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U.S. Department of Health and Human Services

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Enforcement Report for January 23, 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.

 

January 23, 2008
08-04

 

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I

___________________________________
PRODUCT 
The product is packaged in cases of 12/4 oz. plastic bottles; each bottle in a paper board carton. Label information states: Gripe Water All Natural Apple Flavor. An herbal supplement used to ease the gas and stomach discomfort often associated with colic, hiccups and teething. Dietary Supplement. 4 fl. oz. (120 ml), Recall # F-028-8
CODE
Unit: 26952V
RECALLING FIRM/MANUFACTURER
Recalling Firm: MOM Enterprises, Inc., San Rafael, CA, by telephone and letter beginning on September 19, 2007.
Manufacturer: Botanical Laboratories Inc., Ferndale, WA. Firm initiated recall is ongoing.
REASON
FDA confirmed through laboratory analysis of this lot of product the presence of cryptosporidium. The product was sampled and tested after investigating the illness of a 6-week-old infant in Minnesota who consumed the product. Cryptosporidium is a parasite that can cause intestinal infections.
VOLUME OF PRODUCT IN COMMERCE
17,780 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Jackson's Quality Plus Smoked Wild Salmon Spread Net Wt. 7 oz.  Product is in round plastic container, Recall # F-152-8
CODE
SELL BY dates up to and including 01/15/08 stamped on the side of the container. SELL BY dates may have slashes between month/day/year; and may not. The firm is not always consistent with their slashes.
RECALLING FIRM/MANUFACTURER
Quality Plus Products Inc., Bellingham, WA, by press release or telephone on November 29, 2007 and by visit on December 5, 2007. Firm initiated recall is complete.
REASON
Product labeling does not declare egg yolks as a sub-ingredient of horseradish.
VOLUME OF PRODUCT IN COMMERCE
120 cases
DISTRIBUTION
WA

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II

___________________________________
PRODUCT 
Del Rey White Flour Tortillas; all sizes; the tortillas are packaged 12 tortillas per plastic bag, 40 packs per case for 6'' tortillas, 24 packs per case for 8'' tortillas, and 10 packs per case for 10'', 12'', 13'' and 14'' tortillas; the tortillas are labeled as follows:
A) Del Rey Tortillas de Harina (6''), 12 Flour Tortillas, Net Wt. 12 Oz. (340g), For Soft Shell Tacos, UPC 52771-20001;
B) Del Rey Tortillas de Harina (8''), 12 Flour Tortillas, Net Wt. 15 Oz. (425g), Fajita Size, UPC 52771-20003;
C) Del Rey Burritos #2 (10''), 12 Tortillas, Net Wt. 27 oz. (765g), UPC 52771-40001;
D) Del Rey Burritos #3 (12''), 12 Tortillas, Net Wt. 34 oz. (964g), UPC 52771-00001;
E) Del Rey Burritos #3-1/2 (13''), 12 Tortillas, Net Wt. 42 oz. (1191 g), UPC 52771-50001 F) Del Rey Burritos #4 (14''), 12 Tortillas, Net Wt. 54 oz. (1.534 Kg), UPC 52771-50002, Recall # F-153-8
CODE
All sizes of flour tortillas with the Del Rey brand and use-by dates of NOV 11/2007 or earlier (SEP/17/2007, OCT/17/07, OCT/20/07, OCT/24/07, NOV/04/07, NOV/10/07, NOV/11/07)
RECALLING FIRM/MANUFACTURER
Del Ret Tortilleria, Inc., Chicago, IL, by press release and letters dated November 12, 2007 and by telephone or e-mail on November 13 and November 15, 2007. Firm initiated recall is complete.
REASON
Consumption of the flour tortillas has been associated with a series of food borne illness outbreaks among individuals, mostly children, who complained of stomach pains, vomiting, diarrhea, nausea, and headaches. These reported symptoms typically occurred very soon after consuming the flour tortillas and resolved within one day. There does not appear to be any long-term adverse health effects.
VOLUME OF PRODUCT IN COMMERCE
8,784 cases
DISTRIBUTION
DE, FL, IL, IA, KS, ME, MN, NB, NH, NY, WI and Canada

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS III

___________________________________
PRODUCT 
Hostess 100 Calorie Packs Chocolate Cake with Creamy Filling, 6-1.3 oz (37 g) packs Net Wt 7.75 oz. (220 g); 3 mini cakes per pack, 6 packs per box; UPC 0-45000-01114-4, Recall # F-151-8 
CODE
Use By OCT 15 2007 00259A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Interstate Brands Corp Hdqtrs, Kansas City, MO, by e-mail on September 28, 2007.
Manufacturer: Interstate Brands Corp., Schiller Park, IL. Firm initiated recall is ongoing.
REASON
The cakes were off-taste or tasted salty and were found to have levels of sodium bicarbonate in excess of the firm's quality standards.
VOLUME OF PRODUCT IN COMMERCE
22,692 boxes
DISTRIBUTION
IL, IN, IA, KY, MI, MN, MO, OH, PA, WV and WI

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS II

___________________________________
PRODUCT
a) Buffy Coat, Recall # B-0371-08;
b) Red Blood Cells, Recall # B-0372-08;
c) Platelets, Recall # B-0373-08;
d) Fresh Frozen Plasma, Recall # B-0374-08;
e) Recovered Plasma, Recall # B-0375-08
CODE
a) FV16707;
b) FV17274, FV16707, FV16173, FV15720, FV15174, FV14583, KJ85579;
c) FV17274, FV15720, FV15174, FV14583, KJ85579;
d) FV17274, FV15174, KJ85579;
e) FV16173, FV15720, FV14583
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on June 7, 2007. Firm initiated recall is complete.
REASON
Blood products, which tested negative for Hepatitis C, but were collected from a donor who previously tested positive for Hepatitis C, were distributed.
VOLUME OF PRODUCT IN COMMERCE
19 units
DISTRIBUTION
PA and FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0410-08
CODE
Unit: 49KQ13791
RECALLING FIRM/MANUFACTURER
American National Red Cross SW Region – HT, Tulsa, OK, by letter dated July 20, 2005.
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
TX
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0419-08
CODE
Unit # 49KP05974
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross SW Region – HT, Tulsa, OK, by telephone on December 8, 2005.
Manufacturer: American Red Cross Blood Services-SW Region, Farmers Branch, TX. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may compromised the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK
___________________________________
PRODUCT
a) Platelets, Recall # B-0499-08;
b) Recovered Plasma, Recall # B-0500-06
CODE
a) and b) Unit: 2607554
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on June 24, 2005, and by letter and electronic notification on July 22, 2005. 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
TX and Switzerland
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0511-08
CODE
Unit: 6278322 (2 units)
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by facsimile on January 30, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
a) Cryoprecipitated AHF, Recall # B-0512-08;
b) Red Blood Cells, Recall # B-0513-08;
c) Recovered Plasma, Recall # B-0514-08
CODE
a), b), and c) Unit: 71N65637X
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by telephone and letter dated  December 22, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for HIV Group O, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
GA and Switzerland
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0515-08
CODE
Unit: C77707
RECALLING FIRM/MANUFACTURER
South Bend Medical Foundation, South Bend, IN, by letter dated June 7, 2007. Firm initiated recall is complete.
REASON
Blood product, which may have been  contaminated with coagulase negative Staphylococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0516-08;
b) Fresh Frozen Plasma, Recall # B-0517-08;
c) Platelets Leukocytes Reduced, Recall # B-0518-08;
d) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0519-08
CODE
a) Units: 49GW17421, 49GW17221, 49GW17229, 49GW17397, 49GW16791,
49GW16795, 49GW16807, 49GW17380, 49GW17395, 49GW17412, 49GW17203, 49GW17206, 49GW17207, 49GW17209, 49GW17211, 49GW17215, 49GW17217, 49GW17219, 49GW17225, 49GW17226, 49GW17231, 49GW17235, 49GV21062, 49GL15483, 49GW16794, 49GW16796, 49GW16800, 49GW16801, 49GW16803, 49GW16805, 49GW16809, 49GW16811, 49GW16684, 49GW16686, 49GW16689, 49GW16693, 49GW16695, 49GW16697, 49GW16698, 49GW16661, 49GW16664, 49GW16665, 49GW16669, 49GW16671, 49GW16673, 49GW16676, 49GW16639, 49GW16646, 49GW16649, 49GW16651, 49GL15420, 49GL15421, 49GL15423, 49GL15426, 49GL15427, 49GL15432, 49GL15434, 49GL15439, 49GL15440, 49GL15441, 49GN31362, 49GN31373, 49GN31376, 49GN31379, 49GN31381, 49GN31383, 49GN31385, 49GN31388, 49GN31390, 49GW16520, 49GW16522, 49GW16523, 49GW16524, 49GW16530, 49GW16539, 49GC10805, 49GC10807, 49GC10811, 49GC10817, 49GC10823, 49GM11759, 49GM11761, 49GM11763, 49GM11768, 49GV20575, 49GV20583, 49GV20604, 49GV20622, 49GV20628, 49GV20651, 49GV20490, 49GN30699, 49GN30678;

