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U.S. Department of Health and Human Services

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Enforcement Report for September 29, 2004

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 29, 2004
04-39

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________
PRODUCT
Eillien's Chopped Almonds in 5 oz bags. UPC 34952-13124. Recall # F-453-4.
CODE
Sell by dates between 9/19/04 -- 2/11/05.
RECALLING FIRM/MANUFACTURER
Eillien's Candies, Inc., Green Bay, WI, by visits starting May 24, 2004 and a letter on June 7, 2004. Firm initiated recall is ongoing.
REASON
The product was manufactured using almonds that were recalled by Paramount Farms due to their association with an outbreak of Salmonella Enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
1,882 units.
DISTRIBUTION
WI and MI.

_______________________________
PRODUCT
Maryland Style Crab Cake, Frozen. Various sizes packaged in sealed cardboard box. Six boxes to a case. Not for Retail Sale. Sold to restaurants, hotels and caterers. Recall # F-465-4.
CODE
Product shipped prior to 1/19/01.
RECALLING FIRM/MANUFACTURER
Coastal Seafood, Inc., Fairfield, CT, by fax on February 13, 2004. Firm initiated recall is ongoing.
REASON
The product contains undeclared ingredients including wheat, milk, soy, and fish.
VOLUME OF PRODUCT IN COMMERCE
68 cases.
DISTRIBUTION
CT, NY, and PA.
_______________________________
PRODUCT
Lipton Asian Sides "Teriyaki Noodles" Variety. Lo Mein Noodles in a Sweet Teriyaki Sauce, Net wt. 4.7 oz, UPC 41000-02802. Recall # F-475-4.
CODE
"Best If Used By" codes: Aug 31 05B; Sep 01 05B; Sep 02 05B; Sep 04 05B; Sep 05 05B; Sep 09 05B; Sep 11 05B; Sep 12 05B; Sep 13 05B, Sep 14 05B; Sep 15 05B; Sep 16 05B.
RECALLING FIRM/MANUFACTURER
Unilever Bestfoods, Englewood Cliffs, NJ, by letters on July 29, and July 30, 2004, and by press release on July 30, 2004. Firm initiated recall is ongoing.
REASON
The product contains undeclared eggs.
VOLUME OF PRODUCT IN COMMERCE
6,780 pouches.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
FRUBEX Majonez, 320 ml, SALATKOWY, PRODUKT POLSKI. Net Wt. 250 g/8,8 oz. Product is packaged in a glass jar with a metal cap. Recall # F-506-4.
CODE
Date code 27 11 2004.
RECALLING FIRM/MANUFACTURER
Lowell International Co. Inc., Brooklyn, NY, by press release and letters on May 3, 2004. Firm initiated recall is complete.
REASON
Product contains undeclared eggs and type of vegetable used in oil was not specified based on sampling, analysis, and inspectional findings by the New York State Department of Agriculture & Markets (NYSDAM).
VOLUME OF PRODUCT IN COMMERCE
1,459 jars.
DISTRIBUTION
NY, NJ, CT, and MA.

