December 17, 2003
03-51
_______________________________
PRODUCT
Avocado Pulp in 4 lb. unlabeled packages, four packages per case. Recall # F-044-4.
CODE
No codes.
RECALLING FIRM/MANUFACTURER
SSK Enterprises, Mcallen, TX, by letter on September 8, 2003. FDA initiated recall is ongoing.
REASON
Avocado pulp tested positive for Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
1034 pounds.
DISTRIBUTION
WI.
_______________________________
PRODUCT
Margarita brand, Queso Fresco, Mexican Style Fresh White Cheese. This product is a semi-soft, white cheese, wheel shaped approx. 12 cm in diameter and 2 cm tall, labeled with red and green lettering and is packed in a flexible white plastic package. Recall # F-045-4.
CODE
Expiration November 6, 2003, code 37-77 (printed in black lettering).
RECALLING FIRM/MANUFACTURER
Ashe County Cheese Inc., W Jefferson, NC, by letter and press release on October 16, 2003. FDA initiated recall is ongoing.
REASON
Product contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
237 cases, 24/12 oz package per case.
DISTRIBUTION
IL.
In the November 26, 2003 Enforcement Report lists Recall # F-034-4 product as apple juice. The product under recall is apple juice concentrate.
_______________________________
PRODUCT
a) Honest Tea brand First Nation Peppermint Iced Tea, in 16
fluid ounce glass bottles, 12 bottles per case. Recall #
F-046-4;
b) Honest Tea brand Jakarta Ginger Decaf, in 16 fluid ounce
glass bottles, 12 bottles per case. Recall # F-047-4;
c) Honest Tea brand Moroccan Mint Iced Tea, in 16 fluid
ounce glass bottles, 12 bottles per case. Recall #
F-048-4;
d) Honest Tea brand Assam Black Iced Tea, in 16 fluid
ounce glass bottles, 12 bottles per case. Recall #
F-049-4;
e) Honest Tea brand Green Dragon Iced Tea, in 16 fluid
ounce glass bottles, 12 bottles per case. Recall #
F-050-4;
f) Honest Tea brand peach Oo-La-Long Iced Tea, in 16 fluid
ounce glass bottles, 12 bottles per case. Recall #
F-051-4;
g) Honest Tea brand Kashmiri Chai Iced Tea, in 16 fluid
ounce glass bottles, 12 bottles per case. Recall #
F-052-4;
h) Honest Tea brand Decaf Ceylon Iced Tea, in 16 fluid
ounce glass bottles, 12 bottles per case. Recall #
F-053-4;
i) Honest Tea brand Black Forest Berry Iced Tea, in 16 fluid
ounce glass bottles, 12 bottles per case. Recall #
F-054-4;
j) Honest Tea brand Gold Rush Cinnamon Iced Tea, in 16 fluid
ounce glass bottles, 12 bottles per case. Recall #
F-055-4.
CODE
TR3160, TR3161, TR3162, TR3163, TR3164.
RECALLING FIRM/MANUFACTURER
Honest Tea, Bethesda, MD, by e-mail and fax on September 11, 2003, by letter on September 29, 2003 and October 8, 2003. Firm initiated recall is complete.
REASON
Beverage may contain glass pieces.
VOLUME OF PRODUCT IN COMMERCE
803,000 bottles.
DISTRIBUTION
Nationwide.
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PRODUCT
a) Lindberg-Snider brand, "Ruby's Hot Barbecue Sauce",
in 12 oz and 1 gallon bottles. Recall # F-041-4;
b) Lindberg-Snider brand, Barbecue Sauce, in 12 oz and 1
gallon bottles. Recall # F-042-4.
CODE
a) Cases with stamp date of "OCT 1 2003" through "MAR 26
2004";
b) Cases with stamp dates "OCT 1 2003" through "AUG 14
2004".
RECALLING FIRM/MANUFACTURER
Lindberg - Snider Company, Inc., City of Industry, CA, by letter on October
1, 2003. FDA initiated recall is ongoing.
REASON
The product contains undeclared color, FD&C Red #40.
VOLUME OF PRODUCT IN COMMERCE
12 oz. size: 740 cases each containing 12 bottles and 1 gallon size: 472 cases
each containing 4 bottles.
DISTRIBUTION
Nationwide.
____________________________
PRODUCT
Morphine Sulfate Injection, USP, 30mg (1 mg/ml), 30 mL Single-dose Abboject PCA Vial, Rx Only. Recall # D-076-4.