b) Units: 49GW17448, 49GW17405, 49GW17409, 49GW17421, 49GW17221, 49GW16791, 49GW17382, 49GW17412, 49GW17428, 49GW17430, 49GW17203, 49GW17206, 49GW17207, 49GW17215, 49GW17217, 49GW17219, 49GW17225, 49GW17226, 49GW17231, 49GW17235, 49GW16794, 49GW16684, 49GW16697, 49GW16698, 49GW16661, 49GW16669, 49GW16673, 49GW16676, 49GW16639, 49GW16646, 49GW16651, 49GL15420, 49GL15421, 49GL15423, 49GL15426, 49GL15427, 49GL15432, 49GL15434, 49GL15439, 49GL15440, 49GL15441, 49GN31362, 49GN31376, 49GN31379, 49GN31381, 49GN31385, 49GN31388, 49GW16520, 49GW16523, 49GW16524, 49GW16527, 49GW16530, 49GW16535, 49GW16537, 49GW16539, 49GC10805, 49GC10807, 49GC10811, 49GC10817, 49GC10823, 49GM11759, 49GM11761, 49GM11763, 49GM11768, 49GV20575, 49GV20583, 49GV20622, 49GV20628, 49GV20490, 49GN30698, 49GN30699, 49GN30678;

c) Units: 49GN32338, 49GN32339, 49GW17405, 49GW17409, 49GW17421, 49GW17221, 49GW17229, 49GM12123, 49GW17386, 49GW17391, 49GW17392, 49GW17403, 49GW17404, 49GW17408, 49GW17412, 49GW17413, 49GW17420, 49GW17424, 49GW17428, 49GW17203, 49GW17206, 49GW17207, 49GW17215, 49GW17217, 49GW17226, 49GW16693, 49GW16695, 49GW16697, 49GW16673, 49GW16639, 49GW16646, 49GL15423, 49GL15426, 49GL15434, 49GL15439, 49GL15440, 49GL15441, 49GN31388, 49GW16520, 49GW16530, 49GW16535, 49GW16537, 49GW16539, 49GC10823, 49GM11759, 49GM11768, 49GV20575, 49GV20583, 49GN30678, 49GW17380, 49GW17219, 49GW16684, 49GW16651;

d) Unit: 49GW16679
RECALLING FIRM/MANUFACTURER
American National Red Cross SW Region – HT, Tulsa, OK, by telephone beginning June 25, 2004. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.
VOLUME OF PRODUCT IN COMMERCE
219 units
DISTRIBUTION
OK and TX
___________________________________
PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-0520-08;
b) Fresh Frozen Plasma, Recall # B-0521-08;
c) Platelets Leukocytes Reduced, Recall # B-0522-08;
d) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0523-08;
CODE
a) Units: 49GN36384, 49GN36372, 49GN36369, 49GN36362, 49GN36359, 49GW20980, 49GN36702, 49GN36713, 49GN36715, 49GN36718, 49GN36732, 49GN36737, 49GN36739, 49GN36742, 49GV23212, 49GV23211, 49GV23203, 49GV23202, 49GV23200, 49GV23198, 49GV23197, 49GV23194, 49GV23188, 49GV23182, 49GV23179, 49GN36989, 49GV36980, 49GM13778, 49GM13774, 49GM13771, 49GM13768, 49GW21559, 49GW21558, 49GW21550, 49GW21547, 49GW21545, 49GQ53350, 49GQ53329, 49GQ53315, 49GQ53295, 49GL17490, 49GL17489, 49GL17469, 49GL17465, 49GL17462, 49GW21969, 49GW21967, 49GW21965, 49GW21961, 49GM14305, 49GM14313, 49GM14318, 49GM14320, 49GM14286, 49GM14291, 49GM14295, 49GM14298, 49GV23962, 49GV23975, 49GN38764, 49GN38766, 49GN38818;

b) Units: 49GN36370, 49GN36369, 49GN36362, 49GN36359, 49GW20980, 49GN36702, 49GN36735, 49GN36737, 49GN36742, 49GV23212, 49GV23211, 49GV23203, 49GV23202, 49GV23200, 49GV23198, 49GV23197, 49GV23182, 49GV23179, 49GV36980, 49GM13779, 49GM13778, 49GM13774, 49GM13771, 49GM13768, 49GW21559, 49GW21545, 49GQ53350, 49GL17489, 49GL17490, 49GL17462, 49GW21967, 49GW21963, 49GM14313, 49GM14318, 49GM14921, 49GV23938, 49GV23943, 49GV23966, 49GV23975, 49GN38764;

c) 49GN36370, 49GN36369, 49GN36362, 49GN36359, 49GN36702, 49GN36732, 49GN36735, 49GN36737, 49GN36742, 49GV23212, 49GV23203, 49GV23200, 49GV23182, 49GV23179, 49GW21559, 49GW21550, 49GW21547, 49GW21545, 49GQ53350, 49GQ53315, 49GL17490, 49GL17489, 49GW21969, 49GW21967, 49GW21963, 49GW21961, 49GM14291, 49GM14298, 49GV23975, 49GN38764, 49GN38818;

d) 49GN36370, 49GN36735, 49GV23206, 49GV23938, 49GV23966
RECALLING FIRM/MANUFACTURER
American National Red Cross SW Region – HT, Tulsa, OK, by telephone beginning February 2, 2005. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.
VOLUME OF PRODUCT IN COMMERCE
138 units
DISTRIBUTION
OK, TX, NV, UT
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0553-08
CODE
Unit: 49KM17577
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross SW Region – HT, Tulsa, OK, by facsimile or electronic notification on March 23, 2007.
Manufacturer: American Red Cross Blood Services-SW Region, Farmers Branch, TX. 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
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0555-08
CODE
Unit: 49N57219
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross SW Region – HT, Tulsa, OK, by telephone, facsimile and electronic notification on March 23, 2007.
Manufacturer: American Red Cross Blood Services-Southwest Region, Harlingen, TX. 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
TX
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0557-08
CODE
Unit: 49KP10021
RECALLING FIRM/MANUFACTURER
American National Red Cross SW Region – HT, Tulsa, OK, by telephone on June 19, 2007 and by  facsimile on June 21, 2007. Firm initiated recall is complete.
REASON
Blood product, which was inappropriately distributed in a single storage bag, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0558-08
CODE
Unit: 8607814 (part 1)
RECALLING FIRM/MANUFACTURER
Lifesource, Glenview, IL, by telephone on October 2, 2007. Firm initiated recall is complete.
REASON
Blood product, which was labeled as leukoreduced, but was not tested to verify the White Blood Cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0559-08
CODE
Unit: 9422860
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lifesource, Glenview, IL, by telephone on September 25, 2007.
Manufacturer: Lifesource Portage Park, Chicago, IL. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who lived in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
___________________________________
PRODUCT
Platelets, Recall # B-0560-08
CODE
Unit: 7567127
RECALLING FIRM/MANUFACTURER
Lifesource, Glenview, IL, by telephone on August 31, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0561-08
CODE
Unit: 49GV36784
RECALLING FIRM/MANUFACTURER
American National Red Cross SW Region – HT, Tulsa, OK, by facsimile on December 12, 2006. 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
OK

