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U.S. Department of Health and Human Services

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Enforcement Report for March 10, 2004

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.


March 10, 2004
04-10

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

______________________________
PRODUCT
Evergreen Melon Hard Candy, Net Wt. 5 oz., packaged in a
clear, plastic bag. Recall # F-134-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Kien Import Corp., Brooklyn, NY, by press release and letters dated November 19, 2003. New York State initiated recall is complete.
REASON
Undeclared sulfites based on New York State Department of Agriculture & Markets (NYSDAM) sampling and analysis.
VOLUME OF PRODUCT IN COMMERCE
101 cases (50-5 oz. bags per case).
DISTRIBUTION
NY, NJ, PA, RI, MA, VA, MD, NC, and SC.

_______________________________
PRODUCT
MEI YUAN (r) Dried Mango, Net Wt. 3.52 oz., packaged in a
flexible plastic bag. Recall # F-135-4.
CODE
All codes on the market at the time the recall was initiated. Barcode # 710372.
RECALLING FIRM/MANUFACTURER
B.C.N. Trading, Inc., Brooklyn, NY, by press release on December 16, 2002. New York State initiated recall is complete.
REASON
Product contains undeclared sulfites and undeclared color, tartrazine (certifiable as FD&C Yellow #5).
VOLUME OF PRODUCT IN COMMERCE
52 cases (100 packages per case).
DISTRIBUTION
NY, NJ, MA, PA, MD, VA, FL.

_______________________________
PRODUCT
Peregrina Cheese brand QUESO FRESCO, Fresh Cheese, Wt 14
oz. Recall # F-136-4.
CODE
Grocery sticker code '1467', Plant # 36-8431, Barcode # 17424 00024.
RECALLING FIRM/MANUFACTURER
Peregrina Cheese Company, Brooklyn, NY, by Consumer Alert on December 12, 2003. New York State initiated recall is complete.
REASON
The product was contaminated with Listeria monocytogenes based on sampling & analysis by New York State Department of Agriculture & Markets (NYSDAM).
VOLUME OF PRODUCT IN COMMERCE
Unknown.
DISTRIBUTION
NY, and NJ.

_______________________________
PRODUCT
Long Cooked Elbow Macaroni (Eggless), sold in bulk for
further manufacturing. Recall # F-137-4.
CODE
Lot #03163K06.
RECALLING FIRM/MANUFACTURER
Hanover Foods, Corp., Centre Hall, PA, by telephone beginning July 10, 2003. Firm initiated recall is complete.
REASON
The product tested positive for Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
40,741 lbs.
DISTRIBUTION
IN.
 

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
Kaletra (lopinavir/ritonavir) capsules Each soft gelatin
capsule contains lopinavir 133.3, rionavir 33.3 mg, RX
only. Recall # D-113-4.
CODE
Lot Numbers/ Expiration Date: 852002E21(12/03); 852072E 25(06/04).
RECALLING FIRM/MANUFACTURER
TXRX, Houston, TX, by letter on January 6, 2004. Firm initiated recall is complete.
REASON
Counterfeit: An unknown number of bottles these lot numbers are counterfeit, in that they have been repackaged and or/relabeled and may bear extended expiration dates, as the source of the repacked and/or relabeled bottles is unknown.
VOLUME OF PRODUCT IN COMMERCE
182 bottles.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Montana Botanicals Eye Drops (Goldenseal Glycerite and
Kollesol in saline), Herbal Extract, 1 oz.
Recall # D-114-4.
CODE
Lot Numbers: 3001, 3002, 3003, 3004, 3005, 3006, 3007, 3008.
RECALLING FIRM/MANUFACTURER
Montana Botanicals, Hamilton, MT, by telephone and letter on December 12, 2003. FDA initiated recall is complete.
REASON
Lack of assurance of sterility.
VOLUME OF PRODUCT IN COMMERCE
28/1 oz. vials.
DISTRIBUTION
Nationwide.
 