_______________________________
PRODUCT
a) Italian Bread Dough (frozen), Product code 50014, Product of
Canada. Net Case Wt. 28 lb. 2 oz. (24 count case). The
individual loaves of frozen dough are not packaged/labeled.
Recall # F-507-4;
b) French Sub Roll Dough (frozen), Product Code 18155, PRODUCT
of Canada. Net Case Wt. 30 lb. 9 oz. (100 count case).
Individual loaves of frozen dough are not packaged/labeled.
Recall # F-508-4;
c) Deluxe Wheat Sub Roll Dough (frozen), Product Code 08803,
Product of Canada. Net Case Wt. 22 lb. 8 oz. (60 count case).
Individual units of dough are not packaged or labeled.
Recall # F-509-4.
CODE
a) 77004096 USE BY 03AUG04;
b) 77004090 USE BY 28JUL04;
C) 77004146 USE BY 22SEP04.
RECALLING FIRM/MANUFACTURER
Rich Products Corp, Buffalo, NY, by e-mail and/or letter on August 3, 2004. Firm initiated recall is ongoing.
REASON
Products contain undeclared egg powder.
VOLUME OF PRODUCT IN COMMERCE
Wheat sub: 313 cases; French sub 1,421 cases; Italian bread 5,857 cases.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Vanilla Nut Creme, Caffeinated, Decaffeinated, and Swiss
Water Decaffeinated in 8 oz, 1 lb., and 5 lb. containers.
Recall # F-510-4;
b) Sooner Smoother, Caffeinated, Decaffeinated, and Swiss
Water Decaffeinated in 8 oz, 1 lb., and 5 lb. containers.
Recall # F-511-4;
c) Snickerdoodle, Caffeinated, Decaffeinated, and Swiss Water
Decaffeinated in 8 oz, 12 oz, 1 lb., and 5 lb. containers.
Recall # F-512-4;
d) Hazelnut, Caffeinated, Decaffeinated, and Swiss Water
Decaffeinated in 8 oz, 12 oz, 1 lb., and 5 lb. containers.
Recall # F-513-4;
e) Almond Amaretto, Caffeinated, Decaffeinated, and Swiss Water
Decaffeinated in 8 oz, 1 lb., and 5 lb. containers. Recall #
F-514-4;
f) Banana Nut Creme, Caffeinated, Decaffeinated, and Swiss Water
Decaffeinated in 8 oz, 1 lb., and 5 lb. containers. Recall #
F-515-4;
g) Butter Pecan, Caffeinated, Decaffeinated, and Swiss Water
Decaffeinated in 8 oz, 1 lb., and 5 lb. containers. Recall #
F-516-4;
h) Caramel Nut, Caffeinated, Decaffeinated, and Swiss Water
Decaffeinated in 8 oz, 1 lb., and 5 lb. containers. Recall #
F-517-4;
i) Chocolate Hazelnut, Caffeinated, Decaffeinated, and Swiss
Water Decaffeinated in 8 oz, 1 lb., and 5 lb. containers.
Recall # F-518-4;
j) Chocolate Pecan, Caffeinated, Decaffeinated, and Swiss
Water Decaffeinated in 8 oz, 1 lb., and 5 lb. containers.
Recall # F-519-4;
k) Cinnamon Chocolate Almond, Caffeinated, Decaffeinated, and
Swiss Water Decaffeinated in 8 oz, 1 lb., and 5 lb.
containers. Recall # F-520-4;
l) Coco Cabaret, Caffeinated, Decaffeinated, and Swiss Water
Decaffeinated in 8 oz, 1 lb., and 5 lb.
containers. Recall # F-521-4;
m) Coco Mocha Nut, Caffeinated, Decaffeinated, and Swiss Water
Decaffeinated in 8 oz, 1 lb., and 5 lb. containers. Recall #
F-522-4;
n) Dark Roast Hazelnut, Caffeinated, Decaffeinated, and Swiss
Water Decaffeinated in 8 oz, 1 lb., and 5 lb. containers.
Recall # F-523-4;
o) Dutch Chocolate Almond, Caffeinated, Decaffeinated, and Swiss
Water Decaffeinated in 8 oz, 1 lb., and 5 lb. containers.
Recall # F-524-4;
p) Frangelico Cream, Caffeinated, Decaffeinated, and Swiss Water
Decaffeinated in 8 oz, 1 lb., and 5 lb. containers. Recall #
F-525-4;
q) French Vanilla Almond, Caffeinated, Decaffeinated, and Swiss
Water Decaffeinated in 8 oz, 1 lb., and 5 lb. containers.
Recall # F-526-4;
r) Hazelnut Cream, Caffeinated, Decaffeinated, and Swiss
Water Decaffeinated in 8 oz, 1 lb., and 5 lb. containers.
Recall # F-527-4;
s) Holiday Cheer, Caffeinated, Decaffeinated, and Swiss
Water Decaffeinated in 8 oz, 1 lb., and 5 lb. containers.
Recall # F-528-4;
t) Honey Maple Praline, Caffeinated, Decaffeinated, and Swiss
Water Decaffeinated in 8 oz, 1 lb., and 5 lb. containers.
Recall # F-529-4;
u) Mochadoodle, Caffeinated, Decaffeinated, and Swiss
Water Decaffeinated in 8 oz, 1 lb., and 5 lb. containers.
Recall # F-530-4;
v) Nutterfinger, Caffeinated, Decaffeinated, and Swiss
Water Decaffeinated in 8 oz, 1 lb., and 5 lb. containers.
Recall # F-531-4;
w) Pralines & Cr?me, Caffeinated, Decaffeinated, and Swiss
Water Decaffeinated in 8 oz, 1 lb., and 5 lb. containers.
Recall # F-532-4;
x) Southern Pecan, Caffeinated, Decaffeinated, and Swiss
Water Decaffeinated in 8 oz, 1 lb., and 5 lb. containers.
Recall # F-533-4;
y) Toasted Almon, Caffeinated, Decaffeinated, and Swiss
Water Decaffeinated in 8 oz, 1 lb., and 5 lb. containers.
Recall # F-534-4;
z) Amaretto Tea, Caffeinated and Decaffeinated, in 2 lb. bulk
containers. Recall # F-535-4;
aa) Cherry Almond Tea Caffeinated and Decaffeinated, in 2 lb.
bulk containers. Recall # F-536-4.
CODE
Lot codes 0434 through 2254 are stamped on all 1 lb. and 5 lb. coffee. There are no lot codes on the 8 oz. and 12 oz. coffees.
RECALLING FIRM/MANUFACTURER
Neighbors Executive Coffee Service Co, Inc., Oklahoma City, OK, by press release on August 13, and August 16, 2004, and by letters on August 17, 3004. Firm initiated recall is ongoing.
REASON
These products do not bear ingredient statements and contain peanuts and tree nuts as ingredients.
VOLUME OF PRODUCT IN COMMERCE
44,878 lbs of coffee and 96 lbs of tea.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Caravelle brand Whole Black Pepper Seeds in 1-oz plastic bags. Recall # F-537-4.
CODE
TL0550.
RECALLING FIRM/MANUFACTURER
Anhing Corp., Los Angeles, CA, by letter dated August 17, 2004 and by press release dated August 18, 2004. Firm initiated recall is ongoing.
REASON
Pepper seeds are contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
17 cartons of 100 1-oz. bags.
DISTRIBUTION
CA, NV, TX, WI, KA, and FL.

_______________________________
PRODUCT
a) Jane Jane Brand, Frozen Shrimp Ball, Net Wt 5 lbs.
Recall # F-538-4;
b) Jane Jane Brand, Frozen Pollack Fish Ball, Net Wt 5 lbs.
Recall # F-539-4;
c) Jane Jane Brand, Frozen Squid Nugget, Net Wt 5 lbs.
Recall # F-540-4;
d) Jane Jane Brand, Frozen Cuttlefish Ball, Net Wt 5 lbs.
Recall # F-541-4;
e) Jane Jane Brand, Frozen Milkfish Ball, Net Wt 5 lbs.
Recall # F-542-4.
CODE
a) Lot 50040/230138;
b) Lot 50039/230040;
c) Lot 50042/230325;
d) Lot 50043/230440;
e) Lot 50041/230239.
RECALLING FIRM/MANUFACTURER
Walong Marketing, Inc., Buena Park, CA, by press release and letters on July 15, 2004. Firm initiated recall is ongoing.
REASON
Products contain undeclared eggs.
VOLUME OF PRODUCT IN COMMERCE
1,442 packages.
DISTRIBUTION
Nationwide.