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS III

___________________________________
PRODUCT 
Crotalidae Polyvalent Immune Fab (Ovine), Recall # B-0318-08
CODE
Unit: BN200623
RECALLING FIRM/MANUFACTURER
Recalling Firm: Protherics Inc., Brentwood, TN, by letter on October 29, 2007.
Manufacturer: Protherics U.K. Limited, Llandysul, Ceredigion, UK. Firm initiated recall is ongoing.
REASON
The product tested subpotent ate the 24-month time point.
VOLUME OF PRODUCT IN COMMERCE
1877 cartons
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0501-08
CODE
Unit: 2257864
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by visit on January 6, 2006. Firm initiated recall is complete.
REASON
Blood product, which was not quarantined after receiving post donation information concerning an illness at the time of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0502-08
CODE
Units: 5911456, 5933035
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated January 25, 2006. Firm initiated recall is complete.
REASON
Blood products, which were not returned to controlled storage within eight hours following collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
a) Platelets, Recall # B-0506-08;
b) Platelets Pooled Leukocytes Reduced, Recall # B-0507-08;
c) Platelets Pheresis Leukocytes Reduced, Recall # B-0508-08;
d) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0509-08;
e) Red Blood Cells Leukocytes Reduced, Recall # B-0510-08
CODE
a) Units: GR44481, GR44484, GR44490, GR44502, KC15269, and KC15275;
b) Units: GR44489, GR44509, GR44485, GR44508, GR44506, GR44518, GR44495,
    FQ55665, LE57544, GR44491, GR44507, LJ00379, GR44483, KC15050, GR44364,
    GR44379, LE57471, KC15129, LE57455, LE57445, LE57450, and LE57422;
c) Units: KZ86759, LC35416, FQ55483, and LC35408;
d) Units: FW60443, FW60443, FW60443, FW60443, FW60443, FW60443, FW60443,
    FW60443, FW60443, FR58564, FR58564, FR58564, FR58564, FR58564, FR58564,
    FR58564, FR58564, and FR58564;
e) Units: FJ95170, J95170, FJ95170, FQ55474, FQ55474, LC35541, LC35541, and
    LC35541
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on June 20, 2003. Firm initiated recall is complete.
REASON
Blood products, which may have not met acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
58 units
DISTRIBUTION
WI
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0527-08
CODE
Units: 49GG20868, 49KQ14520, 49KQ14522, 49KQ14529
RECALLING FIRM/MANUFACTURER
American National Red Cross SW Region – HT, Tulsa, OK, by telephone and facsimile beginning July 22, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from donors who did not have a complete health history screening, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
OK and TX
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0554-08
CODE
Unit: 49KM17577
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross SW Region – HT, Tulsa, OK, by facsimile or electronic notification on March 23, 2007.
Manufacturer: American Red Cross Blood Services-SW Region, Farmers Branch, TX. 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
CA
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0556-08
CODE
Unit: 49N57219
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross SW Region – HT, Tulsa, OK, by telephone, facsimile and electronic notification on March 23, 2007.
Manufacturer: American Red Cross Blood Services-Southwest Region, Harlingen, TX. 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
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0562-08
CODE
Unit: 49KQ14131
RECALLING FIRM/MANUFACTURER
American National Red Cross SW Region – HT, Tulsa, OK, by telephone on October 19, 2005 and by facsimile on October 20, 2005. 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
TX
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0623-08
CODE
Units: 1642581( Parts 1 and 2), 1669201 (Parts 1 and 2)
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center UC Medical Center, Cincinnati, OH, by letter dated June 20, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the medication Enbrel, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
OH

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II

___________________________________
PRODUCT
Datascope, Panorama Patient Monitoring Network; Panorma Telepack 608; Software Versions 8.1.X, 8.3, 8.3.1, 8.4.1, and 8.5.X, Part Number: 0998-00-0191-04, Recall # Z-0150-2008
CODE
Part Number: 0998-00-0191-04
RECALLING FIRM/MANUFACTURER
Datascope Corporation, Fairfieldm, NJ, by Urgent Product Field Correction notices on October 9, 2007.
REASON
Display problems: If an ECG cable, which has been damaged due to the ingress of liquid or by mechanical trauma, is utilized with the Telepack, it may cause the Telepack to switch between the 3-lead and 5 lead-input modes. During the switching process, the digital heart rate displayed at the Panorama Central Station will be frozen, and subsquent arrthymia alarms will not be announced.
VOLUME OF PRODUCT IN COMMERCE
338 sites
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Actiwatch 16 Part Number 198-0300-00, Actiwatch 16 AM 198-0300-AM;
    Actiwatch 64 Part Number 198-0301-00; Actiwatch 64 AM Part Number
    198-0301-AM, Recall # Z-0324-2008;
b) Actical with Step, Part Number 198-0302-00, Recall # Z-0325-2008;
c) Actiwatch 64 AM, Bandless Part Number 198-0301-AM1, Recall # Z-0326-2008;
d) Actiwatch 16, Basic Startup pkg 198-1010-00; and Actiwatch 64, Basic Startup
    pkg Part Number 198-1000-00, Recall # Z-0327-2008
CODE
a) Serial Numbers: V960641, V960642, V960655, V960656, V960657, V960658, V960660, V960661, V960986, V961113, V961114, V961115, V961116, V961117, V961118, V961119, V961120, V961177, V961178, V961179, V961180, V961181, V961182, V961183, V961184, V961185, V961186, V961187, V961188, V961189, V961191, V961192, V961193, V961194, V961195, V961196, V961197, V961198, V961199, V961200, V961513, V961514, V961515, V961516, V961517, V961518, V961519, V961520, V961593, V961594, V961595, V961596, V961597, V961598, V961599, V961600, V961601, V961602, V961603, V961604, V961605, V961606, V961607, V961608, V961609, V961610, V961611, V961612, V961613, V961614, V961615, V961616, V961617, V961121, V961122, V961123, V961124, V961125, V961126, V961127, V961128, V961321, V961322, V961323, V961324, V961325, V961326, V961327, V961328, V961329, V961330, V961331, V961332, V961333, V961334, V961335, V961336, V961337, V961338, V961339, V961340,V960611, V960617, V960618, V960619, V960620, V960621, V960622, V960629, V960630, V960631, V960632, V960635, V960638, V960639, V960640, V960643, V960644, V960645, V960663, V960669, V960671, V960673, V960678, V960681, V960682, V960684, V960685, V960686, V960689, V960690, V960692, V960693, V960694, V960695, V960696, V960697, V960698, V960701, V960702, V960709, V960710, V960720, V960721, V960722, V960723, V960724, V960725, V960726, V960728, V960729, V960730, V960731, V960732, V960736, V960737, V960742, V960743, V960744, V960745, V960746, V960747, V960748, V960749, V960751, V960752, V960753, V960754, V960755, V960757, V960758, V960760, V960761, V960834, V960835, V960836, V960837, V960838, V960839, V960840, V960841, V960842, V960843, V960844, V960845, V960846, V960847, V960848, V960849, V960850, V960851, V960854, V960855, V960856, V960857, V960858, V960859, V960860, V960861, V960862, V960863, V960871, V960872, V960875, V960876, V960877, V960878, V960879, V960882, V960889, V960891, V960892, V960893, V960894, V960895, V960896, V960897, V960898, V960900, V960902, V960903, V960904, V960913, V960914, V960915, V960916, V960917, V960918, V960919, V960920, V960921, V960922, V960923, V960924, V960925, V960928, V960929, V960930, V960931, V960932, V960933, V960934, V960935, V960936, V960937, V960938, V960939, V960940, V960941, V960942, V960943, V960944, V960945, V960946, V960947, V960948, V960949, V960950, V960951, V960952, V960953, V960954, V960955, V960956, V960957, V960958, V960959, V960960, V960961, V960962, V960963, V960964, V960965, V960966, V960967, V960968, V960969, V960970, V960971, V960972, V960973, V960974, V960975, V960976, V960977, V960978, V960979, V960980, V960981, V960982, V960983, V960984, V960993, V961009, V961016, V961017, V961018, V961021, V961023, V961024, V961025, V961026, V961027, V961028, V961029, V961030, V961032, V961034, V961035, V961036, V961038, V961039, V961040, V961042, V961043, V961044, V961045, V961047, V961048, V961049, V961050, V961051, V961052, V961053, V961054, V961056, V961057, V961058, V961059, V961060, V961064, V961066, V961067, V961068, V961130, V961134, V961144, V961145, V961146, V961147, V961148, V961149, V961150, V961151, V961152, V961201, V961202, V961203, V961204, V961205, V961206, V961207, V961208, V961209, V961210, V961211, V961212, V961213, V961214, V961215, V961216, V961260, V961278, V961283, V961320, V961348, V961351, V961352, V961353, V961354, V961355, V961356, V961357, V961358, V961360, V961367, V961368, V961369, V961370, V961371, V961372, V961373, V961374, V961375, V961376, V961377, V961378, V961379, V961381, V961382, V961383, V961388, V961389, V961390, V961391, V961392, V961393, V961394, V961396, V961397, V961398, V961399, V961400, V961401, V961402, V961403, V961404, V961405, V961406, V961407, V961408, V961409, V961410, V961411, V961412, V961413, V961414, V961415, V961416, V961417, V961418, V961419, V961420, V961421, V961422, V961423, V961424, V961425, V961426, V961427, V961428, V961429, V961430, V961431, V961432, V961433, V961434, V961435, V961436, V961437, V961438, V961439, V961440, V961442, V961444, V961445, V961446, V961447, V961448, V961449, V961450, V961451, V961452, V961453, V961454, V961455, V961456, V961457, V961458, V961459, V961460, V961461, V961462, V961463, V961464, V961465, V961466, V961467, V961468, V961469, V961470, V961471, V961472, V961473, V961474, V961475, V961476, V961477, V961478, V961479, V961480, V961481, V961485, V961486, V961487, V961488, V961510, V961511, V961512, V961521, V961522, V961523, V961524, V961525, V961526, V961529, V961530, V961531, V961532, V961534, V961535, V961536, V961538, V961539, V961540, V961542, V961543, V961544, V961545, V961546, V961547, V961548, V961549, V961550, V961551, V961552, V961553, V961554, V961555, V961556, V961561, V961591, V961592, V961625, V961626, V961627, V961628, V961629, V961630, V961631, V961632, V961633, V961634, V961635, V961636, V961637, V961638, V961639, V961640, V961641, V961642, V961643, V961644, V961645, V961647, V961648, V961649, V961650, V961652, V961653, V961654, V961655, V961656, V961689, V961690, V961691, V961692, V961693, V961694, V961695, V961696, V961697, V961698, V961699, V961700, V961701, V961702, V961703, V961704, V961705, V961706, V961707, V961708, V961713, V961714, V961715, V961716, V961717, V961718, V961727, V961728, V961729, V961730, V961731, V961732, V961733, V961735, V961736, V961737, V961738, V961739, V961740, V961741, V961742, V961896, V961897, V961900, V961901, V961902, V961903, V961904, V961905, V961906, V961907, V961908, V961909, V961910, V961569, V961570, V961571, V961572, V961573, V961574, V961575, V961576, V961752, V961753, V961754, V961755, V961756, V961757, V961758, V961759, V961760, V961761, V961762, V961763, V961764, V961765, V961766, V961768, V961769, V961770, V961771, and V961772;