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

_______________________________
PRODUCT
Darvon Compound USP 32 (Propoxyphene hydrochloride 32 mg,
aspirin 389 mg and caffeine 32.4 mg), 100 Pulvules, Rx
only. Recall # D-111-4.
CODE
Lot Numbers: Lot 03082B, 03083B and 03084B.
RECALLING FIRM/MANUFACTURER
Aaipharma, Wilmington, NC, by email on January 8, 2004. Firm initiated recall is ongoing.
REASON
Dissolution Failure: Aspirin and Propoxphene hydrochloride (6 month stability).
VOLUME OF PRODUCT IN COMMERCE
4,328 bottles.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Mysoline (primidone) Tablets, 50 mg tablets, 500 count
bottles. Rx Only. Recall # D-112-4.
CODE
Lot Number: J0300071.
RECALLING FIRM/MANUFACTURER
Xcel Pharmaceuticals, Inc., San Diego, CA, by letter on February 6, 2004. Firm initiated recall is ongoing.
REASON
Tablet hardness failure.
VOLUME OF PRODUCT IN COMMERCE
1,558 bottles.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
PREMARIN (conjugated estrogens tablets, USP), 0.625 mg, 100
count bottles, RX only. Recall # D-115-4.
CODE
Lot Number/Expiration Date: A30811 (03/05).
RECALLING FIRM/MANUFACTURER
Richmond Division of Wyeth, Richmond, VA, by letter on February 18, 2004. Firm initiated recall is ongoing.
REASON
Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE
114,187.
DISTRIBUTION
Nationwide.
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Source Plasma. Recall # B-0777-4.
CODE
Units: G15357-081, G-15724-081, G-16320-081, G-16716-081, G-17164-081, G-18113-081, G-18279-081, G-20765-081,
G-22736-081, G-22828-081, G-23186-081, G-23251-081,
G-23408-081, G-23504-081, G-23666-081, G-28725-081,
G-28972-081, N-85990-081, N-86018-081, G-62542-081,
G-62649-081, G-76098-081, G-76453-081, G-76844-081,
G-76978-081, G-88286-081, G-91970-081, G-92438-081,
G-92686-081, G-93218-081, G-05106-081, G-05753-081,
G-05910-081, G-06322-081, G-06484-081, G-06851-081,
G-07074-081, G-08859-081, G-09163-081, G-10134-081,
F-00139-081, F-00385-081, F-00958-081, F-01201-081,
F-02561-081, F-02838-081, F-06778-081, F-07032-081,
N-72120-081, G-44664-081, G-54313-081, G-54476-081,
G-54975-081, G-55133-081, G-55611-081, G-55758-081,
G-56227-081, G-56381-081, G-56868-081, G-57013-081,
G-07937-081, G-08380-081, G-08605-081, G-09013-081,
G-09319-081, G-09681-081, G-10676-081, G-11245-081,
G-13006-081, G-13933-081.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Charlotte, NC, by facsimile transmissions dated June 6, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose eligibility to donate was not adequately verified, were distributed.
VOLUME OF PRODUCT IN COMMERCE
70 units.
DISTRIBUTION
NC, Germany, Spain, Switzerland, and the United Kingdom.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0803-4.
CODE
Units W045003037801, W045003037803, W045003037807, W045003037809, W045003037810, W045003037811, W045003037815, W045003037817, W045003037818, W045003037820, W045003037823, W045003037830, W045003037831, W045003037833, W045003037834, W045003037837.
RECALLING FIRM/MANUFACTURER
Community Blood Center of Gtr KC, Kansas City, MO, by telephone on November 11, 2003 and by letter dated December 2, 2003. Firm initiated recall is ongoing.
REASON
Blood products, collected from donors with inaccurate hemoglobin determinations, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units.
DISTRIBUTION
MO, and KS.

_______________________________
PRODUCT
Source Plasma. Recall # B-0813-4.
CODE
Unit # SH935056.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Harrisburg, PA, by facsimile dated December 4, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
France.

_______________________________
PRODUCT
Source Plasma. Recall # B-0814-4.
CODE
Unit # SH914499.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Harrisburg, PA, by facsimile dated March 14, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Germany.

_______________________________
PRODUCT
Source Plasma. Recall # B-0815-4.
CODE
Unit # SH910399.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Harrisburg, PA, by facsimile dated May 12, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Germany.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0843-4;
b) Recovered Plasma. Recall # B-0844-4.
CODE
a) and b) Unit 18233-3650.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on November 24, 2003, and by letter dated December 24, 2003.
Manufacturer: Blood Systems, Inc., Cheyenne, WY. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
WY, and Switzerland.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0845-4;
b) Recovered Plasma. Recall # B-0846-4.
CODE
a) and b) Unit 18232-4789.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by facsimile on October 6, 2003, and by letter dated November 14, 2003.
Manufacturer: Blood Systems, Inc., Cheyenne, WY. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
WY, and Switzerland.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0847-4;
b) Fresh Frozen Plasma. Recall # B-0848-4;
c) Cryoprecipitated AHF. Recall # B-0849-4.
CODE
a) Units 12799-0947, 12799-0948, 12800-5406, 12800-5526,
12800-6624, 12800-7072, 12800-4324;
b) Units 12800-4324, 12800-5526;
c) Unit 12800-7072.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on November 15, 2003, and by letter dated December 16, 2003.
Manufacturer: Blood Systems, Inc., Albuquerque, NM. Firm initiated recall is ongoing.
REASON
Blood products, collected from ineligible donors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units.
DISTRIBUTION
NM, TX, RI, and Switzerland.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0857-4;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-0858-4;
c) Platelets. Recall # B-0859-4;
d) Platelets Irradiated. Recall # B-0860-4;
e) Cryoprecipitated AHF. Recall # B-0861-4;
f) Plasma. Recall # B-0862-4;
g) Fresh Frozen Plasma. Recall # B-0863-4;
h) Recovered Plasma. Recall # B-0864-4.
CODE
a) Unit numbers 18FT23562, 18FT10811, 18FT08290, 18Q99612,
18Q90725, 18Q81863, 18Q79442, 18Q58960, and 18Q52216;
b) Unit numbers 18FT31584, 18FV16891, 18FT26060, 18FV10579,
18FT06307, 18FT02732, 18Q88417, 18Q86307, 18Q84436, and
18Q73195;
c) Unit numbers 18FV16891, 18FT26060, 18FT10811, 18FT08290,
18FT06307, 18Q99612, 18Q90725, 18Q88417, 18Q84436,
18Q81863, 18Q73195, and 18Q52216;
d) Unit number 18FT02732;
e) Unit numbers 18FT10811, 18Q90725, and 18FT23562;
f) Unit number 18FT23562;
g) Unit numbers 18Q81863 and 18Q79442;
h) Unit numbers 18FT31584, 18FV16891, 18FT26060, 18FV10579,
18FT10811, 18FT08290, 18FT06307, 18FT02732, 18Q99612,
18Q90725, 18Q88417, 18Q86307, 18Q84436, 18Q73195,
18Q58960, and 18Q52216;
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Great Lakes Region, Lansing, MI, by letter, facsimile, or telephone on August 13, 2000. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to behavior associated with an increased risk of infection with hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
54 units.
DISTRIBUTION
MI, CA, MA, NJ, NY, PR, TN, and Switzerland.