 

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

_______________________________
PRODUCT
a) Blue Diamond brand Almond Breeze Original in quart TetraPak
paper container. Recall # F-454-4;
b) Blue Diamond brand Almond Breeze Vanilla in quart TetraPak
paper container; Recall # F-455-4;
c) Blue Diamond brand Almond Breeze Chocolate in quart TetraPak
paper container; Recall # F-456-4;
d) Imagine Foods brand Rice Dream Original in quart TetraPak
paper container; Recall # F-457-4;
e) Hain Celestial brand Rice Dream Enriched in quart TetraPak
paper container; Recall # F-458-4;
f) Imagine Foods brand Rice Dream Vanilla Enriched in quart
TetraPak paper container; Recall # F-459-4;
g) Imagine Foods brand Rice Dream Enriched Rice Drink Vanilla in
quart TetraPak paper container; Recall # F-460-4;
h) Imagine Foods brand Soy Enriched vanilla in quart TetraPak
paper container; Recall # F-461-4;
i) Kirkland Signature brand Silk Vanilla Soymilk in quart
TetraPak paper container. Recall # F-462-4;
j) Starbucks Brand Vanilla Silk Soymilk Organic in quart
TetraPak paper container. Recall # F-463-4;
k) Starbucks Brand Plain Silk Soy Beverage in quart TetraPak
paper container. Recall # F-464-4.
CODE
a) and b) Lot: L0407701, Exp. date: 17/MAR/05;
c) Lots: L0407701, L0407801; Exp. dates: 17/MAR/05, 18/MAR/05;
d) Lot: L0407501, Exp. Date: 15/MAR/05;
e) Lots: L0406901, L0407001, L0407501, L0407601, L0408201; Exp.
dates: 9/MAR/05, 10/MAR/05, 15/MAR/05, 16/MAR/05, 22/MAR/05;
f) Lot: L0407601, Exp. Date: 16/MAR/05;
g) Lots: L0406801, L0408201, Exp. Dates: 8/MAR/05, 22/MAR/05;
h) Lot: L0406901, Exp. Date: 9/MAR/05;
i) Lot: L0408101, Exp. Date: 03/21/05;
j) Lots: 4078-01, 4079-01, 4080-01; Exp. dates: 14SEP2004 LCNP,
15SEP2004 LCNP, 16SEP2004 LCNP;
k) Lots: 4072-01, 4073-01, 4076-01, 4077-01; Exp. dates:
08SEP2004 LCNP, 09SEP2004 LCNP, 12SEP2004 LCNP, 13SEP2004
LCNP.
RECALLING FIRM/MANUFACTURER
California Natural Products, Lathrop, CA, by press release on September 9, 2004. Firm initiated recall is ongoing.
REASON
A series of aseptically packaged soy-based and rice-based low-acid beverages were recontaminated after processing.
VOLUME OF PRODUCT IN COMMERCE
67,956 cases, 12 packages per case.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Casco lard crackers. UPC code 7-40477-1019-0. Recall # F-
466-4;
b) Guava crackers. UPC code 7-40477-10105-2. Recall # F-467-4;
c) Ginger crackers. UPC code 7-40477-10112-0. Recall # F-468-4;
d) Cinnamon crackers, UPC 7-40477-10103-8. Recall # F-469-4;
e) Sprinkles crackers, UPC 7-40477-10104-5. Recall # F-470-4;
f) Bread rolls, UPC code 7-40477-10113-7. Recall # F-471-4;
g) Cheese/guava pudding cake, UPC 7-40477-10222-9. Recall #
F-472-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Los Muchachos Bakery, Ponce, PR, by visit beginning on May 14, 2004. Firm initiated recall is ongoing.
REASON
a), c), d), e), and f) Products contain undeclared color - FD&C
Yellow # 5;
b) Product contains undeclared colors - FD&C Yellow # 6 and Red
# 40;
g) Product contains undeclared color - FD&C Red # 40.
VOLUME OF PRODUCT IN COMMERCE
45,260 units.
DISTRIBUTION
PR.

_______________________________
PRODUCT
Cheese bread sticks: 7" x 10" partially baked sheet of breadsticks, toped with garlic/cheddar cheese spread. ITEM # 0300 Rizzuto 200 ea. Each sheet is scored into 10 -- 1" x 7 " segments. There are 20 7" x 10" sheets per case. Recall # F-479-4.
CODE
198/04/11:15 to 198/04/11:50 198 = Julian date, 04=year, last 4 digits=time of day produced.
RECALLING FIRM/MANUFACTURER
T. R. Rizzuto Pizza Crust, Inc., Spokane, WA, by telephone on September 13, 2004. Firm initiated recall is ongoing.
REASON
The product contains glove foreign object.
VOLUME OF PRODUCT IN COMMERCE
109 cases.
DISTRIBUTION
WA and ID.

_______________________________
PRODUCT
a) Asian Noodle Bowl Yakisoba w/vegetables in 12 oz tray and 17
oz. bowl. Recall # F-482-4;
b) Asian Noodle BowlYakisoba w/shrimp in 12 oz. tray and 17 oz
bowl. Recall # F-483-4.
CODE
a) Product coded 0627 through 0705 did not contain an ingredient
statement. Product coded 0711, 0712, and 0740 failed to
declare yellow #5. Code represents pull date (06=June 27 =
day of month); 0740 was a misprint of code;
b) 0711, 0712, 0740.
RECALLING FIRM/MANUFACTURER
M & P Fine Foods, Inc, dba Bento Foods, Lynnwood, WA, by telephone beginning on June 25, 2004, by press release on June 25, 2004 and July 3, 2004 and by letter on July 8, 2004. Firm initiated recall is complete.
REASON
The product contains a missing ingredient statement. Undeclared ingredients that can elicit reactions in sensitive individuals include egg, soy, wheat, FD&C #5, and FD&C Yellow #6.
VOLUME OF PRODUCT IN COMMERCE
102/12 oz. containers, 18/17 oz. containers.
DISTRIBUTION
WA

_______________________________
PRODUCT
Escolar, fresh frozen in plastic lined cardboard carton. Each carton has a different weight depending on what the customer ordered. Recall # F-484-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Pacific Sea Food Company, Mukilteo, WA, by telephone on May 28, 2004. Firm initiated recall is complete.
REASON
The product contains histamine and is unfit for human consumption (decomposed).
VOLUME OF PRODUCT IN COMMERCE
226 lbs.
DISTRIBUTION
WA, MT, and TX.

