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U.S. Department of Health and Human Services

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Enforcement Report for July 6, 2005

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.

July 6, 2005
05-27

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS I

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PRODUCT
Sun Dried Tomatoes, Casale brand, Net Wt. 5 lbs., UPC 026662721725. Product of Turkey. Products are sold in 3 styles: (1) Julienne Cut Regular; (2) Julienne Cut Ready-To-Eat; and (3) Halves Ready-to-Eat. The bag label is identical for all three styles. Reportedly, case labeling identifies each style. (Case labeling was not obtained by NYS Dept. of Agriculture and Markets.) There is no firm name/address on the product labeling. Recall # F-436-5.
CODE
2003 crop
RECALLING FIRM/MANUFACTURER
Recalling Firm: Casa Imports Inc, Utica, NY, by letters dated March 22, 2005.
Manufacturer: Kareks Tarim Orm.veTeks Urun.Ins.Turz.San.Tic.Ltd.Sti., Izmir, Turkey. Firm initiated recall is complete.
REASON
Product contains undeclared sulfites over (9,650 ppm) based on analysis by the New York State Department of Agriculture and Markets.
VOLUME OF PRODUCT IN COMMERCE
102 cases
DISTRIBUTION
NY and PA

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PRODUCT
Mama's Smoked Nova Salmon Packaged in 8 oz. vacuum-packed bags. Recall # F-437-5.
CODE
Individual 8 oz. packages: SELL BY SEP 17 2005 27183,
SELL BY SEP 18 2005 27183. Shipping cartons: 09/17/05 SELL BY 27183, 09/18/05 SELL BY 27183.
RECALLING FIRM/MANUFACTURER
Sea Specialties, Miami, FL, by telephone on April 1, 2005. Firm initiated recall is ongoing.
REASON
The product is contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
119 cases; 12/8-oz. per case
DISTRIBUTION
East Coast of US

______________________________
PRODUCT
Po'Boy Lunch Meat with Cheeses, Po' Boy on Hoagie Bun. The sandwiches are packaged 24 per case. Recall # F-438-5
CODE
101N6 (Julian date stamped on outer label)
RECALLING FIRM/MANUFACTURER
Quik'N Tasty Foods, Belton, MO, by e-mail on April 29, 2005, May 2, 2005 and by press release on May 6, 2005. Firm initiated recall is complete.
REASON
Sandwiches were manufactured using ham that was recalled by Field Packing Company due to its contamination with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
49/24-sandwich cases
DISTRIBUTION
MO, KS, IL, OK, and AZ

______________________________
PRODUCT
ZhenQiWei Foods brand Gold Medal Apricot, Net Wt. 5.3 oz/150 g. Product of China. Serving Size 1 (50 g), Servings per Container 3, the product is packed in a plastic bag. Recall # F-440-5.
CODE
Barcode # 6 922043 184919 and no other coding
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lion Pavilion Ltd, Brooklyn, NY, by press release on May 5, 2005.
Manufacturer: Chengdu Shi Zi Lou Foodstuff Co., LTD, Chengdu, China. Firm initiated recall is complete.
REASON
The product contained undeclared sulfites (902 ppm) based on sampling and analysis by the New York State Department of Agriculture and Markets.
VOLUME OF PRODUCT IN COMMERCE
50 cases (60 - 150 g bags per case)
DISTRIBUTION
NY, IL, TX, FL, LA, IA, and NE

______________________________
PRODUCT
Berkshire Blue Cheese, Made completely by hand of Whole Unpastesurized Jersey Cow's Milk and aged 60 days. Average weight per wheel 2 ¾ lbs. Recall # F-441-5
CODE
Batch codes: "QA" and "QB"
RECALLING FIRM/MANUFACTURER
Berkshire Cheese Makers LLC, Great Barrington, MA, by telephone on March 13, 2005, by letter dated March 14, 2005, and by visit and press release on March 25, 2005. Firm initiated recall is complete.
REASON
The product is contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
13 wheels
DISTRIBUTION
MA

______________________________
PRODUCT
Jell-O Brand Sugar Free, Fat Free Reduced Calorie Instant Pudding & Pie Filling, Vanilla Artificial Flavor; 1.0 oz. boxes/24 per case, UPC # 43000-20552. Recall # F-445-5
CODE
Code number 05 MAR 07 D8
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kraft Inc, Northfield, IL, by press release on April 18, 2005.
Manufacturer: Kraft Foods, Inc., Dover, DE. Firm initiated recall is ongoing.
REASON
Pudding & pie filling mix contains undeclared pistachios.
VOLUME OF PRODUCT IN COMMERCE
51 cases
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Edwards Oreo Cream Pie, Singles, 2 Ready to Eat Pie Slices, Keep Frozen. The product is labeled Edwards Oreo Singles, however the package may contain Edwards Moosetracks Singles which contains peanuts. The outer carton is labeled Edwards Moosetracks Singles 12/2pk, Item number 4010030, Case UPC 10041458117121, Recall # F-446-5.
CODE
Date code: Y8 4 282 (October 8, 2004)
RECALLING FIRM/MANUFACTURER
Edwards Fine Foods - Atlanta, Atlanta, GA, by press release and telephone on April 29, 2005, and telephone and letter on May 2, 2005. Firm initiated recall is ongoing.
REASON
Packages labeled as Oreo Cream Pie Singles actually contained Moosetracks Singles with peanuts as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
8,899 cases
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Dried Sweet Potato Strips, 7 oz. bag. Recall # F-447-5
CODE
All codes
RECALLING FIRM
Recalling Firm: Walong Marketing Inc., Buena Park, CA, by press release and letter on May 19, 2005.
Manufacturer: Fujian Cereals, Oils, & Foodstuffs Imp/Exp Corp, Fuzhou, China. Firm initiated recall is ongoing.
REASON
Product contains undeclared sulfites (1380 ppm) based on analysis by the New York State Department of Agriculture and Markets.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
a) Gandour Sons Halva Plain; a vanilla flavored soft candy
made from sugar, tahini (sesame butter), vanilla and
citric acid packaged in 16 oz. and 32 oz. plastic
containers, 12 containers per case; Made in Lebanon; the
candy was packaged under the following labels:
Ghandour Sons Halva Plain 16 oz. - UPC not known -
item #A0050 and S0050 32 oz. - UPC 74265-00442 - item
#A0050A case labeled as Halawa Vanilla;
Ghandour Sons Halawa Chewy 16 oz. - UPC 46248-11720 -
item #A0049B 32 oz. - UPC not known - item #A0045. Recalling # F-469-5;
b) Gandour Sons Pistachio Halva; a vanilla flavored soft
candy made from sugar, tahini (sesame butter), vanilla,
citric acid and pistachio packaged in 16 oz. and 32 oz.
plastic containers. 12 containers per case; Made in
Lebanon; the candy was packaged under the following
labels: a) Ghandour Sons Extra Pistachio Halva 16 oz. -
UPC 74265-00409 - item #A0051 & S0051 32 oz. -
UPC 74265-00403 - item #A0051A case labeled as Halawa
Pistachio
Ghandour Sons Pistachio Halva in 16 oz. and
32 oz. plastic tubs, Recall # F-470-5;
c) Gandour Sons Mixed Nuts Halva; a vanilla flavored soft
candy made from sugar, tahini (sesame butter), vanilla,
citric acid, cashews (cajou), pistachios and almonds
packaged in 16 oz. and 32 oz. plastic containers. 12
containers per case; Made in Lebanon; the candy was
packaged in the following sizes 16 oz. - UPC 74265-00906
item #A0051C 32 oz. - UPC 74265-00907 - item #A0051D
case labeled as Halawa Mixed Nuts, Recall # F-471-5;
d) Gandour Sons Marble Chocolate Halva, a vanilla/
chocolate flavored soft candy made from sugar, tahini
(sesame butter), vanilla, citric acid, chocolate and
pistachios (which are not listed in the ingredient
statement) packaged in 16 oz. and 32 oz. plastic
containers. 12 containers per case; Made in Lebanon; the
candy was packaged in the following sizes: 16 oz. - UPC
not known - item #A0050B 32 oz. - UPC 74265-00909 - item
#A0050C case labeled as Marble Chocolate with Pistachio
Halva, Recall # F-472-5;
e) Gandour Sons Sugar Free Halva Plain or Sugar Free Halva
Vanilla, a vanilla flavored soft candy made from
sorbitol, tahini (sesame butter), citric acid and
vanilla packaged in 16 oz. and 32 oz. plastic
containers, 12 containers per case; Made in Lebanon; 16
oz. - UPC 74265-00368 - item #A0048 32 oz. - UPC 74265-
00370 - item #A0048A case labeled as A.O. Gahndour
Sugar-Free Halva Plain and Halawa Nature Plain Sugar
Free, Recall # F-473-5;
f) Gandour Sons Sugar Free Pistachio Halva; a vanilla
flavored soft candy made from sorbitol, tahini (sesame
butter), pistachio, citric acid and vanilla, packaged in
16 oz. and 32 oz. plastic containers, 12 containers per
case; Made in Lebanon; the candy was packaged the
following sizes 16 oz. - UPC 74265-00369 - item #A0049
32 oz. - UPC not known - item #A0049A, Recall # F-474-5
CODE
All lots of all sizes and labels
RECALLING FIRM/MANUFACTURER
Recalling Firm: Syrian Bakery Company, Inc. D.B.A. Ziyad Brothers Importing, Cicero, IL, by press release dated May 19, 2005.
Manufacturer: A. O. Ghandour Sons S.A.L., Beirut, Lebanon. Firm initiated recall is ongoing.
REASON
Products are contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
28,500 - 1 lb. tubs and 9,774 - 2 lb tubs
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
Edwards Turtle Pie Slices, 2-pack, Net Wt 5.4 oz (153g), Recall # F-475-5
CODE
Item No. 4009770, Code date Y8 5 071 (followed by shift code letter A or D
RECALLING FIRM/MANUFACTURER
Schwan's Bakery Inc, Suwanee, GA, by press release on May 27, 2005 and by telephone on May 27, 2005. Firm initiated recall is ongoing.
REASON
Packages labeled as Turtle Pie Slices actually contained Pecan Pie Slices with egg as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
388 cases
DISTRIBUTION
Nationwide


RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

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PRODUCT
a) Abilify (aripiprazole) 5 mg, 30 tablet bottles, Rx only,
NDC 59148-007-13. Recall # D-235-5;
b) Abilify (aripiprazole) 10 mg, 30 tablet bottles, Abilify
10 mg Tablets, blisters of 7 (samples), Rx only, NDC 59148-008-13, Recall # D-236-5;
c) Abilify (aripiprazole) 15 mg, 30 tablet bottles, Rx
only, NDC 59148-009-13. Recall # D-237-5;
d) Abilify (aripiprazole) 30 mg, 30 tablet bottles, Rx
only, NDC 59148-011-13, Recall # D-238-5
CODE
a) For 5mg. Lots 4B81979 , 4C83077, 4C92612;
b) For 10mg. Lots 3L69888, 3L69889, 4B81980 - 30
tablet/bottle For 10 mg - 7 tablet blister;
c) For 15mg. Lots 3L69891, 3L69892, 3L69899;
d) For 30 mg. Lot 4B79310
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bristol-Myers Squibb Company, New Brunswick, NJ, by letter on February 18, 2005.
Manufacturer: Bristol-Myers Squibb Manufacturing Company, Mayaguez, PR. Firm initiated recall is ongoing.
REASON
Dissolution Failure
VOLUME OF PRODUCT IN COMMERCE
566,,836 bottles and 300,280 blisters
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Benazepril Hydrochloride Tablets, 40 mg, 100 count bottles, Rx only, NDC 0185-0048-05, Recall # D-253-5
CODE
Lot #W030655, Expiration 08/05
RECALLING FIRM/MANUFACTURER
Recalling Firm: Eon Pharma Lle, Wilson, NC, by letter on May 19, 2005.
Manufacturer: Eon Labs, Inc, Laurelton, NY. Firm initiated recall is ongoing.
REASON
Dissolution failure at 18 month stability.
VOLUME OF PRODUCT IN COMMERCE
9577 bottles (100 tablets per bottle)
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Hydrocortisone Acetate Suppositories, 25 mg, NDC 53265-761-12, (12 packs) and NDC 53265-761-24(24 packs), Recall # D-256-5
CODE
All codes being recalled
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc., Cranbury, NJ, by press release and letter on May 25, 2005.
Manufacturer: Able Laboratories, Inc., South Plainfield, NJ. Firm initiated recall is ongoing.
REASON
There is lack of assurance that testing conducted for release and stability conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
32 lots
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Eyedrops, Extra Relief, Naphazoline hydrochloide 0.012%,
Glycerine 1.2%, 20mL, NDC 67234-010-01,
Recall # D-258-5;
b) Eyedrops, Seasonal Relief, Naphazoline hydrochloide
0.012%, Glycerine 1.2%, Zinc Sulfate, 0.25%, 20mL, NDC 67234-011-01, Recall # D-259-5;
c) Eyedrops, Artifical Tears, Polyvinyl alcohol 0.5%, Povidone, 0.6%, 20mL, NDC 67234-009-01
CODE
a) Lot Numbers: 1235, 1045, 0915
b) Lot Numbers: 1185, 0835
c) Lot Number: 1105
RECALLING FIRM/MANUFACTURER
Natureplex LLC, Memphis, TN, by telephone beginning May 19, 2005, and by letter dated May 24, 2005. Firm initiated recall is ongoing.
REASON
Lack of assurance of sterility
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Size E medical gas cylinders containing Compressed Gas, N.O.S. UN3156 Oxygen-Carbon Dioxide gas, Recall # D-263-5
CODE
Lot # 1022BG04
RECALLING FIRM/MANUFACTURER
Specialty Gases of America Inc, Toledo, OH, by telephone on December 3, 2004. Firm initiated recall is ongoing.
REASON
Incorrect CGA valve used.
VOLUME OF PRODUCT IN COMMERCE
12 size E medical gas cylinders
DISTRIBUTION
MI

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PRODUCT
a) Atenolol Tablets, USP 25 mg, NDC 53265-412-10,
NDC 53265-412-11, (100s and 1000s), Recall # D-265-5;
b) Atenolol Tablets, USP 50 mg, NDC 53265-413-10,and
NDC 53265-413-11, (100s and 1000s), Recall # D-266-5;
c) Atenolol Tablets, USP 100 mg, NDC 53265-414-10,and
NDC 53265-414-11, (100s and 1000s), Recall # D-267-5
CODE
All lots are being recalled
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc., Cranbury, NJ, by press release and letter on May 25, 2005.
Manufacturer: Able Laboratories, Inc., South Plainfield, NJ. Firm initiated recall is ongoing.
REASON
There is a lack of assurance that testing conducted for release and stability conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
68 lots
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
a) Hydrocodone Bitartrate and Acetaminophen Tablets, USP,
5 mg/325 mg CIII, NDC 53265-345-10,and NDC 53265-345-50,
(100s and 500s), Recall # D-268-5;
b) Hydrocodone Bitartrate and Acetaminophen Tablets, USP,
5 mg/500 mg CIII, NDC 53265-329-10,and NDC 53265-329-50,
(100s and 500s), Recall # D-269-5;
c) Hydrocodone Bitartrate and Acetaminophen Tablets, USP,
7.5 mg/325 mg CIII, NDC 53265-335-10,and NDC 53265-335-
50, (100s and 500s), Recall # D-270-5;
d) Hydrocodone Bitartrate and Acetaminophen Tablets, USP,
7.5 mg/500 mg CIII, NDC 53265-330-10,and NDC 53265-330-
50, (100s and 500s), Recall # D-271-5;
e) Hydrocodone Bitartrate and Acetaminophen Tablets, USP,
7.5 mg/650 mg CIII, NDC 53265-332-10,and NDC 53265-332-
50, (100s and 500s), Recall # D-272-5;
f) Hydrocodone Bitartrate and Acetaminophen Tablets, USP,
10 mg/325 mg CIII, NDC 53265-328-10,and NDC 53265-328-
50, (100s and 500s), Recall # D-273-5;
g) Hydrocodone Bitartrate and Acetaminophen Tablets, USP,
10 mg/500 mg CIII, NDC 53265-331-10,and NDC 53265-331-
50, (100s and 500s), Recall # D-274-5;
h) Hydrocodone Bitartrate and Acetaminophen Tablets, USP,
10 mg/650 mg CIII, NDC 53265-333-10,and NDC 53265-333-
50, (100s and 500s), Recall # D-275-5;
i) Hydrocodone Bitartrate and Acetaminophen Tablets, USP,
7.5 mg/57.0 mg CIII, NDC 53265-334-10,and NDC 53265-334-
50, (100s and 500s), Recall # D-276-5
CODE
All codes are being recalled.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc., Cranbury, NJ, by press release and letter on May 25, 2005.
Manufacturer: Able Laboratories, Inc., South Plainfield, NJ. Firm initiated recall is ongoing.
REASON
There is a lack of assurance that testing conducted for release and stability conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
149 lots
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Acetaminophen & Codeine Phosphate Tablets, USP,
300 mg/30mg CIII, NDC 53265-285-10, NDC 53265-285-11,
NDC 53265-285-50, (100s, 500s and 1000s),
Recall # D-277-5;
b) Acetaminophen & Codeine Phosphate Tablets, USP,
300 mg/60mg CIII, NDC 53265-286-10, NDC 53265-286-50,
NDC 53265-286-11, (100s, 500s and 1000s),
Recall # D-278-5;
CODE
All lots are being recalled
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc., Cranbury, NJ, by press release and letter on May 25, 2005.
Manufacturer: Able Laboratories, Inc., South Plainfield, NJ. Firm initiated recall is ongoing.
REASON
There is a lack of assurance that testing conducted for release and stability conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
64 lots
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Clorazepate Dipotassium Tablets, USP, 3.75 mg, CIV,
NDC 53265-048-10, (100s), Recall # D-279-5;
b) Clorazepate Dipotassium Tablets, USP, 7.5 mg, CIV,
NDC 53265-049-10, and NDC 53265-049-50, (100s and 500s),
Recall # D-280-5;
c) Clorazepate Dipotassium Tablets, USP, 15 mg, CIV,
NDC 53265-050-10, (100s), Recall # D-281-5
CODE
All lots are being recalled
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc., Cranbury, NJ, by press release and letter on May 25, 2005.
Manufacturer: Able Laboratories, Inc., South Plainfield, NJ. Firm initiated recall is ongoing.
REASON
There is a lack of assurance that testing conducted for release and stability conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
30 lots
DISTRIBUTION
Nationwide


RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

______________________________
PRODUCT
Vivelle-Dot, Transdermal System, (estradiol) 0.1 mg, 8 systems per carton (retail), 2 units per carton (physician samples). Recall # D-257-5
CODE
Batch #/Expiry: 76061011, May 05; 76991011, May 05; 74961021, May 05; 74961012, May 05; (Physician samples) 74961022, May 05; (Physician samples) 76981011, May 05; 79151011, Jun 05; 79151012, Jun 05 (Physician samples) 79751011, Jun 05; 80251011, Jun 05.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Novartis Pharmaceuticals, Corp, East Hanover, NY, by letters on March 24, 2005.
Manufacturer: Noven Pharmaceuticals, Miami, FL. Firm initiated recall is ongoing.
REASON
Stability Failure
VOLUME OF PRODUCT IN COMMERCE
340,726 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
a) PREMARIN (conjugated estrogens USP),0.45 mg, 100-tablet
bottles, Rx, NDC 0046-0936-81. Recall # D-261-5;
b) PREMARIN (conjugated estrogens USP), 1.25 mg, Rx. 100-
tablet bottles- NDC 0046-0866-81. 1000-tablet bottles -
NDC 0046-0866-91. Recall # D-262-5
CODE
a) A52584, Exp. 6/2005 and A84755, Exp. 3/2006;
b) 100 tablet bottles: A36363 Exp. 7/2005; A77945 Exp.
10/2006; 1000 tablet bottles: A34501 Exp. 7/2005; A52586
Exp. 7/2005
RECALLING FIRM/MANUFACTURER
Recalling Firm: Richmond Division of Wyeth Pharmaceuticals, Richmond, VA, by letters dated May 31, 2005.
Manufacturer: Wyeth Pharmaceuticals, Rouses Point, NY. Firm initiated recall is ongoing.
REASON
Dissolution Failure
VOLUME OF PRODUCT IN COMMERCE
173,870 - 0.45/100's; 50,636 - 1.25/100's; 18,492 - 1.25/1000's
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Estraderm® (estradiol transdermal system) 0.05 mg/day,
Rx only. 8 individual sealed patches/systems per patient
calendar pack, 6 patient calendar packs per pharmacy
shelf box. Each patient calendar pack of 8 systems is a
1-month supply. Pharmacy shelf box of 6 patient calendar
packs/8 systems each - NDC # 0083-2310-62, patient
calendar packs of 8 systems - NDC # 0083-2310-08,
individual transdermal pouch (system) - NDC # 0083-2310-
01 --- Transdermal pouch labeling in part: NDC 0083-
2310-01, NOVARTIS, 0.05, ESTRADERM® estradiol
transdermal system, Delivers 0.05 mg/day, Rx only.
Patient calendar pack labeling in part: NDC 0083-2310-
08, NOVARTIS, ESTRADERM® estradiol transdermal system,
Delivers 0.05 mg/day, Rx only, 0.05. Pharmacy shelf box
labeling in part: NDC 0083-2310-62, 0.05, Estraderm®
estradiol transdermal system, Delivers 0.05 mg/day, Rx
only, TRANSDERMAL USE ONLY. Contents: 6 patient calendar
packs of 8 systems each. Recall # D-282-5;
b) Estraderm® (estradiol transdermal system) 0.1 mg/day, Rx
only. 8 individual sealed patches/systems per patient
calendar pack, 6 patient calendar packs per pharmacy
shelf box. Each patient calendar pack of 8 systems is a
1 month supply. Pharmacy shelf box of 6 patient calendar
packs/8 systems - NDC # 0083-2320-62, patient calendar
packs of 8 systems - NDC # 0083-2320-08, individual
pouch (system) - NDC # 0083-2320-01 --- Transdermal
pouch labeling in part: NDC 0083-2320-01, NOVARTIS, 0.1,
ESTRADERM® estradiol transdermal system, Delivers 0.1
mg/day, Rx only. Patient calendar pack labeling in part:
NDC 0083-2320-08, NOVARTIS, ESTRADERM® estradiol
transdermal system, Delivers 0.1 mg/day, Rx only, 0.1.
Pharmacy shelf box labeling in part: NDC 0083-2320-62,
0.1, Estraderm® estradiol transdermal system, Delivers
mg/day, Rx only, TRANSDERMAL USE ONLY. Contents: 6
patient calendar packs of 8 systems each.
Recall # D-283-5
CODE
a) Estraderm® 0.05 mg lot numbers: F0003 (exp. 2/28/06),
F0004 (exp. 3/31/06), F0005 (exp. 4/30/06), F0006 (exp.
5/31/06), F0007 (exp. 6/30/06), F0009 (exp. 6/30/06).
b) Estraderm® 0.1 mg lot numbers: F4066 (exp. 3/31/06),
F4067 (exp. 4/30/06), F4068 (exp. 4/30/06), F4069 (exp. 6/30/06), F4070 (exp. 7/31/06). Pharmacy shelf box of 6 patient calendar packs of 8 systems: NDC 0083-2320-62; patient calendar packs of 8 systems: NDC 0083-2320-08; individual system pouch: NDC 0083-2320-01.
RECALLING FIRM/MANUFACTURER
Novartis Pharmaceuticals, Corp, Suffern, NY, by letters on June 14/15, 2005. Firm initiated recall is ongoing.
REASON
Labeling: the patient booklet contained in each patient calendar pack of 8 systems does not include the required current black box warning for estrogens as contained in the approved NDA labeling (the black box warning was updated in August 2004).
VOLUME OF PRODUCT IN COMMERCE
514,026 patient calendar packs containing 8 systems each (85,671 pharmacy shelf boxes) for all 11 lots
DISTRIBUTION
Nationwide & PR


RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1399-5
CODE
Unit number LE09535
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on February 14, 2005. Firm initiated recall is complete.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1401-5
CODE
Unit numbers: 04LP62413P1 and 04LP62413P2
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by telephone on March 13, 2005, and by letter on March 14, 2005. Firm initiated recall is complete.
REASON
Blood product, that tested positive for microorganisms, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1402-5
CODE
Units 2033390, 2088829
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc, Lexington, KY, by letter dated December 24, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
KY

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1403-5;
b) Platelets, Recall # B-1404-5;
c) Fresh Frozen Plasma, Recall # B-1405-5
CODE
a) and c) Unit numbers: 4533010, 4314751;
b) Unit number: 4314751
RECALLING FIRM/MANUFACTURER
Recalling Firm: Oklahoma Blood Institute, Oklahoma City, OK, by facsimile on April 15, 2003.
Manufacturer: Oklahoma Blood Institute, South Oklahoma City Donor Center, Oklahoma City, OK. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the medication, Plaquenil, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
FL, VA, OK, and NY

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1406-5
CODE
Unit numbers: LX04393 (split unit)
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on March 3, 2005. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Staphylococcus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1407-5
CODE
Unit number: 21KK83081
RECALLING FIRM/MANUFACTURER
American National Red Cross, Pacific Northwest Region, Portland, OR, by telephone on January 12, 2004 and by letter dated January 14, 2004. 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
CA

_______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1411-5
CODE
Unit number: 4481982
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Oklahoma City, OK, by facsimile on October 3, 2002 and April 9, 2003, and by letter dated April 9, 2003. Firm initiated recall is ongoing.
REASON
Blood product, which was incorrectly labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1412-5
CODE
Unit number: 4508793
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Oklahoma City, OK, by facsimile on October 23, 2002. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not appropriately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1420-5
CODE
Unit number: 102980352
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by letter dated November 12, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who was diagnosed with malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced,
Recall # B-1421-5;
b) Platelets Leukocytes Reduced, Recall # B-1422-5;
c) Recovered Plasma, Recall # B-1423-5
CODE
a) Unit numbers: 13LH19446, 13LH17176, 13LH12217,
13LH10375, 13GP08522, and 13FR60402;
b) Units 13LH17176 and 13GP08522;
c) Units 13LH17176, 13LH12217, 13LH10375, 13LH06225,
13LH04234, 13LH01852, 13LG99823, 13LG97569, 13LG95049,
13LG90908, 13LG88643, 13LG86575, 13LG84550, 13GP08522
and 13FR60402
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Detroit, MI, by telephone or facsimile on February 5 and/or February 7, 2005, and by letter dated March 14, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who engaged in multiple high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
23 units
DISTRIBUTION
MI, CA, and Switzerland

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1424-5
CODE
Unit 13LH08898
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Detroit, MI, by telephone on May 4, 2004 and by letter dated May 5, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1425-5
CODE
Unit number: 13GX75765
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Detroit, MI, by telephone on November 1, 2004 and by letter dated November 11, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had lived in a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1426-5
CODE
Unit 21Y81420
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Portland, OR, by telephone on January 24, 2004 and by letter dated February 2, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OR

_______________________________
PRODUCT
Red Blood Cells, Recall # B-1429-5
CODE
Unit number: 41GF49836
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Alabama Region, Birmingham, AL, by telephone on June 25, 1997. Firm initiated recall is complete.
REASON
Blood product, that was not properly quarantined after the donor of the product reported a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL

_______________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced,
Recall # B-1434-5
b) Platelets Pheresis, Leukocytes Reduced Irradiated,
Recall # B-1435-5
CODE
a) Part 1, Unit numbers: 22KG64304, 22KG66995, 22KG65254,
22KG68895, 22KG68896, 22KG68898, 22LE00422, 22LE00877,
22LE00861, 22KG64055, 22KG64059, 22KG64062, 22KG64070,
22KG64179, 22KG64190, 22KG65237, 22KG65393, 22KG66212,
22KG66289, 22KG66399, 22KG66846, 22KG66870, 22KG66881,
22KG66904, 22KG66913, 22KG66985, 22KG67010, 22KG67055,
22KG67102, 22KG67109, 22KG67137, 22KG67182, 22KG67184,
22KG67617, 22KG68828, 22KG68829, 22KG68847, 22KG68860,
22KG68862, 22KG68882, 22KG68885, 22KG68889, 22KG68908,
22KG68919, 22KG68920, 22KG68924, 22KG68925, 22KG68926,
22KG68929, 22KG70409, 22KG70425, 22KG70428, 22KG70435,
22KG70465, 22KG70467, 22KG70468, 22KG70469, 22KG70477,
22KG70478, 22LE00401, 22LE00402, 22LE00406, 22LE00413,
22LE00421, 22LE00429, 22LE00434, 22LE00447, 22LE00453,
22LE00463, 22LE00465, 22LE00471, 22LE00473, 22LE00478,
22LE00479, 22LE00484, 22LE00488, 22LE00493, 22LE00495,
22LE00503, 22LE00510, 22LE00517, 22LE00518, 22LE00523,
22LE00530, 22LE00806, 22LE00809, 22LE00818, 22LE00824,
22LE00828, 22LE00837, 22LE00848, 22LE00850, 22LE00872,
22LE00873, 22LE00879, 22LE00886, 22LE00888, 22LE00890,
22LE00897, 22LE00902, 22LE64086, 22KG64324, 22KG65246,
22KG65406, 22KG66899, 22KG66260, 22KG67087, 22LE00525,
22KG66108, 22KG67146, 22KG67148, 22KG67152, 22KG68866,
22LE00426, 22KG64087, 22KG64113, 22KG64118, 22KG64213,
22KG64214, 22KG64362, 22KG64365, 22KG64399, 22KG65206,
22KG65241, 22KG65250, 22KG65262, 22KG65285, 22KG65292,
22KG65375, 22KG65394, 22KG65440, 22KG65450, 22KG65576,
22KG66153, 22KG66176, 22KG66229, 22KG66230, 22KG66307,
22KG66327, 22KG66368, 22KG66386, 22KG66395, 22KG66806,
22KG66811, 22KG66831, 22KG66850, 22KG66910, 22KG66947,
22KG67030, 22KG67085, 22KG67093, 22KG67095, 22KG67104,
22KG67107, 22KG67128, 22KG67154, 22KG67162, 22KG67167,
22KG67169, 22KG67175, 22KG67195, 22KG67199, 22KG67604,
22KG67609, 22KG67612, 22KG67618, 22KG67625, 22KG67626,
22KG68801, 22KG68804, 22KG68807, 22KG68812, 22KG68813,
22KG68817, 22KG68834, 22KG68849, 22KG68854, 22KG68867,
22KG68878, 22KG68879, 22KG68893, 22KG68897, 22KG68904,
22KG68910, 22KG68913, 22KG68915, 22KG68932, 22KG68934,
22KG70405, 22KG70413, 22KG70415, 22KG70417, 22KG70419,
22KG70422, 22KG70424, 22KG70430, 22KG70434, 22KG70447,
22KG70455, 22KG70474, 22KG70475, 22KG70485, 22KG70486,
22LE00403, 22LE00412, 22LE00415, 22LE00418, 22LE00420,
22LE00425, 22LE00433, 22LE00440, 22LE00443, 22LE00444,
22LE00445, 22LE00449, 22LE00454, 22LE00455, 22LE00457,
22LE00482, 22LE00483, 22LE00487, 22LE00497, 22LE00498,
22LE00501, 22LE00502, 22LE00504, 22LE00505, 22LE00508,
22LE00509, 22LE00521, 22LE00529, 22LE00531, 22LE00532,
22LE00533, 22LE00535, 22LE00536, 22LE00541, 22LE00542,
22LE00544, 22LE00547, 22LE00549, 22LE00551, 22LE00553,
22LE00836, 22LE00842, 22LE00845, 22LE00854, 22LE00855,
22LE00860, 22LE00866, 22LE00874, 22LE00876, 22LE00882,
22LE00884, and 22LE00906
Part 2, Unit numbers 22KG66846, 22KG66995, 22LE00445,
22KG67167, 22KG70431, 22KG70470, 22KG64070, 22KG64175,
22KG65237, 22KG65415, 22KG66381, 22KG66881, 22KG66904,
22KG67011, 22KG67083, 22KG67087, 22KG67102, 22KG67110,
22KG67162, 22KG67182, 22KG67184, 22KG67617, 22KG68889,
22KG68926, 22KG68934, 22LE00405, 22LE00413, 22LE00421,
22LE00446, 22LE00484, 22LE00496, 22LE00500, 22LE00531,
22LE00851, 22LE00858, 22LE00859, 22LE00886, 22LE00897,
22KG65441, 22KG65458, 22LE00536, 22LE00843, 22KG64050,
22KG64214, 22KG65375, 22KG65468, 22KG65576, 22KG66153,
22KG66260, 22KG66286, 22KG66368, 22KG66395, 22KG66811,
22KG67043, 22KG67088, 22KG67089, 22KG67107, 22KG67139,
22KG67169, 22KG68817, 22KG68828, 22KG68841, 22KG68849,
22KG68859, 22KG68878, 22KG68918, 22KG70405, 22KG70409,
22KG70417, 22KG70451, 22KG70457, 22KG70471, 22KG70478,
22KG70482, 22LE00411, 22LE00412, 22LE00417, 22LE00424,
22LE00425, 22LE00447, 22LE00478, 22LE00480, 22LE00486,
22LE00494, 22LE00501, 22LE00502, 22LE00530, 22LE00542,
22LE00823, 22LE00830, 22LE00839, 22LE00854, 22LE00871,
22LE00872, 22LE00874, and 22LE00893
Non-standard, Unit numbers: 22KG70431, 22KG66316,
22KG67043, 22KG67127, 22LE00404, and 22KG68841
b) Part 1, Unit numbers 22KG64200, 22KG65410, 22KG65458,
22KG65468, 22KG67111, 22KG68938, 22KG70449, 22KG70470,
22KG70471, 22LE00439, 22LE00500, 22LE00827, 22LE00823,
22LE00411, 22LE00863, 22KG64050, 22KG64108, 22KG64125,
22KG65449, 22KG66182, 22KG66939, 22KG66984, 22KG67110,
22KG68803, 22KG68816, 22KG68886, 22KG68900, 22KG70451,
22LE00424, 22LE00512, 22LE00513, 22LE00527, 22LE00528,
22LE00557, 22LE00898, and 22LE00901
Part 2, Unit numbers 22KG67003, 22LE00553, 22KG65406,
22KG67111, 22KG64262, 22KG68801, 22KG68900,
and 22LE00884
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by facsimile on January 21, 2004, and by letter on February 2, 2004. Firm initiated recall is complete.
REASON
Blood products, collected during a period when quality control testing was not performed, were distributed. 
VOLUME OF PRODUCT IN COMMERCE
401 units
DISTRIBUTION
PA and NJ

_______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1438-5
CODE
Unit number: 41LW65808
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Alabama Region, Birmingham, AL, by telephone on April 19, 1997. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that previously tested positive for antibodies to red blood cell antigen E (anti-E), was distributed without labeling to reflect the anti-E positive results.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1439-5
b) Platelets, Recall # B-1440-5
c) Fresh Frozen Plasma, Recall # B-1441-5
CODE
a), b), and c) Unit number 41KT30661
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Alabama Region, Birmingham, AL, by letter on January 20, 1997. Firm initiated recall is complete.
REASON
Blood products, that tested negative for antibodies to human immunodeficiency virus (anti-HIV), but were collected from a donor that previously tested repeatedly reactive for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
AL

______________________________
PRODUCT
Platelets Pheresis, Recall # B-1442-5
CODE
Unit number: 41GP11527
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Alabama Region, Birmingham, AL, by letter on December 23, 1996. Firm initiated recall is complete.
REASON
Blood products, that tested negative for antibodies to human immunodeficiency virus (anti-HIV), but were collected from a donor that previously tested repeatedly reactive for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1443-5
b) Recovered Plasma, Recall # B-1444-5
CODE
a) and b) Unit number: 41FY46607
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Alabama Region, Birmingham, AL, by letter and facsimile on January 3, 1997. Firm initiated recall is complete.
REASON
Blood products, that tested negative for antibodies to human immunodeficiency virus (anti-HIV), but were collected from a donor that previously tested repeatedly reactive for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL and CA

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated, Recall # B-1448-5
CODE
Unit number: 41FN37773
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Alabama Region, Birmingham, AL, by telephone on May 6, 1999. Firm initiated recall is complete.
REASON
Blood product, that tested positive for Cytomegalovirus (CMV), was incorrectly labeled negative for CMV and distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL

______________________________
PRODUCT
a) Red Blood Cells (Apheresis), Recall # B-1449-5
b) Red Blood Cells (Apheresis) Leukocytes Reduced,
Recall # B-1450-5
CODE
a) Unit numbers: 6992765 (Parts 1 & 2)
b) Unit numbers: 6993428 (Parts 1 & 2), 6993468 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
Central Jersey Blood Center, Shrewsbury, NJ, by facsimile on March 31, 2004, Firm initiated recall is complete.
REASON
Blood products, collected on an instrument that had not been validated for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
NJ and FL

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1451-5
b) Platelets, Leukocytes Reduced,
Recall # B-1452-5
c) Recovered Plasma, Recall # B-1453-5
CODE
a), b), and c) Unit number: 13FH98595
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southeastern Michigan Region, Detroit, MI, by e-mail on October 8, 2004, by telephone on October 29, 2004, and by letter dated November 3, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA and MI

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1454-5
b) Platelets, Leukocytes Reduced,
Recall # B-1455-5
c) Fresh Frozen Plasma, Recall # B-1456-5
CODE
a) Unit numbers: 13FN90776 and 13GL22015
b) Unit number: 13GL22015
c) Unit number 13FN90776
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southeastern Michigan Region, Detroit, MI, by telephone on July 29, 2004, and by letter on August 12, 2004. Firm initiated recall is complete.
REASON
Blood products, that tested negative for the antibodies to human T lymphotropic virus, types I and II (anti-HTLV-I/II), but were collected from an ineligible donor due to previous positive testing for anti-HTLV-I/II, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
MI


RECALLS AND FIELD CORRECTIONS: Biologics - CLASS III

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1400-5
CODE
Unit numbers: Y04873, X28073, and Y04868
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter on December 6, 2004. Firm initiated recall is complete.
REASON
Blood products, that were incorrectly leukoreduced, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
VA