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-0867-4;
b) Recovered Plasma. Recall # B-0868-4.
CODE
a) and b) Unit V63255.
RECALLING FIRM/MANUFACTURER
Stanford Medical School Blood Center, Palo Alto, CA, by letters dated March 19, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who emigrated from an area of high risk for human immunodeficiency virus (HIV) Group O, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0869-4.
CODE
Unit T86580.
RECALLING FIRM/MANUFACTURER
Stanford Medical School Blood Center, Palo Alto, CA, by letter dated August 29, 2002. 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
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0870-4.
CODE
Unit 224250339 (split).
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Las Vegas, NV, by telephone on August 31, 2001. Firm initiated recall is complete.
REASON
Blood products, which were collected in a manner that compromised the sterility of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NV.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0871-4.
CODE
Unit 224245527.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Las Vegas, NV, by telephone on August 13, 2001. Firm initiated recall is complete.
REASON
Blood product, which did not have a red blood cell volume documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NV.
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Recovered Plasma. Recall # B-0850-4.
CODE
Units 12799-0947, 12799-0948, 12800-5406, 12800-6624, 12800-7072.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on November 15, 2003, and by letter dated December 16, 2003.
Manufacturer: Blood Systems, Inc., Albuquerque, NM. Firm initiated recall is complete.
REASON
Blood products, collected from ineligible donors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
NM, TX, RI, and Switzerland.

_______________________________
PRODUCT
Cryoprecipitated AHF. Recall # B-0872-4.
CODE
Unit 192493870.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Reno, NV, by telephone on January 25, 2002. Firm initiated recall is complete.
REASON
Blood product, which was prepared from plasma that was not frozen within 8 hours of phlebotomy, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NV.

_______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0873-4.
CODE
Units 192476855, 192476857 (split), 192476850, and 192476854 (split).
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Las Vegas, NV, by telephone on July 26, 2001. Firm initiated recall is complete.
REASON
Blood products, which were not stored under continuous agitation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
NV.
 

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
a) General Electric Seneographe 2000D Digital Mammography
X-Ray System. Recall # Z-0282-04;
b) General Electric Seneographe DMR Mammography X-Ray
System (all versions). Recall # Z-0283-04;
c) General Electric Seneographe 700T Mammography X-Ray
System. Recall # Z-0284-04;
d) General Electric Seneographe 800T Mammography X-Ray
System. Recall # Z-0285-04;
e) General Electric Seneographe 500 Mammography X-Ray
Systems (all versions). Recall # Z-0286-04;
f) General Electric Seneographe 600 Mammography X-Ray
Systems (all versions). Recall # Z-0287-04.
CODE
All serial numbers.
RECALLING FIRM/MANUFACTURER
General Electric Med Systems, Waukesha, WI, by letters dated February 6, 2004. Firm initiated recall is ongoing.
REASON
The mammography system's information for users lacked the technical specification for the minimum filtration permanently installed in the useful beam and the technical specification for the maximum line current.
VOLUME OF PRODUCT IN COMMERCE
6,931 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Datex-Ohmeda S/5 and AS/3 Anesthesia Delivery Units (The S/5 units are a later version of the AS/3 units. The conversion from AS3 to S5 occurred during the summer of 2000. This change was mainly a product name change, with a slight color variation to the shade of white being used externally on the machine. There were no design or feature and function modifications when the name change occurred.) Recall # Z-0545-04.
CODE
Serial numbers between 40013635 and 40162379.
RECALLING FIRM/MANUFACTURER
Datex-Ohmeda, Inc., Madison, WI, by letters dated February 3, 2004. Firm initiated recall is ongoing.
REASON
Anesthetic agents could be delivered at concentrations above the concentration set on the S/5 and AS/3 Anesthesia Delivery Units (ADU) having serial numbers within a specified range.
VOLUME OF PRODUCT IN COMMERCE
8,700 units.
DISTRIBUTION
Nationwide, and Internationally.

_______________________________
PRODUCT
Hem-o-Lok"SMX Ligating Clip, REF 544220, Non-absorbable Polymer Ligation Clips, Sterile EO, Single use, Disposable. Recall # Z-0547-04.
CODE
Lot number 988384.
RECALLING FIRM/MANUFACTURER
Weck, Research Triangle Park, NC, by letter, email, and fax beginning January 23, 2004. Firm initiated recall is ongoing.
REASON
Malformation of the Hem-o-lok SMK clip.
VOLUME OF PRODUCT IN COMMERCE
70 sales units (containing 14 cartridges with 4 clips on each cartridge).
DISTRIBUTION
Nationwide, Korea and France.

_______________________________
PRODUCT
CryoValve Pulmonary Valve and Conduit. Donor #29640, Model #PV00 (Pulmonary Valve). Recall # Z-0548-04.
CODE
Serial #6194362.
RECALLING FIRM/MANUFACTURER
CryoLife Inc., Kennesaw, GA, by letter on December 10, 2003. Firm initiated recall is complete.
REASON
As part of this ongoing retrospective review, CryoLife has identified a donor who does not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

_______________________________
PRODUCT
VACUTAINER Brand Push Button Blood Collection Sets.
Recall # Z-0549-04.
CODE
Batch #3218665.
RECALLING FIRM/MANUFACTURER
Becton Dickinson & Company, Franklin Lakes, NJ, by direct contact on December 22, 2003. Firm initiated recall is complete.
REASON
A hole was noticed in the blister pack that is used to package the device and provides the sterility barrier. Sterility could be compromised.
VOLUME OF PRODUCT IN COMMERCE
4,400.
DISTRIBUTION
CA, and VA.