_______________________________
PRODUCT
a) South Bend Chocolate Company Chocolate/Walnut fudge, Product
# 227, in unlabeled 4.5 lb. Aluminum bakers tins. Recall #
F-485-4;
b) South Bend Chocolate Company Peanut Butter fudge, Product
# 228, in unlabeled 4.5 lb. Aluminum bakers tins. Recall #
F-486-4;
c) South Bend Chocolate Company Peanut Butter and Chocolate
fudge, product # 229, in unlabeled 4.5 lb. Aluminum bakers
tins. Recall # F-487-4;
d) South Bend Chocolate Company Maple Walnut fudge, Product
# 231, in unlabeled 4.5 lb. Aluminum bakers tins. Recall #
F-488-4;
e) South Bend Chocolate Company Rocky Road fudge, Product
# 241, in unlabeled 4.5 lb. Aluminum bakers tins. Recall #
F-489-4;
f) South Bend Chocolate Company Turtle fudge, product 243, in
unlabeled 4.5 lb. Aluminum bakers tins. Recall # F-490-4;
g) South Bend Chocolate Company Chocolate fudge, Product
# 226, in unlabeled 4.5 lb. Aluminum bakers tins. Recall #
F-491-4;
h) South Bend Chocolate Company Vanilla fudge, Product
# 244, in unlabeled 4.5 lb. Aluminum bakers tins. Recall #
F-492-4;
i) South Bend Chocolate Company Candy Cane fudge, product # 272,
in unlabeled 4.5 lb. Aluminum bakers tins. Recall # F-493-4;
j) South Bend Chocolate Company LaSalle Mint fudge, Product
# 246, in unlabeled 4.5 lb. Aluminum bakers tins. Recall #
F-494-4;
k) South Bend Chocolate Company Nuccifudge, product # 273, in
unlabeled 4.5 lb. Aluminum bakers tins. Recall # F-495-4;
l) South Bend Chocolate Company Pumpkin fudge, product # 242,
in unlabeled 4.5 lb. Aluminum bakers tins. Recall #
F-496-4;
m) South Bend Chocolate Company candy mixture containing
Chocolate covered peanuts, chocolate covered raisins and
Chocolate chocolate covered malted milk in gold 1 and 2 pound
tins, red (item tin 1) and 2 (item tin1) pound tins and
Snowing Evening Vignette 1 pound tins (item tin WF). Recall
# F-497-4;
n) South Bend Chocolate Company 3 tower set containing chocolate
covered peanuts, chocolate covered blueberries and chocolate
covered malted milk balls in three tier gift boxes; item
GUND3. Recall # F-498-4;
o) South Bend Chocolate Company pecan turtle candy in 4 piece
clear plastic boxes; item 126. Recall # F-499-4;
p) South Bend Chocolate Company assortment of milk chocolate
candy in 5 piece clear plastic boxes; item 125. Recall #
# F-500-4;
q) South Bend Chocolate Company mint meltaways candy in 3 tier
gold colored 5 count boxes; item Tier. Recall # F-501-4;
r) South Bend Chocolate Company Gourmet assortment of mixed
chocolates in 5 oz., 8 oz., 12 oz. and 26 oz. gold boxes.
Items 121, 122, 123 and 124. Recall # F-502-4;
s) Chicago Chocolate Company Gourmet assortment of mixed
chocolates in 4.8 oz, 9/6 ox., 1.2 lb. Gold boxes; items
CH801, CH802, CH803, AND CH805. Recall # 503-4;
t) South Bend Chocolate Company key lime cream candy, item 267.
Recall # F-504-4;
u) Chicago Chocolate Company Gourmet split assorted
chocolates in 9.6 oz, 9/6 oz., 1.2 lb. and 1.8 lb boxes;
items CH821, CH822, and CH823. Recall # 505-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
South Bend Chocolate Company, South Bend, IN, by press release on December 24, 2003, Recall letters dated January 7, 2004 and January 13, 2004. Firm initiated recall is complete.
REASON
These products contain undeclared ingredients including allergen and colors.
VOLUME OF PRODUCT IN COMMERCE
Unknown.
DISTRIBUTION
Nationwide.
 

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III

_______________________________
PRODUCT
a) Baladna Chickpeas Red; Net Wt. 14 oz.poly bag, 24 bags per
case and 16 oz. poly gags, 24 bags per case. Recall #
F-476-4;
b) Baladna Red Pistachios; Net Wt. 14 oz. poly bag, 24 bags per
case, 16 oz. poly bags, 24 bags per case, and 25 lb. Bulk
cases. Recall # F-477-4;
c) Baladna Coconut, (some bags are labeled as Baladna Coconut
Macaroon), Net Wt. 14 oz. poly bag, 24 bags per case. Recall
# F-478-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Midland Dist. Inc., Blue Island, IL, by letters on September 3, 2004. Firm initiated recall is ongoing.
REASON
a) and b) The products contain undeclared color FD&C Red 3;
c) The coconut contains undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
7,179 -- 14 oz. bags, 1,424 -- 16 oz. bags and 25 -- 25lb. Bulk cases.
DISTRIBUTION
Nationwide and Canada.