b) Serial Numbers: B100001, B100002, B100003, B100005, B100006, B100007, B100008, B100009, B100023, B100024, B100025, B100026, B100027, B100028, B100029, B100030, B100031, B100032, B100033, B100034, B100035, B100036, B100037, B100038, B100039, B100041, B100042, B100043, B100044, B100045, B100046, B100047, B100048, B100049, B100050, B100051, B100052, B100053, B100054, B100055, B100056, B100057, B100058, B100059, B100060, B100061, B100062, B100063, B100064, B100065, B100066, B100067, B100068, B100069, B100070, B100071, B100072, B100073, B100074, B100075, B100076, B100077, B100078, B100079, B100080, B100081, B100082, B100083, B100084, B100085, B100086, B100087, B100088, B100089, B100090, B100091, B100092, B100093, B100094, B100095, B100096, B100097, B100098, B100099, B100100, B100101, B100102, B100103, B100104, B100105, B100106, B100107, B100108, B100109, B100110, B100111, B100112, B100113, B100114, B100115, B100116, B100117, B100118, B100119, B100120, B100121, B100122, B100123, B100124, B100125, B100126, B100127, B100128, B100129, B100130, B100131, B100132, B100133, B100134, B100135, B100136, B100137, B100138, B100139, B100140, B100141, B100142, B100143, B100144, B100145, B100146, B100147, B100148, B100149, B100150, B100151, B100152, B100153, B100154, B100155, B100156, B100157, B100158, B100159, B100160, B100161, B100162, B100163, B100164, B100165, B100166, B100167, B100168, B100169, B100170, B100171, B100172, B100173, B100174, B100175, B100176, B100177, B100178, B100179, B100180, B100181, B100182, B100183, B100184, B100185, B100186, B100187, B100188, B100189, B100190, B100191, B100192, B100193, B100194, B100195, B100196, B100197, B100198, B100199, B100200, B100201, B100202, B100203, B100204, B100205, B100206, B100207, B100208, B100209, B100210, B100211, B100212, B100213, B100214, B100215, B100216, B100217, B100218, B100219, B100220, B100221, B100222, B100223, B100224, B100225, B100226, B100227, B100228, B100229, B100230, B100231, B100232, B100233, B100234, B100235, B100236, B100237, B100238, B100239, B100240, B100241, B100242, B100243, B100244, B100245, B100246, B100247, B100248, B100249, B100250, B100251, B100252, B100253, B100254, B100255, B100256, B100257, B100258, B100259, B100260, B100261, B100262, B100263, B100264, B100265, B100266, B100267, B100268, B100269, B100270, B100271, B100272, B100273, B100274, B100275, B100276, B100277, B100278, B100279, B100280, B100281, B100282, B100283, B100284, B100285, B100286, B100287, B100288, B100289, B100290, B100291, B100292, B100293, B100294, B100295, B100296, B100297, B100298, B100299, B100300, B100301, B100302, B100303, B100304, B100305, B100306, B100307, B100308, B100309, B100310, B100311, B100312, B100313, B100314, B100315, B100316, B100317, B100318, B100319, B100320, B100321, B100322, B100323, B100324, B100325, B100326, B100327, B100328, B100329, B100330, B100331, B100332, B100333, B100334, B100335, B100336, B100337, B100338, B100339, B100340, B100341, B100342, B100343, B100344, B100345, B100346, B100347, B100348, B100349, B100350, B100351, B100352, B100353, B100354, B100355, B100356, B100357, B100358, B100359, B100360, B100361, B100362, B100363, B100364, B100365, B100366, B100367, B100368, B100369, B100370, B100371, B100372, B100373, B100374, B100375, B100376, B100377, B100378, B100379, B100380, B100381, B100382, B100383, B100384, B100385, B100386, B100387, B100388, B100389, B100390, B100391, B100392, B100393, B100394, B100395, B100396, B100397, B100398, B100399, B100400, B100401, B100402, B100403, B100406, B100407, B100408, B100409, B100410, B100411, B100412, B100413, B100414, B100415, B100416, B100417, B100418, B100419, and B100420;

c) Serial Numbers: V960132, V960133, V960135, V960191, V960253, V960254, V960255, V960256, V960257, V960314, V960460, V960461, V960469, V960481, V960483, V960487, V960488, V960504, V960505, and V960550;

