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U.S. Department of Health and Human Services

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Enforcement Report for September 5, 2007

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.

September 5, 2007
07-36

 

RECALLS AND FIELD CORRECTIONS:  FOODS AND COSMETICS - CLASS I

___________________________________
PRODUCT
Jermuk Group Jermuk Classic Medicinal Table Natural Sparkling Mineral Water. The product is in a 0.5 liter translucent green glass bottle. The product is shipped in cases that contain 12 bottles, Recall # F-357-7
CODE
All
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aa Impex Group Inc., Philadelphia, PA, by telephone beginning on May 1, 2007.
Manufacturer: "Jermuk" CJSC, Jermuk, Armenia. Firm initiated recall is complete.
REASON
This product was found to contain excessive levels of arsenic.
VOLUME OF PRODUCT IN COMMERCE
50 cases
DISTRIBUTION
PA
___________________________________
PRODUCT
a) Gerber Organic Whole Grain Oatmeal Cereal for Baby, Net Wt. 8 oz.;
    UPC Code is 15000 12502, Recall # F-467-7;   
b) Gerber Organic Whole Grain Rice Cereal for Baby, Net. Wt. 8 oz.,
    UPC Code is 15000 12504, Recall # F-468-7
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gerber Products Co., Fremont, MI, by press release and letter dated July 13, 2007, and by telephone between July 13 and July 16, 2007.
Manufacturer: Gerber Products Co., Fort Smith, AR. Firm initiated recall is ongoing.
REASON
These cereals may contain lumps of cereal which do not dissolve in water or milk and pose a potential choking hazard.
VOLUME OF PRODUCT IN COMMERCE
3,171,504 boxes
DISTRIBUTION
Nationwide, Jamaica, Saint Maarten and the Cayman Islands (BWI)
___________________________________
PRODUCT
a) Toby's Toasted Sesame Dressing in a 12 ounce glass jar. The label is clear and
    has black lettering. Labeling: Toby's Toasted Sesame Dressing. Dairy Free.
    Tahini (ground organic sesame seeds), water, tofu (*organic, non-GMO
    soybeans, water, magnesium chloride), canola oil, wine vinegar, tamari soy
    sauce, sesame oil, herbs & spices, Recall # F-491-7;
b) Toby's Lite Sour Creme In a 8 ounce plastic container with red, white and
    blue label. Labeling: Toby's Lite Sour Creme, NET WT 8 OZ 226.8 G.
    MADE WITH ORGANICALLY GROWN NON-GMO SOYBEANS.
    NO PRESERVATIVES.KEEP REFRIGERATED. Ingredients: Tofu
    (Organic Non-GMO Soybeans, Water, Magnesium Chloride), Organic
    Cane Juice, Organic Lemon Juice, Cider Vinegar, Sea Salt, Non-GMO
    Canola Oil, Organic Sesame Tahini, Herbs and Spices, Recall # F-492-7
CODE
a) Best by date between 6/14/07 and 7/19/07;
b) EXP JUNE 10 or EXP JUNE 17
RECALLING FIRM/MANUFACTURER
Toby’s Family Foods, LLC, Springfield, OR, by telephone on June 4, and June 5, 2007. Firm initiated recall is complete.
REASON
Products were manufactured using tahini, which was contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
202 Toasted Sesame Dressing; 77 Lite Sour Cream
DISTRIBUTION
CA, WA, and OR

RECALLS AND FIELD CORRECTIONS:  FOODS AND COSMETICS - CLASS II 
___________________________________
PRODUCT
a) Frozen breaded trout nuggets sold under the Clear Springs brand and Sysco
    Portico brand, all sold bulk in 10 lb. cases: Clear Springs Brand,
    Rainbow Treasures, 1 oz. fish shaped nuggets, UPC number 10 070765 08893;
    Sysco Portico Brand, Rainbow Treasures, 1 oz. fish shaped nuggets
    UPC #5870324 & UPC 00074865 77352; Clear Springs Brand, Minced
    Portions 3oz. square shaped fish patties, UPC number 10 070765 08895;
    Clear Springs Brand, Minced Portions 3.7oz., fish pattie, UPC number 10 070765 
    08888, Recall # F-493-7;
b) Frozen breaded trout nugget, Hot & Spicy Popcorn Trout, packed bulk in 10 lb.
    cases under the Clear Springs Brand, UPC 10 070765 08751, Recall # F-494-7
CODE
a) Code is Julian date, single digit for year and batch number (DDDYBB):
    258606 347604, 347611, 002701, 002702, 002718, 004701, 004702, 004703,
    016704, 016707, 016708, 016714, 016719, 018701, 018702, 018704, 018707,
    018708, 018710, 018714, 108715, 023702, 023710, 023718, 025701, 025702,
    025703, 025704, 025705, 025706, 025707, 025708, 025701 09, 025711, 025714,
    025715, 025716, 030701, 030707, 030709, 030710, 030711, 030713, 030714,
    030715, 030717, 033703, 033706, 033709, 033711, 033715, 033717, 038707,
    038710, 0380711, 0380714, 0380716, 0380718, 0380719, 045701, 045704,
    045705, 045707, 045709, 045710, 045711, 045712, 052701, 052702, 052705,
    052709, 053701, 053720, 057703, 057704, 057709, 0587 01, 058702, 058715,
    074706, 074707, 074708, 074709, 074710, 088702, 088705, 088706, 088710,
    088711, 088712, 088713, 088714, 088715, 088716, 093714, 093717, 121720,
    128705, 128706, 128707, 128708, 128709, 149705;
b) 080602, 226601, 226602, 226604, 226606
RECALLING FIRM/MANUFACTURER
Clear Spring Foods Inc. – Specialty Plant, Buhl, ID, by e-mail or fax beginning on June 2, 2007. Firm initiated recall is complete.
REASON
The product lists whey as an ingredient but does not list milk as the source of the whey as required by FALCPA.
VOLUME OF PRODUCT IN COMMERCE
9,063/10 lb cases and 89 cases of 6/ 5 lb boxes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
SIMILAC Special Care Premature Infant Formula with Iron, Ready to feed bottles, birth to 12 months, 24 Cal/fl oz, 2 FL Oz. plastic bottles. The 2 FL OZ plastic bottles are packaged in cartons. Each carton contains 8/2 FL ounce plastic bottles. Six cartons are packaged into a case, Recall # F-500-7
CODE
The individual 2 FL oz. bottles contain lot numbers 44427X8, use by date 1 SEP 2007; 44427X81, use by date 1 SEP 2007, and 50005X8, use by date 1 MAR 2008. The cartons and cases in which the 2 FL oz bottles are packaged contain a different lot code than is on the individual bottles. The carton and case lot numbers are 46815D5, 47847D5, and 52023D5.
RECALLING FIRM/MANUFACTURER
Ross Products Division Abbott Laboratories, Columbus, OH, by letter and telephone beginning on May 25, 2007. Firm initiated recall is ongoing.
REASON
Infant Formula does not contain labeled amount of iron.
VOLUME OF PRODUCT IN COMMERCE
5,431
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  FOODS AND COSMETICS - CLASS III 
___________________________________
PRODUCT
Sensible Portions All Natural Multi Grain Crisps Cheddar Excellent Source of Whole Grains, Baked Snack Net Wt. 1.3 oz. (37g) World Gourmet Marketing LLC Wayne, NJ 07474 Nutrition Facts: Total Fat 1.5 g 2%RDA Saturated Fat 0 g Trans Fat 0 g Sodium 160 mg 7% RDA Protein 2g, Recall # F-495-7
CODE
All products
RECALLING FIRM/MANUFACTURER
Recalling Firm: World Gourmet Marketing, LLC, Butler, NJ, by telephone on April 19, 2007.
Manufacturer: Ideal Snacks, Inc., Liberty, NY. Firm initiated recall is complete.
REASON
A package of Multi Grain Crisps contains incorrect content information on the Nutrition Facts panel label.
VOLUME OF PRODUCT IN COMMERCE
5,760 units
DISTRIBUTION
NJ

___________________________________
PRODUCT
a) be Powered Protein Bar all natural chocolate raspberry,
    be Powered Protein Bar all natural chocolate raspberry ,
    4 bars 2.0 oz (57 g) total net wt 8.0 oz (227g); Supports peak energy,
    heart-healthy protein for a leaner body, helps support healthy immune
    function, Recall # F-496-7;
b) be Powered Protein Bar all natural wild berry, be Powered Protein Bar
    all natural wild berry , 4 bars 2.0 oz (57 g) total net wt 8.0 oz (227g);
    Supports peak energy, heart-healthy protein for a leaner body, helps
    support healthy immune function, Recall # F- F-497-7;
c) be Healthy Kids Snack Bar all natural peanut butter, 5 bars 1.5 oz (43 g)
    total net wt 7.5 oz (215g); low fat, whole grain, high energy, perfect snack
    for after school, practice or anytime, healthy eating for healthy kids,
    Recall # F-498-7;
d) be Healthy Kids Snack Bar all natural chocolate chip, 5 bars 1.5 oz (43 g)
    total net wt 7.5 oz (215g); low fat, whole grain, high energy, perfect snack
    for after school, practice or anytime, healthy eating for healthy kids,
    Recall # F-499-7
CODE
a) 1-85337-00030-2 single 1-85337-00080-7 4pk 1-85337-09080-8 4 pk+2 bonus;
b) 1-85337-00031-9 single 1-85337-00081-4 4pk 1-85337-09081-5 4pk+ 2 bonus;
c) 1-85337-00251-1 5pk;
d) 1-85337-00250-4 5pk
RECALLING FIRM/MANUFACTURER
Recalling Firm: Be unlimited, Ltd, Milwaukee, WI, by telephone, on June 1, 2007.
Manufacturer: Colorado Baking Company, Colorado Springs, CO. Firm initiated recall is ongoing.
REASON
Manufacturing issue has been identified that results in the potential for these products to develop mold prior to their expiration date.
VOLUME OF PRODUCT IN COMMERCE
430,200 bars
DISTRIBUTION
MN