_______________________________
PRODUCT
Clinical Chemistry Urea Nitrogen. Recall # Z-0550-04.
CODE
Lots: 05073HW00, 04022HW00, 03041HW00.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories Diagnostic Div, South Pasadena, CA, by letters on November 24, 2003. Firm initiated recall is ongoing.
REASON
Low results due to contaminant.
VOLUME OF PRODUCT IN COMMERCE
568.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
SCIPRO Flexible Stone Dislodger and Retrieval Set. Catalog #SP3000146ST. Recall # Z-0554-04.
CODE
Lot # OML30403-01.
RECALLING FIRM/MANUFACTURER
Scion Cardio-Vascular, Inc., Miami, FL, by letter on May 23, 2003. Firm initiated recall is complete.
REASON
Possible difficulty for the user in opening the stone retrieval basket.
VOLUME OF PRODUCT IN COMMERCE
28.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) BE 183 Series Manual Jet Ventilator. Part #BE 183-SU.
Recall # Z-0555-04;
b) BE 183 Series Manual Jet Ventilator with Regulator and
Gauge. Part #BE 183-SU. Recall # Z-0556-04.
CODE
a) Lot number P0907203;
b) Lot number P0908103.
RECALLING FIRM/MANUFACTURER
Instrumentation Industries, Inc., Bethel Park, PA, by telephone and letters dated September 17, 2003. Firm initiated recall is complete.
REASON
Possible external debris in the on/off plunger.
VOLUME OF PRODUCT IN COMMERCE
46 units.
DISTRIBUTION
CA, FL, GA, NY, OH, OR, TX, and UT.

_______________________________
PRODUCT
SCIPRO Flexible Stone Dislodger and Retrieval Set, Catalog # SP3000146-ST used for removal of calculi, fragments of medical devices and other foreign objects uring urological or gatroenterological procedures. Recall # Z-0557-04.
CODE
Lot number OML30522-01.
RECALLING FIRM/MANUFACTURER
Scion Cardio-Vascular, Inc., Miami, FL, by letter on June 30, 2003. Firm initiated recall is complete.
REASON
The firm received field complaints that is was difficult to open the stone retrieval basket during use.
VOLUME OF PRODUCT IN COMMERCE
41.
DISTRIBUTION
IL, and AL.

_______________________________
PRODUCT
a) 2.5mm Hex Driver. Recall # Z-0558-04;
b) 4mm Hex Driver. Recall # Z-0559-04.
CODE
a) Lot #04160301, Catalog Number OP20004,
Lot # O2F108, O2F109, O2G322, O2G323, O2G324, O3E221,
Catalog Number SP00005-US;
b) Lot # 02190301, 05120311, Part # MU20012, Revision I.
RECALLING FIRM/MANUFACTURER
U&I America, Murray, UT, by letter on January 14, 2003. Firm initiated recall is complete.
REASON
Reports of hex driver tips breaking off or becoming worn or stripped.
VOLUME OF PRODUCT IN COMMERCE
620 units.
DISTRIBUTION
MN.

_______________________________
PRODUCT
Crossfire Acetabular II Insert. Catalog No. 2041C-2642. Recall # Z-0560-04.
CODE
Lot 48921601.
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics, Mahwah, NJ, by letters dated January 9, 2004 and January 12, 2004. Firm initiated recall is complete.
REASON
This device is not approved for sale in the U.S.
VOLUME OF PRODUCT IN COMMERCE
3 devices.
DISTRIBUTION
MI.