d) Serial Numbers: V960700, V960703, V960735, V960739, V960740, V960864,     V960865, V960866, V960868, V960869, V960870, V961013, V961014, V961015,     and V960659
RECALLING FIRM/MANUFACTURER
Mini-Mitter Company, Inc., Bend, OR, by letter dated June 26, 2007. Firm initiated recall is ongoing.
REASON
Communication Failure: the devices have a memory chip that has a limited number of read/write cycles which can trigger set up information and/or subject information anomalies or intermittent communication annomalies. If left unaddressed, the issues can lead to permanent communication failure.
VOLUME OF PRODUCT IN COMMERCE
1,073 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
SERFAS Energy Suction Probe, Model 279-351-100, 3.5mm 90-S, Recall # Z-0484-2008
CODE
Lot Numbers: 06361AE2 06362AE2 07004AE2 07008AE2 07010AE2 07012AE2 07016AE2 07017AE2 07018AE2 07022AE2 07025AE2 07026AE2 07029AE2 07031AE2 07036AE2 07038AE2 07043AE2, and 07044AE2
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Endoscopy, San Jose, CA, by recall notice dated April 27, 2007.
Manufacturer: Stryker Puerto Rico, Inc., Arroyo, PR. Firm initiated recall is ongoing.
REASON
Device Shut off/on: Device may not turn off after taking finger/foot off of activating switch and may activate without pushing a button. (Patient burns may result from these device malfunctions)
VOLUME OF PRODUCT IN COMMERCE
6,037 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
GE Medical Systems Information Technologies Clinical Information Center (CIC) Pro v5.0.3 & v5.0.6 systems, GE Healthcare, Clinical Systems, Recall # Z-0519-2008
CODE
JA104480715GA JA104521071GA JA106405918GA JA106405954GA JA106426089GA JA106426106GA JA104290048GA JA104389244GA JA104480664GA JA104480715GA JA105111564GA JA105121632GA JA105151746GA JA105151749GA JA105171811GA JA105342546GA JA1054833330GA JA105493389GA JA105493412GA JA1060043963GA JA10606491GA JA106074297GA JA106134601GA JA1061446747GA JA106164772GA  JA106245153GA JA106295351GA JA106355517GA JA106365600GA JA106426063GA JA106426100GA JA106486211GA JA106486215GA JA107096739GA JA107096742GA JAI06345514GA SCH06430010GA SCH06440050GA SCH06440062GA SCH06460310GA SCH06470347GA SCH06470350GA SCH06510406GA SCH07040470GA SCH07050547GA SCH0706057GA SCH07070604GA SCH07070653GA SCH07080669GA. SCH07080671GA SCH07080699GA SCH07080709GA SCH07080731GA SCH07120796GA SCH07120809GA SCH07120825GA SCH07130839GA SCH07130865GA SCH07130882GA SCH07140933GA SCH07150953GA SCH07150963GA SCH07161062GA SCH07181099GA SCH07191148GA SCH07191156GA. SCH07201187GA SCH07201190GA SCH07211226GA SCH07231266GA SCH07231276GA SCH07231291GA SCH07231303GA SCH07261336GA SCH07261339GA SCH07261351GA SCH07261354GA SCH07301566GA SCH073115892GA SCH07321745GA SCH07331762GA SCH07331774GA SCH07331792GA SCH07331810GA SCH07331811GA SCH07361897GA SCH07361902GA SCH07361911GA SCH07361931GA SCH07361956GA SCH07362006GA SCH07382330GA SCH07080714GA SCH07392353GA SCH07161009GA JA104380193GA SCH06240003GA SCH06430007GA SCH06430009GA SCH06430030GA SCH06430035GA SCH06430036GA SCH06430039GA SCH06430041GA SCH06430045GA SCH06430048GA SCH06440049GA SCH06440051GA SCH06440052GA SCH06440053GA SCH06440056GA SCH06440058GA SCH06440060GA SCH06440063GA SCH06440064GA SCH06440065GA SCH06440067GA SCH06440069GA SCH06440072GA SCH06440076GA SCH06440077GA SCH06440080GA SCH06440082GA SCH06440083GA SCH06440084GA SCH06440094GA SCH06440117GA SCH06440119GA SCH06440121GA SCH06440122GA SCH06440123GA SCH06440126GA SCH06440128GA SCH06440136GA SCH06440144GA SCH06440151GA SCH06440155GA SCH06440161GA SCH06440175GA SCH06440184GA SCH06440185GA SCH06440187GA SCH06440190GA SCH06440202GA SCH06450208GA SCH06450209GA SCH06450210GA SCH06450214GA SCH06450215GA SCH06450217GA SCH06450219GA SCH06450223GA SCH06450227GA SCH06450232GA SCH06470352GA SCH06510388GA SCH06510389GA SCH06510390GA SCH06510391GA SCH06510398GA SCH06510409GA SCH06510410GA SCH06510412GA SCH06510414GA SCH06510417GA SCH06510418GA SCH06510419GA SCH06510421GA SCH06510426GA SCH06510427GA SCH06510428GA SCH06510429GA SCH06510430GA SCH06510431GA SCH07040496GA SCH07050506GA SCH07050520GA SCH07050556GA SCH07060590GA SCH07070610GA SCH07070626GA SCH07110764GA SCH07110777GA SCH07120806GA SCH07120830GA SCH07140890GA SCH07140894GA SCH07140904GA SCH07140906GA SCH07140912GA SCH07140922GA SCH07140936GA SCH07140938GA SCH07140942GA SCH07150948GA SCH07150960GA SCH07150994GA SCH07151000GA SCH07151003GA SCH07151006GA SCH07161019GA SCH07161025GA SCH07161054GA SCH07161062GA SCH07161063GA SCH07221233GA SCH07221244GA SCH07261343GA SCH07291492GA SCH07291511GA SCH07291513GA SCH07301516GA SCH07301519GA SCH07301522GA SCH07301523GA SCH07301524GA SCH07301525GA SCH07301529GA SCH07301531GA SCH07301532GA SCH07301534GA SCH07301535GA SCH07301540GA SCH07301541GA SCH07301542GA SCH07301543GA SCH07301544GA SCH07301545GA SCH07301548GA SCH07301550GA SCH07301551GA SCH07301553GA SCH07301554GA SCH07301555GA SCH07301556GA SCH07301558GA SCH07301560GA SCH07301562GA SCH07301564GA SCH07301565GA SCH07301566GA SCH07301567GA SCH07301568GA SCH07301569GA SCH07301571GA SCH07301572GA SCH07301573GA SCH07301574GA SCH07301575GA SCH07301577GA SCH07301580GA SCH07301581GA SCH07301582GA SCH07311583GA SCH07311586GA SCH07311587GA SCH07311591GA SCH07311592GA SCH07311593GA SCH07311597GA SCH07311608GA SCH07311611GA SCH07311613GA SCH07321667GA SCH07321686GA SCH07321694GA SCH07321698GA SCH07321699GA SCH07321721GA SCH07331766GA SCH07341852GA SCH07361897GA SCH07361927GA SCH07362014GA SCH07362027GA SCH07362046GA SCH07362047GA SCH07362048GA SCH07362049GA SCH07362053GA SCH07362056GA SCH07372059GA SCH07372086GA SCH07382337GA SCH07382338GA SCH07382341GA SCH07382343GA SCH07382344GA SCH07392350GA SCH07392352GA SCH07392400GA SCH07392436GA SCH07392437GA JA104290036GA JA104370161GA JA104380192GA JA104390295GA JA104390313GA JA104390314GA JA104390315GA JA104390317GA JA104460552GA JA104470591GA JA104531093GA JA104531110GA JA104531116GA JA104531143GA JA105021248GA JA105021253GA JA105071395GA JA105071411GA JA105141715GA JA105141716GA JA105141717GA JA105141718GA JA105181851GA JA105202014GA JA105222072GA JA105282322GA JA105342529GA JA105513687GA JA105523759GA JA105523763GA JA105523779GA JA105523790GA JA105523794GA JA106033886GA JA106054039GA JA106074244GA JA106074253GA JA106074290GA JA106094376GA JA106094424GA JA106094425GA JA106124553GA JA106134594GA JA106134598GA JA106144669GA JA106144680GA JA106154726GA JA106164735GA JA106265212GA JA106345518GA JA106345527GA JA106355556GA JA106365586GA JA106365593GA JA106365610GA JA106395798GA SCH07110763GA SCH07150978GA SCH07161055GA SCH07281441GA SCH07321737GA SCH07361991GA SCH07382241GA SCH07382269GA SCH07382292GA SCH07382310GA SCH07382315GA SCH07382316GA SCH07382340GA SCH07392384GA SCH07321750GA SCH07341849GA SCH06430021GA SCH06430031GA SCH06430044GA SCH06430047GA