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS I

___________________________________
PRODUCT
Caffeine Citrated, Powder, Purified, A mixture of equal parts of Caffeine and Citric Acid, Assay (as Caffeine).......Approx 50%, supplied in 125 gram, 500 gram, and 2.5 kg containers, CAUTION: For manufacturing or laboratory use only, Recall # D-958-2007
CODE
Lot #TS0225, Lot #VI1203, Lot #UK0821
RECALLING FIRM/MANUFACTURER
Recalling Firm: Spectrum Laboratory Products, Inc., Gardena, CA, by telephone starting May 17, 2007, press release on May 18, 2007, and by letter on May 23-25, 2007.
Manufacturer: Spectrum Chemicals and Laboratory Products, Inc., New Brunswick, NJ. Firm initiated recall is ongoing.
REASON
Material is subpotent.
VOLUME OF PRODUCT IN COMMERCE
454 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Compounded Colchicine Injection in glass vials, all strengths and all sizes, for IV use only, Recall # D-964-2007
CODE
All lots
RECALLING FIRM/MANUFACTURER
Apothecure, Inc., Dallas, TX, by letter and telephone on May 1, 2007. Firm initiated recall is ongoing.
REASON
Several deaths have been reported in connection with superpotent colchicine injection compounded by ApotheCure Inc.
VOLUME OF PRODUCT IN COMMERCE
3,536 vials
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________
PRODUCT
a) Cocaine The Legal Alternative Energy Supplement, 8.4 FL OZ aluminum cans,
    UPC code: 689076418843, Recall # D-959-2007;
b) Free Cocaine The Legal Alternative Energy Supplement, 8.4 FL OZ aluminum
    cans, UPC code #689076419048, Recall # D-960-2007;
c) Cut Cocaine The Legal Alternative Energy Supplement; 8.4 FL OZ aluminum
    cans, UPC code #689076418942, Recall #  D-961-2007
CODE
All
RECALLING FIRM/MANUFACTURER
Recalling Firm: Redux Beverages, LLC, Murrieta, CA, by letter and telephone on May 7, 2007.
Manufacturer: Gluek Brewing Co., Cold Springs, MN. Firm initiated recall is ongoing.
REASON
Unapproved New Drug; product's name and certain claims rendered the product an unapproved new drug.
VOLUME OF PRODUCT IN COMMERCE
Approximately 100,416 cases/24 cans per case
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Thyro-Tab 0.025mg, 150,000-tablet bulk drums intended for repackaging,
    Rx only, Recall # D-962-2007;
b) Levothroid (levothyroxine sodium tablets, USP), 25 mcg, 100- and 1,000-tablet
    bottles, RX only, NDC 0456-1320-01 (100-ct.) and NDC 0456-1320-00 (1,000-ct.),
    Recall # D-963-2007
CODE
a) Lot HA20206, Exp. Aug 2007, and Lot HA23606, Exp. Sep 2007;
b) Lots 080647 and 080654, Exp. Aug 2007 (from bulk lot HA20206);
     Lots 090640 and 090646 (from bulk lot HA23606)
RECALLING FIRM/MANUFACTURER
Lloyd Inc of Iowa, Shenandoah, IA, by telephone and letter dated June 27, 2007 and July 12, 2007. Firm initiated recall is ongoing.
REASON
Subpotent. 9 month stability.
VOLUME OF PRODUCT IN COMMERCE
3,826,958 bulk tablets; 18,798/100-tablet bottles; 1,392/1,000-tablet bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Ampicillin and Sulbactam for Injection, USP, 3 grams equivalent to 2 g of ampicillin plus 1 g of sulbactam, Rx only 10 vials, For IM or IV use, Sterile, Recall # D-966-2007
CODE
Lot P1683, Exp. October 2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter, New Providence, NJ, by letter on July 18, 2007.
Manufacturer: G.C. Hanaford Manufacturing Company, Syracuse, NY. Firm initiated recall is ongoing.
REASON
Presence of Particulate Matter.
VOLUME OF PRODUCT IN COMMERCE
23,650
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Springfresh Fluoride Toothpaste, labeled ingredients include Sodium monofluorophosphate and Glycerin. Sold in 4 package styles: packet, clear plastic tube, white opague plastic tube and aluminum tubes; container sizes: 0.15 oz, 0.3 oz, 0.6 oz, 0.7 oz, 0.85 oz, 1.5 oz, 2.75 oz, 3 oz, 4.6 oz, 6.4 oz, 7 oz, and 3 gm. Product of China, Recall # D-967-2007
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm:  American Amenities, Inc. Woodinville, WA, by fax on June 13, 2007 and June 15, 2007, and by letter on June 18, 2007.
Manufacturer: Suzhou Qing Xin Daily Chemical Co., Ltd, Suzhou, China (Mainland). Firm initiated recall is ongoing.
REASON
Toothpaste from China may contain the poisonous chemical diethylene glycol (DEG).
VOLUME OF PRODUCT IN COMMERCE
51,756 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Oral Bright Fresh Fluoride Toothpaste and Toothpaste/Toothbrush combo, Fresh Spearmint Flavor, Net Wt 6.4 oz, labeled ingredients include Sodium Monofluorophosphate 0.8% and Diglycol, Recall # D-968-2007
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: PR Retail Stores, Inc., Carolina, PR, by fax on June 4, 2007.
Manufacturer: Goldcredit International Enterprises, Wuxi, Jiangsu, China (Mainland). Firm initiated recall is ongoing.
REASON
Toothpaste from China may contain the poisonous chemical diethylene glycol (DEG).
VOLUME OF PRODUCT IN COMMERCE
Approximately 115,920 tubes
DISTRIBUTION
PR
___________________________________
PRODUCT
Spearmint Fluoride Toothpaste, labeled ingredients include Sodium Monofluorophosphate, made in China, sold as individual tubes and in kits under the following labels and sizes: a) Tri-Leaf brand: 17g, 24g, 42g, 78g, 130g; b) Select Medical Products brand: 24g, 43g, 77g, Recall # D-969-2007
CODE
All lots within expiry
RECALLING FIRM/MANUFACTURER
Recalling Firm: Amsino International Inc, Pomona, CA, by telephone on July 12, 2007 and by letters on July 13, 2007.
Manufacturer: Shanghai Whitecat Shareholding Co., Ltd, Shanghai, China (Mainland). Firm initiated recall is ongoing.
REASON
Toothpaste from China may contain the poisonous chemical diethylene glycol (DEG).
VOLUME OF PRODUCT IN COMMERCE
61,739 cases
DISTRIBUTION
Nationwide and Canada

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III

___________________________________
PRODUCT
Adagen (pegademase Bovine injection), 1.5 mL single dose vials, 250 units per mL, Sterile for intramuscular use only, NDC 57665-001-01, Recall # D-965-2007
CODE
Lot Number NA0709 Expiration Date: 10/30/2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Enzon Inc, Readington, NJ, by letter on August 10, 2007.
Manufacturer: Enzon Pharmaceuticals, Inc, South Plainfield, NJ. Firm initiated recall is ongoing.
REASON
Superpotent. In-vitro enzyme (6 month stability).
VOLUME OF PRODUCT IN COMMERCE
1,060 vials (265 packages of 4 vials each)
DISTRIBUTION
TN, France and Australia

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1428-07
CODE
Unit: 9040539
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on May 19, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who received rabies vaccine, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1429-07
CODE
Unit: 03M72705
RECALLING FIRM/MANUFACTURER
Mayo Clinic Rochester Division of Transfusion Medicine, Rochester, MN, by telephone on March 9, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who received a body piercing within 12 months of donating, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN
___________________________________
PRODUCT
Recovered Plasma, Recall # B-1431-07
CODE
Unit: 3952910
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by email on July 5, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL

___________________________________
PRODUCT
Recovered Plasma, Recall # B-1432-07
CODE
Unit: 4853593
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by facsimile on March 7, 2006. Firm initiated recall is complete.

REASON
Blood product, which was collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1437-07
CODE
Unit: 9876918 (split product)
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on July 11, 2006. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1438-07
CODE
Units: 53LT93418, 53LT93424, and 53LT93436
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake and Potomac Region, Baltimore, MD, by telephone and letter on July 11, 2006. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
MD and DC
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1439-07
CODE
Units: 53LT92257 (split unit)
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake and Potomac Region, Baltimore, MD, by telephone on April 4, 2006 and by letter dated April 5, 2006. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MD
___________________________________
PRODUCT
a) Cryoprecipitated AHF, Recall # B-1440-07;
b) Plasma Cryoprecipitate Reduced, Recall # B-1441-07
CODE
a) and b) Unit: J58617
RECALLING FIRM/MANUFACTURER
Virginia Blood Service, Inc., Richmond, VA, by letter dated August 4, 2006. 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
2 units
DISTRIBUTION
VA and NC
___________________________________
PRODUCT
Cryoprecipitated AHF, Recall # B-1442-07
CODE
Unit: H58881
RECALLING FIRM/MANUFACTURER
Virginia Blood Service, Inc., Richmond, VA, by telephone on October 9, 2005, and by  letter dated November 9, 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
VA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # 1443-07
CODE
Unit: J32626
RECALLING FIRM/MANUFACTURER
Virginia Blood Service, Inc., Richmond, VA, by email on June 23, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1447-07
CODE
Units: 5609059 and 5609099
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Alexandria, LA, by telephone on May 5, and 12, 2005. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-1450-07
CODE
Unit: 4320311 (split product)
RECALLING FIRM/MANUFACTURER
Central Jersey Blood Center, Shrewsbury, NJ, by facsimile on December 4, 2006. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1451-07
CODE
Units: 5617247, 3776422, and 5571330
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Alexandria, LA, by facsimile on June 17, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to areas considered  endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
LA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1452-07
CODE
Unit: 7119005 (split product)
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Alexandria, LA, by telephone on January 31, 2005 and by facsimile on March 21, 2005.  Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1453-07
CODE
Unit: 4320230
RECALLING FIRM/MANUFACTURER
Central Jersey Blood Center, Shrewsbury, NJ, by facsimile on December 13, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1454-07
CODE
Unit: 7212391
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on May 10, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a therapeutic donor and not labeled to indicate the type of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1473-07
CODE
Unit: 71X307875
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on April 9, 2006. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS III

___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1390-07
CODE
Unit: 7792066
RECALLING FIRM/MANUFACTURER
Coral Blood Services, Inc., Scarborough, ME, by telephone on February 20, 2007. 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
CA
_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1445-07;
b) Fresh Frozen Plasma, Recall # B-1446-2007
CODE
a) and b) Unit: 5612960
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Alexandria, LA, by telephone on February 7, 2005 and by facsimile on March 2, 2005. Firm initiated recall is complete.
REASON
Blood product, which was improperly tested for syphilis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II