CODE
Lot No/Exp. Date: 05-220-DK (01 June 2005).
RECALLING FIRM/MANUFACTURER
Abbott Labs, North Chicago, IL, by letter on November 20, 2003. Firm initiated recall is ongoing.
REASON
Mispackaging; A vial labeled as Meperidine HCI Injection, USP 10 mg/ml was found in a sealed holding carton labeled to contain Morphine Sulfate Injection, USP 1 mg/ml.
VOLUME OF PRODUCT IN COMMERCE
83,550 units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Bactroban Nasal( Ointment (Mupirocin Calcium Ointment 2 %), 1.0 gram Single-Use Tubes, Rx Only. Recall # D-074-4.
CODE
Lot SKAK; Expiration date: 10/04.
RECALLING FIRM/MANUFACTURER
GlaxoSmithKline, Zebulon, NC, by letter on November 16, 2003. Firm initiated recall is ongoing.
REASON
Superpotent; Stability (6 month).
VOLUME OF PRODUCT IN COMMERCE
12,500 cartons (10 tubes/carton).
DISTRIBUTION
Nationwide.
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PRODUCT
Cold & Hot Therapy Pain Relief Cream, Extra Strength (Methyl Salicylate 30% and Menthol 10%) Net Weight 1.25 oz. (35.4g). Sold under other brands as: 1) Brooks Pharmacy Cold and Hot Extra Strength Therapy Pain Relief Cream, Net Weight 1.25 oz. (35.4g); 2) Pathmark Extra Strength Cold and Hot Therapy Pain Relief Cream, Net Weight 1.25 oz. (35.4g); 3) Extra Strength Cold & Hot pain relief cream, Net Wt. 3 oz. (85 g). Recall # D-075-4.
CODE
Code/Exp. date: 2H06A/August 2004; 2H29C/August 2004;
2113B/September 2004; 2117B/October 2004; 2K07B/November 2004; 3A14A/January 2005; 3B26B/ February 2005; 3C24D/March 2005; 3D22A/April 2005; 3E19B/March 2005; 3F19E/June 2005; 3G09C/July 2005; 3G16A/July 2005; 3H25D/August 2005; 3126A/September 2005.
RECALLING FIRM/MANUFACTURER
Qualis Inc., Des Moines, IA, by telephone on October 16, 2003. Firm initiated recall is ongoing.
REASON
Subpotent; (Methyl Salicylate) 12-month stability.
VOLUME OF PRODUCT IN COMMERCE
11,868 (1.25-oz.) & 35,724 (3-oz.) tubes.
DISTRIBUTION
Nationwide.
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PRODUCT
a) CryoGraft, Hemi Patellar Tendon;
b) CryoGraft, Peroneus Tendon;
c) CryoGraft, Tibialis Tedon. Recall # B-0177-4.
CODE
a) Donor #68139, Model #T030, Serial #7980070; Model #T030,
Serial #7980005, Model #T030, Serial #7979893;
b) Donor #68139, Model #T090, Serial #7979915, Model #T090,
Serial #7979904;
c) Donor #68139, Model #T080, Serial #7979995; Model #T080,
Serial #7979987, Model #T080, Serial #7979945.
RECALLING FIRM/MANUFACTURER
CryoLife, Inc, Kennesaw, GA, by
letter dated September 19, 2003. Firm initiated recall is ongoing. Firm
initiated recall is Complete. [12-18-2003:
This is corrected information replacing original (grayed out) text.]
REASON
Human tissue, procured from a donor whose tissue was initially positive for
Steptococcus species (group A, beta-hemolytic), was implanted. The recipient
developed an infection from the same microorganism.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
AZ, CO, KY, TN, and TX.
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PRODUCT
a) ComfortGel Nasal Mask size small. Recall # Z-0178-04;
b) ComfortGel Nasal Mask size medium. Recall # Z-0179-04;
c) ComfortGel Nasal Mask size large. Recall # Z-0180-04.
CODE
a) Part number 1009041; Lot numbers 030612, 130418, 030417,
030415,030409, 030321, 030320, 030316, 030312, 030311,
030310, 030306, 030305, 030303, and 030228;
b) Part number 1009042; Lot numbers 030604, 030603, 030528,
030520, 030501, 030422, 030421, 030408,030325, 030319,
030314, 030312, 030311, 030227, 030226, 020826, and
020823;
c) Part number 1009043; Lot numbers 030826, 030814, 030528,
030307, and 020822.