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1408-5
CODE
Unit number: 13GX81026
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southeastern Michigan Region, Detroit, MI, by telephone on September 9, 2004. Firm initiated recall is complete.
REASON
Blood product, which was not leukoreduced within the appropriate time period after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI

_______________________________
PRODUCT
Cryoprecipitated AHF, Recall # B-1409-5
CODE
Unit numbers: 1348260, 1353412
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc, Orlando, FL, by telephone on August 17, 1999. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking cortisone, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced,
Recall # B-1413-5
b) Fresh Frozen Plasma, Recall # B-1414-5
c) Plasma Frozen, Recall # B-1415-5
d) Red Blood Cells For Further Manufacturing,
Recall # B-1416-5
CODE
a) Unit Numbers: 20LE01439, 20LE01440, 20LE01441,
20LE01442, 20LE01443, 20LE01444, 20LE01445, 20LE01446,
20LE01447, 20LE01448, 20LE01449, 20LE01450, 20LE01451,
20LE01452, 20LE01454, 20LE01455, 20LE01458, 20LE01459,
20LE01460, 20LE01461, 20LE01462, 20LE01463, 20LE01464,
20LE01465, 20LE01466, 20LE01467, 20LE01468, 20LE01469,
20LE01470, 20LE01471, 20LE01472, 20LE01473, 20LE01474,
20LE01478, 20LE01479, 20LE01480, 20LE01481, 20LE01482,
20LE01483, 20LE01484, 20LE01485, 20LE01486, 20LE01487,
20LE01488, 20LE01489, 20LE01490, 20LE01491, 20LE01492,
20LE02051, 20LE02052, 20LE02053, 20LE02054, 20LE02055,
20LE02056, 20LE02057, 20LE02059, 20LE02060, 20LE02061,
20LE02062, 20LE02063, 20LE02064, 20LE02065, 20LS12704,
20LS12705, 20LS12706, 20LS12707, 20LS12709, 20LS12710,
20LS12711, 20LS12712, 20LS12713, 20LS12714, 20LS12716,
20LS12717, 20LS12718, and 20LS12719
b) Unit Numbers: 20LE01484, 20LE01485, 20LE01486,
20LE01487, 20LE01488, 20LE01489, 20LE01490, 20LE01491,
20LE01492, and 20LE02063
c) Unit 20LE01454
d) Units 20LE01439, 20LE01440, 20LE01441, 20LE01442,
20LE01443, 20LE01444, 20LE01445, 20LE01446, 20LE01447,
20LE01448, 20LE01449, 20LE01450, 20LE01451, 20LE01452,
20LE01455, 20LE01456, 20LE01458, 20LE01459, 20LE01460,
20LE01461, 20LE01462, 20LE01463, 20LE01464, 20LE01465,
20LE01466, 20LE01467, 20LE01468, 20LE01469, 20LE01470,
20LE01471, 20LE01472, 20LE01473, 20LE01474, 20LE01478,
20LE01479, 20LE01480, 20LE01481, 20LE01482, 20LE01483,
20LE02051, 20LE02052, 20LE02053, 20LE02054, 20LE02055,
20LE02056, 20LE02057, 20LE02059, 20LE02060, 20LE02061,
20LE02062, 20LE02064, 20LE02065, 20LS12704, 20LS12705,
20LS12706, 20LS12707, 20LS12709, 20LS12710, 20LS12711,
20LS12712, 20LS12713, 20LS12714, 20LS12716, 20LS12717,
20LS12718, and 20LS12719
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Boise ID, by telephone, letters, and/or electronic mail on October 21 and 23, 2002, March 5, 2003, May 7, 11, and 12, 2004, and/or April 13, 2005. Firm initiated recall is complete.
REASON
Blood products, which were manufactured from whole blood that lacked assurance of proper storage temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
153 units
DISTRIBUTION
ID, CA, GA, and Switzerland

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-1419-5
CODE
Unit number: 101854239
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc, Scottsdale, AZ, by telephone on October 8, 2004. Firm initiated recall is complete.
REASON
Blood product, which was labeled with the incorrect expiration, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ

_______________________________
PRODUCT
a) Platelets, Leukocytes Reduced, Irradiated,
Recall # B-1430-5
b) Platelets Pheresis, Leukocytes Reduced,
Recall # B-1431-5
c) Platelets Pheresis, Leukocytes Reduced, Irradiated,
Recall # B-1432-5
CODE
a) Unit number: 4187829
b) Unit number: 4228321, 4228339, 4369688,
4369691, 4369964, 4373365, 4377117, 4378982,
4378984, 4228322, 4228342, 4230589-parts 1,
2 and 3, 4215069-parts 1 and 2, 4215071-parts
1 and 2, 4215079-parts 1 and 2, 4221060-parts
1 and 2, 4231852-parts 1 and 2, 4369959-parts
1 and 2, 4369963-parts 1, 2 and 3, 4373351-parts
1 and 2, 4373353-parts 1 and 2, 4373355,
4373358-parts 1 and 2, 4373705-parts 1, 2 and 3,
4377123-parts 1 and 2
c) Units 4377124, 4228322, 4228342
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated April 8, 2004. Firm initiated recall is complete.
REASON
Blood products, with incomplete bacterial detection testing performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
45 units
DISTRIBUTION
TX and NY

_______________________________
PRODUCT
Red Blood Cells, Recall # B-1433-5
CODE
Unit number: 21KM60001
RECALLING FIRM/MANUFACTURER
American Red Cross, Pacific Northwest Region, Portland, OR, by telephone on February 24, 2004, and by letter, dated February 26, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for Leishmania, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OR

_______________________________
PRODUCT
Source Plasma, Recall # B-1436-5
CODE
Unit numbers: 04LKYA5095 and 04LKYA5748
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Louisville, KY, by facsimile on June 4, 2004. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from a donor that was not properly evaluated after reporting a viral illness, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC

_______________________________
PRODUCT
Fresh Frozen Plasma (Apheresis), Recall # B-1437-5
CODE
Unit number: 41GP39591
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Alabama Region, Birmingham, AL, by telephone on March 7, 1997. Firm initiated recall is complete.
REASON
Blood product was not frozen in the appropriate time frame after collection and was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL

_______________________________
PRODUCT
Red Blood Cells, Irradiated, Recall # B-1445-5
CODE
Unit number: 41FQ52489
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Alabama Region, Birmingham, AL, by telephone on December 18, 1997, and by letter on December 26, 1997. Firm initiated recall is complete.
REASON
Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL

_______________________________
PRODUCT
Red Blood Cells, Irradiated, Recall # B-1446-5
CODE
Unit numbers: 26KR05718, 26KR05716, and 26FN06219
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Alabama Region, Birmingham, AL, by telephone on July 14, 1998, and by letter on July 23, 1998. Firm initiated recall is complete.
REASON
Blood products, labeled with the incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
AL

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1447-5
CODE
Unit number: 41GF50704
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Alabama Region, Birmingham, AL, by telephone on November 17, 1997, and by letter on November 24, 1997. Firm initiated recall is complete.
REASON
Blood product exposed to unacceptable storage temperatures was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL


RECALLS AND FIELD CORRECTIONS: Devices - CLASS II

_______________________________
PRODUCT
FHC 66-ZD-MD micro Targeting Drive System: System for Stereotactic Positioning Used with the Power Assist (66-DA-ME) or Display Assembly (66-DA-EN), Recall # Z-0895-05
CODE
All codes
RECALLING FIRM/MANUFACTURER
FHC, Inc, Bowdoinham, ME, by letter dated March 14, 2005 and March 25, 2005. Firm initiated recall is ongoing.
REASON
Potential for non-sterile pin to contaminate sterile field.
VOLUME OF PRODUCT IN COMMERCE
169 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
View Forum 2003 software, SW 3.4L1, Recall # Z-0896-05
CODE
The firm utilizes site numbers: 534544, 520177, 520633, 532261, 504927, 532134, 534573, 531862, 521928, 522027, 521424, 533804, 532053
RECALLING FIRM
Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letter on April 29, 2005.
Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing.
REASON
Automated analysis of vascular obstruction tool in software gives unreliable calibration and analysis results when using unprocessed images acquired on the Philips Allura FD10.
VOLUME OF PRODUCT IN COMMERCE
13 devices
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Dr. Fog Endoscopic fog prevention kit, Recall # Z-0897-05
CODE
Lot 2007-05; exp. May 2007
RECALLING FIRM/MANUFACTURER
Aspen Surgical Products, Inc, Byron Center, MI, by telephone on May 15, 2005. Firm initiated recall is complete.
REASON
An improper expiration date was placed on the individual packages, although the dispenser box and carton contained the correct expiration date.
VOLUME OF PRODUCT IN COMMERCE
2460 packages
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
a) Gold Hub Capistrano Cannula, Catalog Nos. HK10C15;
HK10C23; HK12C15; HK12C23; HK14C15; HK14C23; HK16C5;
HK16C8; HK16C12; HK16C15; HK18C8; HK18C6,
Recall # Z-0898-05
b) Gold Hub Finesse Cannula, Catalog Nos. HK10F23;
HK12F10; HK12F15; HK12F23; HK14F10; HK14F15; HK14F23;
HK16F5; HK16F8, Recall # Z-0899-05
c) Gold Hub Monty Cannula, Catalog Nos. IC14HM20;
IC16HM15; IC18HM15; IC14HM20; IC16HM15; IC18HM15,
Recall # Z-0900-05
CODE
All codes
RECALLING FIRM
HK Surgical Inc, San Juan Capistrano, CA, by letters on December 3, 2004, April 11-14, 2005. Firm initiated recall is ongoing.
REASON
Risk of hubs becoming disconnected from the cannula.
VOLUME OF PRODUCT IN COMMERCE
732 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
a) Pronto Series Power Wheelchair, model M50,
Recall # Z-0901-05
b) Pronto Series Power Wheelchair, model M51,
Recall # Z-0902-05
c) Pronto Series Power Wheelchair, model M61,
Recall # Z-0903-05
CODE
All serial numbers between 05A000-05C999
RECALLING FIRM/MANUFACTURER
Invacare Corporation, Elyria, OH, by telephone between May 9 and May 25, 2005, and by letter dated April 2005. Firm initiated recall is ongoing.
REASON
If the arm of the wheelchair is overloaded, the joystick mounting bracket and/or arm pivot may fail due to variability in the plastic used by the supplier to make the components. This failure may cause the user or a caregiver to fall if they are leaning on the arm, and result in injury.
VOLUME OF PRODUCT IN COMMERCE
1556 units
DISTRIBUTION
Nationwide and France