_______________________________
PRODUCT
a) The device is in a tyvek pouch and is labeled in part:
Aviator Peripheral Dilatation Catheter REF Cat. No. Lot
No., Use By Method of Sterilization ETO Min. Guiding
Catheter ID Nominal Pressure Rated Burst Pressure.
Recall # Z-0566-04;
b) The device is labeled as Sterile and is packaged in a
Tyvek pouch with the following labeling: PALMAZ Genesis
TRANSHEPATIC BILIARY STENT on Aviator RX Delivery
System REF Cat. No. Cordis ENDOVASCULAR Lot No.,
Recall # Z-0567-04.
CODE
a) New Lots with October 2003 or newer dating embedded in
lot number ("1003" MMYY in the second to fifth digit of
Lot Number) and any older ones with a Green Dot
indicating that they passed Cordis Inspection ARE NOT
COVERED. The following previsouly uninspected lots were
covered under the recall: AVIATOR ITEM_NO LOT_NO
4224015S R0103043 4224015S R0202421 4224015S R0403032
4224015S R0603169 4224015S R0902952 4224015S R1102231
4224015S S0602108 4224015X R0303535 4224015X R0402115
4224015X R0603722 4224015X R0902953 4224015X R1002434
4224015X S0502104 4224020S R0102364 4224020S R0102920
4224020S R0103968 4224020S R0202151 4224020S R0202862
4224020S R0203105 4224020S R0203499 4224020S R0302900
4224020S R0502712 4224020S R0503318 4224020S R0602462
4224020S R0702480 4224020S R0802055 4224020S R0802263
4224020S R0802850 4224020S R0802863 4224020S R1002174
4224020S S0102054 4224020S S0102686 4224020S S0202251
4224020S S0602109 4224020S S1002019 4224020S S1002209
4224020X R0103044 4224020X R0103196 4224020X R0103714
4224020X R0103969 4224020X R0202004 4224020X R0202206
4224020X R0203106 4224020X R0302095 4224020X R0303719
4224020X R0603339 4224020X R0702481 4224020X R0702652
4224020X R0702915 4224020X R0802056 4224020X R0802269
4224020X R0902477 4224020X R1002935 4224020X R1102003
4224020X R1102019 4224020X S0102050 4224020X S0602110
4224020X S1002020 4224030S R0202207 4224030S S0102051
4224030X R0202209 4224030X R0303023 4224030X R0603480
4224030X R0703380 4224030X R0802270 4224030X R1002567
4224030X R1002681 4224030X S0102052 4224030X S0303012
4224040S R0202005 4224040S R0902705 4224040S S0202252
4224040X R0202210 4224040X R0203503 4224040X R0502606
4224040X R0603723 4224040X R0902562 4224040X R1202527
4224515S R0102923 4224515S R0303021 4224515S R0702656
4224515S R1002682 4224515X R0202422 4224515X R0303534
4224515X R0502832 4224520S R0302096 4224520S R0702482
4224520S S0302254 4224520X R0202423 4224520X R0202863
4224520X R0402641 4224520X R0502377 4224530X R0102922
4224530X R0302596 4224540X R0402885 4224540X S0602136
4225015S R0103045 4225015S R0103398 4225015S R0103971
4225015S R0802864 4225015S S0502035 4225015S S0802199
4225015X R0103474 4225015X R0302097 4225015X R0303202
4225015X R0703132 4225015X R0902478 4225015X R1102232
4225015X S0402079 4225015X S0502134 4225020S R0102365
4225020S R0102366 4225020S R0102663 4225020S R0102703
4225020S R0103046 4225020S R0103715 4225020S R0202152
4225020S R0202698 4225020S R0202864 4225020S R0203107
4225020S R0302328 4225020S R0503679 4225020S R0702978
4225020S R0802271 4225020S R0802851 4225020S R0802865
4225020S S0102001 4225020S S0102415 4225020S S0802200
4225020X R0103475 4225020X R0103717 4225020X R0103970
4225020X R0202446 4225020X R0203108 4225020X R0203505
4225020X R0402642 4225020X R0403309 4225020X R0502092
4225020X R0503943 4225020X R0602336 4225020X R0702688
4225020X R0702916 4225020X R0702977 4225020X R0802272
4225020X R0802852 4225020X R0803122 4225020X R1002175
4225020X S0202007 4225020X S0402218 4225020X S0502383
4225020X S0802201 4225030S R0202565 4225030S S0502102
4225030X R0202566 4225030X S0202048 4225030X S0502103
4225040S R0302967 4225040S S0502135 4225040X R0103399
4225040X R0202699 4225040X R0403334 4225040X R0502378
4225040X R1002713 4225040X S0402219 4225515S R0202700
4225515S R0503714 4225515S S0802202 4225515X R0202788
4225515X R0303022 4225515X R0702689 4225515X R0802273
4225515X R1102020 4225520S R0202766 4225520S R0302647
4225520S R0602805 4225520X R0202767 4225520X R0302648
4225520X R0403033 4225520X R0602339 4225520X R0602812
4225520X S0502036 4225520X S0602137 4225530X R0402680
4225540X R0402116 4225540X R0403826 4226015S R0202768
4226015S R0203748 4226015S R0403620 4226015S R0502500
4226015S R0603490 4226015S R0702508 4226015S R1102583
4226015S S0802203 4226015X R0302649 4226015X R0602863
4226015X R0603487 4226015X R0902216 4226015X R1102230
4226015X S0202253 4226015X S1002212 4226020S R0102367
4226020S R0102665 4226020S R0102704 4226020S R0202003
4226020S R0202153 4226020S R0702510 4226020S R0702976
4226020S R0802853 4226020S R0902707 4226020S S0102149
4226020S S0102171 4226020S S0102262 4226020S S0302289
4226020S S0802180 4226020X R0103718 4226020X R0202785
4226020X R0203110 4226020X R0402117 4226020X R0502093
4226020X R0503154 4226020X R0602006 4226020X R0603725
4226020X R0702511 4226020X R0702690 4226020X R0702917
4226020X R0702975 4226020X R0703642 4226020X R0802274
4226020X R0802854 4226020X S0402220 4226020X S0802204
4226030S R0202786 4226030S S0602139 4226030X R0202787
4226030X R0302650 4226030X R0702700 4226030X R0702937
4226040S S0302319 4226040X R0103476 4226040X R0403827
4226040X R1102486 4226040X S0602111 4226515S R0402170
4226515S R0503379 4226515S R1002435 4226515X R0402171
4226515X R0503715 4226515X R0702512 4226515X R0802301
4226515X R0802855 4226520S R0402172 4226520X R0303203
4226520X R0402682 4226520X R0602007 4226520X R0702697
4226520X R1102487 4226530X R0402179 4226540X R0402174
4227015S R0402734 4227015S R0403621 4227015S R0502094
4227015S R0502501 4227015X R0203747 4227015X R0802304
4227015X S0602112 4227020S R0202154 4227020S R0402175
4227020S R0502548 4227020S R0602241 4227020S R0602595
4227020S S0102151 4227020X R0402176 4227020X R0402735
4227020X R0502095 4227020X R0602008 4227020X R0702699
4227020X R0702934 4227020X R0703246 4227020X R0802134
4227020X R0802302 4227020X R0802866 4227030S S0402222
4227030X R0402177 4227030X R0402760 4227040S R0402178
4227040S R0502096 4227040X R0503680 4227040X R0702936
4227040X R0802303 4227040X S0602113.
b) New Lots with October 2003 or newer dating embedded in
lot number ("1003" MMYY in the second to fifth digit of
Lot Number) and any older ones with a Green Dot
indicating that they passed Cordis Inspection ARE NOT
COVERED. The following previously uninspected lots were
covered under the recall: AVIATOR ITEM_NO LOT_NO
4224015S R0103043 4224015S R0202421 4224015S R0403032
4224015S R0603169 4224015S R0902952 4224015S R1102231
4224015S S0602108 4224015X R0303535 4224015X R0402115
4224015X R0603722 4224015X R0902953 4224015X R1002434
4224015X S0502104 4224020S R0102364 4224020S R0102920
4224020S R0103968 4224020S R0202151 4224020S R0202862
4224020S R0203105 4224020S R0203499 4224020S R0302900
4224020S R0502712 4224020S R0503318 4224020S R0602462
4224020S R0702480 4224020S R0802055 4224020S R0802263
4224020S R0802850 4224020S R0802863 4224020S R1002174
4224020S S0102054 4224020S S0102686 4224020S S0202251
4224020S S0602109 4224020S S1002019 4224020S S1002209