RECALLING FIRM/MANUFACTURER
Respironics, Inc., Murrysville, PA, by telephone on September 29, 2003. Firm initiated recall is complete.
REASON
Product does not contain built in exhalation port.
VOLUME OF PRODUCT IN COMMERCE
72 units.
DISTRIBUTION
Nationwide and Canada.
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PRODUCT
TC-PLUS Solution Femoral Component Size 12L, part 21041-C. Recall # Z-0170-04.
CODE
Lot 0006.13.2635.
RECALLING FIRM/MANUFACTURER
Plus Orthopedics, San Diego, CA, by letters on September 9, 2003 . Firm initiated recall is ongoing.
REASON
Inaccurate dimensions of the device.
VOLUME OF PRODUCT IN COMMERCE
5.
DISTRIBUTION
TX.
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PRODUCT
Stryker brand Ortho Tec pulsed irrigation/suction handpiece and tubing set; part number 0203-020-000. Recall # Z-0171-04.
CODE
Lots 03082022, 03082042, 0308102, 03082122, 03082162, 03082202, 03082222, 03092242, 03092302, 03092322, 03092342, 03092402, 03092422, 03092442 and 03092462.
RECALLING FIRM/MANUFACTURER
Stryker Instruments, Instruments Div., Kalamazoo, MI, by letters dated November 12, 2003. Firm initiated recall is ongoing.
REASON
Product sterility may have been compromised by an inadequate package seal.
VOLUME OF PRODUCT IN COMMERCE
296 boxes.
DISTRIBUTION
Nationwide, France and United Kingdom.
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PRODUCT
AxSYM Analyzer, Small Heater Block Clamp. Recall # Z-0173-04.
CODE
All Serial Numbers.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX, by letter on June 6, 2002. Firm initiated recall is ongoing.
REASON
Clamp can cause misaligned seating of heater block resulting in inaccurate dispension of MEIA Wash Buffer or MUP into the reaction cell. Causes inconsistent results.
VOLUME OF PRODUCT IN COMMERCE
15,437.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Invacare IVC Home Care Bed (Foot Section with new head
actuator from Linak. Recall # Z-0174-04.
CODE
Foot section model numbers and serial number ranges: Model # Beginning S/N Ending S/N 5490IVC 03D891256 03E035155 5890IVC 03D889942 03E002241 5491IVC 03E969254 03E433379 5891IVC 03E970154 03E971163 Bed Models that include the recalled food sections: 5310IVC, 5311IVC, 5410IVC, 5411IVC Bed package model numbers which include the affected Beds and foot sections: BED-21VC, BED-4IVC, BED-9IVC, BED-10IVC, BED-19IVC, BED-21IVC, BED-22IVC, BED-23IVC, BED-24IVC, BED-25IVC, BED-26IVC, BED-27IVC, BED-28IVC, BED-29IVC, BED-32IVC, BED-33IVC, BED-34IVC, BED-35IVC, BED-36IVC, BED-37IVC, CBED-2IVC, CBED-4IVC, CBED-4BIVC, CBED-11IVC, CBED-11BIVC, CBED-12IVC, CBED-12BIVC, CBED-19IVC, CBED-22IVC, CBED-23IVC, CBED-26IVC, CBED-28IVC.
RECALLING FIRM/MANUFACTURER
Invacare Corporation, Elyria, OH, by telephone and letters on June 9, 2003. Firm initiated recall is ongoing.
REASON
Pull tube on bed may bend or separate causing inoperability of bed or head section to fall.
VOLUME OF PRODUCT IN COMMERCE
5,926.
DISTRIBUTION
Nationwide and Canada.
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PRODUCT
BrachyVision software, catalog #AL15521003, CD-ROM (set of four) packaged in plastic sleeve and inserted into Varian Medical Systems Imaging Products Vision binder. Recall # Z-0176-04.
CODE
Versions 6.1 and 6.5.
RECALLING FIRM/MANUFACTURER
Varian Brachytherary Virginia, Charlottesville, VA, by Customer Technical Bulletin on May 21, 2003 and by letter on October 31, 2003. Firm initiated recall is ongoing.
REASON
The manufacturer's instructions for using radiation treatment software may cause healthcare practitioner to administer an incorrect treatment to the patient.
VOLUME OF PRODUCT IN COMMERCE
29 sets.
DISTRIBUTION
Nationwide and Internationally.
