, 1518-000425, 1518-000428, 1518-000429, 1518-000430, 1518-000431, 1518-000433, 1518-000415, 1518-000420, 1518-000432, 1518-000408, 1518-000419, 1518-000417, 1518-000405, 1518-000409, 1518-000410, 1518-000411, 1518-000413, 1518-000414, 1518-000418, 1518-000401, 1518-000416, 1518-000396, 1518-000412, 1518-000017, 1518-000021, 1518-000290, 1518-000279, 1518-000284, 1518-000287, 1518-000288, 1518-000289, 1518-000615, 1518-000618, 1518-000572, 1518-000571, 1518-000641, 1518-000642, 1518-000643, 1518-000644, 1518-000640, 1518-000306, 1518-000568, 1518-000638, 1518-000639, 1518-000687, 1518-000553, 1518-000498, 1518-000499, 1518-000500, 1518-000246, 1518-000679, 1518-000680, 1518-000681, 1518-000678, 1518-000407, 1518-000307, 1518-000327, 1518-000316, 1518-000315, 1518-000676, 1518-000677, 1518-000673, 1518-000675, 1518-000674, 1518-000330, 1518-000731, 1518-000346, 1518-000352, 1518-000351, 1518-000350, 1518-000347, 1518-000348, 1518-000546, 1518-000547, 1518-000549, 1518-000550, 1518-000551, 1518-000552, 1518-000555, 1518-000513, 1518-000514, 1518-000097, 1518-000098, 1518-000320, 1518-000321, 1518-000326, 1518-000329, 1518-000250, 1518-000269, 1518-000300, 1518-000746, 1518-000747, 1518-000748, 1518-000749, 1518-000750, 1518-000751, 1518-000150, 1518-000153, 1518-000151, 1518-000154, 1518-000149, 1518-000148, 1518-000147, 1518-000146, and 1518-000152
RECALLING FIRM/MANUFACTURER
Spacelabs Healthcare, Inc., Issaquah, WA, by letters on October 5, 2007, November 30, 2007 and December 7, 2007. Firm initiated recall is ongoing.
REASON
Inaccurate partial pressure readings; readings are not compensated for ambient pressure in mmHg or kPa.
VOLUME OF PRODUCT IN COMMERCE
722 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
Intuitive brand da Vinci S, 5 mm Instrument Cannula Model/Part Number: 420011-02, Recall # Z-0669-2008
CODE
Lot Numbers Affected: SA070902, SA071101, and SA071401
RECALLING FIRM/MANUFACTURER
Intuitive Surgical, Inc., Sunnyvale, CA, by letters on November 19, 2007. Firm initiated recall is ongoing.
REASON
Sharp Edges: the 5mm Cannula may have a sharp edge on the inner diameter of the Cannula. The defective cannula may cause particulate shavings to be skive (scraping) from the instrument shafts during surgery.
VOLUME OF PRODUCT IN COMMERCE
89 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, (The system
    consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system
    and a digital detector), Recall # Z-0690-2008;
b) GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, (The system consists of
    an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital
    detector), Recall # Z-0691-2008;
c) GE Innova 4100 / 4100 IQ. , (The system consists of an a monoplane positioner, a  
    vascular or cardiac table, an X-ray system and a digital detector), Recall # Z-0692-
    2008
CODE