___________________________________
PRODUCT
Varian On-Board Imager Device versions 1.2 and 1.3, when used with Cone Beam Computed Tomography. Medical Linear Accelerator, Recall # Z-1195-2007
CODE
Serial numbers: H070002-H072113
RECALLING FIRM/MANUFACTURER
Varian Medical Systems Inc, Palo Alto, CA, by letter on April 18, 2007. Firm initiated recall is ongoing.
REASON
Patient positioning errors may occur because of mechanical variations during product installation.
VOLUME OF PRODUCT IN COMMERCE
291 devices
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Abbott CELL-DYN 3000 Hematology Analyzer, Model number
    CELL-DYN 3000 CS: List Numbers 91323-01 and 91323-03,
    CELL-DYN 3000 SL: List Numbers 91325-01 and 91325-03,
    Recall # Z-1198-2007;
b) Abbott CELL-DYN 3500 Hematology Analyzer, Model number
    CELL-DYN 3500 CS, List Numbers 91340-01 and 91340-03, 
    Model number CELL-DYN 3500 SL, List Numbers 91350-01 and 91350-03,
    91350-01 1 EACH CD3500 SL ANALYZE(1 EACH) 1.000 0031192P,
    91350-03 1 EACH CD3500SL ANAL-REF(1 EACH) 1.000 30336P96,
    91350-03 1 EACH CD3500SL ANAL-REF 1.000 32159P96 05/05/2000,
    91340-03 1 EACH CD 3300/3500CS(1 EACH) 1.000 30276N96 06/21/2000,
    Recall # Z-1199-2007;
c) Abbott CELL-DYN 3700 Hematology Analyzer, Model number CELL-DYN 3700 CS, List Numbers 02H30-01and 91340-02, all serial numbers distributed on or before May 3, 2007. Model number CELL-DYN 3700 SL, List Numbers 02H31-01 and 02H31-03, all serial numbers distributed on or before May 3, 2007: 02H30-01 EA CD3700 CS(EA) 1.000 20222AN 01/16/2004 0708421226 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 21423AK 04/16/2003 0705836717 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 20575AK 01/17/2001 0700657123 ZINS 1024, 02H30-01 EA CD3700 CS(EA) 1.000 20088AN 11/14/2001 0701853939 ZINS 1024, 02H31-01 EA CD3700 SL(EA) 1.000 21086AK 04/02/2002 0702540521 ZINC 1024, 02H31-01 EA CD3700 SL 1.000 20158AK 01/20/2000 30001171534T2 NC 1024, 02H30-01 EA CD3700 CS 1.000 19966AN 03/17/2000 30003160556T2 NC 1024, 02H31-01 EA CD3700 SL 1.000 20210AK 02/15/2000 30002100642T2 NC 1024, 02H30-01 EA CD3700 CS(EA) 1.000 19999AN 11/20/2000 0700475941 ZINC 1024, 02H31-01 EA CD3700 SL(EA) 1.000 20333AK 05/30/2000 0700023564 ZINS 1024, 02H31-01 EA CD3700 SL(EA) 1.000 21162AK 05/29/2002 0702793182 ZINC 1024, 02H31-01 EA CD3700 SL(EA) 1.000 20662AK 10/09/2001 0701535236 ZINC 1024, 02H31-01 EA CD3700 SL(EA) 1.000 21151K 04/26/2002 0702654355 ZINC 1024, 02H31-01 EA CD3700 SL 1.000 20215AK 02/23/2000 30002110316T2 NC 1024, 02H31-01 EA CD3700 SL(EA) 1.000 20564AK 11/29/2000 0700519556 ZINC 1024, 02H31-01 EA CD3700 SL(EA) 1.000 20564AK 11/29/2000 0700519556 ZINC 1024, 02H31-01 EA CD3700 SL(EA) 1.000 21526AK 08/22/2003 0707048787 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 21195AK 05/29/2002 0702793121 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 21193AK 05/29/2002 0702759492 ZOR 1025, 02H30-01 EA CD3700 CS 1.000 19953AN 01/21/2000 39912022083U3 SALE 1025 02H30-01 EA CD3700 CS 1.000 19966AN 03/08/2000 30002101167U2 SALE 1025 02H31-01 EA CD3700 SL 1.000 20210AK 01/27/2000 39912213420U2 SALE 1025 02H31-01 EA CD3700 SL 1.000 20215AK 01/27/2000 39912212921U2 SALE 1025 02H31-01 EA CD3700 SL 1.000 20333AK 05/18/2000 30004103499U2 SALE 1025, 02H31-01 EA CD3700 SL(EA) 1.000 20565AK 11/29/2000 0700519549 ZINS 1024, 02H30-01 EA CD3700 CS 1.000 19953AN 01/27/2000 30001270601T2 NC 1024, 02H30-01 EA CD3700 CS(EA) 1.000 19999AN 10/31/2000 0700430444 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20088AN 10/25/2001 0701722636 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20106AN 02/14/2002 0702285397 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20564AK 11/30/2000 0700531142 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20565AK 11/30/2000 0700531141 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20574AK 12/01/2000 0700419159 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20575AK 12/01/2000 0700419161 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20576AK 12/01/2000 0700419160 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20662AK 03/08/2001 0700818411 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21086AK 03/01/2002 0702067225 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21151AK 04/22/2002 0702638488 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21162AK 04/26/2002 0702536142 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 21508AK 08/18/2003 0706963179 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 22038AK 03/10/2005 0721127803 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 22039AK 03/10/2005 0721127803 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 22035AK 03/08/2005 0721102104 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 22041AK 03/10/2005 0721127061 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 20576AK 01/17/2001 0700657124 ZINS 1024, 02H31-01 EA CD3700 SL(EA) 1.000 20574AK 11/29/2001 0701921151 ZINS 1024, 02H31-01 EA CD3700 SL(EA) 1.000 22055AK 03/22/2005 0721231650 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 21836AK 08/26/2004 0710348806 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 20368AK 06/15/2000 0700067140 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20369AK 06/20/2000 0700087363 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20370AK 06/20/2000 0700087363 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20371AK 06/20/2000 0700087363 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20372AK 06/20/2000 0700087363 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20373AK 06/21/2000 0700067141 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20340AK 05/26/2000 0700022704 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20344AK 05/30/2000 0700022198 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20347AK 05/26/2000 0700022704 ZOR 1025, 02H30-01 EA CD3700 CS(EA) 1.000 20010AN 10/11/2000 0700390326 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20036AN 02/27/2001 0700702499 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20037AN 02/28/2001 0700665110 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20039AN 03/08/2001 0700764419 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20059AN 05/23/2001 0701034352 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20069AN 07/13/2001 0701274789 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20073AN 07/25/2001 0701296466 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20075AN 07/25/2001 0701296466 ZOR 1025 02H31-03 EA CD3700 SL REFURB(EA) 1.000 20117AK96 03/12/2004 0708902744 ZOR 1025 02H31-03 EA CD3700 SL REFURB(EA) 1.000 20154AK96 08/28/2006 0724669259 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20200AN 07/01/2003 0706596666 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20201AN 07/01/2003 0706596666 ZOR 1025 02H30-01 EA CD3700 CS(EA) 1.000 20233AN 02/17/2004 0708707057 ZOR 1025 02H31-03 EA CD3700 SL REFURB(EA) 1.000 20465AK96 09/29/2006 0724957687 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20645AK 02/27/2001 0700702498 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20646AK 02/27/2001 0700702498 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20700AK 03/29/2001 0700368389 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20703AK 03/29/2001 0700368389 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20704AK 03/29/2001 0700368389 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20705AK 03/29/2001 0700368389 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20707AK 03/30/2001 0700844563 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20708AK 03/29/2001 0700368389 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20710AK 03/30/2001 0700844563 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20711AK 03/30/2001 0700844563 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20712AK 03/30/2001 0700844563 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20716AK 03/30/2001 0700844563 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20742AK 04/24/2001 0700847325 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20869AK 08/06/2001 0701363650 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20870AK 08/07/2001 0701326067 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20871AK 08/07/2001 0701326067 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20877AK 08/14/2001 0701419772 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20881AK 08/14/2001 0701419772 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20882AK 08/14/2001 0701419772 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20883AK 08/15/2001 0701428194 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20884AK 08/15/2001 0701428194 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20885AK 08/16/2001 0701419773 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20886AK 08/16/2001 0701419773 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20887AK 08/16/2001 0701419773 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20888AK 08/16/2001 0701419773 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20889AK 08/17/2001 0701419778 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20891AK 08/21/2001 0701419774 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20892AK 08/21/2001 0701419774 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20893AK 08/21/2001 0701419774 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20894AK 08/23/2001 0701458396 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20896AK 08/28/2001 0701419775 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20897AK 08/23/2001 0701458396 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20898AK 08/23/2001 0701439537 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20902AK 08/28/2001 0701419775 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20903AK 08/29/2001 0701419776 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20904AK 08/28/2001 0701419775 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20905AK 08/28/2001 0701419775 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20907AK 08/28/2001 0701419775 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20908AK 08/31/2001 0701419777 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20909AK 08/29/2001 0701419776 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20910AK 08/29/2001 0701419776 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20911AK 08/29/2001 0701419776 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20912AK 08/29/2001 0701419776 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20913AK 08/31/2001 0701419777 