 

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
Subutex (buprenorphine), 2 mg, 30 sublingual tablet, Rx only.
NDC 12496-1278-2. Recall # D-273-4.
CODE
Lot number 406401.
RECALLING FIRM/MANUFACTURER
Reckitt Benckiser Pharmaceut Inc., Richmond, VA, by letters on August 23, 2004. Firm initiated recall is ongoing.
REASON
Mispackaging: Subutex 2 mg bottles contain Subutex 8 mg tablets.
VOLUME OF PRODUCT IN COMMERCE
3,750 bottles of 30 tablets.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) BISOPROLOL FUMARATE TABLETS, 5 mg, Rx only, 30 Tablets
(NDC 53489-555-07) and 100 Tablets (NDC 53489-555-01), Recall
# D-275-4;
b) BISOPROLOL FUMARATE TABLETS, 10 mg, Rx only, 30 Tablets
(NDC 53489-556-07) and 100 Tablets (NDC 53489-556-01), Recall
# D-276-4.
CODE
a) Lot 50346 exp. 07/05, Lot 50347 exp. 07/05, and Lot 50348
exp. 07/05;
b) Lot 49257 exp. 07/05, Lot 49258 exp. 07/05, Lot 49731 exp.
10/05, and Lot 49732 exp. 10/05.
RECALLING FIRM/MANUFACTURER
Mutual Pharmaceutical Co., Inc., Philadelphia, PA, by letter dated July 1, 2004. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: The product exceeds limit for impurities.
VOLUME OF PRODUCT IN COMMERCE
3,799,160 tablets.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Zemuron Injection (rocuronium bromide), 10mg/5mL Injection, 5 mL Multidose Vials, Box of 10, For IV use only, NDC 0052-0450-15. Recall # D-277-4.
CODE
Lot 3159804032 exp March 2006.
RECALLING FIRM
Organon USA Inc., West Orange, NJ, by letters on August 20, 2004 and August 24, 2004. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility; three vials upstream of the filler were found to contain a foreign liquid identified as Steris LpH SE
VOLUME OF PRODUCT IN COMMERCE
208,840 vials.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Phenytoin Oral Suspension, USP, 125 mg/5 mL, NDC 60432-131-
08. Recall # D-278-4;
b) Tannihist-12 RF Suspension, Carbetapentane Tannate 30 mg/5 mL
and Chlorpheniramine Tannate 4 mg/5mL, Rx only. Recall # D-
279-4.
CODE
Lots 25020A, 25029A, 25426A, 25496A, 25499A, 25500A, 25544A,
25556A, 25625A, 25638A, 25700A, 25706A, 25776A, 25777A,
25813A, 25820A, 25898A, 25899A, 25900A, 25962A, 25963A,
25974A, 26017A, 26021A, 26026A, 26058A, 26061A, 26094A,
26106A, 26108A, 26201A, 26312A, 26314A, 26385A, 26446A,
26448A, 26484A, 26486A, 26491A, 26508A, 26511A, 26532A,
26536A, 26596A, 26601A, 26604A, 26618A, 26620A, 26639A,
26642A, 26676A, 26680A, 26683A;
b) Lot Numbers: 4 oz. lots 25203A, 25328A, 25428A, 25486A,
25561A, 26039A, 25689A, 26083A, 26140A, 25822A, 25854C,
26412A 16 oz. lots 25205A, 25313A, 25754A, 25903A, 25904A,
26466A.
RECALLING FIRM/MANUFACTURER
Morton Grove Pharmaceuticals, Inc., Morton Grove, IL, by letters dated September 9, 2004. Firm initiated recall is ongoing.
REASON
Superpotent: Super-potency of the active ingredient.
VOLUME OF PRODUCT IN COMMERCE
555,225 bottles.
DISTRIBUTION
Nationwide.

 

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

_______________________________
PRODUCT
Potassium Chloride Extended Release Tablets USP, 1500 mg, 20 mEq K, 100 and 500 tablet bottles, Rx ONLY, Manufactured by Andrx Pharmaceuticals, Inc., Fort Lauderdale, FL 33314 NDC 62037-720-01. Recall # D-274-4.
CODE
Lot Numbers: 720D054 (100's), 720D052, 720D057 and 720D002 (500's), Expiration Date Oct-05.
RECALLING FIRM/MANUFACTURER
Andrx Pharmaceuticals, Inc., Davie, FL, by letters on April 22, 2004. Firm initiated recall is ongoing.
REASON
Dissolution Failure (4 hour timepoint).
VOLUME OF PRODUCT IN COMMERCE
4,396, 400 Tablets.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Tartaric Acid, NF. Product size configuration: 250 gram bottle. Recall # D-280-4.
CODE
Item # TX0016-1 Lot # TM0324.
RECALLING FIRM/MANUFACTURER
EMD Chemicals Inc., Gibbstown, NJ, by telephone and letters on August 5, 2004. Firm initiated recall is complete.
REASON
One lot of Tartaric Acid, NF is out of specification for sulfate.
VOLUME OF PRODUCT IN COMMERCE
33 bottles.
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
Senokot (standardized senna concentration) Tablets, 8.6 sennosides, 50 count bottles, NDC 0034-1200-50. Recall # D-281-4.
CODE
Lot 7C21 exp. 8/31/05.
RECALLING FIRM/MANUFACTURER
The Purdue Frederick Company, Stamford, CT, by letters on September 1, 2004. Firm initiated recall is ongoing.
REASON
Mispackaging: Two orange Senokot-S tablets found within a bottle of Senokot Tablets (brown tablets).
VOLUME OF PRODUCT IN COMMERCE
72,492 bottles
DISTRIBUTION
Nationwide.

BIOLOGICS - SAFETY ALERT

_______________________________
PRODUCT
Sample First Sampling Systems which are components of the following Baxter Fenwal Blood-Pack units: 4R1486, 4R1487, 4R3322, 4R3323, 4R3324, 4R3454, 4R3455, and 4R3456. Safety Alert # N-0027-04.
CODE:
This relates to systems usage and codes are irrelevant.
RESPONSIBLE FIRM/MANUFACTURER
Baxter Healthcare Corporation, Deerfield, IL, by "Important Product Safety Information" letters dated February 4, 2004 and February 10, 2004. Letters reiterated Sample First usage instructions and instructed users to check the sample pouch to ensure that there is no anticoagulant present.
REASON
The infectious disease testing sample collected in the Sample First sample pouch may become diluted with anticoagulant if the cannula is inadvertently broken, or if clamping is compromised during Blood-Pack handling.
VOLUME OF PRODUCT IN COMMERCE
107,214 units.
DISTRIBUTION
TX, MA, PA, MO, IL, RI, IA, IN, MN, LA, CA, AZ, and FL.