a) 600010VA01 HU1094VA01 HU1116VA01 HU1205VA01 0850060723 DZ1006VA01 0910162009 0910162010 0910162011 0910162012 0910163011 0910163014 0910162013 010120RX44 0002673668 604875AINNOVA1 416480INNOVA 604682INNOVA1 604682INNOVA2 604875AINNOVA2 26814ANGI2 082416100014 082416150002 082416100011 082416130026 082416010005 082416010007 082416030005 082416040011 082416040012 082416040014 082416050003 082416060001 082416070006 082416100009 082416100012 082416100017 082416120008 082416130016 082416130019 082416130023 082416130024 082416160007 082416180003 082416200004 082416210007 082416220010 082416120009 2664023INNOVA CS1118VA03 CS1006VA04 FI1017VA02 FI1017VA03 FI1025VA01 A4166952 B1650215 B5483438 M1334109 M2068110 M2569315 M2844529 M4176519 M4183841 M4200108 M4211066 M4496941 B4192944 M2621511 HC4348XR02 PC0052XR07 PC0052XR08 507902XR01 HC0222XR35 HC4355XR06 00060VAS02 00159VAS04 00192VAS04 00192VAS05 00234VAS01 00282VAS02 00371VAS01 00440VAS02 00440VAS03 00463VAS06 00888VAS02 01065VAS01 05208VAS02 05217VAS02 05451VAS01 10507VAS01 00197VAS01 H2077VAS27 0828160007 0002644132 08301600206936 083016002101586 083016102100795 083016202101036 083016202101917 083016242100936 083016282101457 083016602101386 083016802100516 083016802100866 083016802100916 083016862101407 083016862101656 083016862101916 83016802100337 83016862100377 083016602101807 083016802101197 "08301680520687 (temp 0002673438)" 083016822101187 0835160017 0835160018 IE1100VA02 A5333036 A5333037 A147111802 A5125125 A5129025 A5131858 A5155141 A5164510 A5219606 A5220710 A5286803 A5400910 A5605743 A5624112 A5800506 A5807919 A58080104 B5120723 B5219603 C5123625 C5123626 C5323515 A5624127 YV0053 YV0054 YV0057 YV0058 YV0059 YV0060 YV0061 YV0062 YV0063 YV0064 YV0065 YV0066 YV0067 YV0068 YV0069 YV0070 YV0071 YV0072 YV0073 YV0074 YV0075 YV0076 YV0077 YV0078 YV0079 YV0080 YV0081 YV0100 KW1018VA05 KW1018VA01 KW1018VA02 KW1018VA03 LV4000VA02 LV4000VA03 LV4001VA02 LT4000VA04 0002679402 0002684003X 644INNOVA21 83INNOVA2588441 MA1004VA02 NO1009VA03 600151VA01 600042VA03 PER00218 0002674834 787844INNOVACL1 787844INNOVACL2 787844INNOVACL3 SA1011VA01 SA1054VA02 0847160002 0847160003 FEB52055 ME612436 CEE15663 SD1038VA01 A004RX01 A020RX13 468668XR01 SY1001VA02 SY2005VA01 0853060191 853060197 06052VAS01 20001VAS02 34009VAS06 34134VAS02 35049VAS01 58010VAS01 80002VAS01 505848CATH1 505848EP 318448INNOVA3 305682IN2 4105502100 410554INNOVA2 208367INNOVA 208381CCL1 2035762100 717217CA10002 843797TCL1 214947MINNOVA 214947MINNOVA2 PRESBYDEP 303839CL2 252384CATH1 303788CL1 4436432100 4107872100 8184092100 864255SFCL2 219932DCL2 305364P2100 954987CL4 713794LAB1 727869CATH3 727869CCL2 727869EP5 208227CATH1 8157412100 816861KCVAI2 308865GIN1 865693CCL 865693CCL2 608775NOVA2 0002507622 310825INNOVA21 516562INNOVA6 516562INNOVA7 865977CCL 217383CCL2A 541732CV2 0002698287 0002698301 251435ICV3 239436CATH4 732776CATH4 212305CATH1 212604INNOVA1 65049321 304424INNOVA 610983INNOVA2 201447LAB1 215453INNOVA21 253627INNOVA1 229228INNOV21C 8053702100 RPINNOVA2100 303425CL3 305682IN2X 317355INNOVA3 318448CA1000 330363LAB3 330375LAB2 336538ARCL1 360456XCL4 405604D2100 408559INV1 410554INNOVA1 414291CL2 414649INNOVA2 417269SCLA 417347FCV4 423495MCATH1 501257VALAB1 508335CA1 508856IN21 509575YM2100 516562INNOVA2A 518243LAB1 518243LAB2 561548ET2 570476INNOVA21 573761SMC2 573815BCR2 573815BCR3 573815BCR4 574535IN21 602239CLAB2 607737CL1 608775NOVA1 610250INNOVA1 610250INNOVA3 610776INNOVA21 612273INNOVA2 615284CV3 615342CV3 615446CV1 617636CL1 630856H2100 650369SV4 651582IN3 