4224020X R0103044 4224020X R0103196 4224020X R0103714
4224020X R0103969 4224020X R0202004 4224020X R0202206
4224020X R0203106 4224020X R0302095 4224020X R0303719
4224020X R0603339 4224020X R0702481 4224020X R0702652
4224020X R0702915 4224020X R0802056 4224020X R0802269
4224020X R0902477 4224020X R1002935 4224020X R1102003
4224020X R1102019 4224020X S0102050 4224020X S0602110
4224020X S1002020 4224030S R0202207 4224030S S0102051
4224030X R0202209 4224030X R0303023 4224030X R0603480
4224030X R0703380 4224030X R0802270 4224030X R1002567
4224030X R1002681 4224030X S0102052 4224030X S0303012
4224040S R0202005 4224040S R0902705 4224040S S0202252
4224040X R0202210 4224040X R0203503 4224040X R0502606
4224040X R0603723 4224040X R0902562 4224040X R1202527
4224515S R0102923 4224515S R0303021 4224515S R0702656
4224515S R1002682 4224515X R0202422 4224515X R0303534
4224515X R0502832 4224520S R0302096 4224520S R0702482
4224520S S0302254 4224520X R0202423 4224520X R0202863
4224520X R0402641 4224520X R0502377 4224530X R0102922
4224530X R0302596 4224540X R0402885 4224540X S0602136
4225015S R0103045 4225015S R0103398 4225015S R0103971
4225015S R0202697 4225015S R0302599 4225015S R0403333
4225015S R0802864 4225015S S0502035 4225015S S0802199
4225015X R0103474 4225015X R0302097 4225015X R0303202
4225015X R0703132 4225015X R0902478 4225015X R1102232
4225015X S0402079 4225015X S0502134 4225020S R0102365
4225020S R0102366 4225020S R0102663 4225020S R0102703
4225020S R0103046 4225020S R0103715 4225020S R0202152
4225020S R0202698 4225020S R0202864 4225020S R0203107
4225020S R0302328 4225020S R0503679 4225020S R0702978
4225020S R0802271 4225020S R0802851 4225020S R0802865
4225020S S0102001 4225020S S0102415 4225020S S0802200
4225020X R0103475 4225020X R0103717 4225020X R0103970
4225020X R0202446 4225020X R0203108 4225020X R0203505
4225020X R0402642 4225020X R0403309 4225020X R0502092
4225020X R0503943 4225020X R0602336 4225020X R0702688
4225020X R0702916 4225020X R0702977 4225020X R0802272
4225020X R0802852 4225020X R0803122 4225020X R1002175
4225020X S0202007 4225020X S0402218 4225020X S0502383
4225020X S0802201 4225030S R0202565 4225030S S0502102
4225030X R0202566 4225030X S0202048 4225030X S0502103
4225040S R0302967 4225040S S0502135 4225040X R0103399
4225040X R0202699 4225040X R0403334 4225040X R0502378
4225040X R1002713 4225040X S0402219 4225515S R0202700
4225515S R0503714 4225515S S0802202 4225515X R0202788
4225515X R0303022 4225515X R0702689 4225515X R0802273
4225515X R1102020 4225520S R0202766 4225520S R0302647
4225520S R0602805 4225520X R0202767 4225520X R0302648
4225520X R0403033 4225520X R0602339 4225520X R0602812
4225520X S0502036 4225520X S0602137 4225530X R0402680
4225540X R0402116 4225540X R0403826 4226015S R0202768
4226015S R0203748 4226015S R0403620 4226015S R0502500
4226015S R0603490 4226015S R0702508 4226015S R1102583
4226015S S0802203 4226015X R0302649 4226015X R0602863
4226015X R0603487 4226015X R0902216 4226015X R1102230
4226015X S0202253 4226015X S1002212 4226020S R0102367
4226020S R0102665 4226020S R0102704 4226020S R0202003
4226020S R0202153 4226020S R0702510 4226020S R0702976
4226020S R0802853 4226020S R0902707 4226020S S0102149
4226020S S0102171 4226020S S0102262 4226020S S0302289
4226020S S0802180 4226020X R0103718 4226020X R0202785
4226020X R0203110 4226020X R0402117 4226020X R0502093
4226020X R0503154 4226020X R0602006 4226020X R0603725
4226020X R0702511 4226020X R0702690 4226020X R0702917
4226020X R0702975 4226020X R0703642 4226020X R0802274
4226020X R0802854 4226020X S0402220 4226020X S0802204
4226030S R0202786 4226030S S0602139 4226030X R0202787
4226030X R0302650 4226030X R0702700 4226030X R0702937
4226040S S0302319 4226040X R0103476 4226040X R0403827
4226040X R1102486 4226040X S0602111 4226515S R0402170
4226515S R0503379 4226515S R1002435 4226515X R0402171
4226515X R0503715 4226515X R0702512 4226515X R0802301
4226515X R0802855 4226520S R0402172 4226520X R0303203
4226520X R0402682 4226520X R0602007 4226520X R0702697
4226520X R1102487 4226530X R0402179 4226540X R0402174
4227015S R0402734 4227015S R0403621 4227015S R0502094
4227015S R0502501 4227015X R0203747 4227015X R0802304
4227015X S0602112 4227020S R0202154 4227020S R0402175
4227020S R0502548 4227020S R0602241 4227020S R0602595
4227020S S0102151 4227020X R0402176 4227020X R0402735
4227020X R0502095 4227020X R0602008 4227020X R0702699
4227020X R0702934 4227020X R0703246 4227020X R0802134
4227020X R0802302 4227020X R0802866 4227030S S0402222
4227030X R0402177 4227030X R0402760 4227040S R0402178
4227040S R0502096 4227040X R0503680 4227040X R0702936
4227040X R0802303 4227040X S0602113.
RECALLING FIRM/MANUFACTURER
Cordis Corporation, Miami Lakes, FL, by letters on September 26, 2003. Firm initiated recall is complete.
REASON
A packaging defect may compromise the device's sterility barrier.
VOLUME OF PRODUCT IN COMMERCE
39,726 devices.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
AMS TAPSYSTEM Model 2A Esophageal Pulse generator (used in the Operating Room at Hospitals). Recall # Z-0568-04.
CODE
THE FOLLOWING SERIAL NUMBERS ARE INVOLVED IN THE RECALL: 1031 1073 1120 1162 1210 1256 1296 1348 1401 1475 1033 1074 1121 1163 1211 1257 1297 1349 1403 1476 1034 1075 1122 1164 1212 1258 1298 1350 1404 1477 1035 1077 1124 1165 1213 1260 1304 1351 1407 1478 1037 1078 1127 1168 1214 1261 1305 1354 1408 1480 1038 1080 1128 1169 1216 1262 1306 1355 1409 1481 1039 1081 1129 1170 1217 1264 1307 1356 1410 1482 1041 1085 1130 1174 1218 1266 1308 1357 1411 1483 1042 1086 1131 1177 1220 1267 1309 1360 1412 1485 1046 1087 1132 1178 1221 1268 1310 1361 1413 1486 1047 1089 1133 1180 1222 1269 1311 1365 1414 1487 1048 1090 1134 1183 1223 1270 1314 1366 1415 1488 1049 1091 1136 1184 1224 1271 1319 1372 1416 1489 1050 1092 1137 1185 1225 1272 1320 1375 1417 1492 1051 1094 1138 1186 1226 1274 1324 1376 1418 1493 1052 1096 1139 1187 1228 1275 1325 1377 1420 1494 1053 1098 1140 1188 1229 1276 1326 1378 1421 1495 1054 1101 1141 1189 1231 1277 1328 1379 1422 1496 1056 1103 1142 1190 1232 1278 1329 1380 1423 1497 1057 1104 1143 1191 1233 1279 1330 1381 1436 1498 1058 1105 1144 1192 1234 1280 1331 1382 1444 1499 1059 1106 1146 1193 1235 1281 1332 1383 1445 1500 1060 1107 1147 1195 1236 1283 1333 1384 1459 1563 1061 1108 1154 1196 1238 1284 1335 1386 1460 1568 1063 1109 1155 1197 1242 1285 1337 1388 1462 1569 1064 1110 1156 1198 1243 1286 1338 1390 1465 1570 1066 1111 1157 1201 1244 1289 1339 1393 1466 1571 1068 1112 1158 1205 1248 1290 1340 1395 1467 1572 1069 1114 1159 1206 1250 1291 1341 1396 1472 1070 1116 1160 1208 1253 1292 1342 1398 1473 1071 1117 1161 1209 1255 1294 1347 1400 1474.
RECALLING FIRM/MANUFACTURER
Cardiocommand, Inc., Tampa, FL, by letter on October 31, 2003 and January 15, 2004. Firm initiated recall is ongoing.
REASON
The device may exhibit spurious heart rate increase during esophageal atrial pacing during simultaneous adjacent use of electrosurgical coagulation devices.
VOLUME OF PRODUCT IN COMMERCE
307 devices.
DISTRIBUTION
Nationwide, Canada, Hong Kong, and the Netherlands.