_______________________________
PRODUCT
a) Virotek SAFEL*E*T 1.0 mm Safety Lancets, 1.0 mm depth,
stock code 5000052, packaged in single unit blister
packs, 150 or 200 per box, 6 boxes per carton,
Recall # Z-0904-05
b) Virotek SAFEL*E*T 2.0 mm Safety Lancets, 2.0 mm depth,
stock code 5000052, packaged in single unit blister
packs, 200 per box, 6 boxes per carton, stock code
5000101, packaged in single unit blue cap packaging, 100
per box and stock code 5000115, packaged in single unit
blue cap packaging, 200 per box, Recall # Z-0905-05
CODE
a) Lot numbers 0013, 0014, 0015, 0016, 0017, 0019, 0021
b) Lot numbers 0018, 0023, 0024, 0025, 0026, 0027, 0028
RECALLING FIRM
Efoora, Inc. dba Virotek, L.L.C., Buffalo Grove, IL, by fax and DHL delivery on May 5, 2005 through May 27, 2005. Firm initiated recall is ongoing.
REASON
The sterility of the lancets may be compromised due to inadequate packaging seals.
VOLUME OF PRODUCT IN COMMERCE
1,013,650 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
a) B-Sure brand one step home pregnancy test, Items 28030
(case of 48 kits) and 28031 (case of 144 kits), Recall
# Z-0909-05
b) Lover brand lubricated latex condoms in various
presentations, item numbers 29042, 29044, 29045, 29047,
29095, 29095D, 29096, 29097, 29111, 29112, 29145, 29146,
29147 and 29148, Recall # Z-0910-05
c) Lover brand lubricated latex condoms spermicidal, item
number 29043, Recall # Z-0911-05
CODE
All lots
RECALLING FIRM/MANUFACTURER
Harmony Brands Llc, Oak Park, MI, by press release on March 25, 2005 and by letter beginning on March 28, 2005. Firm initiated recall is ongoing.
REASON
Lack of assurance of safety and efficacy; products are from unknown sources.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
i-STAT Celite ACT Cartridge. ACT, activated clotting time, celite activated clotting time test. i-STAT Catalog Number -- 420300; Abbott Catalog Number -- 07G01-01 (USA and Canada); Abbott Catalog Number -- 07G10-02 (Rest of world). Recall # Z-0912-05
CODE
Lot Numbers: R04174B; R04175; R04175A; R04183; R04183A; R04183B; R04183C; R04190A; R04190B; R04205; R04205A; R04212A; R04212B; R04233; R04239; R04245; R04245A; R04245B; R04253; R04261; R04261A; R04262; R04274; R04274A; R04275; R04293; R04293A; R04294; R04294A; R04305; R04305A; R04305B; R04306; R04309; R04309A; R04315; R04315A; R04315B; R04322; R04323; R04323A; R04329; R04337; R04337A; R04342; R04343; R04350; R04350A; R04350B; R05006; R05014; R05014A; R05032B; R05032C; R05043; R05043A; R05044; R05048B; R05048C
RECALLING FIRM
Abbott Laboratories, East Windsor, NJ, by letter on March 16, 2005. Firm initiated recall is ongoing.
REASON
Misidentification of Celite ACT cartridge as kaolin ACT Cartridge in the analyzer.
VOLUME OF PRODUCT IN COMMERCE
256,125 cartridges
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
LeadCare Blood Lead Testing System Kits, Catalog number: 70-2233, Recall # Z-0914-05
CODE
Lot CA6, Expiration date 2/5/05
Lot CA7, Expiration date 2/06/05
Lot CA8, Expiration date 5/18/05
Lot CA9, Expiration date 10/5/05
Lot CCA, Expiration date 12/11/05
Lot CCE, Expiration date 6/17/06
Lot CCF, Expiration date 7/11/06
Lot CCH, Expiration date 7/12/06
RECALLING FIRM/MANUFACTURER
Esa Biosciences, Inc, Chelmsford, MA, by letter and telephone beginning May 19, 2005. Firm initiated recall is ongoing.
REASON
Lead test results may be reported lower than the actual value.
VOLUME OF PRODUCT IN COMMERCE
14,760 test kits
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
ACL Futura, ACL Advance and ACL TOP Coagulation Analyzers used with the HemosIL RecombiPlasTin reagent, Models: 290001 999001, Recall # Z-0915-05
CODE
Serial Number's beginning with 05041164 280000 with S/N's beginning with 0505354
RECALLING FIRM
Instrumentation Laboratory Co, Lexington, MA, by an Urgent Product Notification on May 19, 2005. Firm initiated recall is ongoing.
REASON
Patient prothrombin time (PT) may report low for individuals on anticoaglant therapy.
VOLUME OF PRODUCT IN COMMERCE
617 units
DISTRIBUTION
Nationwide and Canada

_______________________________
PRODUCT
a) Carroll Healthcare brand Arro bed models BA3180-151 AE,
BA3180-151 PE, BA3180-151 FE, BA3180-171 AE, BA3180-171
FE and BA3180-171 FE. Recall # Z-0919-05
b) Carroll Healthcare brand Spirit bed; models BBH2180-
111AE, BBH2180-111PE and BBH2180-111FE.
Recall # Z-0920-05
CODE
a) Serial numbers 374061 through 374065, 374489 through
374519, 374521 through 374531, 375262, 376203 through
376211, 376229 through 376236, 376268 through 376284,
376698, 377647, 377648, 380181, 381593, 382244, 382373
through 382382, 383163 through 383166, 384390 through
384399, 386463 through 386468, 387057 through 387066,
387977 through 388004, 388039 through 388046, 388049
through 388063, 388153 through 388195, 388515 through
388527, 388529, 388728 through 388735 and 389410 through
389414
b) Serial numbers 376078, 376079, 376155, 376156, 376219,
376220, 376223 through 376225, 376228, 376680 through
376683, 377067, 377262, 378422 through 378424, 378543
through 378552, 378698 through 378700, 378801 through
378806, 378811, 379168 through 379178, 379191, 379419
through 379421, 379472 through 379476, 379605 through
379611, 379719, 379720, 379831 through 379842, 379957
through 379959, 380047 through 380050, 380172 through
380180, 381130 through 381139, 381215, 381320 through
381326, 381416, 381589, 381590, 381595 through 381599,
381964, 381965, 382007 through 382010, 382167, 382168,
382171, 382172, 382283, 382422, 382764 through 383767,
383127, 383148, 383286 through 383288, 383484 through
383488, 383521, 383624, 383625, 383642, 383643, 383787,
383788, 384091 through 384100, 384225, 384226, 384480,
384727 through 384750, 384839, 384840, 385291 through
385297, 385752 through 385796, 385958, 386044 through
386063, 386327 through 386336, 386356 through 386361,
386366, 386412, 386435 through 386438, 386487 through
386492, 386511, 386530, 386570 through 386572, 386719
through 386724, 386733, 386746, 386776, 386926 through
386935, 386942, 386943, 387054 through 387056, 387495
through 387498, 387568, 387823, 388035 through 388038,
388207, 388468, 388542 through 388551, 388765 through
388771, 388796, 388877 through 388881, 389124, 389274,
389340 through 389389, 389417 through 389431 and 390437
through 390442
RECALLING FIRM/MANUFACTURER
Carroll Healthcare Inc, London, Ontario, Canada, by fax on May 17, 2005. Firm initiated recall is ongoing.
REASON
The diodes in the control panel may fail, which could result in the thermal breakdown of the circuit board inside of the control box, and cause the bed to cease functioning.
VOLUME OF PRODUCT IN COMMERCE
361 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Flexible Implant tube, blind end, 350 mm, part #GM11003730, Available as single unit or contained in the Flexible Interstital Implant Tube Set, part number GM11004680. For use with the Varian GammaMed Plus brachytherapy afterloader device. Recall # Z-0921-05
CODE
Lot 04/21/1
RECALLING FIRM
Recalling Firm: Varian Medical Systems, Charlottesville, VA, by Customer Technical Bulletin on April 14, 2005.
Manufacturer: Willy Rusch AG GmbH, Kernen-Rommelshausen, Germany. Firm initiated recall is ongoing.
REASON
A defective treatment applicator in a cancer therapy medical device may become separated potentially causing patient injury.
VOLUME OF PRODUCT IN COMMERCE
392 devices
DISTRIBUTION
CT, MI, PA, CO, VT and MO and Internationally