SCH06440068GA SCH06440099GA SCH06440160GA SCH06440178GA SCH06440191GA SCH06440197GA SCH06450206GA SCH06510424GA SCH07040492GA SCH07040495GA SCH07050514GA SCH07050527GA SCH07050537GA SCH07050558GA SCH07060580GA SCH07060600GA SCH07070622GA SCH07070627GA SCH07070648GA SCH07110748GA SCH07110768GA SCH07110770GA SCH07110780GA SCH07120827GA SCH07130840GA SCH07130843GA SCH07130845GA SCH07130848GA SCH07130849GA SCH07130851GA SCH07130854GA SCH07140887GA SCH07150950GA SCH07150964GA SCH07150999GA SCH07151004GA SCH07181100GA SCH07211200GA SCH07221240GA SCH07281432GA SCH07281445GA SCH07291478GA SCH07301527GA SCH07301536GA SCH07301537GA SCH07321725GA SCH07331754GA SCH07331804GA SCH07331834GA SCH07341840GA SCH07341845GA SCH07341846GA SCH07341850GA SCH07341866GA SCH07361972GA SCH07362031GA SCH07372075GA SCH07372085GA SCH07372167GA SCH07382202GA SCH07382245GA SCH07382270GA SCH07382271GA SCH07382277GA SCH07382278GA SCH07382290GA SCH07382293GA SCH07382296GA SCH07382307GA SCH07382308GA SCH07382312GA SCH07382317GA SCH07382331GA SCH07382332GA SCH07382335GA SCH07382336GA SCH07392348GA SCH07392349GA SCH07392351GA SCH07392355GA SCH07392356GA SCH07392358GA SCH07392361GA SCH07392362GA SCH07392364GA SCH07392372GA SCH07392375GA SCH07392376GA SCH07392379GA SCH07392381GA SCH07392387GA SCH07392390GA SCH07392391GA SCH07392404GA SCH07291463GA SCH07291477GA SCH07291493GA SCH07291496GA SCH07372133GA SCH07382205GA SCH07382209GA SCH07382276GA SCH07382283GA SCH07382306GA SCH07382319GA SCH07382323GA SCH07211225GA SCH07291485GA SCH06430032GA SCH06430046GA SCH06440075GA SCH06440085GA SCH06440087GA SCH06440088GA SCH06440089GA SCH06440091GA SCH06440097GA SCH06440130GA SCH06440134GA SCH06440135GA SCH06440138GA SCH06440141GA SCH06440154GA 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JA106385746GA JA106385747GA JA106385750GA JA106395759GA JA106395760GA JA106395777GA JA106395796GA JA106415995GA JA106466172GA SCH06430008GA SCH06430011GA SCH06430012GA SCH06430013GA SCH06430015GA SCH06430016GA SCH06430020GA SCH06430022GA SCH06430023GA SCH06430024GA SCH06430025GA SCH06430026GA SCH06430027GA SCH06430028GA SCH06430029GA SCH06430038GA SCH06440050GA SCH06440057GA SCH06440062GA SCH06440142GA SCH06440145GA SCH06440146GA SCH06440148GA SCH06440149GA SCH06440150GA SCH06440152GA SCH06440153GA SCH06440157GA SCH06440158GA SCH06440159GA SCH06440163GA SCH06440164GA SCH06440167GA SCH06440173GA SCH06440198GA SCH06440203GA SCH06440205GA SCH06460287GA SCH07040493GA SCH07050502GA SCH07050510GA SCH07050554GA SCH07060570GA SCH07060572GA SCH07060584GA SCH07060592GA SCH07060598GA SCH07070611GA SCH07070612GA SCH07070620GA SCH07070641GA SCH07070652GA SCH07070655GA SCH07140903GA SCH07191162GA SCH07211211GA SCH07211212GA SCH07261346GA SCH07261350GA SCH07261359GA SCH07301528GA SCH07301547GA 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JA105252186GA JA105252187GA JA105252189GA JA105252208GA JA105262317GA JA106225038GA JA106285245GA JA106295332GA JA106295387GA JA106295394GA JA106335493GA JA106345506GA JA106345530GA JA106345532GA JA106355543GA JA106355555GA JA106355559GA JA106355561GA JA106355563GA JA106355564GA JA106355565GA JA106355572GA JA106365585GA JA106415990GA JA106416003GA JA106416040GA JA106415984GA SCH07060596GA SCH07321746GA SCH07382258GA JA105191910GA JA105212036GA JA105232106GA JA105242165GA JA105262250GA JA105262256GA JA105322406GA JA105332419GA JA105433021GA JA105463200GA JA106124580GA JA106235062GA SCH07140895GA JA105262285GA JA105433050GA JA105453132GA JA105453171GA JA105463188GA SCH07120822GA SCH07130852GA SCH07130860GA SCH07130872GA SCH07130874GA SCH07150970GA SCH07150971GA SCH07150990GA SCH07151002GA SCH07161013GA SCH07161033GA SCH07161046GA SCH07362024GA SCH06440125GA SCH06440172GA SCH06440180GA SCH06440182GA SCH06440183GA SCH06440201GA SCH06450216GA SCH06450220GA SCH06450222GA SCH06450226GA 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SCH07331836GA SCH07341858GA SCH07341859GA SCH07341865GA SCH07341873GA SCH07351888GA SCH07351891GA SCH07351892GA SCH07361901GA SCH07361908GA SCH07361912GA SCH07361924GA SCH07361931GA SCH07361937GA SCH07361940GA SCH07361948GA SCH07361949GA SCH07362021GA SCH07362032GA SCH07372095GA SCH07372097GA SCH07372100GA SCH07372102GA SCH07382231GA SCH07382232GA SCH07382233GA SCH07382242GA SCH07382253GA SCH07382254GA SCH07382264GA SCH07382324GA SCH07382326GA JA105171813GA JA105171836GA JA105191941GA JA105191942GA JA105191958GA JA105201984GA JA105252197GA JA105433035GA JA106023822GA JA106023827GA JA106395888GA SCH06510408GA SCH06510435GA SCH07110788GA SCH07110792GA SCH07130857GA SCH07130858GA SCH07140928GA SCH07140934GA SCH07150984GA SCH07150996GA SCH07161029GA SCH07161057GA SCH07171077GA SCH07171078GA SCH07171080GA SCH07181087GA SCH07181088GA SCH07181090GA SCH07181091GA SCH07181094GA SCH07181095GA SCH07191108GA SCH07191126GA SCH07201194GA SCH07211214GA SCH07281430GA SCH07311651GA SCH07321659GA 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SCH07201186GA SCH07211205GA SCH07311616GA SCH07321696GA SCH07321697GA SCH07321719GA SCH07321720GA SCH07382216GA SCH07382227GA SCH07382246GA SCH06430033GA SCH06440059GA SCH07040473GA SCH07040478GA SCH07040482GA SCH07110746GA SCH07110765GA SCH07150945GA SCH07261365GA SCH07261376GA SCH07261384GA SCH07261385GA SCH07351878GA SCH07351879GA SCH07351884GA SCH07351885GA SCH07361909GA SCH07362025GA SCH07382309GA JA106395812GA SCH07030458GA SCH07130883GA SCH07201178GA SCH07392460GA SCH06440100GA SCH06510436GA SCH07030464GA SCH07050528GA SCH07070619GA SCH07080695GA SCH07080699GA SCH07080709GA SCH07080716GA SCH07110750GA SCH07120829GA SCH07372091GA SCH07382279GA SCH07382288GA SCH07382291GA SCH07382302GA SCH07392392GA SCH07392395GA SCH07392396GA SCH07392397GA SCH07392406GA SCH07392409GA JA105021203GA JA106305432GA JA106305450GA JA106516571GA JA106516573GA JA106516578GA SCH07040475GA SCH07150997GA SCH07311652GA SCH07321684GA SCH07321712GA SCH07321744GA JA105483353GA SCH06230001GA SCH06230002GA SCH06320005GA SCH06320006GA SCH07050526GA SCH07050531GA SCH07050547GA SCH07050550GA SCH07050551GA SCH07070614GA SCH07150992GA SCH07221252GA SCH07221261GA SCH07231310GA SCH07261397GA SCH07301546GA SCH07331805GA SCH07331824GA SCH07341843GA SCH07361915GA SCH07361946GA SCH07361950GA SCH07362045GA SCH07362050GA SCH07362051GA SCH07372058GA SCH07372064GA SCH07372099GA SCH07372117GA SCH07382200GA SCH07382240GA SCH07382243GA SCH07382329GA SCH07392347GA SCH07392354GA JA105463225GA JA105463228GA JA106023833GA JA106023851GA JA106486197GA JA106486210GA JA106486211GA JA105191959GA JA106285243GA SCH07060571GA SCH07120832GA SCH07080701GA SCH07080710GA SCH07110751GA SCH07110754GA SCH07120811GA SCH07120836GA SCH07130856GA SCH07130862GA SCH07130864GA SCH07130868GA SCH07130869GA SCH07281405GA SCH07281425GA SCH07321722GA SCH07341838GA SCH07351876GA SCH07351890GA SCH07361893GA SCH07361902GA