_______________________________
PRODUCT
PER-FIT Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube REF # 511080. Recall # Z-0569-04.
CODE
Lot Number K223373.
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc, Keene, NH, by telephone on December 12, 2003, and sales representative visits from December 12, 2003 through December 15, 2003. Firm initiated recall is ongoing.
REASON
Lid tray incorrectly labeled as Tube I.D.7.0mm instead of correct size 8.0mm.
VOLUME OF PRODUCT IN COMMERCE
30 cases (2/Case).
DISTRIBUTION
AZ, CA, CO, CT, FL, GA, IN, MA, NJ, NY, TN, TX, and WI.

_______________________________
PRODUCT
Template Needle, Series 17, 20 cm, with Threaded Female hub and Bent Stylet, Closed-End, Disposable. Packaged in single, 10, 15, 20 per package. Recall # Z-0570-04.
CODE
Lots F01068, F01099, F01100, and F01128.
RECALLING FIRM/MANUFACTURER
Alpha-Omega Services, Inc., Bellflower, CA, by fax and telephone on September 4, 2003. Firm initiated recall is complete.
REASON
Template needle may fracture leaving tip in patient.
VOLUME OF PRODUCT IN COMMERCE
1,290.
DISTRIBUTION
LA, MN, CA, VA, CO, TX, ID, NY, KS, and WA.