_______________________________
PRODUCT
Envisor, M2540 Diagnostic Ultrasound System, Part numbers: 453561193003, SW C.O.O. Recall # Z-0923-05
CODE
Serial numbers(domestic) 20505841, 20505867, 20505884, 20505885, 20505886, 20505890, 20505898, 20505907, 20505908, 20505913, 20505923, 20505925, 305056015, 30505960, 30505978, 30505980, 30505997. System Base ID (international): US30505949, US20505848, US20505899, US20505900, US30505999, US30506012, US30506013, US30506016, US30506017, US30506014, US30505977, US30505976, US30505984, US30505985, US30505986, US30505975, US30505987, US20505850, US20505849, US20505840, US30505993, US30505992, US20505865, US20505874, US20505872, US20505873, US20505864, US20505868, US20505877, US30505950, US20505838, US20505857, US20505858, US20505901, US20505905, US20505906, US30505965, US20505918, US30505938, US30505939, US30505942, US30505930, US30505988, US30505964, US30505967, US30505973, US20505837, US20505856, US20505879, US20505883, US20505922, US20505924, US20505844, US20505832, US20505847, US20505845, US20505833, US20505846, US20505871, US20505870, US30505958, US30505957, US30505959, US30505946, US20505881, US20505916, US30505937, US20505882, US30505963, US20505914, US20505921, US30505995, US30505996, US30506000, US30506018, US30505991, US30505983, US30505989, US30505990, US20505843, US20505842, US30506001, US20505828, US30505994, US20505829, US30505966, US20505862, US20505861, US20505859, US20505860, US30505981, US30505982, US20505896, US20505895, US30505933, US30505926, US30505929, US30505927, US30505928, US30505932, US20505869, US30505954, US30505952, US30505953, US30505934, US30505935, US30505951, US30505940, US30505941, US30505945, US20505912, US30506005, US30506006, US30506003, US30506008, US30506007, US30506002, US30506004, US30506009, US30506011, US30506010, US30505974, US30505962, US30505972, US20505866, US20505855, US20505834, US20505830, US20505917, US20505888, US20505889, US20505887, US20505878, US20505897, US30505971, US30505970, US30505943, US30505947, US20505903, US20505904, US30505944, US30505979, US20505892, US20505891, US20505893, US20505876, US20505880, US30505936, US30505955, US30505956, US30505948, US30505968, US20505902, US20505894, US30505969, US20505875
RECALLING FIRM/MANUFACTURER
Philips Ultrasound, Inc., Bothell, WA, by letter on May 13, 2005. Firm initiated recall is ongoing.
REASON
A defect in the software allows incorrect measurement results to be entered into the system's built-in report.
VOLUME OF PRODUCT IN COMMERCE
194 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
Cancellous Bone Screw, 6.5 x 50 mm, Model 0214807, Recall # Z-0924-05
CODE
Lot/Unit Code: 044152
RECALLING FIRM
Recalling Firm: Plus Orthopedics USA, San Diego, CA, by telephone beginning June 2, 2005.
Manufacturer: Intraplant AG, Cham, Switzerland. Firm initiated recall is complete.
REASON
Screw is mislabeled as a 50 mm screw when in fact it is 45 mm long.
VOLUME OF PRODUCT IN COMMERCE
54 in the USA and 78 in Europe
DISTRIBUTION
ID, TX, VA and Europe

_______________________________
PRODUCT
BD 25G Spinal Needles. (Spinal Anesthesia Needle), Recall # Z-0928-05
CODE
Reorder Number, Lot Number: 400440, 4275101; 400440, 4282078; 400440, 4317744; 400479, 3196624; 400479, 4161815; 400479, 4254414; 400479, 4324795; 400496, 4173091; 400590, 3191978; 400590, 4121350; 400621, 4146482; 401586, 3182399; 405078, 3196618; 405078, 4169804; 405078, 4194109; 405078, 4268754; 405078, 4282079; 405078, 4324791; 405078, 4349021; 405138, 4173087; 405138, 4181398; 405140, 3224096; 405140, 4110295; 405140, 4237191; 405140, 4295872, 405140, 4314481; 405140, 4336365; 405170, 4201356; 405170, 4201357 405180, 4096782; 405180, 4145523; 405180, 4148675; 405234, 3174061; 405234, 4062807; 405234, 4105111; 405234, 4163586; 405234, 4265265; 405234, 4282715; 405234, 4282716; 405234, 4314480; 405234, 4358850; 409442, 3174062; 409442, 3226365; 409442, 4110275; 409442, 4121348; 409442, 4230810; 409442, 4230813; 409442, 4257418; 409442, 4300308; 409442, 4320423; 409442, 4329215; 409442, 4349941
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letters on March 16, 2005.
Manufacturer: Becton-Dickinson P R, Inc, Juncos, PR. Firm initiated recall is ongoing.
REASON
A significant level of 25G spinal needle hub leakage complaints was observed. Subsequent investigation found the leakage to be attributable to improper formation of the spinal needle hub, specifically an undersized taper and the prescence of a slight sink in the taper surface.
VOLUME OF PRODUCT IN COMMERCE
801,580 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Animas Model IR 1250 Insulin Pump, Recall # Z-0929-05
CODE
All units Model IR1250.
RECALLING FIRM
Animas Corporation, West Chester, PA, by letter on April 11, 2005, telephone on April 12, and April 25, 2005. Firm initiated recall is ongoing.
REASON
Pump failed to respond to keypad button presses after using the food database feature.
VOLUME OF PRODUCT IN COMMERCE
1,866 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5 mm obturator; product code 67P035, Recall # Z-0930-05
CODE
Lot G651610
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc, Gary, IN, by letter dated April 26, 2005. Firm initiated recall is ongoing.
REASON
The obturator may be 3.0 mm in length instead of the labeled 3.5 mm.
VOLUME OF PRODUCT IN COMMERCE
48 units
DISTRIBUTION
CT, GA, IL, IN, MN, MO, NM and NC

______________________________
PRODUCT
PTFE (Polytetrafluoroethylene) felt. Catalog #s: M002000193041, M002000193061, M002000193811, M002000193821, M002000193931, M002000193841, M002000193861, M002000193881. Recall # Z-0931-05
CODE
Lot Numbers: 7337514; 7337515; 7337516; 7337717; 7350604; 7356745; 7356747; 7359759; 7359760; 7360535; 7360536; 7384480; 7384483; 7384484; 7384485; 7384486; 7384487; 7412113
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Scimed, Maple Grove, MN, by letters on April 19, 2005.
Manufacturer: Boston Scientific Corp, Wayne, NJ. Firm initiated recall is ongoing.
REASON
Units of these lots may have areas of lower density resulting in lower tensile and suture retention strength.
VOLUME OF PRODUCT IN COMMERCE
290 multi-pack units (5 per package)
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Tyco Healthcare Kendall Argyle Neonatal Pediatric PICC, 1.9 Fr/Ch x 30 cm Dual Lumen PICC Catheter, REF 43304. A single catheter in a thermoformed tray with a Tyvek lid. The lidded tray is packaged one per carton. Recall # Z-0932-5
CODE
158125 and 158128
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kendall Healthcare Products Co, Mansfield, MA, by visits on April 27 and 28, 2005.
Manufacturer: Kendall a Division of Tyco Healthcare Group LP, Argyle, NY. Firm initiated recall is complete.
REASON
Holes in thermoformed tray compromising the sterility of the product.
VOLUME OF PRODUCT IN COMMERCE
120 units
DISTRIBUTION
AZ, CA, IL, IN, NY, and TX

_________________________________________________
PRODUCT
Radical Handheld Pulse Oximeter, Recall # Z-0933-05
CODE
Serial numbers-- P3027 through P3148 and serial numbers less than or equal to 102999.
RECALLING FIRM
Masimo Corporation, Irvine, CA, by letter on June 10, 2005.
Firm initiated recall is ongoing.
REASON
Speaker component failure resulting in cessation of an audible alarm even though the condition continues that caused the alarm.
VOLUME OF PRODUCT IN COMMERCE
8110
DISTRIBUTION
Nationwide and Worldwide.

______________________________
PRODUCT
a) Ev3 Protégé GPS Self-Expanding Nitinol Stent and
Delivery Technology (Biliary System). Model No. SERB65-
09-60-120. Sterile EO, Single Use, Recall # Z0934-05
b) Ev3 Protégé GPS Self-Expanding Nitinol Stent and
Delivery Technology (Biliary System). Model No. SERB65-
08-20-120. Sterile EO, Single Use, Recall # Z0935-05
c) Ev3 Protégé GPS Self-Expanding Nitinol Stent and
Delivery Technology (Biliary System). Model No. SERB65-
10-30-120. Sterile EO, Single Use, Recall # Z0936-05
CODE
a) Lot 117182
b) Lot 1179167
c) Lot 1179173
RECALLING FIRM
Ev3, Plymouth, MN, by visit on June 10, 2005. Firm initiated recall is ongoing.
REASON
3 devices from 3 separate lots were re-labeled with incorrect stent dimensions (diameter and length).
VOLUME OF PRODUCT IN COMMERCE
3 devices
DISTRIBUTION
FL and PA

______________________________
PRODUCT
Potassium Electrode Tip; Part No.s: 668281 Tip Assembly - Synchron Family 669117 Packaged - Synchron Family 441104 Electrode Assembly-EL-ISE 445604 Electrode Packaged- EL-ISE, Recall # Z-0937-05
CODE
Multiple lots are involved. |SYNCRHON: | | | |Lot 446 - Manufactured 20 NOV 2004* |231 |N/A** | |Lot 450 - Manufactured 12 DEC 2004 |880 | | |Lot 501 - Manufactured 03 JAN 2005 |30 | | |Lot 504 - Manufactured 24 JAN 2005 |698 | | |Lot 507 - Manufactured 21 FEB 2005 |400 | | |Lot 508 - Manufactured 28 FEB 2005 |130 | | |Lot 512 - Manufactured 28 MAR 2005 |1643 | | |Lot 517 - Manufactured 02 MAY 2005 |2020 | | | | | | |EL-ISE: | | | |Lot 0446 - Manufactured 20 NOV 2004* |20 |N/A** | |Lot 0504 - Manufactured 24 JAN 2005 |30 | | |Lot 0508 - Manufactured 28 FEB 2005 |30 | | |---------------------------------------------+---------------+---------------------|
RECALLING FIRM
Beckman Coulter, Inc, Brea, CA, by letters on May 20, 2005. Firm initiated recall is ongoing.
REASON
Does not meet performance criteria and exhibits upward trend of result recoveries during calibration period.
VOLUME OF PRODUCT IN COMMERCE
2,686 units
DISTRIBUTION
Nationwide and Canada