 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1982-4.
CODE
Unit numbers: E00576, PPKF and PPK2.
RECALLING FIRM/MANUFACTURER
Northern Illinois Blood Bank, Inc., Rockford, IL, by telephone on June 27, 2004, and by letter on July 7, 2004. Firm initiated recall is complete.
REASON
Blood product, contaminated with Oerskovia xanthineolytica, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-2007-4.
CODE
Unit number: 24630-7532.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter, dated January 30, 2004.
Manufacturing Firm: Blood Systems, Inc. Rapid City, SD. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AZ.

_______________________________
PRODUCT
Human Tissues for Transplantation, Corneas. Recall # B-2009-4.
CODE
NY-04-05-015 OU.
RECALLING FIRM/MANUFACTURER
Sight Society of Northeastern New York, dba Lions Eye Bank at Albany, Albany, NY, by telephone on August 13, 2004, and by letter, dated August 13, 2004. Firm initiated recall is complete.
REASON
Human tissues for transplantation, that tested negative for viral markers, but was procured from an ineligible donor due to a high-risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 Tissues.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-2035-4.
CODE
Unit 027P68791.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Alleghenies Region, Johnstown, PA, by telephone on May 9, 2004. Firm initiated recall is complete.
REASON
Blood product, in which the corresponding whole blood unit was contaminated with gram positive cocci, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WV.

_______________________________
PRODUCT
Red Blood Cells (Apheresis). Recall # B-2037-4.
CODE
Unit number 22FZ00636.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on April 27, 2004, and by letter on April 28, 2004. Firm initiated recall is complete.
REASON
Blood product was collected in a manner that may compromise the sterility of the product.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-2038-4.
CODE
Unit number 9034189 (distributed as two split units).
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Greenville, SC, by letter on March 19, 2004. Firm initiated recall is ongoing.
REASON
Blood products, collected using automated equipment that had not been validated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
GA and SC.

_______________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced. Recall # B-2039-4;
b) Platelets Pheresis, Leukocytes Reduced Irradiated. Recall #
B-2040-4.
CODE
a) Unit numbers 9034693 and 9034747; and the following units
were distributed as two split units, unit numbers 9034919
and 9034720;
b) Unit number 9034693.
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Greenville, SC, by telephone on April 20, 2004. Firm initiated recall is complete.
REASON
Blood products, collected using automated equipment that had not been validated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units.
DISTRIBUTION
GA and SC.

_______________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced. Recall # B-2041-4;
b) Platelets Pheresis, Leukocytes Reduced Irradiated. Recall #
B-2042-4.
CODE
a) Unit numbers 9025228 and 9025256; and the following unit
was distributed as two split units, unit number 9025227;
b) Unit number 9025228.
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Greenville, SC, by telephone and letter on March 19, 2003. Firm initiated recall is complete.
REASON
Blood products, collected using automated equipment that had not been validated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
SC.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-2046-4.
CODE
Unit 22KG77115.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on April 2, 2004 and by letter on April 13, 2004. Firm initiated recall is complete.
REASON
Blood product, in which the corresponding whole blood unit was contaminated with gram positive bacilli, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-2047-4.
CODE
Unit 2503378 -- split A.
RECALLING FIRM/MANUFACTURER
LifeSource Blood Services, Glenview, IL, by telephone on August 9, 2004. Firm initiated recall is complete.
REASON
Platelets, with a decreased plasma volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-2048-4;
b) Recovered Plasma. Recall # B-2049-4.
CODE
a) and b) Unit numbers 49KT03614 and 49GE00986.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southwest Region, Tulsa, OK, by facsimile on March 9, 2004. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a reported history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
TX, OK, and Switzerland.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-2050-4
CODE
Unit number 21GL76582.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pacific Northwest Region, Portland, OR, by letter on November 25, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OR.

_______________________________
PRODUCT
Red Blood Cells (Apheresis). Recall # B-2051-4.
CODE
Unit number 22GL08371.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone and letter on April 28, 2004. Firm initiated recall is complete.
REASON
Blood product was collected in a manner that may compromise the sterility of the product.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-2052-4;
b) Platelets. B-2053-4;
c) Recovered Plasma. B-2054-4.
CODE
a), b), and c) Unit number 0034115
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Sarasota, FL, by electronic mail and facsimile on July 7, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the drug Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
FL.

_______________________________
PRODUCT
Platelets, Leukocytes Reduced. Recall # B-2056-4.
CODE
Unit number 22KC28392.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by facsimile on May 7, 2004. Firm initiated recall is complete.
REASON
Blood product collected from an ineligible donor due to history of close contact with an individual having viral hepatitis.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ.

_______________________________
PRODUCT
Red Blood Cells, Recall # B-2057.
CODE
Unit 4221862.
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK, by letter dated July 29, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was taking the medication Tazorac, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AK and NJ.

 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

______________________________
PRODUCT
Red Blood Cells. Recall # B-2002-4.
CODE
Unit numbers: W11293, W11294, W11295, W11290, W11291.
RECALLING FIRM/MANUFACTURER
Blood Center of Northcentral Wisconsin, Wausau, WI, by letter, dated August 10, 2000. Firm initiated recall is complete.
REASON
Blood products, collected in expired collection bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
WI.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-2008-4.
CODE
Unit number: 24630-7532.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter, dated January 30, 2004.
Manufacturing Firm: Blood Systems, Inc. Rapid City, SD. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Removed, Irradiated. Recall # B-2013-4.
CODE
Unit number: 71J465211.
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Center, Gainesville, FL, by facsimile on July 12, 2004. Firm initiated recall is complete.
REASON
Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated. Recall # B-2033-4.
CODE
Unit numbers: 71L614462 and 71L522186.
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Center, Gainesville, FL, by telephone on April 15, 2004. Firm initiated recall is complete.
REASON
Blood products, which were labeled with an incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
FL.
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-2034-4.
CODE
Units 3971672, 2979195.
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, IN, by telephone on July 7, 2004. Firm initiated recall is complete.
REASON
Blood products, that failed to meet the leukocyte reduced criteria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IN.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-2036-4.
CODE
Unit number 0793803.
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Greenville, NC, by telephone on November 4, 2003. Firm initiated recall is complete.
REASON
Blood product that was out of controlled storage for 30 minutes was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NY.