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20914AK 08/31/2001 0701419777 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20915AK 08/31/2001 0701419777 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20917AK 08/31/2001 0701419777 ZOR 1025 02H31-03 EA CD3700 SL REFURB(EA) 1.000 20940AK96 03/08/2004 0708891681 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20967AK 10/19/2001 0701730439 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20970AK 10/19/2001 0701730439 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20987AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20989AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20991AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20992AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20993AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20994AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20996AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20997AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20998AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20999AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21000AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21001AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21002AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21003AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21004AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21005AK 12/03/2001 0701935471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21045AK 01/28/2002 0702203580 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21046AK 01/28/2002 0702203580 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21048AK 01/28/2002 0702203580 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21049AK 01/28/2002 0702203580 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21050AK 01/28/2002 0702203580 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21058AK 02/07/2002 0702203581 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21059AK 02/07/2002 0702203581 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21060AK 02/07/2002 0702203581 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21061AK 02/07/2002 0702203581 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21062AK 02/08/2002 0702270892 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21063AK 02/11/2002 0702277975 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21064AK 02/08/2002 0702270892 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21065AK 02/13/2002 0702282548 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21067AK 02/11/2002 0702277975 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21068AK 02/13/2002 0702282548 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21069AK 02/15/2002 0702299928 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21070AK 02/19/2002 0702311964 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21076AK 02/26/2002 0702357048 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21082AK 02/28/2002 0702357049 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21083AK 02/28/2002 0702357049 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21084AK 02/28/2002 0702357049 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21089AK 03/07/2002 0702409793 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21090AK 03/07/2002 0702409793 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21091AK 03/08/2002 0702409156 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21092AK 03/08/2002 0702409156 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21093AK 03/07/2002 0702409793 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21094AK 03/07/2002 0702409793 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21095AK 03/08/2002 0702409156 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21096AK 03/12/2002 0702409789 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21097AK 03/12/2002 0702409789 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21098AK 03/13/2002 0702409790 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21099AK 03/12/2002 0702409789 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21100AK 03/14/2002 0702409791 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21101AK 03/13/2002 0702409790 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21102AK 03/13/2002 0702409790 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21103AK 03/19/2002 0702409792 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21104AK 03/14/2002 0702409791 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21105AK 03/19/2002 0702409792 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21107AK 03/19/2002 0702409792 ZOR 1025 02H31-03 EA CD3700 SL REFURB(EA) 1.000 21127AK96 02/27/2004 0708817941 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21163AK 04/25/2002 0702452514 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21180AK 05/09/2002 0702726859 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21181AK 05/10/2002 0702726862 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21182AK 05/09/2002 0702726859 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21183AK 05/10/2002 0702726862 ZOR 1025 02H31-03 EA CD3700 SL REFURB(EA) 1.000 21244AK96 08/28/2006 0724669259 ZOR 1025 02H31-03 EA CD3700 SL REFURB(EA) 1.000 21245AK96 08/17/2006 0724616503 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21473AK 07/01/2003 0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21474AK 07/01/2003 0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21475AK 07/01/2003 0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21476AK 07/01/2003 0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21478AK 07/01/2003 0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21479AK 07/01/2003 0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21480AK 07/01/2003 0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21481AK 07/01/2003 0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21482AK 07/01/2003 0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21483AK 07/01/2003 0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21485AK 07/01/2003 0706596666 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21590AK 11/20/2003 0707872598 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21592AK 11/20/2003 0707872598 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21624AK 01/21/2004 0708229861 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21625AK 01/21/2004 0708229861 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21627AK 01/26/2004 0708229862 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21628AK 01/26/2004 0708229862 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21629AK 01/26/2004 0708230220 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21630AK 01/27/2004 0708520940 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21639AK 02/05/2004 0708585282 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21640AK 02/05/2004 0708585282 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21643AK 02/10/2004 0708585283 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21644AK 02/12/2004 0708585284 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21645AK 02/10/2004 0708585283 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21647AK 02/17/2004 0708688571 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21650AK 02/23/2004 0708707082 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21651AK 02/24/2004 0708707083 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21652AK 02/23/2004 0708707082 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21654AK 03/04/2004 0708707085 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21655AK 03/04/2004 0708707085 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21656AK 03/04/2004 0708707086 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21657AK 03/04/2004 0708707086 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21658AK 03/04/2004 0708707089 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21659AK 03/04/2004 0708707089 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21660AK 03/05/2004 0708788543 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21662AK 03/05/2004 0708707090 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21663AK 03/05/2004 0708707090 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21711AK 05/05/2004 0708707092 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21712AK 05/05/2004 0708707092 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21713AK 05/06/2004 0708707095 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21714AK 05/06/2004 0708707095 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21715AK 05/06/2004 0708707098 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21716AK 05/06/2004 0708707098 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21839AK 08/26/2004 0710361988 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21841AK 08/26/2004 0710361988 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 21843AK 08/26/2004 0710361988 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22022AK 02/10/2005 0720995106 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22111AK 04/13/2005 0721376532 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22113AK 06/02/2005 0721693890 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22114AK 06/02/2005 0721693890 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22118AK 06/02/2005 0721693890 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22119AK 06/02/2005 0721705699 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22138AK 06/02/2005 0721705699 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22154AK 06/02/2005 0721705699 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22169AK 06/02/2005 0721705699 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22171AK 06/02/2005 0721705699 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22184AK 07/27/2005 0722063784 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22186AK 08/01/2005 0722086543 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22187AK 08/01/2005 0722086543 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22200AK 08/01/2005 0722086543 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22201AK 08/01/2005 0722086543 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22215AK 07/27/2005 0722063784 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22217AK 07/27/2005 0722063784 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22218AK 07/27/2005 0722063784 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22220AK 09/09/2005 0722368703 