661327INNOVA1 661327INNOVA2 706291CLIN1 713375U2100 713375UCA 717217INN21 717544GECATH2 717544GECATH3 718470EP 718780CATH3 727942CATH2 732324INN1 732923INN 770HMCCL1 781340IN1 781340IN3 785354HRTEP 803256PCL5 808547QCV1A 808547QCV3A 812238UN21 813615CL1 813615CL8 813615CL9 813615EP3 814452EP 815741CA1000 815759CARDIAC1 817329BG2100 843724CL1 843724CL2 843724CL3 843724EP1 845368LAB1 845368LAB2 856853IN2100 858554INNOVA2 858554INNOVA3 864255SFCL1 904597CATH 910343EP1 910343EP2 910671INOV21 916781INNOVA2 937208INNOVA2 954735CL2 954987CCL7 954987CCL8 970350CL2 9704CHINNOVA 973579LAB1 985898INNOVAA 985898INNOVAB CM2100 ECXV1406F FHOMEP 508941IN21 508335INNOVA 843692CATH3 828213IN21 901765EP 410554INNOVA4 and 410554INNOVA3;

b) HU1099VA04 0850060719 0850060724 0850060726 0850060727 0850060728 378INV31 0910064009 0910163012 0910163013 0910163015 BE5003VA02 140024RX09 BA4080VA01 2573329 2667313 BG4549VA02 082416040018 082416140004 082416290001 082416140003 082416130018 082416080001 082416010006 082416020004 082416020005 082416030006 082416040015 082416040019 082416100013 082416110002 082416110003 082416120010 082416140002 082416150001 082416160008 082416160009 082416160013 082416180004 082416190004 082416190001 082416190002 082416190003 082416210006 082416210008 082416220008 082416270002 082416300001 082416310003 082416310006 082449100050 082416160011 082416160012 082416170002 082416040017 082416070004 2625365INNOVA 2645993INNOVA CS1006VA03 0002655786 M2030709 M4163030 M4166988 M5480755 M6083613 A6017504 GE1005VA01 HC4348XR01 HC1536XR04 00203VAS01 01367VAS02 A5127281 A5112597 A5162256 A5333035 A5812244 B5274834 B5332001 B5810907 YV0036 YV0162 YV0048 YV0163 XF0250 YV0033 YV0034 YV0035 YV0038 YV0039 YV0040 YV0042 YV0043 YV0044 YV0045 YV0046 YV0047 YV0049 YV0050 YV0051 KW1055VA01 0834160003 83INNOVA1188379 0920169007 2048000INNOVA 2664627INNOVA PL1082VA01 600098VA01 RU2457VA01 RU1482VA02 RU1475VA01 RU1550VA01 MPX82206 FPG86403 FPG93008 DPM32143 DPN88402 0853060194 01012VAS01 41018VAS01 58002VAS01 60001VAS01 215576INNOVA1 518525LAB1 760242CATH1 404686CRI3 4103623100 281420LAB23100 541382CV3 205783BCL5 540953INNOVA 2035763100 508941IN1 717217INN31 843797TCL2 573815BCR1 361980INNOVA2 214590PH3100 313593IC2 561266IN31 303629CL4 303629EP 3027443100 7018573100 303788CL2 812450EP1 239939CLA 850862IN3100 352333CATH1 352333CATH2 8184093100 919731WMINOV 305364P3100 205877CCL1 808547QCV2A 281440CL3 208227CATH2 2014183100 7028533100 865693CCL1 765453INNOVA1 609757IN3100 6619483100 219326IN31 7022333100 816969LSCATH 209334LINNOVA1 310319SM3100 502587LAB1 219877IN31 9734293100 215335INNOVA1 239436CATH3 239513CRLAB1 8053703100 615222H 812858GWLAB1 812858GWLAB2 8014793100 270688INN 65049331 850747BR3100 6106483100 8508573100 850469BCV1 8508573100 ECXV1406C 413447CATH BPINNOVA3R 207662CL4 207879CL131 770991CL3 951788INNOVA3 951788INNOVA2 541677MINNOVA1 5033703100 417269SCLD 7278253100 253968INNOVA 254742KDCL1 662377CV4 412437INNOVA 9202623100 8019643100 303425CL4 2197573100 0002595303 228818VASC 316651INNOVA31 316962WCVC1 316962WCVC2 325428CATH1 325428CATH3 336832MCPV 360456XCL3 361857CATH1 405272SCL2 405372S3100 405604D3100 405840OIC3100 406447VAIN3 406543IN3 