SCH07361911GA SCH07361926GA SCH07361932GA SCH07361939GA SCH07372066GA SCH06440147GA SCH06440156GA SCH06440165GA 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JA106395859GA JA106395870GA JA106395871GA JA106395872GA JA106395873GA JA106395874GA JA106395875GA JA106395879GA JA106395884GA JA106395891GA JA106395897GA JA106405935GA JA106405968GA JA106405969GA JA106416010GA JA106486187GA JA106486250GA JA106486253GA JA106094355GA SCH06440143GA SCH06440168GA SCH06440176GA SCH07110782GA SCH07161053GA SCH07171076GA SCH07171081GA SCH07171084GA SCH07171086GA SCH07181093GA SCH07181097GA SCH07191109GA SCH07211220GA SCH07331755GA SCH07341851GA SCH07361943GA SCH07382251GA SCH07382256GA SCH07382257GA SCH07382268GA SCH07382286GA SCH07382300GA SCH07392357GA SCH07392388GA JA104380218GA JA104390305GA JA104440464GA JA106164760GA JA106204942GA JA106204945GA JA106204948GA JA106204955GA JA106214988GA JA106214992GA JA106214998GA JA106215000GA JA106215014GA JA106215016GA JA106215021GA JA106215023GA JA106225025GA JA106225053GA JA106235065GA JA106235069GA JA106235070GA JA106235071GA JA106235072GA JA106375624GA JA106375636GA JA106375641GA JA107026678GA JA107036702GA JA107036704GA JA107036707GA JA107036709GA JA107036710GA JA107036717GA JA107036718GA JA107036719GA JA107036722GA JA107036726GA JA107036729GA SCH07030466GA SCH07050543GA SCH07090745GA SCH07040479GA SCH07050499GA SCH07060579GA SCH07060586GA SCH07070630GA SCH07070635GA SCH07080740GA SCH07110772GA SCH07120810GA SCH07150988GA SCH07161034GA SCH07191141GA SCH07191145GA SCH07191146GA SCH07191147GA SCH07191155GA SCH07191164GA SCH07201168GA SCH07231292GA SCH07231309GA SCH07281406GA SCH07281414GA SCH07281415GA SCH07281424GA SCH07281433GA SCH07281437GA SCH07311619GA SCH07321700GA SCH07331793GA SCH07331806GA SCH07331810GA SCH07331811GA SCH07331817GA SCH07331822GA SCH07361899GA SCH07361903GA SCH07361907GA SCH07361913GA SCH07361921GA SCH07361922GA SCH07361925GA SCH07382294GA SCH07382325GA SCH07392411GA SCH07392420GA JA105513611GA JA105513614GA JA106285264GA SCH07392461GA SCH07040494GA SCH07080717GA SCH07080727GA SCH07080729GA SCH07110760GA SCH07110779GA SCH07130873GA SCH07140905GA SCH07140913GA 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JA105493445GA JA105493446GA JA105493447GA JA105493448GA JA105493449GA JA105493450GA JA105493451GA JA105493453GA JA105493455GA JA105503461GA JA105503462GA JA105503465GA JA105503470GA JA105503472GA JA105503473GA JA106013815GA JA106023848GA JA106104479GA JA106204962GA SCH06440093GA SCH06440101GA SCH06440102GA SCH06440107GA SCH06460300GA SCH06460309GA SCH07070660GA SCH07201193GA SCH07231293GA SCH07060565GA SCH06460302GA SCH06460310GA SCH06460312GA SCH07050518GA SCH07080683GA SCH07040471GA SCH07070654GA SCH07070661GA SCH07080671GA SCH07120794GA SCH07161023GA SCH07191142GA SCH07191143GA SCH07191144GA SCH07191150GA SCH07191151GA SCH07191153GA SCH07191159GA SCH07301517GA JA105161760GA JA106124571GA JA106204967GA SCH06440081GA SCH06470327GA SCH06470354GA SCH06470361GA SCH07050525GA SCH07050560GA SCH07060567GA SCH07060595GA SCH07070608GA SCH07080719GA SCH07110787GA SCH07221236GA SCH07221238GA SCH07221239GA SCH07221243GA SCH07221247GA SCH07221253GA SCH07231263GA SCH07361986GA SCH07362011GA 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JA106174806GA SCH07080715GA SCH07161058GA JA105232089GA JA104440467GA JA106506477GA JA104430398GA JA105402885GA JA105433013GA JA105433019GA JA105433024GA JA105151747GA JA106154714GA JA106164758GA JA106355575GA JA106365583GA JA105473247GA JA105473248GA JA105513622GA JA105523710GA JA106215024GA JA106225041GA JA106225044GA JA106064150GA JA106385658GA JA106204933GA JA106214991GA SCH07040474GA SCH07050503GA SCH07060566GA SCH07060585GA SCH07070650GA SCH07070651GA SCH07080672GA SCH07080682GA SCH07080685GA SCH07080688GA SCH07080691GA SCH07080697GA SCH07080698GA SCH07080700GA SCH07080705GA SCH07080706GA SCH07080725GA SCH07110747GA SCH07120833GA SCH07140892GA SCH07140897GA SCH07140901GA SCH07140902GA SCH07231294GA SCH07231312GA SCH07331783GA SCH07341869GA SCH07341871GA SCH07341872GA SCH07361910GA SCH07361960GA SCH07361967GA SCH07361968GA SCH07372122GA SCH07372129GA SCH07321716GA SCH07331762GA SCH06460284GA SCH07070639GA SCH07080733GA SCH07231283GA SCH07341855GA SCH07362034GA SCH07331760GA 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SCH06440196GA SCH06440204GA SCH06450211GA SCH06450212GA SCH06450239GA SCH06450245GA SCH06450271GA SCH06460290GA SCH06470363GA SCH06510415GA SCH06510433GA SCH07030457GA SCH07040480GA SCH07060578GA SCH07060581GA SCH07060587GA SCH07070658GA SCH07080668GA SCH07080687GA SCH07080720GA SCH07080724GA SCH07120821GA SCH07150982GA SCH07161015GA SCH07161041GA SCH07161048GA SCH07231266GA SCH07231291GA SCH07261341GA SCH07261369GA SCH07261371GA SCH07261383GA SCH07281429GA SCH07291467GA SCH07372078GA SCH07392428GA SCH07392431GA JA104370151GA JA105021186GA JA105101522GA JA105322353GA JA105322369GA JA105443062GA JA105443063GA JA106043988GA SCH06450230GA SCH06450235GA SCH06450262GA SCH06450264GA SCH07361956GA SCH07361957GA SCH07362037GA JA106054021GA JA106054022GA JA106054024GA JA106054025GA JA106285262GA JA106285292GA JA106355536GA SCH06470328GA SCH07060594GA SCH07150963GA SCH07291468GA SCH07321718GA SCH07361964GA SCH07362006GA SCH07321715GA SCH07321717GA SCH07120818GA SCH07120826GA SCH07120834GA 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RECALLING FIRM/MANUFACTURER
Recalling Firm: General Electric Medical Systems Information Technology, Wauwatosa, WI, by letter on October 16, 2007.
Manufacturer: General Electric Medical Systems Information Technology, Milwaukee, WI. Firm initiated recall is ongoing.
REASON
Potential for Loss of Audible Alarming and ECG Tab Setting Changes; from Clinical Information Center (CIC) Pro v5.0.3 & 5.0.6 when used in combination with Telemetry and bedside monitors.
VOLUME OF PRODUCT IN COMMERCE
3,115 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Sechrist Hyperbaric Chamber Gurney, Standard Gurney & Stretcher Model,
    P/N: 21502, Recall # Z-0733-2008;
b) Sechrist Hyperbaric Chamber Gurney, Standard Gurney & Deluxe Wide
    Stretcher Model, P/N 21464, Recall # Z-0734-2008;
c) Sechrist Hyperbaric Chamber Gurney, Hydraulic Gurney & Deluxe Wide
    Stretcher Model, P/N 21465, Recall # Z-0735-2008;
d) Sechrist Hyperbaric Chamber Gurney, Hydraulic Gurney & Standard Stretcher
    Model, P/N 21466, Recall # Z-0736-2008;
e) Sechrist Hyperbaric Chamber Gurney, Standard Gurney without Side rails &
    Stretcher Model, P/N 21487, Recall # Z-0737-2008
CODE