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PRODUCT
CA Cellulose Acetate High Efficiency Hollow Fiber Dialyzers; Model CA 210, product code 5M1736; 24 units per case. Recall # Z-0177-04.
CODE
Lot numbers A00K09, exp 10/2003; A01C04, exp 2/2004; C01A08, exp 12/2003; E01B15, exp 1/2004.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corp., Round Lake, IL, by letters dated October 30, 2003. Firm initiated recall is ongoing.
REASON
Use of the dialyzers may cause iritis (red eye) patient reactions.
VOLUME OF PRODUCT IN COMMERCE
34,865 units.
DISTRIBUTION
Nationwide, and Internationally.
_______________________________
PRODUCT
Otto Bock Kimba Plus Pediatric Tilt-in-Space Postural Mobility Systems (Strollers), Product Numbers HR32571001-012, HRK3269=06-027_X, R32651001-012, HRK3283=01-026_X, HRK3269=01-026_X, HRK3283=02-026_X, HRK3269=02-026_X, HRK3283=03-027_X, HRK3269=03-027_X, HRK3283=04-027_X, HRK3269=04-027_X, HRK3283=05-026_X, HRK3269=05-026_X, and HRK3283=06-027_X. Recall #Z-0181-04.
CODE
The affected strollers were sold between August 1, 2002 and September 23, 2003. The affected strollers are those strollers equipped with the trigger-activated tilting mechanism. (The firm''s notification letter has photographs of the trigger-activated tilting mechanism which can be used to identify the devices needing correction.)
RECALLING FIRM/MANUFACTURER
Bock, Otto, Orthopedic Ind., Inc., Minneapolis, MN, by letters dated October 23, 2003. Firm initiated recall is ongoing.
REASON
Under certain conditions the tilt mechanism of the strollers may not function properly allowing the child to fall out if the seat belt is not fastened.
VOLUME OF PRODUCT IN COMMERCE
707 strollers.
DISTRIBUTION
Nationwide, Canada, and Mexico.
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PRODUCT
a) Ronci Surgical Universal Imaging Extension used with the
Ronci Pain Management Table System Catalog Number: R-934-25A. Recall # Z-0182-04;
b) Stryker Universal Imaging Extension (OEM) Catalog
Number: R--934-TRIO-A1. Recall # Z-0183-04;
c) Trumpf Universal Imaging Extension (OEM) Catalog NUmber:
F-PMT-A. Recall # Z-0184.04.
CODE
a) S/N''S: R00043, R001080, R001092, R001198, R0001341,
R001370, R001374, R001366, R001337, R001497, R001478,
R001493, R001501, R001529, R001812, R001816, R002023;
b) Serial Numbers: 217335, 214331.
c) Serial Number: 192478.
RECALLING FIRM/MANUFACTURER
The OR Group, Acton, MA, by letter on November 6, 2003. Firm initiated recall is ongoing.
REASON
Imaging table with extension may fail if the table leg is incorrectly positioned and the load exceeds the maximum weight of 400 lb.
VOLUME OF PRODUCT IN COMMERCE
20.
DISTRIBUTION
Nationwide.
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PRODUCT
a) Ross 14 FR Gastrostomy Tube, Item # 152.
Recall # Z-0185-04;
b) Ross 16 FR Gastrostomy Tube, Item # 153.
Recall # Z-0186-04;
c) Ross 18 FR Gastrostomy Tube, Item # 154.
Recall # Z-0187-4;
d) Ross 20 FR Gastrostomy Tube, Item # 155.
Recall # Z-0188-04;
e) Ross 22 FR Gastrostomy Tube, Item # 156.
Recall # Z-0189-04;
f) Ross 24 FR Gastrostomy Tube, Item # 159.
Recall # Z-0190-04;
g) Ross 26 FR Gastrostomy Tube, Item # 50158.
Recall # Z-0191-04;
h) Ross 16 FR Easy-Feed Gastrostomy Tube, Item # 50112.
Recall # Z-0192-04;
i) Ross 18 FR Easy-Feed Gastrostomy Tube, Item # 50114.
Recall # Z-0193-04;
j) Ross 20 FR Easy-Feed Gastrostomy Tube, Item # 50116.
Recall # Z-0194-04;
k) Ross 22 FR Easy-Feed Gastrostomy Tube, Item # 50118.
Recall # Z-0195-04;
l) Ross 14 FR Magna-Port Gastrostomy Tube, Item # 51358.
Recall # Z-0196-04;
m) Ross 16 FR Magna-Port Gastrostomy Tube, Item # 51360.