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22221AK 09/09/2005 0722368703 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22233AK 09/08/2005 0722353178 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22260AK 10/12/2005 0722601656 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22261AK 10/12/2005 0722601656 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22287AK 11/10/2005 0722807036 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22303AK 02/02/2006 0723378074 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22318AK 12/20/2005 0723075608 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22341AK 01/18/2006 0723279431 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22357AK 03/03/2006 0723573497 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22385AK 02/02/2006 0723378074 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22404AK 03/24/2006 0723666112 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22486AK 06/08/2006 0724084813 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22518AK 06/27/2006 0724306909 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22579AK 08/14/2006 0724403267 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22581AK 08/14/2006 0724403267 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22582AK 08/14/2006 0724403267 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22584AK 08/14/2006 0724381933 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22586AK 08/16/2006 0724600552 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22606AK 08/31/2006 0724658143 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22610AK 09/11/2006 0724831647 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22618AK 09/11/2006 0724794142 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22645AK 10/09/2006 0725013284 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 20407AK 07/18/2000 0700159975 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20409AK 07/18/2000 0700159975 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20414AK 07/24/2000 0700159976 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20415AK 07/24/2000 0700159976 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20417AK 07/24/2000 0700159976 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20418AK 07/24/2000 0700159976 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20419AK 07/25/2000 0700179062 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20435AK 08/07/2000 0700214053 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20438AK 08/09/2000 0700214054 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20474AK 09/11/2000 0700242470 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20478AK 09/21/2000 0700242471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20480AK 09/21/2000 0700242471 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20484AK 09/21/2000 0700242472 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20487AK 09/21/2000 0700242472 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20516AK 10/11/2000 0700308524 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20518AK 10/13/2000 0700242473 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20527AK 10/19/2000 0700242474 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20528AK 10/19/2000 0700242474 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20531AK 10/24/2000 0700242475 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20533AK 10/24/2000 0700242475 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20555AK 11/14/2000 0700242476 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20556AK 11/15/2000 0700488515 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20607AK 01/22/2001 0700242477 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20609AK 01/23/2001 0700668678 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20619AK 02/06/2001 0700311274 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20620AK 02/06/2001 0700242478 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20621AK 02/06/2001 0700311274 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20623AK 02/06/2001 0700242478 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20642AK 02/27/2001 0700399168 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20653AK 02/28/2001 0700311275 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20684AK 03/20/2001 0700311276 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20687AK 03/20/2001 0700764417 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20688AK 03/20/2001 0700311276 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20691AK 03/22/2001 0700311277 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20692AK 03/22/2001 0700311277 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20698AK 03/27/2001 0700311278 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 20702AK 03/27/2001 0700311278 ZOR 1025, 02H31-01 EA CD3700 SL(EA) 1.000 20366AK 06/15/2000 0700067139 ZOR 1025, 02H30-01 EA CD3700 CS 1.000 19954AN 01/19/2000 30001052430U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20201AK 01/19/2000 30001052492U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20202AK 01/19/2000 30001052475U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20222AK 02/07/2000 30001272996U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20227AK 02/10/2000 30001272997U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20228AK 02/10/2000 30001272998U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20230AK 02/15/2000 30002100624U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20232AK 02/15/2000 30002100624U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20237AK 02/18/2000 30001273000U3 SALE 1025, 02H31-01 EA CD3700 SL 1.000 20239AK 02/18/2000 30001272999U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20242AK 02/28/2000 30001273003U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20243AK 02/22/2000 30001273001U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20246AK 02/23/2000 30001273002U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20280AK 03/30/2000 30003070642U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20285AK 03/31/2000 30003070647U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20286AK 03/31/2000 30003070652U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20296AK 04/13/2000 30003070646U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20298AK 04/13/2000 30003070659U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20306AK 04/21/2000 30004112193U3 SALE 1025, 02H31-01 EA CD3700 SL(EA) 1.000 22669AK 01/24/2007 0725624482 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22711AK 01/24/2007 0725624482 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22725AK 01/24/2007 0725624482 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22746AK 03/08/2007 0725853549 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22747AK 03/19/2007 0725947869 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22748AK 03/08/2007 0725853549 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22750AK 03/19/2007 0725947869 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22758AK 03/19/2007 0725947869 ZOR 1025, 02H31-01 EA CD3700 SL 1.000 20239AK 02/18/2000 30001272999U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20242AK 02/28/2000 30001273003U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20243AK 02/22/2000 30001273001U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20246AK 02/23/2000 30001273002U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20280AK 03/30/2000 30003070642U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20285AK 03/31/2000 30003070647U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20286AK 03/31/2000 30003070652U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20296AK 04/13/2000 30003070646U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20298AK 04/13/2000 30003070659U3 SALE 1025 02H31-01 EA CD3700 SL 1.000 20306AK 04/21/2000 30004112193U3 SALE 1025, 02H31-01 EA CD3700 SL(EA) 1.000 22669AK 01/24/2007 0725624482 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22711AK 01/24/2007 0725624482 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22725AK 01/24/2007 0725624482 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22746AK 03/08/2007 0725853549 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22747AK 03/19/2007 0725947869 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22748AK 03/08/2007 0725853549 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22750AK 03/19/2007 0725947869 ZOR 1025 02H31-01 EA CD3700 SL(EA) 1.000 22758AK 03/19/2007 0725947869 ZOR 1025, Recall # Z-1200-2007
CODE
All serial numbers distributed before May 3, 2007.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Santa Clara, CA, by letter on August 16, 2007, and visit to follow.  Firm initiated recall is ongoing.
REASON
The product failed electrostatic discharge testing, which could result in product failure.
VOLUME OF PRODUCT IN COMMERCE
3,429 total units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
ABL8O FLEX Software Version 1.10 included in the ABL8O Flex Analyzer, Model Number 914863, Recall # Z-1201-2007
CODE
Lot numbers: 17293, 17384, 17440, 17515, 17572 and 17663
RECALLING FIRM/MANUFACTURER
Sendx Medical Inc., Carlsbad, CA, by e-mail on June 6, 2007. Firm initiated recall is ongoing.
REASON
The ABL8O FLEX software version 1.10 contains errors in the derived parameter calculation for cBase(B,ox) and cBase(Ecf,ox). These incorrect calculations result in a mild to moderate lowering of the base excess value, the severity depending on the concentration of hemoglobin and the oxygen saturation in the sample. Elevated hemoglobin concentrations have the greatest impact on this calculation error.
VOLUME OF PRODUCT IN COMMERCE
165 CDs
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Abbott AxSYM System Digoxin III Reagent Pack, Recall # Z-1202-2007
CODE
Lot # 42740Q100 Exp Date: 05/11/07 Lot # 46181Q100 Exp Date: 08/10/07 Lot # 42722Q100 Exp Date: 05/11/07
RECALLING FIRM/MANUFACTURER
Abbott Diagnostic International, Ltd, Barceloneta, PR, by letter dated March 30, 2007. Firm initiated recall is ongoing.
REASON
Customers are receiving error codes (1062, 1063, 1113, & 1118) when running patient samples on the AxSYM Digoxin III assay.
VOLUME OF PRODUCT IN COMMERCE
2,579 kits
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Assorted sterile surgical kits/ trays:
    DeRoyal Neuro Tray, REF 89-4502.05, sterile, Rx only, assembled in Mexico; 
    DeRoyal D/C LEEPS, Hysteroscopes 80015, REF 89-4915.02, sterile, Rx only,
    assembled in Mexico;