_______________________________
PRODUCT
Misys Laboratory with Lab Access Results application for versions 5.3 and later. Recall # Z-0938-05
CODE
Versions 5.3 and later
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by fax on May 13, 2005. Firm initiated recall is ongoing.
REASON
Software anomaly may rarely allow modification of previously reported specimen results.
VOLUME OF PRODUCT IN COMMERCE
258 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
Mysis Laboratory version 6.1, Recall # Z-0939-05
CODE
Version 6.1
RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by Product Safety Notice on May 10, 2005. Firm initiated recall is ongoing.
REASON
When a previously reported microbiology organism result is deleted on a selected patient, reported susceptibilities will not stay with associated organisms and one or more susceptibilities on the culture will be deleted.
VOLUME OF PRODUCT IN COMMERCE
21
DISTRIBUTION
Nationwide, United Kingdom and Denmark

_______________________________
PRODUCT
a) CLBS-7-12* Cotton-Leung Biliary Stent Set * Stent
Diameter: 7 Fr. * Length (Between Flaps): 12 CM. *
Standard Wire Guide: .035"/480 CM. *Pushing Catheter:
7 FR. Disposable - Single Use Only - Rx Only,
Recall # Z-0940-05
b) Low Profile Gatrostomy - Contents include: Passport &
Obturator * Disposable - Single Use Only,
Recall # Z-0941-05
CODE
a) Lot Number: R1698831, Labeled Reorder Number CLBS-7-12
b) Lot Number: WR1827952, Labeled Reorder Number LPG-20-
2.4-A and Lot Number: W1834577, Labeled Reorder Number
PASS-20-3.4-A
RECALLING FIRM/MANUFACTURER
Wilson-Cook Medical Inc, Winston Salem, NC, by email/fax on June 17, 2005. Firm initiated recall is ongoing.
REASON
The reorder number listed on the product label is inaccurate.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
Brazil, Japan and Hong Kong


RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
AxSYM total B-hCG Ragent is composed of one bottle of Coated Microparticles, one bottle of Alkaline Phosphatase Conjugate and one bottle of Specimen Diluent. Recall # Z-0893-05
CODE
2614Q100 (5/13/2005); 26278Q100, 26381Q100 (6/21/2005)
RECALLING FIRM/MANUFACTURER
Abbott Health Products, Inc., Barceloneta, PR, by letter on March 24, 2005. Firm initiated recall is ongoing.
REASON
Abbott Diagnostics is investigating a recent increase in customer complaints for AxSYM calibration error code 1048 and controls out of range when using AxSYM Total B-hCG reagent lots. Testing has shown that protein aggregates are present in the specimen diluents of both IMx and the AxSYM Total B-hCG reagent kits. This is responsible for the calibration errors and shift in control values.
VOLUME OF PRODUCT IN COMMERCE
2,496 kits
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
IMx total B-hCG Reagent is composed of one bottle of Coated Microparticles, one bottle of Alkaline Phosphatase Conjugate, one bottle of 4 Methylumbelliferyl Phosphate and one bottle of Specimen Diluent, Recall # Z-0894-05
CODE
25459Q100
RECALLING FIRM
Abbott Health Products, Inc., Barceloneta, PR, by letter on March 24, 2005. Firm initiated recall is ongoing.
REASON
Abbott Diagnostics is investigating a recent increase in customer complaints for IMx calibration error code 157 and controls out of range when using IMx total B-hCG Reagent Lot 25459Q100. Testing has shown that protein aggregates are present in the specimen diluents of both IMx and the AxSYM Total B-hCG reagent kits. This is responsible for the calibration errors and shift in control values.
VOLUME OF PRODUCT IN COMMERCE
793 kits
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
VITROS Immunodiagnostic Products TOTAL T4 Reagent Pack, Ref #874 4468, 100 coated wells. Recall # Z-0913-05
CODE
Lot 710, Exp. 7/28/05
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ortho-Clinical Diagnostics, Rochester, NY, by letters dated March 15, 2005.
Manufacturer: Ortho-Clinical Diagnostics, Cardiff, United Kingdom. Firm initiated recall is ongoing.
REASON
Potential for positively biased results in QC and patient samples.
VOLUME OF PRODUCT IN COMMERCE
2,199 reagent packs
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
a) EBI Ball Tip Guide Wire 3.2mm x 55cm found in the Ankle
Arthrodesis Nail Instr., Part Number 469055.
Recall # Z-0916-05
b) EBI Ball Tip Guide Wire 3.2mm x 98cm found in the
Holland Nail Flexible Reamer Accessory P/N 469060.
Recall # Z-0917-05
c) Threaded Tip GD Pin 1/8in x 9in Pk 5 Sterile found in
Uniflex Profile Tibial Nail P/N 329640.
Recall # Z-0918-05
CODE
a) Lot Number: 069811; 120055; 120056; 120057; 123827;
125637; 125638
b) Lot Numbers: 130843; 130846
c) Lot Numbers: 065882; 122235; 132557; 132560; 877265
RECALLING FIRM
EBI, L.P., Parisippany, NJ, by letter on March 16, 2005. Firm initiated recall is ongoing.
REASON
The wire appears to be soft and the wire bent during insertion. This causes kinks in which the reamer could not pass over the bent/kinked wire.
VOLUME OF PRODUCT IN COMMERCE
599 units
DISTRIBUTION
Nationwide, Italy and Spain

_______________________________
PRODUCT
Prostate Seeding Needle for Use with the Mick Applicator; an 18 gauge needle, 17 cm long with a white molded plastic hub. The non-sterile prostate seeding needles were shipped in bulk for packaging, sterilization and distribution by the customers; the bulk packages were labeled as follows: a) part no. B0140268, Prostate Seeding Set, MICK, and b) part no. 2380US-18E-17, 18GA x 17CM MK Prostate Seeding Nee, InterV - Recall # Z-0922-05
CODE
Part number B0140286, lot numbers 0747, 0839, 0840, 3412, 3413, 3414, 3415, 4078, 4088 and 4089; Part number 2380US-18E-17, lot number 0015
RECALLING FIRM/MANUFACTURER
Manan Medical Products, Inc., Wheeling, IL, by letters on May 3, 2005. Firm initiated recall is complete.
REASON
The hub of the prostate seeding needle does not release as expected from the applicator as expected during procedures.
VOLUME OF PRODUCT IN COMMERCE
22,900 needles
DISTRIBUTION
FL and GA

_______________________________
PRODUCT
a) The Maestro System 204-503, Straight Permucosal Ext, 5mm
x 3mm, Recall # Z-0925-05
b) The Maestro System 225-312, Profile Abutment for Cement,
5mm, Recall # Z-092605
CODE
a) Lot Number: C0205048
b) Lot Number: C0205065
RECALLING FIRM
BioHorizons Implant Systems, Inc., Birmingham, AL, by telephone and email on June 3, 2005. Firm initiated recall is ongoing.
REASON
The product labeled as a profile abutment for Cement contained a Straight Permucosal Ext, 5mm x 3mm.
VOLUME OF PRODUCT IN COMMERCE
28 units
DISTRIBUTION
PA, TX, MI, VA and Russia

_______________________________
PRODUCT
DiaSorin Anti-Cardiolipin IgA ELISA Kit, catalog no. 7800. Made in the United Kingdon. Recall # Z-0927-05
CODE
Lots FS1123 and FS2184
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stillwater, MN, by letter on November 1, 2004.
Manufacturer: Euro Diagnostica AB, Malmo, Sweden. Firm initiated recall is ongoing.
REASON
DiaSorin Anti-Cardiolipin IgA Kit, positive control was on the low limit of the acceptable range (1-35 U/mL).
VOLUME OF PRODUCT IN COMMERCE
49 kits
DISTRIBUTION
NY, KS, GA and MT


RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINES - CLASS III

_______________________________
PRODUCT
Blue Seal brand Chick Starter-AM Crumbles - Medicated, active ingredient: Amprolium 113.5g/ton (0.0125%), sold in 25 lb. and 50 lb. bags, Recall # V-086-5
CODE
A0735
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blue Seal Feeds, Inc., Londonderry, NH, by telephone on May 5-6, 2005.
Manufacturer: Blue Seal Feeds, Inc., Arcade, NY. Firm initiated recall is complete.
REASON
The product is subpotent (76.8% of label claim). Acceptable potency is 80%-120%.
VOLUME OF PRODUCT IN COMMERCE
230/25-lb. bags, and 96/50-lb. bags
DISTRIBUTION
NY, NJ, OH, PA and MD

_______________________________
PRODUCT
Co-op 13% Elite Starter - OTC, Medicated, Bovine feed, 50 lb. bags, Recall # V-088-5
CODE
Lot numbers: 9138594036, 9139594036
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tennessee Farmers Cooperative, Jackson, TN, by telephone on May 19, 2005.
Manufacturer: Tennessee Farmers Cooperative, La Vergne, TN. Firm initiated recall is complete.
REASON
Bovine feed, which was below specification for Oxytetracycline, was distributed.
VOLUME OF PRODUCT IN COMMERCE
8,000 lbs
DISTRIBUTION
TN

END OF ENFORCEMENT REPORT FOR July 6, 2005

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