413582C3100 414447CL1 414647CL1 414649CL3 414649CL4 414805INNOVA1 415925INV1 417885JCL7 417885JCL8 423495MCL6 423844CCL1 478274CTH1 502852INNOVA 510797INV8 512901NI3100 516562INNOVA8 516562INNOVA9 516663INNOVA1A 530244XC106 561548CL4 570476INNOVA31 573458CL1 573632CRC2 6012883100CV2 603421PCL 610595CL1 610770INNOVA31 610983INNOVA1 616392INNOVA 617732IN9 618241GSI3100 620225INNOVA31 631968INNOVA2 631968INNOVA3 662377CV2 671GMHAINVA 708WESTSUB3100 713359INC 713948INA 717782INNOVA31A 718245UNITY 718470INNOVA2 718780CATH2 732776CATH6 770991CL1 772LWCL1 775982CATH2 781340IN2 803255CL1 804285CATH1 814676C1 815344CARDIAC3 815756KCHSPEC 816478MC1 816861KCVAI1 816943STJIC1 816985NKCI 847362CONCATH4 856596IN3100 864255SFCL3 901516R3 903UT3100 904276CTH1 909464IN3 909825VAINNOVA 910343NHIN4 913345MI1 940626DCH3100 954987CCL9 956698INN31 970350CL1 970945CL1 973877LAB4 ECXV1406B FHORLCL7 580548B3100 941798CLAB2 760323DRINNOVA 718270INNOVA1 603580ECL1 410740CV MARTINSVILLE310 480728LAB2 865481CCL2 405610NW3100 8157413100 251633PROV 907562CATH1 919784REP1 601883CL1 650369SV3 610954INNOVA1 760242CATH2 314768SMCL1A 2035763100A 402559UCB 561694IN1 2036883100 and 388567772VASMET;

c) 0850060718 0850060720 0850060721 0850060722 0850060725 514842AINNOVA 613548INNOVA3 082406070010 082406310005 082416030007 082416040020 082416100016 082416130020 082416130021 082416130025 082416220006 FI1015VA02 M1230007 HC0220XR07 00490VAS02 01278VAS01 10091VAS01 083006202101017 IE1100VA01 IL1043VA01 A5102671 A5163317 A5605732 XF0150 XF0151 XF0152 XF0153 XF0154 XF0155 XF0200 YV0006 YV0007 XF0156 YV0009 KW1001VA03 KW1001VA04 KW1018VA04 LB1037VA01 600042VA02 600152VA01 RU2714VA01 RU2992VA01 RU1050VA03 SA1005VA06 0002603739 0002603828 3184734100 706774USP3 6309784100 6616324100 304256INNOVA 2035764100 352596SPEC 423495MSPEC2 5135844100 719560INN41 303320OR41 303399IR 303436ANGIO 3027444100 574294IN41 804594CATH 239939INNOVA 574535IN41 252847PRS3 864255SF4100 305823IN4100 7137764100 3016094100 414649CL2 812858GWSP 212639ACT1 8014794100 304424CCINOVA 309655FSP1A 4134474100 5033704100 509474SH41 813745INTV 813972INTV 201541SP1 229228INNOV41V 281401T4100 918744JR4100 22925941V2 586573SP1 SHOWCASE4100 508856OR41 314569SJRM12 314966DPHSP 317887INNOVAPV 330489SPEC9 352333INVOR 386254HS1 386254HS2 386HPOS1 404466SF41A 404GHSIR1 410337INNOVA2 412647OR10 414649DVI 419696LAB1 505848CATH2 505848V4100 508650IN41 509482HFI 512901NI4100 530888ANG206 541686SPR1 561548VAS2 570321LAB2 605333RM10 610988INNOVA4 617636IN1 619229INNOVA1 623848SP 630275G41 630275G41B 650493ANGIOCT 662244GTSP 678EJCIR1 706291RINN2 706651SP1 706733SP1 708783CL4100 708783SP4100 713375U4100 718630LIBERTY 727791INNOVA 770535N4100 803256SP 804594ANGIO 812238UN41 812825INNOVA1 813615CL10 815740SC4100 817465AR4100 817922BA4100 843577CL2 845368RM10 850747IN4100 863687INV24 864573LAB2 865373SP 865481SUR 908522SP1 915577SP1 918682IN41 954MW4100 970247INNOVA COR359867 DR4100 FHORL4100 PEMBROKE4100 RADNETXV1 RHD4100 480512SP 8458584100 770736SP1 423495M4100E 423493I4100 8593134100 313343SP1 708202VA41 708WESTSUB4100 and 509575YM4100
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, Waukesha, WI, by letter on November 9, 2007.
Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Firm initiated recall is ongoing.
REASON
Frozen Image Problems: During an acquisition (fluoro and/or record), there have been cases reported where an image became "frozen" on the DL (digital leader acquisition system) live monitor screen. In such cases, the system continued to send out X-rays without reporting an error message. The result was that the live imaging screen displayed an older "frozen" image until the operator released the pedal. During an intervention, an operator could be misled to believe that the "frozen" image is instead a live dynamic image. This translates to an inability to see/control stent, endo-prosthesis placement, glue injection, or other device placement during an intervention and thus an increased patient risk of catheter, guidewire, glue an/or device misplacement.
VOLUME OF PRODUCT IN COMMERCE
868 units                                                  
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Biomet CC Cruciate Tibial Tray, 67 mm.; Product No. 141232, Recall # Z-0706-2008;
b) Biomet CC Cruciate Tibial Tray, 75 mm.; Product No. 141234, Recall # Z-0707-2008
CODE
a) Lot Number: 448530;
b) Lot Number: 448740
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by letter dated December 12, 2007. Firm initiated recall is ongoing.
REASON
Mislabeled as to size: Package labeled as containing a 67 mm tray actually contains a 75 mm tray and vice versa.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Caspar Titanium Aneurysm Clip Appliers, Catalog No/Part #: FT420T, Casper
    Applier F/Mini Ti-Clipsstr 146 mm, Recall # Z-0708-2008;
b) Caspar Titanium Aneurysm Clip Appliers, Catalog No/Part #: FT430T, Casper
    Applier F/Std Ti-Clipsstr 146 mm, Recall # Z-0709-2008
CODE
a) Part #: FT420T;
b) Part #: FT430T
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aesculap Inc., Center Valley, PA, by letter on or about December 18, 2007.
 Manufacturer: Aesculap AG & Co. KG, Tuttlingen, Germany. Firm initiated recall is ongoing.
REASON
Breakage: the inner rod of the applier may corrode and break
VOLUME OF PRODUCT IN COMMERCE
144 clips
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog
    Number: 00-AG087312, .035/300cm, stiff/angled/standard, sold as a single hydrophilic
    guidewire in both sterile and bulk non-sterile packaging configurations, Recall # Z-
    0882-2008;
b) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog
    Number: 00-AG387307, .035/150cm, stiff/straight/standard, sold as a single
    hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations,
    Recall # Z-0883-2008;
c) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog
    Number: 00-AG387308, .035/180cm, stiff/straight/standard, sold as a single
    hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations,
    Recall # Z-0884-2008;
d) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog
    Number: 00-AG387309, .035/300cm, stiff/straight/standard, sold as a single
    hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations,
    Recall # Z-0885-2008;
e) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog
    Number: 00-AG387310, .035/150cm, stiff/angled/standard, sold as a single hydrophilic
    guidewire in both sterile and bulk non-sterile packaging configurations, Recall # Z-
    0886-2008;
f) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog
    Number: 00-AG387311, .035/180cm, stiff/angled/standard, sold as a single hydrophilic
    guidewire in both sterile and bulk non-sterile packaging configurations, Recall # Z-
    0887-2008;
g) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog
    Number: 00-AG387312, .035/300cm, stiff/angled/standard, sold as a single hydrophilic
    guidewire in both sterile and bulk non-sterile packaging configurations, Recall # Z-
    0888-2008;
h) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog
    Number: 00-AG387319, .038/150cm, stiff/straight/standard, sold as a single
    hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations,
    Recall # Z-0889-2008;
i) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog     
    Number: 00-AG387320, .038/180cm, stiff/straight/standard, sold as a single
    hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations,       
    Recall # Z-0890-2008;
j) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog
    Number: 00-AG387324, .038/300cm, stiff/angled/standard, sold as a single
    hydrophilic guidewire in both sterile and bulk non-sterile packaging configurations,
    Recall # Z-0891-2008
CODE
a) Lot Numbers: 99513867, 99508829, and 99508830;
b) Lot Numbers: 99508645, 99497398, and 99535020;
c) Lot Numbers: 99502708, and 99510894;
d) Lot Numbers: 99496751;
e) Lot Numbers: 99504912, 99509169, and 99534483;
f) Lot Numbers: 99504955, 99496794, and 99537348;
g) Lot Numbers: 99505290, 99504749, and 99525828;
h) Lot Number: 99503850;
i) Lot Number: 99504098;
j) Lot Number: 99504587
RECALLING FIRM/MANUFACTURER
Argon Medical Devices, Inc., Athens, TX, by letter on November 15, 2007. Firm initiated recall is ongoing.