    DeRoyal ACF Tray, REF 50-11919.13, sterile, Rx only, assembled in Mexico;
    DeRoyal Ortho III, REF 89-2761.04, sterile, Rx only, assembled in Mexico;
    DeRoyal Shoulder Tray, REF 89-3948.05, sterile, Rx only;
    DeRoyal Cath Lab Tray, REF 89-4100.03, sterile, Rx only;
    DeRoyal Total Knee Tray, REF 89-4191.06, sterile, Rx only;
    DeRoyal LAP Chole Tray Piggyback, REF 89-4017.05, sterile, Rx only;
    DeRoyal Knee Arthroscopy Tray, REF 89-4206.04, sterile, Rx only;
    DeRoyal Thoracotomy Tray, REF 89-4199.06, sterile, Rx only;
    DeRoyal LAP GYN, REF 89-2995.07, sterile, Rx only;
    DeRoyal Extremity Pack, REF 89-3068.11, sterile, Rx only;
    DeRoyal Head and Neck Tray, REF 89-3281.04, sterile, Rx only;
    DeRoyal Sinus Tray, REF 89-3952.03, sterile, Rx only, DeRoyal;
    DeRoyal Arthroscopy, REF 89-4052.03, sterile, Rx only;
    DeRoyal Arthroscopy Tray, REF 89-4138.02, sterile, Rx only;
    DeRoyal Plastics Tray, REF 89-4197.04, sterile, Rx only;
    DeRoyal Laparotomy Pack, REF 89-4312.04, sterile, Rx only;
    DeRoyal OR Tray, REF 89-4422.02, sterile, Rx only;
    DeRoyal Breast Augmentation Pack, REF 89-4447.03, sterile, Rx only;
    DeRoyal ORTHO Pack, REF 89-4482.03, sterile, Rx only;
    DeRoyal Major Joint Tray, REF 89-4613.06, sterile, Rx only;
    DeRoyal Hip Joint Tray, REF 89-4614.05, sterile, Rx only;
    DeRoyal Podiatry Tray, REF 89-4976.02, sterile, Rx only;
    DeRoyal Extremity Tray, REF 94-0148.03, sterile, Rx only;
    DeRoyal Arthroscopy Tray, REF 89-4998.03, sterile, Rx only;
    DeRoyal Shoulder Arthroscopy Tray, REF 89-5678.01, sterile, Rx only;
    DeRoyal Lap Banding Pack, REF 89-5693.01, sterile, Rx only;
    DeRoyal C-Section Pack, REF 89-5703.01, sterile, Rx only;   
    DeRoyal Shoulder Pack, REF 89-5715.01, sterile, Rx only;
    DeRoyal C/V Pack Tray, REF 20-011700.12, sterile, Rx only;
    DeRoyal Heart Pack, REF 20-12059.16A, sterile, Rx only;
    DeRoyal Arthroscopy Tray, REF 89-3146.06, sterile, Rx only;
    DeRoyal Pacemaker, REF 89-4024.06, sterile, Rx only;      
    DeRoyal Major Lithotomy Tray, REF 89-4193.05, sterile, Rx only;
    DeRoyal Angiography Drape Pack, REF 89-4278.05, sterile, Rx only;
    DeRoyal Minor General Pack, REF 89-4289.05, sterile, Rx only;
    DeRoyal Back Table Set Up - Knee, REF 50-11617.07 A, sterile, Rx only;
    DeRoyal Total Knee Tray, REF 50-12456.07, sterile, Rx only;
    DeRoyal Extremity Tray, REF 89-4697.03, sterile, Rx only;
    DeRoyal C-Section Pack, REF 50-13134.08, sterile, Rx only;
    DeRoyal Major Vascular Tray, REF 89-3561.06, sterile, Rx only;
    DeRoyal LAP Hernia/Band Tray, REF 89-5707.01, sterile, Rx only;
    DeRoyal C-Section Pack, REF 50-13134.09, Rx only;
    DeRoyal Ortho Basic Tray, REF 89-2650.14, sterile, Rx only;
    DeRoyal Head/Neck Pack, REF 89-5736.01, exp. 2012-04, sterile, Rx only;
    DeRoyal Major Pack, REF 50-12783.06, sterile, Rx only;      
    DeRoyal AAA Tray, REF 89-3453.05 A, sterile, Rx only,
    DeRoyal AAA Tray, REF 89-3453.05 B, sterile, Rx only;
    DeRoyal Foot Pack, REF 89-5713.01, sterile, Rx only;
    DeRoyal Cardiac Cath Tray, REF 50-13027.16, sterile, Rx only;
    DeRoyal PEDS Accessory Tray, REF 50-13017.16, sterile, Rx only;
    DeRoyal Head and Neck Tray, REF 50-7738.18, sterile, Rx only;
    DeRoyal Spine Tray II Pgybk, REF 89-3792.04 A, sterile, Rx only;
    DeRoyal Spine Tray II Pgybk, REF 89-3792.04 B, sterile, Rx only;
    DeRoyal C-Section Tray, REF 94-0007.08, Rx only;
    DeRoyal Open Heart Tray, REF 89-4196.10 A, sterile, Rx only;
    DeRoyal Open Heart Tray, REF 89-4196.10 B, sterile, Rx only;
     DeRoyal Open Heart Tray, REF 89-4196.10 S, sterile, Rx only;
    DeRoyal Shoulder Tray, REF 89-4184.05, sterile, Rx only;
    DeRoyal Cysto Tray, REF 89-3251.07, sterile, Rx only;
    DeRoyal C-Section Tray, REF 89-3619.04, sterile, Rx only; 
    DeRoyal Shoulder Tray, REF 89-3948.05, sterile, Rx only; 
    DeRoyal Hand/Foot Tray, REF 89-4181.06, sterile, Rx only;
    DeRoyal Major Pack, REF 89-4251.03, sterile, Rx only;
    DeRoyal Knee Arthroscopy Pack, REF 89-4307.05, sterile, Rx only;
    DeRoyal LAP Chole Tray, REF 89-4342.02, sterile, Rx only;
    DeRoyal Shoulder Arthroscopy, REF 89-4453.02, sterile, Rx only;
    DeRoyal Radical Prost Tray Pgybk, REF 89-4558.03, sterile, Rx only,
    DeRoyal General Pack, REF 89-5231.03, sterile, Rx only;
    DeRoyal Knee Arthroscopy Pack, REF 89-5295.01, sterile, Rx only;
    DeRoyal Thoracotomy Tray, REF 50-8130.09, sterile, Rx only;
    DeRoyal JIT C-Section Pack, REF 89-2572.06, sterile, Rx only;
    DeRoyal C-Section w/Pouch Drape, REF 89-3435.02, sterile, Rx only;
    DeRoyal LAP Chole Tray, REF 50-11064.09, sterile, Rx only;
    DeRoyal Open Heart Tray II, REF 89-3181.05, sterile, Rx only;
    DeRoyal Carotid/AV Fistula Tray, REF 89-3712.02, sterile, Rx only;
    DeRoyal Open Heart Tray, REF 50-4504.14, sterile, Rx only;
    DeRoyal LAP Chole Tray, REF 50-12788.08, sterile, Rx only;
    DeRoyal Carotid Tray, REF 50-7650.22, sterile, Rx only;
    DeRoyal General/Plastic Tray Standard, REF 89-5031.01, sterile, Rx only;
    DeRoyal Cataract Tray, REF 50-12183.07, sterile, Rx only;
    DeRoyal Cath Lab Tray, REF 50-12050.11, sterile, Rx only;
    DeRoyal Ear Tray, REF 50-3028.18, sterile, Rx only;
    DeRoyal All Service Basic, REF 89-2651.09, sterile, Rx only;
    DeRoyal CV Drape Pack, REF 89-5137.01, sterile, Rx only;
    DeRoyal Extremity Tray, REF 89-5164.02, sterile, Rx only;
    DeRoyal Shoulder Arthroscopy, REF 89-5258.05, sterile, Rx only;
    DeRoyal C Section Tray Pgybk, REF 94-0101.08, sterile, Rx only;
    DeRoyal Cysto Tray, REF 89-3251.07, sterile, Rx only;
    DeRoyal Liposuction Tray, REF 89-3763.02, sterile, Rx only;
    DeRoyal Foot Pack Pgybk, REF 89-3794.07 A, sterile, Rx only;
    DeRoyal Shoulder Pack, REF 89-5725.01, , Rx only;
    DeRoyal Open Heart Tray I, REF 89-3182.05, sterile, Rx only;
    DeRoyal Arteriogram Tray, REF 50-12994.14, sterile, Rx only;  
    DeRoyal Total Hip, REF 50-13535.08, sterile, Rx only;     
    DeRoyal Basic Pack, REF 89-2746.03, sterile, Rx only;
    DeRoyal Arthroscopy Tray, REF 89-3645.03, sterile, Rx only;
    DeRoyal C-Section Pack, REF 89-2310.02, sterile, Rx only;
    DeRoyal Total Knee Tray, REF 89-3987.04, sterile, Rx only;
    DeRoyal Podiatry Tray Pgybk, REF 50-9406.16, sterile, Rx only;
    DeRoyal Basic Endo Tray, REF 89-3456.04, sterile, Rx only;
    DeRoyal Minor Tray, REF 89-3823.13, sterile, Rx only;
    DeRoyal Shoulder Pack, REF 89-5154.01, sterile, Rx only;
    DeRoyal LAP Chole Tray, REF 89-5291.01, sterile, Rx only;
    DeRoyal Hand Pack, REF 89-5810.01, sterile, Rx only9;
    DeRoyal LAP Chole Tray, REF 50-11036.07, sterile, Rx only;
    DeRoyal CABG Pack, REF 50-13509.10, sterile, Rx only;
    DeRoyal Total Hip Basin Set, REF 89-1319.05, sterile, Rx only;
    DeRoyal Total Knee Basin Set, REF 89-1321.07, sterile, Rx only;
    DeRoyal Total Hip, REF 89-2608.06, sterile, Rx only;
    DeRoyal Angiography Tray, REF 89-3558.07, sterile, Rx only;
    DeRoyal Abdohyst, Lapaexpl, REF 89-2497.12, sterile, Rx only;
    DeRoyal General Surgery Tray, REF 89-4094.02, sterile, Rx only;
    DeRoyal Neuro/Spine Basin Pack, REF 89-5717.01, sterile, Rx only;
    DeRoyal TAH Tray, REF 89-2672.09, sterile, Rx only;
    DeRoyal LAP Hernia Tray, REF 89-3468.04, sterile, Rx only;
    DeRoyal C-Section Tray 3/Case, REF 50-2688.19, sterile, Rx only;   
    DeRoyal Peripheral Vascular Tray, REF 89-3874.05, sterile, Rx only;
    DeRoyal Major Abdominal Tray, REF 89-4155.04, sterile, Rx only;
    DeRoyal Open Heart Pack, REF 89-5339.02 A, sterile, Rx only;
    DeRoyal Open Heart Pack, REF 89-5339.02 B, sterile, Rx only;
    DeRoyal LAP Chole Tray, REF 50-12892, sterile, Rx only;
    DeRoyal Auxilary Towel Pack, REF 50-12925.11, sterile, Rx only;
    DeRoyal Fayette Arthroscopy Tray, REF 50-12975.06, sterile, Rx only;
    DeRoyal Craniotomy Tray, REF 89-3563.11, sterile, Rx only;
    DeRoyal O.R. Basin Tray 4/CS, REF 50-3482.22, sterile, Rx only;
    DeRoyal Basic Set, REF 89-3514.05, sterile, Rx only;
    DeRoyal C-Section Tray, REF 89-4849.02, sterile, Rx only;
    DeRoyal Arthroscopy Tray, REF 89-3188.07, sterile, Rx only;
    DeRoyal Major Vascular Tray, REF 89-3561.07, sterile, Rx only;
    DeRoyal Basic Pack, REF 89-4101.06, sterile, Rx only;     
    DeRoyal Basic Extremity Pack, REF 89-4309.05, sterile, Rx only;
    DeRoyal Minor Joint Tray, REF 89-4615.05, sterile, Rx only;
    DeRoyal Shoulder Arthroscopy Pack, REF 89-4974.03, sterile, Rx only;
    DeRoyal Basic Set, REF 94-0146.05, sterile, Rx only;      
    DeRoyal C-Section Pack, REF 50-12111.02, sterile, Rx only;
    DeRoyal Upper Extremity Value Set, REF 89-4426.04, sterile, Rx only;
    DeRoyal Laparotomy Pack, REF 50-12471.07, sterile, Rx only;
    DeRoyal Podiatry Tray, REF 50-835.06, sterile, Rx only;   
    DeRoyal Basic Cath Tray, REF 89-4173.05, sterile, Rx only;
    DeRoyal Cardiac Cath Tray, REF 50-13119.19, sterile, Rx only;
    DeRoyal Limb Pack, REF 50-3836.23, sterile, Rx only;
    DeRoyal Extremity Tray, REF 89-5113.05, sterile, Rx only;
    DeRoyal Basic Pack, REF 89-5798.01, sterile, Rx only;   
    DeRoyal Pacemaker Tray, REF 89-3727.06, sterile, Rx only;
    DeRoyal Kellog Back Pack, REF 89-5817.01, sterile, Rx only;
    DeRoyal Basic Pack, REF 89-5155.02, sterile, Rx only
    DeRoyal Abdominalplasty Tray, REF 89-5677.01, sterile, Rx only;
    DeRoyal Extremity Pack, REF 89-5812.01, sterile, Rx only;
    DeRoyal General Orthopedic Tray, REF 89-2851.06, sterile, Rx only;
    DeRoyal Total Hip Pack, REF 89-3876.03, sterile, Rx only;
    DeRoyal LAMI Pack, REF 89-4114.03, sterile, Rx only;
    DeRoyal Podiatry Tray, REF 50-13341.04, sterile, Rx only;
    DeRoyal Total Knee Tray, REF 89-3288.04, sterile, Rx only;
    DeRoyal Basic LAP Tray, REF 89-3297.06, sterile, Rx only;
    DeRoyal Radical Prost Tray Pgybk, REF 89-4558.03, sterile, Rx only;
    DeRoyal NW ASC Shoulder Arthro, REF 89-4569.07, sterile, Rx only;
    DeRoyal TVT Pack, REF 89-5782.01, sterile, Rx only;
    DeRoyal Double Basin Set, REF 89-0191.05, sterile, Rx only;
    DeRoyal Vascular AV Fistula Pack, REF 50-8118.08, sterile, Rx only;
    DeRoyal Arthroscopy Pack, REF 50-12988.10, sterile, Rx only;
    DeRoyal Gyn Laparoscopy, REF 89-2646.10, sterile, Rx only;
    DeRoyal Heart Tray, REF 89-3916.05 A, sterile, Rx only;
    DeRoyal Heart Tray, REF 89-3916.05 B, sterile, Rx only;
    DeRoyal Arthroscopy Tray, REF 89-5714.01, sterile, Rx only;
    DeRoyal Lumbar Disk, REF 89-3390.06, sterile, Rx only;
    DeRoyal Cath Lab Accessory Tray, REF 89-4023.07, sterile, Rx only;
    DeRoyal Extremity Pack, REF 89-2565.08, sterile, Rx only;