Recall # Z-0197-04;
n) Ross 18 FR Magna-Port Gastrostomy Tube, Item # 51362.
Recall # Z-0198-04;
o) Ross 20 FR Magna-Port Gastrostomy Tube, Item # 51364.
Recall # Z-0199-04;
p) Ross 22 FR Magna-Port Gastrostomy Tube, Item # 51366.
Recall # Z-0200-04;
q) Ross 24 FR Magna-Port Gastrostomy Tube, Item # 54738.
Recall # Z-0201-04;
r) Ross 28 FR Magna-Port Gastrostomy Tube, Item # 54736.
Recall # Z-0202-04;
s) Ross 18 FR Introducer Gastrostomy Kit with Brown Mueller
T-Fastener Set, Item # 50190. Recall # Z-0203-04;
t) Ross 22 FR Versa-PEG Gastrostomy Kit, Item # 50520.
Recall # Z-0204-04;
u) Ross 18 FR Lap G Laparoscopic Gastrostomy Kit with Brown
Mueller T-Fastener Set, Item # 51174. Recall #Z-0205-04.
CODE
a) Lot Numbers: 03590GZ00, 91083GZ00, 92185GZ00, 95422GZ00;
b) Lot Numbers: 02550GZ00, 91051GZ00, 92181GZ00, 94375GZ00,
96457GZ00;
c) Lot Numbers: 01502GZ00, 04632GZ00, 05667GZ00, 05686GZ00,
89877GZ00, 90981GZ00, 91104GZ00, 92182GZ00, 92213GZ00,
95409GZ00;
d) Lot Numbers: 02551GZ00, 03614GZ00, 89972GZ00, 91052GZ00,
91155GZ00, 92214GZ00, 95396GZ00, 96463GZ00;
e) Lot Numbers: 01523GZ00, 04654GZ00, 93288GZ00, 95423GZ00;
f) Lot Numbers: 04635GZ00, 90012GZ00, 92186GZ00, 96439GZ00,
87767GZ00;
g) Lot Numbers: 02541GZ00, 91163GZ00, 96458GZ00;
h) Lot Numbers: 02531GZ00, 90013GZ00;
i) Lot Numbers: 01494GZ00, 05692GZ00, 91069GZ00;
j) Lot Numbers: 01501GZ00, 06695GZ00, 93290GZ00;
k) Lot Numbers: 01512GZ00, 93291GZ00, 94336GZ00;
l) Lot Numbers: 05689GZ00, 92195GZ00, 96468GZ00;
m) Lot Numbers: 01520GZ00, 03615GZ00, 06710GZ00, 88835GZ00,
90983GZ00, 91074GZ00, 91129GZ00, 92212GZ00, 96442GZ00;
n) Lot Numbers: 02533GZ00, 04647GZ00, 05680GZ00, 91050GZ00,
91125GZ00, 92211GZ00, 95400GZ00, 96467GZ00;
o) Lot Numbers: 01519GZ00, 04641GZ00, 06708GZ00, 89960GZ00,
90029GZ00, 90046GZ00, 92194GZ00, 95397GZ00, 96462GZ00;
p) Lot Numbers: 01526GZ00, 06709GZ00, 93282GZ00;
q) Lot Numbers: 01507GZ00, 04636GZ00, 04663GZ00, 94349GZ00,
95425GZ00;
r) Lot Numbers: 92177GZ00, 95431GZ00;
s) Lot Numbers: 02565GZ00, 03600GZ00, 04643GZ00, 05676GZ00,
06719GZ00, 89942GZ00, 90015GZ00, 91105GZ00, 92199GZ00,
93261GZ00, 94322GZ00 95410GZ00, 96470GZ00;
t) Lot Number: 01511GZ00;
u) Lot Numbers: 01528GZ00, 04666GZ00, 91053GZ00, 91157GZ00,
94377GZ00, 96466GZ00;
RECALLING FIRM/MANUFACTURER
Ross Products Division, Abbott Laboratories, Columbus, OH, by telephone, fax, and letter on November 14. 2003. Firm initiated recall is ongoing.
REASON
An increase in reported balloon failures, which may result in tube displacement.
VOLUME OF PRODUCT IN COMMERCE
210,846 (11,605 foreign).
DISTRIBUTION
Nationwide, and Internationally.
END OF ENFORCEMENT REPORT FOR DECEMBER 17, 2003
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Hypertext created by clb 2003-DEC-17.