REASON
Degradation -- Hydrophilic guidewires may exhibit degradation of blue Pebax cladding causing particulate to dislodge potentially resulting in embolism.
VOLUME OF PRODUCT IN COMMERCE
2,861 devices
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single
    lumen catheters with a single proximal hub for attachment to a dye delivery system.
    Catalog No. 16599-301. 6F MULTI PIT 124 (Single Pack). Distal Curve FL4, FR4,
    PIG 145. 100 and 110 cm Length. Made in Mexico, Recall # Z-0935-2008;
b) Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single
    lumen catheters with a single proximal hub for attachment to a dye delivery system.
    Catalog No. 16599-89. 6F AR MOD (Single Pack). Distal curve AR MOD. 100 cm
    length, Recall # Z-0936-2008;
c) Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single
    lumen catheters with a single proximal hub for attachment to a dye delivery system.
    Catalog No. 16599-04. 6F FR6 (5-pack). Distal curve FR6. 100 cm length,
    Recall # Z-0937-2008;.
d) Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single
    lumen catheters with a single proximal hub for attachment to a dye delivery system.
    Catalog No. 16599-195. 6F LCB (5-pack). Distal curve LCB. 100 cm length,
    Recall # Z-0938-2008;
e) Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single
    lumen catheters with a single proximal hub for attachment to a dye delivery system.
    Catalog No. 16599-202. 6F IM T (t-pack). Distal curve IM T. 100 cm length, Recall #
    Z-0939-2008;
f) Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single
    lumen catheters with a single proximal hub for attachment to a dye delivery system.
    Catalog No. 16599-86. 6F AR2 (5-pack). Distal curve AR2. 100 cm length,
    Recall # Z-0940-2008;
g) Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single
    lumen catheters with a single proximal hub for attachment to a dye delivery system.
    Catalog No. 16599-201. 6F IM (5-pack). Distal curve IM. 100 cm length, Recall # Z-
    0941-2008;
h) Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single
    lumen catheters with a single proximal hub for attachment to a dye delivery system.
    Catalog No. 16599-302. 6F MULTI PIG 155 (5-pack). Distal curve FL4, FR4, PIG
    155. 100 and 110 cm length, Recall # Z-0942-2008;
i) Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single
    lumen catheters with a single proximal hub for attachment to a dye delivery system.
    Catalog No. 16599-98. 6F AL2 (5-pack). Distal curve AL2. 100 cm length,
    Recall # Z-0943-2008;
j) Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single
    lumen catheters with a single proximal hub for attachment to a dye delivery system.
    Catalog No. 16599-01. 6F FR3.5 (5-pack). Distal curve FR3.5. 100 cm, Recall # Z-
    0944-2008,
k) Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single
    lumen catheters with a single proximal hub for attachment to a dye delivery system.