_______________________________
PRODUCT
Source Plasma. Recall # B-2043-4.
CODE
Unit numbers 04ATXC3364, 04ATXC3366, 04ATXC3367, 04ATXC3375, 04ATXC3377, 04ATXC3378, 04ATXC3382, 04ATXC3383, 04ATXC3384, 04ATXC3386, 04ATXC3390, 04ATXC3398, 04ATXC3399, 04ATXC3400, 04ATXC3401, 04ATXC3403, 04ATXC3404, 04ATXC3405, 04ATXC3409, 04ATXC3413, 04ATXC3421, 04ATXC3423, 04ATXC3424, 04ATXC3428, 04ATXC3429, 04ATXC3435, 04ATXC3437, 04ATXC3441, 04ATXC3443, 04ATXC3444, 04ATXC3447, 04ATXC3452, 04ATXC3455, 04ATXC3456, 04ATXC3457, 04ATXC3458, 04ATXC3459, 04ATXC3462, and 04ATXC3467.
RECALLING FIRM/MANUFACTURER
Plasma Center-Tyler, Inc., Austin, TX , by telephone on June 24, 2004. Firm initiated recall is complete.
REASON
Blood products, untested tested for human immunodeficiency virus (HIV) p24 antigen by the enzyme immunoassay (EIA) test, were distributed.
VOLUME OF PRODUCT IN COMMERCE
39 units.
DISTRIBUTION
Austria.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-2044-4.
CODE
Unit number: E65215.
RECALLING FIRM/MANUFACTURER
HCSC-Blood Center, Miller Memorial Blood Center, Bethlehem, PA, by telephone on March 3, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor when quality control for hemoglobin testing was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated. Recall # B-2045-4.
CODE
Unit 22FC17689.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on April 12, 2004, and by letter dated April 14, 2004. Firm initiated recall is complete.
REASON
Blood product, corresponding to Platelets that were contaminated with Propionibacterium acnes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-2058.
CODE
Unit 4221862.
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK, by letter dated July 29, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was taking the medication Tazorac, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AK and NJ.

 

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

_______________________________
PRODUCT
8870 software application card Version AAA 02, BBB 04, BBC 02, and BBD 01, which is used in conjunction with the Model 8840 N'Vision Clinician Program. Recall # Z-1334-04.
CODE
Software Version AAA 02, BBB 04, BBC 02, and BBD 01.
RECALLING FIRM/MANUFACTURER
Medtronic Inc, Neurological & Spinal Division, Columbia Heights, MN, by letters on August 24, 2004. Firm initiated recall is ongoing.
REASON
Users may mistakenly enter a periodic bolus interval into the minutes field, rather than the hours field, resulting in drug overdoses. This issue is limited to programming the SynchroMed and SynchroMed EL pumps.
VOLUME OF PRODUCT IN COMMERCE
4,466 cards.
DISTRIBUTION
Nationwide and Internationally.

___________________________________
PRODUCT
The LTV Series ventilators provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. This is a prescription medical device intended for use by personnel under the direction of a physician. The ventilator is suitable for use in institutional, home and transport settings. Recall # Z-1485-04.
CODE
Ventilators manufactured prior to September 2003. Affected LTV Model/ Serial's: LTV 1000- S# A06500, LTV 950- S# C07000, LTV 900- S# B03500, LTV 800- S# D01400.
RECALLING FIRM/MANUFACTURER
Pulmonetic Systems, Inc, Minneapolis, MN, by letter on September 7, 2004. Firm initiated recall is ongoing.
REASON
LTV Series of Ventilators (Models 1000, 950, 900 and 800). The ventilator has not consistently switched to internal battery operation when the external DC power source has become inadequate to supply stable power, resulting in loss of ventilation to the patient.
VOLUME OF PRODUCT IN COMMERCE
10,299 units.
DISTRIBUTION
Nationwide and Internationally.

*****CORRECTION*****

In the September 22, 2004 Enforcement Report 04-38, Recall # Z-1458/71-04, the CODE information has been amended from "All lots" to "Lot numbers ending in the letters "S" or "T".