    DeRoyal Custom hand Tray, REF 89-4593.03, sterile, Rx only;
    DeRoyal Basic Major Tray, REF 94-0283.11, sterile, Rx only;
    DeRoyal Cardiac Cath Lab Tray, REF 89-5109.01, sterile, Rx only;
    DeRoyal Open Heart Drape Pack, REF 89-5202.01, sterile, Rx only;   
    DeRoyal Total Hip A&B Pack Pgybk, REF 89-5285.01 A, sterile, Rx only;
    DeRoyal Total Hip A&B Pack Pgybk, REF 89-5285.01 B, sterile, Rx only;
    DeRoyal Clevens Facelift Pack, REF 89-5728.01, sterile, Rx only;
    DeRoyal C-Section Tray, REF 50-12505.08, sterile, Rx only;
Recall # Z-1204-2007
b) Assorted non- sterile Tracecarts (with sterile component(s));
    1) DeRoyal C-Section Tracecart, REF 53-1746.02, non-sterile, Rx only;
    2) DeRoyal CABG Tracepak, REF 90-2838.11, non-sterile, Rx only;
    3) DeRoyal CABG Tracecart, REF 53-1865.03, non-sterile, Rx only;
    4) DeRoyal Thoracotomy Tracecart 1/CS, REF 53-0464.13, non-sterile, Rx only;
    5) DeRoyal Neuro Tracecart, REF 53-1763.02, non-sterile, Rx only;
    6) DeRoyal Heart Tracecart, REF 53-1897.02, Rx only;
    7) DeRoyal LAP Chole Tracecart, REF 53-1862.03, non-sterile, Rx only;
    8) DeRoyal LAP Chole Tracepak, REF 90-2774.10, non-sterile, Rx only;
    9) DeRoyal Total Knee Tracecart, REF 53-1838.02, non-sterile, Rx only; 
   10) DeRoyal Valve/CABG Tracecart II, REF 53-1807.06, non-sterile, Rx only;
   11) DeRoyal Heart Tracecart, REF 53-1725.13, non-sterile, Rx only;
   12) DeRoyal C-Section Tracecart, REF 53-1837.03, non-sterile, Rx only;
   13) DeRoyal C-Section Tracecart, REF 53-1781.04, non-sterile, Rx only;
   14) DeRoyal Carotid/AV Fistula Tracecart, REF 53-1760.03, non-sterile, Rx only;
   15) DeRoyal Neuro Tracecart, REF 53-1815.06, non-sterile, Rx only,
   16) DeRoyal AAA Tracecart, REF 53-1765.08, non-sterile, Rx only;
   17) DeRoyal LAP Chole Tracecart, REF 53-1767.08, non-sterile, Rx only,
Recall # Z-1205-2007
CODE
a) DeRoyal Neuro Tray, REF 89-4502.05, Lots: 12319975, exp 2008-01 and
    12521971, exp 2008-01,
    DeRoyal Diskectomy Pack, REF 89-4504.03, Lots: 12319983, exp 2009-02 and   
    12521989, exp 2009-02;
    Shoulder Tray, REF 89-3948.05, Lot 12319595, exp 2012-04;
    DeRoyal Cath Lab Tray, REF 89-4100.03, Lots: 12219616, exp 2012-07 and
    12519205, exp 2012-05;
    DeRoyal Total Knee Tray, REF 89-4191.06, Lot 12364881, exp 2009-02;
    DeRoyal LAP Chole Tray Piggyback, REF 89-4017.05, Lot 12364899, exp 2011-10;
    DeRoyal Knee Arthroscopy Tray, REF 89-4206.04, Lot 12364944, exp 2009-01;
    DeRoyal Thoracotomy Tray, REF 89-4199.06, Lot 12365082, exp 2011-01;
    DeRoyal D/C LEEPS, Hysteroscopes 80015, REF 89-4915.02, Lot 12365162,
    exp 2009-06;
    DeRoyal ACF Tray, REF 50-11919.13, Lot 12365381, exp 2009-01;
    DeRoyal Ortho III, REF 89-2761.04, Lot 12365584, exp 2012-04;
    DeRoyal LAP GYN, REF 89-2995.07, Lot 12365681, exp 2010-03;
    DeRoyal Extremity Pack, REF 89-3068.11, Lot 12365728, exp 2012-01;
    DeRoyal Head and Neck Tray, REF 89-3281.04, Lot 12365939, exp 2012-04;
    DeRoyal Sinus Tray, REF 89-3952.03, Lot 12366270, exp 2011-10;
    DeRoyal Arthroscopy, REF 89-4052.03, Lot 12366341, exp 2011-01;
    DeRoyal Arthroscopy Tray, REF 89-4138.02, Lot 12366448, exp 2010-01;
    DeRoyal Plastics Tray, REF 89-4197.04, Lot 12366544, exp 2011-071;
    DeRoyal Laparotomy Pack, REF 89-4312.04, Lot 12366632, exp 2009-02;
    DeRoyal OR Tray, REF 89-4422.02, Lot 12366755, exp 2012-04;
    DeRoyal Breast Augmentation Pack, REF 89-4447.03, Lot 12366801, exp 2010-01,    
    DeRoyal ORTHO Pack, REF 89-4482.03, Lot 12366923, exp 2008-02;
    DeRoyal Major Joint Tray, REF 89-4613.06, Lot 12367205, exp 2012-03;
    DeRoyal Hip Joint Tray, REF 89-4614.05, Lot 12367192, exp 2012-03;
    DeRoyal Podiatry Tray, REF 89-4976.02, Lot 12367344, exp 2011-12;
    DeRoyal Extremity Tray, REF 94-0148.03, Lot 12367408, exp 2012-04;
    DeRoyal Arthroscopy Tray, REF 89-4998.03, Lot 12367521, exp 2010-02;
    DeRoyal Shoulder Arthroscopy Tray, REF 89-5678.01, Lot 12368259, exp 2012-02;     
    DeRoyal Lap Banding Pack, REF 89-5693.01, Lots: 12368304, exp 2010-01 and  
    12580436, exp 2010-01;
    DeRoyal C-Section Pack, REF 89-5703.01, Lot 12368380, exp 2010-02;
    DeRoyal Shoulder Pack, REF 89-5715.01, Lot 12368460, exp 2012-04;
    DeRoyal C/V Pack Tray, REF 20-011700.12, Lot 12368654, exp 2011-10;
    DeRoyal Heart Pack, REF 20-12059.16A, Lot 12368726, exp 2009-01;
    DeRoyal Arthroscopy Tray, REF 89-3146.06, Lot 12332598, exp 2010-01;
    DeRoyal Pacemaker, REF 89-4024.06, Lot 12332871, exp 2008-07;
    DeRoyal Major Lithotomy Tray, REF 89-4193.05, Lot 12332951, exp 2009-04;    
    DeRoyal Angiography Drape Pack, REF 89-4278.05, Lot 12332993, exp 2008-12;  
    DeRoyal Minor General Pack, REF 89-4289.05, Lot 12333005, exp 2012-04;
    DeRoyal Back Table Set Up - Knee, REF 50-11617.07 A, Lot 12334155,
    exp 2010-02;
    DeRoyal Total Knee Tray, REF 50-12456.07, Lot 12345743, exp 2009-01;
    DeRoyal Extremity Tray, REF 89-4697.03, Lot 12428901, exp 2010-01;
    DeRoyal C-Section Pack, REF 50-13134.08, Lot 12345786, exp 2011-09;
    DeRoyal Major Vascular Tray, REF 89-3561.06, Lot 12346308, exp 2009-01;
    DeRoyal LAP Hernia/Band Tray, REF 89-5707.01, Lots: 12332598, exp 2012-01
    and 12580532, exp. 2011-11;
    DeRoyal C-Section Pack, REF 50-13134.09, Lot 12428987, exp 2011-12;
    DeRoyal Ortho Basic Tray, REF 89-2650.14, Lot 12429040, exp 2012-04;
    DeRoyal Head/Neck Pack, REF 89-5736.01, Lots: 12430307, exp 2012-04 and   
    12475708, exp. 2012-04;
    DeRoyal Major Pack, REF 50-12783.06, Lot 12323683, exp 2011-04;
    DeRoyal AAA Tray, REF 89-3453.05 A, Lots: 12324310, exp 2009-12 and
    12572647, exp 2010-02;
    DeRoyal AAA Tray, REF 89-3453.05 B, Lot 12572647, exp 2010-02;
    DeRoyal Foot Pack, REF 89-5713.01, Lot 12429963, exp 2010-01;
    DeRoyal Cardiac Cath Tray, REF 50-13027.16, Lot 12274383, exp 2008-12;
    DeRoyal Dr. D. C. Pack, REF 50-8858.24, Lots: 12242699, exp 2012-03 and    
    12384540, exp 2012-04;
    DeRoyal PEDS Accessory Tray, REF 50-13017.16, Lot 12458553, exp 2010-01;
    DeRoyal Head and Neck Tray, REF 50-7738.18, Lot 12411413, exp 2009-02;
    DeRoyal Spine Tray II Pgybk, REF 89-3792.04 A, Lot 12411552, exp 2009-01;
    DeRoyal Spine Tray II Pgybk, REF 89-3792.04 B, Lot 12411552, exp 2009-01;
    DeRoyal C-Section Tray, REF 94-0007.08, Lot 12411886, exp 2009-01;
    DeRoyal Open Heart Tray, REF 89-4196.10 A, Lot 12411958, exp 2009-10;
    DeRoyal Open Heart Tray, REF 89-4196.10 B, Lot 12411958, exp 2009-10;
    DeRoyal Open Heart Tray, REF 89-4196.10 S, Lot 12411958, exp 2009-10;
    DeRoyal Shoulder Tray, REF 89-4184.05, Lot 12411991, exp 2009-03;
    DeRoyal Cysto Tray, REF 89-3251.07, Lot 12412441, exp 2009-11;
    DeRoyal C-Section Tray, REF 89-3619.04, Lot 12412539, exp 2009-12;
    DeRoyal Shoulder Tray, REF 89-3948.05, Lot 12412643, exp 2012-04;     
    DeRoyal Hand/Foot Tray, REF 89-4181.06, Lot 12412782, exp 2011-07;
    DeRoyal Major Pack, REF 89-4251.03, Lot 12412926, exp 2009-03;
    DeRoyal Knee Arthroscopy Pack, REF 89-4307.05, Lot 12412942, exp 2012-01;    
    DeRoyal LAP Chole Tray, REF 89-4342.02, Lot 12412951, exp 2011-10;
    DeRoyal Shoulder Arthroscopy, REF 89-4453.02, Lot 12412993, exp 2012-01;
    DeRoyal Radical Prost Tray Pgybk, REF 89-4558.03, Lot 12413099, exp 2009-03;   
    DeRoyal General Pack, REF 89-5231.03, Lot 12413355, exp 2012-01;
    DeRoyal, Powell, TN 37849 DeRoyal Knee Arthroscopy Pack, REF 89-5295.01,
    Lot 12413443, exp 2010-01;
    DeRoyal Thoracotomy Tray, REF 50-8130.09, Lot 12414227, exp 2009-03;
    DeRoyal JIT C-Section Pack, REF 89-2572.06, Lot 12586395, exp 2008-09;
    DeRoyal C-Section w/Pouch Drape, REF 89-3435.02, Lot 12403616, exp 2012-04;    
    DeRoyal LAP Chole Tray, REF 50-11064.09, Lot 12403878, exp 2011-12;
    DeRoyal Open Heart Tray II, REF 89-3181.05, Lot 12403915, exp 2010-03;
    DeRoyal Carotid/AV Fistula Tray, REF 89-3712.02, Lots: 12404070, exp 2009-03,
    12521946, exp 2008-12, 12459425, exp 2009-04; 
    DeRoyal Open Heart Tray, REF 50-4504.14, Lot 12383918, exp 2011-07;
    DeRoyal LAP Chole Tray, REF 50-12788.08, Lot 12383951, exp 2011-10;
    DeRoyal Carotid Tray, REF 50-7650.22, Lot 12384013, exp 2009-02;
    DeRoyal General/Plastic Tray Standard, REF 89-5031.01, Lot 12384030,
    exp 2010-01;
    DeRoyal Cataract Tray, REF 50-12183.07, Lot 12384072, exp 2010-03;
    DeRoyal Cath Lab Tray, REF 50-12050.11, Lot 12404070, exp 2009-12;
    DeRoyal Ear Tray, REF 50-3028.18, Lot 12384435, exp 2012-04;
    DeRoyal All Service Basic, REF 89-2651.09, Lot 12384831, exp 2012-04;
    DeRoyal CV Drape Pack, REF 89-5137.01, Lot 12385024, exp 2012-04;
    DeRoyal Extremity Tray, REF 89-5164.02, Lot 12385032, exp 2011-08;
    DeRoyal Shoulder Arthroscopy, REF 89-5258.05, Lots: 12385083,
    exp 2010-01 and 12454739, exp. 2010-01;
    DeRoyal C Section Tray Pgybk, REF 94-0101.08, Lot 12355044, exp 2008-11;
    DeRoyal Cysto Tray, REF 89-3251.07, Lot 12355247, exp 2009-11;
    DeRoyal Liposuction Tray, REF 89-3763.02, Lot 12355271, exp 2012-04;
    DeRoyal Foot Pack Pgybk, REF 89-3794.07 A, Lot 12355343, exp 2009-03;
    DeRoyal Shoulder Pack, REF 89-5725.01, Lot 12358149, exp 2010-03, sterile;
    DeRoyal Open Heart Tray I, REF 89-3182.05, Lot 12411958, exp 2011-10;
    DeRoyal Endo Tray, REF 89-3462.06, Lots: 12358350, exp 2009-01 and
    12459353, exp 2009-03;
    DeRoyal Arteriogram Tray, REF 50-12994.14, Lots: 12364354, exp 2011-11 and
    12555935, exp. 2012-01;
    DeRoyal Total Hip, REF 50-13535.08, Lot 12364362, exp 2009-01;
    DeRoyal Basic Pack, REF 89-2746.03, Lot 12364573, exp 2012-04;
    DeRoyal Arthroscopy Tray, REF 89-3645.03, Lot 12364821, exp 2009-01;
    DeRoyal Dr. K. Tray, REF 89-4004.05, Lot 12364872, exp 2010-02;
    DeRoyal C-Section Pack, REF 89-2310.02, Lot 12538617, exp 2008-12;
    DeRoyal Total Knee Tray, REF 89-3987.04, Lot 12519150, exp 2009-03;
    DeRoyal Podiatry Tray Pgybk, REF 50-9406.16, Lot 12519176, exp 2011-11;
    DeRoyal Basic Endo Tray, REF 89-3456.04, Lots: 12459409, exp 2009-02 and
   12521866, exp 2009-02;
    DeRoyal Minor Tray, REF 89-3823.13, Lot 12587742, exp 2011-10;
    DeRoyal Shoulder Pack, REF 89-5154.01, Lot 12588323, exp 2012-01;
    DeRoyal LAP Chole Tray, REF 89-5291.01, Lot 12588462, exp 2010-01;
    DeRoyal Hand Pack, REF 89-5810.01, Lot 12589019, exp 2010-01;
    DeRoyal LAP Chole Tray, REF 50-11036.07, Lot 12589060, exp 2011-11;
    DeRoyal CABG Pack, REF 50-13509.10, Lot 12589107, exp 2008-10;
    DeRoyal Total Hip Basin Set, REF 89-1319.05, Lots: 12589158, exp 2009-02
    and 12459311, exp 2009-02;
    DeRoyal Total Knee Basin Set, REF 89-1321.07, Lots: 12589166, exp 2009-02