    Catalog No. 16599-03. 6F FR5 (5-pack). Distal curve FR5. 100 cm length, Recall # Z-
    0945-2008
CODE
a) Catalog No./outer box Material No. (UPN) /inner pouch UPN /Lot (Batch) No. 16599-
    301/H749165993010/H749165993010/0020032538 and 16599-  
    301/H749165993010/H749165993010/002003517;
b) Catalog No./outer box Material No. (UPN) /inner pouch UPN /Lot (Batch) No. :
    16599-89/H74916599890/H74916599890/0020032541;
c) Catalog No./outer box Material No. (UPN) /inner pouch UPN /Lot (Batch) No. :
    16599-04/H74916599042/H74916599040/0020033644; and 16599-
    04/H74916599042/H74916599040/0020036932;
d) Catalog No./outer box Material No. (UPN) /inner pouch UPN /Lot (Batch) No. :
    16599-195/H749165991952/H749165991950/0020033662;
e) Catalog No./outer box Material No. (UPN) /inner pouch UPN /Lot (Batch) No. :
    16599-202/H749165992022/H749165992020/0020033665;
f) Catalog No./outer box Material No. (UPN) /inner pouch UPN /Lot (Batch) No. :
    16599-86/H74916599862/H74916599860/0020033690;
g) Catalog No./outer box Material No. (UPN) /inner pouch UPN /Lot (Batch) No. :
    16599-201/H749165992012/H749165992010/0020035115;
h) Catalog No./outer box Material No. (UPN) /inner pouch UPN /Lot (Batch) No. : 
    16599-302/H749165993022/H749165993020/0020035141;
i) Catalog No./outer box Material No. (UPN) /inner pouch UPN /Lot (Batch) No. :
    16599-98/H74916599982/H74916599980/0020035149
j) Catalog No./outer box Material No. (UPN) /inner pouch UPN /Lot (Batch) No. :
    16599-01/H74916599012/H74916599010/0020036925;
k) Catalog No./outer box Material No. (UPN) /inner pouch UPN /Lot (Batch) No. :
    16599-03/H74916599032/H74916599030/0020036931
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston ScientificMaple Grove, MN, by letter dated November 20, 2007.
Manufacturer: Pacific Device De Mexico S A De C V, Tijuana B C Mexico. Firm initiated recall is ongoing.
REASON
Flash may be protruding from the lumen of the catheter shaft. If this flash is present in the catheter, there is the potential of an embolization resulting from the flash detaching from the device during the procedure.
VOLUME OF PRODUCT IN COMMERCE
211 single units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS III

___________________________________
PRODUCT
a) Medtronic Trillium Affinity NT, 541T, Integrated CVR/Membrane Oxygenator,
    Plasma Resistant Fiber [PRF], (both Model 541T), Recall # Z-0476-2008;
b) Medtronic Blood Collection Reservoir, 40 micron, Catalog/Model # EL240,
    Recall # Z-0477-2008
CODE
a) Lot Numbers: 8870107 and 8851934;
b) Lot Numbers: 8763774, 8763791 and 8763782
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Perfusion Systems, Brooklyn Park, MN, by telephone on October 1, 2007 and by letters dated October 5, 2007. Firm initiated recall is ongoing.
Manufacturer: Medtronic Mexico, S. De R. L. De C.V., Tijuana, Baja California, Mexico. Firm initiated recall is ongoing.
REASON
Unapproved Component Resin: Affinity NT Integrated CVR Membrane Oxygenators and EL 240 Auto transfusion Blood Collection Reservoirs contain components made from an unapproved resin
VOLUME OF PRODUCT IN COMMERCE
447 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Cyberonics, VNS Therapy System Model 250 Handheld programming system using Dell x5 handheld and preprogrammed with software v7.1 and higher, Recall # 0568-2008
CODE
All Model 250 units using Dell x5 handheld computers.
RECALLING FIRM/MANUFACTURER
Cyberonics, Inc., Houston, TX, by letter on October 1, 2007 and November 15, 2007. Firm initiated recall is ongoing.
REASON
Screen Freezes-- The Dell X5 Handheld PC screen will freeze caused due to incompatibility between the Microsoft 2002 OS and the model Dell X5 handheld computer. Once frozen, the handheld device becomes non-responsive to user input.
VOLUME OF PRODUCT IN COMMERCE
6,642 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Smiths Medical, Add-On Kids Kit , Blood Sampling System, Product Code: MX4037,
    Recall # Z-0695-2008;
b) Smiths Medical, Add-On Kids Kit , Blood Sampling System, Product Code: MX4033,
    Recall # Z-0696-2008
CODE
a) and b) Lot Numbers: 1189082, 1231444, 1178100, and 1225588
RECALLING FIRM/MANUFACTURER
Smiths Medical Asd, Inc., Dublin, OH, by letters dated November 19, 2007. Firm initiated recall is ongoing
REASON
Misbranded. The product codes are labeled incorrectly with a green promotional label for "New split septum sampling site. Only use needle-free access devices .......", however this product code contains a sampling site which is accessed with a shrouded needle, NOT with a needle-free access device.
VOLUME OF PRODUCT IN COMMERCE
1,690 kits
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR FEBRUARY 6, 2008

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