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
a) ACOM.M angiographic x-ray system. Model number 4371741.
Recall # Z-1477-04;
b) ACOM.M angiographic x-ray system. Model number 5215707.
Recall # Z-1478-04.
CODE
a) Serial numbers: 1024 through 1639;
b) Serial numbers 1087, 1088,1089,1093, 1094, 1493, 1174, 1176,
and 1212.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on June 16, 2004. Firm initiated recall is ongoing.
REASON
Possible problem reviewing images on the ACOM.M.
VOLUME OF PRODUCT IN COMMERCE
237 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Hill-Rom brand VersaCare Bed; Model P3200. Recall # Z-1482-04.
CODE
All units.
RECALLING FIRM/MANUFACTURER
Hill-Rom, Inc., Batesville, IN, by letters dated August 24, 2004. Firm initiated recall is ongoing.
REASON
Pivot bolts on the sleep deck may become loose and fall out, allowing the head section to shift or to drop to one side, and a grounding warning label is missing.
VOLUME OF PRODUCT IN COMMERCE
5,048 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm). Recall # Z-1483-04.
CODE
Serial Numbers: MC01475-D3; MC02325-K3; MC01476-D3; MC02120-I3; MC02017-I3; MC02004-I3; MC02011-I3; MC02018-I3; MC02047-I3; MC02039-I3; MC02196-I3; MC02279-K3; MC02295-K3; MC02298-K3; MC01478-D3; MC01491-D3; MC01496-D3; MC01865-G3; MC01455-D3; MC02281-K3; MC02237-I3; MC05179-C4; MC05180-C4; MC05191-C4; MC05194-C4; MC05206-C4; MC05218-C4; MC05223-C4; MC01497-D3; MC01452-D3; MC01473-D3; MC01490-D3; MC01493-D3; MC01861-G3; MC02354-K3; MC02293-K3; MC02303-K3; MC02316-K3; MC02134-I3; MC02138-I3; MC02148-I3; MC02321-K3; MC02292-K3; MC01487-D3; MC02285-K3; MC02309-K3; MC02313-K3; MC05082-C4; MC05107-C4; MC02306-K3; MC01862-G3; MC01918-H3; MC01479-D3; MC05183-C4; MC05189-C4; MC01474-D3; MC01477-D3; MC01450-D3; MC05072-C4; MC05075-C4; MC05083-C4; MC05089-C4; MC05090-C4; MC05105-C4; MC05178-C4; MC05195-C4; MC05209-C4; MC05210-C4; MC05212-C4; MC05213-C4; MC05214-C4; MC05215-C4; MC05217-C4; MC05224-C4; MC01448-D3; MC01449-D3; MC01464-D3; MC01481-D3; MC01495-D3; MC01859-G3; MC01867-G3; MC01890-H3; MC02348-K3; MC02359-K3; MC02363-K3; MC01453-D3; MC01860-G3; MC02199-I3; MC01460-D3; MC01806-G3; MC01954-H3; MC02135-I3; MC02136-I3; MC02146-I3; MC02168-I3; MC02171-I3; MC02278-K3; MC02280-K3; MC05172-C4; MC05173-C4; MC05174-C4; MC05181-C4; MC05184-C4; MC05188-C4; MC05190-C4; MC05201-C4; MC05203-C4; MC05208-C4; MC05219-C4; MC05222-C4; MC05225-C4; MC05227-C4; MC02002-I3; MC02005-I3; MC02006-I3; MC02008-I3; MC02020-I3; MC02023-I3; MC02025-I3; MC02027-I3; MC02030-I3; MC02034-I3; MC02043-I3; MC02044-I3; MC02048-I3; MC02052-I3; MC05182-C4; MC05185-C4; MC05192-C4; MC05199-C4; MC01869-G3; MC02326-K3; MC02344-K3; MC02357-K3; MC02365-K3; MC01866-G3; MC01868-G3; MC01929-H3; MC01949-H3; MC02187-I3; MC02277-K3; MC01482-D3; MC01488-D3; MC02177-I3; MC02290-K3; MC02317-K3.
RECALLING FIRM/MANUFACTURER
Datascope Corp., Mahwah, NJ, by letter on July 28, 2004. Firm initiated recall is ongoing.
REASON
The Trio Monitor has latex feet. It is not labeled per 21 CFR801.437 to indicate that it contains latex.
VOLUME OF PRODUCT IN COMMERCE
146 units.
DISTRIBUTION
Nationwide.
____________________________
PRODUCT
CryoValve, Conduit and Pulmonary Valve and Conduit. Donor #66949. Model #SGPV00. Recall # Z-1484-04.
CODE
Serial #7988716.
RECALLING FIRM/MANUFACTURER
CryoLife, Inc., Kennesaw, GA, by telephone on April 12, 2004. Firm initiated recall is complete.
REASON
CryoLife received information regarding a positive culture for Group A Streptococcus infection in a recipient of tissue procured from the attached donor.
VOLUME OF PRODUCT IN COMMERCE
1 tissue.
DISTRIBUTION
NM.
 

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
a) Gluteraldehyde Concentration Indicators "Browne GA
Indicator for CIDEX PLUS Products. Recall # Z-1479-04;
b) Gluteraldehyde Concentration Indicators "Browne GA
Indicator for CIDEX Products. Recall # Z-1480-04;
c) Orthophthaladehyde Concentration Indicator Browne CIDEX
OPA Indicator. Recall # Z-1481-04.
CODE
a) CIDEX PLUS code 2924 lots: 9467, 9514, 9517, 9533 CIDEX PLUS
code 2926, lots: 9504, 9518, 9534, 9624, 9655;
b) CIDEX Activated code 2927, lots: 9520, 9656, 9695, 9804,
9896, 10001 CIDEX Activated Code 2920, lots: 9447, 9522,
9621, 9622, 9661, 9662, 96666, 9764, 9897;
c) CIDEX OPA code 20392, lots: 9272, 9273, 9433, 9434, 9436,
9461, 9512, 9513, 9537, 9538, 9578, 9593, 9664, 9699, 9743,
9744, 9745, 9746, 9814, 9815, 9816, 9854, 9935, 9984, 9985,
10019, 10028, 10036, 10037, 8101, 8144, 8218, 8233, 8321,
8482, 8483, 8510, 8511, 8512, 8513, 8514, 8618, 8630, 8631,
8632, 8636, 8637, 8638, 8792, 8793, 8794, 8795, 8796, 8797,
8798, 8978, 8980, 8981, 9130, 9131, 9133, 9270, 9271, 9272
CIDEX OPA code 20393, lots: 8079, 8102, 8219, 8223, 8421,
8456, 8515, 8550, 8633, 8639, 8970, 8982, 9075, 9260, 9274,
9275, 9536, 9564, 9663, 9796, 9907, 9908, 10000.
RECALLING FIRM/MANUFACTURER
Advanced Sterilization Products, Irvine, CA, by e-mail letter on September 4, 2003. Product alert was issued on all test strips sold in US dated September 24 and October 3, 2003. Foreign affiliates sent letters dated September 4, 5, 11, 19, & 24, 2003. Firm initiated recall is complete.
REASON
Performance failure complaints, moisture ingress into the bottles was causing failure or variability in results.
VOLUME OF PRODUCT IN COMMERCE
122,914 cases.
DISTRIBUTION
Nationwide and Internationally.

END OF ENFORCEMENT REPORT FOR September 29, 2004

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