Serial Numbers: (all Model Numbers-21502, 21464, 21465, 21466. and 21487) 0604081092 0606087510 0503071536 0503071538 0408061454 0408061455 0408060131 0408061453 0609082336 0604081093 0606087506 0508081371 0508081372 0609082331 0609082333 0609079892 0506069872 0506069875 0601082091 0601082092 0607081892 0607081893 0512070332 0512070337 0604081037 0604081039 0512070333 0601083589 0502072058 0502072219 0504070085 0601083584 0609079893 0502072070 0404059009 0405060916 0406062857 0407058697 0511075672 0610079808 0612087522 0610079809 0505075450 0506070797 0506070799 0508081000 0509074722 0612087681 0612087685 0508080999 0509074952 0408066081 0411068040 0403059871 0403059875 0511075668 0511075670 0505075448 0506069874 0508081375 0508081376 0403060956 0312058058 0312058062 0309052388 0601082095 0509074723 0509074725 0402059070 0402060431 0402060433 0402060435 0502072217 0502072220 0405059703 0503071540 0504070055 0504070057 0504070060 0506070733 0610079810 0509074846 0403060959 0411068039 0606086093 0606086097 0310057034 0310057035 0606086091 0612080504 0603079025 0609082334 0610079806 0609079889 0609082335 0406061037 0409065507 0409065508 0409065509 0409065510 0409065530 0409065532 0409065534 0409067666 0502072216 0608080023 0608080025 0501072513 0501072514 0611079017 0611081316 0504070053 0607081884 0604081423 0605082514 0601083586 0601083588 0606087507 0611081188 0611081192 0505074492 0607081882 0403059872 0403059874 0404059003 0508081334 0508081336 0502077104 0502077105 0502077107 0612087526 0603079027 0506069871 0601082094 0409064823 0409065992 0503071533 0503071534 0408060133 0403060953 0403060958 0409065529 0413060960 0506069883 0506069884 0509074954 0509074959 0309052386 0312058184 0408060132 0408060134 0601083583 0403060523 0403060525 0604081420 0605082515 0502077103 0503071620 0503071621 0503071622 0401059731 0401059732 0612087534 0507073997 0506070701 0403060952 0502071581 0601083585 0601083590 0401059207 0502072218 0508080997 0509074726 0505074497 0606086099 0606086100 0607081881 0608080024 0502071587 0403060957 0409067665 0604081090 0609082439 0611081315 0402060345 0403059959 0403060524 0601082056 0601082057 0608078598 0310057037 0504070052 0505075447 0502072073 0310057030 0609082438 0501071493 0501071494 0502071887 0503071541 0508081333 0509074845 0407060485 0408067475 0403059951 0403059958 0403060051 0409065994 0409065995 0406062858 0406062859 0502071588 0502071589 0403060053 0601082051 0506070702 0506070704 0312052343 0311050367 0502071585 0502071586 0402060341 0402060344 0406062856 0403060955 0611081189 0611081311 0510072561 0511075671 0502072225 0403060954 0601082055 0402060343 0403060521 0604081416 0604081422 0509074842 0509074843 0509074844 0310057036 0312058183 0612087536 0503071539 0504070058 0506070796 0506070798 0506070800 0612087523 0612087525 0406061036 0406066193 0508081374 0309052272 0509074730 0310057029 0612080502 0604081095 0606087901 0403059953 0405059702 0405059704 0612087682 0612087684 0611079016 0611079019 0611081191 0603079023 0604081094 0606087509 0502072055 0502072056 0502072057 0401059203 0401059734 0408061456 0612080501 0612087531 0510072562 0401059205 0612087524 0509074841 0612087533 0612087535 0511075667 0511075669 0409065531 0409065533 0409065535 0406066191 0406066192 0310057032 0311050368 0401059327 0505074499 0506070681 0601082054 0601083587 0403060054 0403060058 0312058182 0507073995 0507073996 0507074000 0409064961 0409064962 0409064963 0606087903 0606087905 0608078597 0608078599 0609079887 0609079891 0506070734 0404059006 0509074956 0509074960 0408067471 0408067472 0403060052 0609082436 0611079020 0502072072 0502072223 0502072224 0401059330 0405060915 0407058699 0407058700 0504070051 0504070054 0407067635 0501071496 0501072515 0405060917 0406061039 0411068041 0411068201 0312058055 0402060342 0612087532 0312052341 0401059328 0401059329 0402059069 0510072560 0510072565 0403059954 0403059955 0312058181 0606087508 0506070682 0510072564 0407067632 0608078596 0507073998 0509074953 0509074955 0607081885 0608080021 0504070059 0506070732 0506070735 0612087686 0401059733 0401059735 0407060481 0407060484 0409067667 0409067668 0403060056 0403060057 0502072074 0402060434 0405059701 0405060914 0411068202 0411068204 0603079024 0502071584 0502071590 0312052342 0312058185 0309052276 0310057028 0310057033 0512070331 0512070335 0611081187 0611081190 0406059343 0407060482 0408061452 0408067474 0501072516 0502071582 0502071583 0502071889 0502071890 0606087904 0607081894 0409065993 0409065996 0610079804 0610079807 0609082337 0403059957 0403059960 0403060055 0406059342 0406061038 0406066194 0403059873 0403060951 0404059007 0404059008 0611079018 0611081313 0411068203 0604081417 0604081091 0509074951 0509074957 0604081418 0604081419 0604081421 0610079805 0509074724 0509074727 0502071888 0502071891 0605082512 0605082516 0510072563 0512070334 0607081891 0607081895 0506069873 0506069881 0506069882 0506069885 0612087521 0507073999 0611081312 0611081314 0502072222 0503071623 0503071624 0504070056 0505075446 0505075449 0506070731 0605082510 0605082511 0509074721 0508080994 0502077106 0505074494 0505074498 0309052387 0612087683 0604081036 0604081040 0605082513 0601082093 0601082096 0404059001 0404059005 0404059010 0508080991 0508080996 0310057031 0508080992 0508080993 0505074491 0505074500 0504070081 0504070082 0609082332 0612080505 0508081335 0508081373 0612080503 and 0612080506
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sechrist Industries Inc, Anaheim CA, by letters beginning on November 9, 2007.
Manufacturer: Stryker Medical, Div. of Stryker Corp., Portage, MI. Firm initiated recall is ongoing.
REASON
Brake Problems: The stretcher brake cams may crack while attempting to lock the stretcher brake. 
VOLUME OF PRODUCT IN COMMERCE
559 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS III
___________________________________
PRODUCT
Biomet 3i, Certain PreFormance Temporary Cylinder, Catalog Number: IPFTC42, Dental Implant, Recall # Z-0128-2008
CODE
Lot Number: 707303, Expiration Date: 08/31/2012
RECALLING FIRM/MANUFACTURER
Biomet 3i, Palm Beach Gardens, FL, by telephone beginning on September 27, 2007. Firm initiated recall is ongoing.
REASON
Incorrect assembly: The product does not allow for the screw to pass through the access hole and engage the implant properly. Therefore, the provisional restoration will not be seated on the implant platform.
VOLUME OF PRODUCT IN COMMERCE
114 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Nova 8 Analyzer Calibrator Pack (Catalog/REF # 15196), Recall # Z-0295-2008
CODE
Lot Numbers: 610633, 701034, 704053, 707222
RECALLING FIRM/MANUFACTURER
Nova Biomedical Corp., Waltham, MA, by telephone on September 17, 2007. Firm initiated recall is complete.
REASON
Elevated Normalized Ionized Calcium (nCa) and Normalized Ionized Magnesium (nMg) calculated values on patient samples.
VOLUME OF PRODUCT IN COMMERCE
2,411 units
DISTRIBUTION
Nationwide and Internationally

END OF ENFORCEMENT REPORT FOR JANUARY 23, 2008

 

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