    and 12628508, exp 2009-02;
    DeRoyal Total Hip, REF 89-2608.06, Lot 12490799, exp 2012-03;
    DeRoyal Angiography Tray, REF 89-3558.07, Lot 12490975, exp 2008-12;
    DeRoyal Abdohyst, Lapaexpl, REF 89-2497.12, Lot 12491601, exp 2008-09;
    DeRoyal General Surgery Tray, REF 89-4094.02, Lot 12490975, exp 2012-02;
    DeRoyal Neuro/Spine Basin Pack, REF 89-5717.01, Lot 12491994, exp 2011-10;   
    DeRoyal TAH Tray, REF 89-2672.09, Lot 12587523, exp 2010-02;
    DeRoyal LAP Hernia Tray, REF 89-3468.04, Lot 12459361, exp 2009-03;
    DeRoyal C-Section Tray 3/Case, REF 50-2688.19, Lot 12586512, exp 2012-05;
    DeRoyal Peripheral Vascular Tray, REF 89-3874.05, Lot 12586555, exp 2011-10;
    DeRoyal Major Abdominal Tray, REF 89-4155.04, Lot 12466107, exp 2011-11;
    DeRoyal Open Heart Pack, REF 89-5339.02 A, Lots: 12589326, exp 2009-01 and
    12572727, exp 2009-01;
    DeRoyal Open Heart Pack, REF 89-5339.02 B, Lot 12572727, exp 2009-01;
    DeRoyal LAP Chole Tray, REF 50-12892, Lot 12586889, exp 2009-02;
    DeRoyal Auxilary Towel Pack, REF 50-12925.11, Lot 12586918, exp 2012-05;
    DeRoyal Fayette Arthroscopy Tray, REF 50-12975.06, Lots: 12586951,
    exp 2010-02 and 12429488, exp. 2010-02;
    DeRoyal Craniotomy Tray, REF 89-3563.11, Lots: 12473315, exp 2008-11 and
    12604848, exp 2010-01, sterile;
    DeRoyal O.R. Basin Tray 4/CS, REF 50-3482.22, Lot 12473374, exp 2012-04;
    DeRoyal Basic Set, REF 89-3514.05, Lot 12473420, exp 2012-05;
    DeRoyal C-Section Tray, REF 89-4849.02, Lot 12473462, exp 2009-02;
    DeRoyal Arthroscopy Tray, REF 89-3188.07, Lot 12474086, exp 2012-02;
    DeRoyal Major Vascular Tray, REF 89-3561.07, Lot 12474211, exp 2009-02;
    DeRoyal Basic Pack, REF 89-4101.06, Lot 12474351, exp 2012-05;
    DeRoyal Basic Extremity Pack, REF 89-4309.05, Lot 12474529, exp 2011-11;
    DeRoyal Minor Joint Tray, REF 89-4615.05, Lot 12474756, exp 2011-08;
    DeRoyal Shoulder Arthroscopy Pack, REF 89-4974.03, Lot 12474799,
    exp 2012-02;
    DeRoyal Basic Set, REF 94-0146.05, Lots: 12474861, exp 2012-05 and
    12579945, exp 2012-05;
    DeRoyal C-Section Pack, REF 50-12111.02, Lot 12475767, exp 2012-04;
    DeRoyal Upper Extremity Value Set, REF 89-4426.04, Lot 12454667,
    exp 2008-07;
    DeRoyal Laparotomy Pack, REF 50-12471.07, Lot 12429402, exp 2012-04;
    DeRoyal Podiatry Tray, REF 50-835.06, Lot 12429568, exp 2012-04;
    DeRoyal Basic Cath Tray, REF 89-4173.05, Lot 12429200, exp 2010-01;
    DeRoyal Cardiac Cath Tray, REF 50-13119.19, Lot 12429234, exp 2008-10;
    DeRoyal Limb Pack, REF 50-3836.23, Lot 12429285, exp 2012-04;
    DeRoyal Extremity Tray, REF 89-5113.05, Lot 12656023, exp 2012-05;
    DeRoyal Basic Pack, REF 89-5798.01, Lot 12628268, exp 2012-03;
    DeRoyal Pacemaker Tray, REF 89-3727.06, Lot 12640110, exp 2012-05;
    DeRoyal Kellog Back Pack, REF 89-5817.01, Lot 12640523, exp 2009-02;
    DeRoyal Basic Pack, REF 89-5155.02, Lot 12624777, exp 2010-01;
    DeRoyal Abdominalplasty Tray, REF 89-5677.01, Lot 12364573, exp 2009-10;
    DeRoyal Extremity Pack, REF 89-5812.01, Lot 12624929, exp 2012-05;   
    DeRoyal General Orthopedic Tray, REF 89-2851.06, Lots: 12578336,
    exp 2012-05;
    DeRoyal Total Hip Pack, REF 89-3876.03, Lot 12578598, exp 2012-05;
    DeRoyal LAMI Pack, REF 89-4114.03, Lot 12578660, exp 2008-12;
    DeRoyal Podiatry Tray, REF 50-13341.04, Lot 12578811, exp 2008-12;
    DeRoyal Total Knee Tray, REF 89-3288.04, Lot 12578993, exp 2012-05;
    DeRoyal Basic LAP Tray, REF 89-3297.06, Lot 12579005, exp 2012-01;
    DeRoyal Radical Prost Tray Pgybk, REF 89-4558.03, Lots: 12579806,
    exp 2009-03 and 12537016, exp 2009-04;
    DeRoyal NW ASC Shoulder Arthro, REF 89-4569.07, Lot 12579814,
    exp 2008-12;
    DeRoyal TVT Pack, REF 89-5782.01, Lots: 12580727, exp 2010-01
    and 12538203, exp 2010-01;
    DeRoyal Double Basin Set, REF 89-0191.05, Lot 12580807, exp 2008-11;
    DeRoyal Vascular AV Fistula Pack, REF 50-8118.08, Lot 12580874, exp 2012-05;
    DeRoyal Arthroscopy Pack, REF 50-12988.10, Lot 12556006, exp 2012-05;
    DeRoyal Gyn Laparoscopy, REF 89-2646.10, Lot 12556196, exp 2011-11;
    DeRoyal Heart Tray, REF 89-3916.05 A, Lot 12571927, exp 2009-03;
    DeRoyal Heart Tray, REF 89-3916.05 B, Lot 12571927, exp 2009-03;
    DeRoyal Arthroscopy Tray, REF 89-5714.01, Lot 12572401, exp 2010-02;
    DeRoyal Lumbar Disk, REF 89-3390.06, Lot 12535310, exp 2009-03;
    DeRoyal Cath Lab Accessory Tray, REF 89-4023.07, Lot 12535547, exp 2009-02;
    DeRoyal Extremity Pack, REF 89-2565.08, Lot 12535598, exp 2012-05;
    DeRoyal Custom hand Tray, REF 89-4593.03, Lot 12537067, exp 2009-01;
    DeRoyal Basic Major Tray, REF 94-0283.11, Lot 12537201, exp 2012-05;
    DeRoyal Cardiac Cath Lab Tray, REF 89-5109.01, Lot 12537251, exp 2012-05;
    DeRoyal Open Heart Drape Pack, REF 89-5202.01, Lot 12537358, exp 2012-05;
    DeRoyal Total Hip A&B Pack Pgybk, REF 89-5285.01 A, Lot 12537500,
    exp 2009-01;
    DeRoyal Total Hip A&B Pack Pgybk, REF 89-5285.01 B, Lot 12537500,
    exp 2009-01;
    DeRoyal Clevens Facelift Pack, REF 89-5728.01, Lot 12538094, exp 2010-01;
    DeRoyal C-Section Tray, REF 50-12505.08, Lot 12538596, exp 2008-12;
b) 1) Lot: 12781158, exp 2008-10, 2) Lot 12830124, exp 2010-01, 
     3) Lot: 12585413, exp 2008-08, 4) Lot 12388751, exp 2009-02,
     5) Lot: 12680189, exp 2008-11, 6) Lot 12729915, exp 2008-11,
     7) Lot: 12924403, exp 2010-05, 8)) Lot 12493236, exp 2011-09,
     9) Lot: 12585296, exp 2009-03, 10) Lot 12570676, exp 2008-1105,
   11) Lot: 12617657, exp 2008-02, 12) Lot 11829924, exp 2008-10,
   13) Lot: 12866047, exp 2008-10, 14) Lot 12585405, exp 2009-03,
   15) Lot: 12671151, exp 2008-01, 16) Lot 12862695 exp 2009-04,
   17) Lot: 12671101, exp 2009-02
RECALLING FIRM/MANUFACTURER
DeRoyal Lafollette, LaFollette, TN, by letters on July 3, 2007 and July 18, 2007. Firm initiated recall is ongoing.
REASON
Packaging failure. Lack of sterility assurance.
VOLUME OF PRODUCT IN COMMERCE
1,826 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Spectrum Designs Medical Anatomical I (Silhouette) Malar Facial Implant, Catalog Number 120-224S, Recall # Z-1206-2007
CODE
Lot number 30838, serial numbers BAE256 through BAE275, manufactured June, 2006. Expiration date is five years from date of manufacture.
RECALLING FIRM/MANUFACTURER
Spectrum Designs, Inc., Carpinteria, CA, by telephone on June 15, 2007, and by letters on June 18, 2007. Firm initiated recall is complete.
REASON
The product is being recalled because it was discovered that at least one unit in the lot contained a mismatched pair (two rights and no left). Since the lot was produced with equal numbers of pairs, it is assumed that one other unit was packaged with two lefts and no right. This was discovered through a physician complaint.
VOLUME OF PRODUCT IN COMMERCE
15 pair (left/right)
DISTRIBUTION
Nationwide
__________________________________
PRODUCT
Multi-Link Vision RX Coronary Stent System, 3.0 x 15mm, Part number 1007848-15, Recall # Z-1211-2007
CODE
Lot # 7052951
RECALLING FIRM/MANUFACTURER
Abbott Vascular-Cardiac Therapies dba Guidant Corporation, Temecula, CA, by letters on July 16, 2007. Firm initiated recall is ongoing.
REASON
The affected single lot did not meet an internal specification. One unit failed the test criteria for stent dislodgment testing.
VOLUME OF PRODUCT IN COMMERCE
43 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Smiths CADD Yellow Medication Cassette Reservoir, With clamp and female
    Luer, Nonvented stopper included, 100 ml PC 4689-24A, REF 21-7100-24,
    Sterile, Recall # Z-1213-2007;
b) Smiths CADD Medication Cassette Reservoir, With clamp and female Luer,
    Nonvented stopper included, 50 ml PC 4694-24A, REF 21-7001-24, Sterile,
    Recall # Z-1214;
c) Smiths CADD Medication Cassette Reservoir, With clamp and female Luer,
    Nonvented stopper included, 100 ml PC 4695-24A, REF 21-7002-24, Sterile EO,
    Recall # Z-1215
CODE
a) 083X16, 084X16, 116X16, 131X16,137X16, 140X16, 146X16, 151X16,
    162X16, 185X16, 198X16, 224X16, 225X16;
b) 102X16, 117X16, 118X16, 130X16, 133X16, 135X16, 139X16, 147X16,
    150X16, 158X16, 165X16, 178X16, 180X16, 181X16, 188X16, 191X16,
    194X16, 202X16, 205X16, 226X16;
c) 081X16, 082X16, 085X16, 088X16, 089X16, 090X16, 091X16, 094X16, 095X16,
    096X16, 097X16, 104X16, 105X16, 106X16, 107X16, 109X16, 110X16, 112X16,
    113X16, 115X16, 119X16, 120X16, 121X16, 122X16, 123X16, 128X16, 129X16,
    136X16, 138X16, 142X16, 144X16, 145X16, 149X16, 152X16, 154X16, 155X16,
    157X16, 160X16, 161X16, 163X16, 164X16, 167X16, 168X16, 169X16, 170X16,
    171X16, 172X16, 173X16, 176X16, 177X16, 179X16, 182X16, 183X16, 186X16,
    187X16, 189X16, 190X16, 192X16, 195X16, 196X16, 199X16, 200X16, 203X16,
    204X16, 206X16, 207X16, 209X16, 210X16, 211X16, 212X16, 213X16, 214X16,
    216X16, 218X16, 220X16, 221X16, 222X16, 223X16, 228X16, 229X16
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smiths Medical MD, Inc., Saint Paul, MN, by letter on June 18, 2007.
Manufacturer: Smiths Healthcare Manufacturing S.A. de C.V., Tijuana, B.C., Mexico. Firm initiated recall is ongoing.
REASON
Smith Medical has become aware that an increase in pH may occur with some medications when instilled in the Affected Cassettes. Also, a small number of catheter occlusions have been reported from one customer when these cassettes have been used for delivering Flolan.
VOLUME OF PRODUCT IN COMMERCE
148,377 boxes (1780524 cassettes)
DISTRIBUTION
Nationwide and Internationally
__________________________________
PRODUCT
a) LX125 Swivel Collimator, Model D800; Manual Radiographic Collimator,
    Recall # Z-1216-2007;
b) LX125V Swivel Collimator, Model E600; Manual Radiographic
    Collimator, Recall # Z-1217-2007;
c) PCS125 Swivel Collimator, Model F100; Manual Radiographic Collimator,
    Recall # Z-1218-2007
CODE
a) Serial numbers NA578-1092 to NE785-0201, all swivel units manufactured
    between 11/14/1992 and 02/13/2001;
b) Serial numbers VA163-1192 to VB985-0798, all swivel units manufactured
    between 11/14/1992 and 07/31/1998;
c) Serial numbers WA153-1092 to WA153-0697, all swivel units manufactured
    between 10/01/1992 and 06/30/1997
RECALLING FIRM/MANUFACTURER
Summit Industries, Inc., Chicago, IL, by letters dated August 3, 2007. Firm initiated recall is ongoing.
REASON
The D800 Swivel Collimator may come loose from the tube stand and fall onto the x-ray table.
VOLUME OF PRODUCT IN COMMERCE
3,034 units
DISTRIBUTION
Nationwide and Internationally

END OF ENFORCEMENT REPORT FOR SEPTEMBER 5, 2007

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