_______________________________
PRODUCT
a) Millex-GS Syringe Filter Unit 0.22 um, Sterile Catalog
Number: SLGSM33SS. Recall # Z-0573-04;
b) Millex-HA Syringe Driven Filter Unit, 0.45 um, Sterile
Catalog Number: SLHAM33SS. Recall # Z-0574-04;
c) Millex-AA Syringe Driven Filter 0.8 um, Sterile Catalog
Number: SLAAM33SS. Recall # Z-0575-04;
d) Millex GS- Syringe Filter 0.22um, Sterile Catalog
Number: SLGS033SS. Recall # Z-0576-04.
e) Millex HA Syringe Filter 0.45um, Sterile Catalog Number:
SLHA033SS. Recall # Z-0577-04.
CODE
a) Lot Number: F2PN86704;
b) Lot number: F2PN86705;
c) Lot Number: F2PN86703;
d) Lot Numbers: F2JN63560 F2KN78263 F2MN78127 F2NN78129
F2NN86699 F2PN69885 R3AN96873 R3AN96873Q R3AN97497
R3AN97497Q R3DN04753 R3DN04754 R3HN06269 R3HN06271
R3HN06272 R3HN89115 R3HN89117 R3JN94935 R3JN94936
R3JN94938 R3JN94940;
e) Lot Numbers: F2KN69893 F2MN78131 F2NN82062 F2PN78264
R3DN04757 R3DN04758 R3HN06273 R3HN06274 R3HN89112
R3HN89113 R3HN93120 R3JN17305 R3JN25568 R3JN93121
R3KN94945 R3MN58189.
RECALLING FIRM/MANUFACTURER
Millipore Corp., Bedford, MA, by letter on January 26, 2004. Firm initiated recall is ongoing.
REASON
Lack of assurance of sterility.
VOLUME OF PRODUCT IN COMMERCE
5,950 units.
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
a) 4-Way Tee with 2 one-way valves, Ref 395945 Lot***,
SINGLE USE ONLY, Qty 1 ea. Carton labeling was similar
to individual unit labeling, except for, ***Qty 50 ea.
Recall # Z-0578-04;
b) RFMD T-Piece With 2 one-way valves & tubing, Ref 395940,
Lot***, SINGLE USE ONLY, Qty 1 ea. Carton labeling was
similar to individual unit labeling, except for, ***Qty
50 ea. Recall # Z-0579-04;
c) One Way Valve/Male to Female Flow, 22 mm I.D./22 mm
O.D., Ref 396799, Lot ***, SINGLE USE ONLY, Latex Free,
Quantity 50 Each. Recall # Z-0580-04;
d) One Way Valve/Female to Male Flow, 22 mm I.D./22 mm
O.D., Ref 396798, Lot ***, SINGLE USE ONLY, Latex Free,
Quantity 50 Each. Recall Z-0581-04.
CODE
a) Lot numbers: 116040, 116039, 114795, 113887, 113886,
113232, 113230, 113095, 113027, 119110, 118134, 119988,
119989, 129179, 128393, 128028, 126119, 126118, 124951,
123197, 123198, 122461, 122033, 131793, 120731;
b) Lot numbers: 108273, 109600, 111314, 111229, 113984,
113932, 113931, 112991, 112514, 111588, 111589, 111558,
111557, 117867, 117866, 116471, 116163, 115616, 114992,
116865, 118714, 118055, 118054, 118053, 119421, 120628,
120521, 120021,120741, 120742, 122619, 122621, 122620,
123017, 123016, 123837, 126217, 125471, 125117, 124069,
126626, 126625, 127052, 127051, 128481, 128322, 127549,
127550, 129360, 129109, 129991, 130186, 130187;
c) Lot numbers: 010905, 011020, 020305, 020530, 020705,
020925, 030120, 031120, 030325, 030415;
d) Lot numbers: 020305, 010905, 020530, 020705, 020925,
021015, 021115, 030220, 030515, 030415, 030825, 030120.
RECALLING FIRM/MANUFACTURER
Rusch Inc., Duluth, GA, by letter and telephone on February 3, 2004. Firm initiated recall is ongoing.
REASON
Valve cap may become loose and enter the air circuitry.
VOLUME OF PRODUCT IN COMMERCE
539 units.
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
EPROM and Control Software (embedded), version 5.08, for the GammaMed 12i/t Afterloader. Recall # Z-0582-04.
CODE
Serial numbers (Domestic units): 724 215 765 210 212 217 218 214 767 213 743 706708 784 727 795 710 899 702 898 820 219 750 757 894 799 852 821 216 788 202 873 786 896 797 826 709 889 848.
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Charlottesville, VA, by letters on February 2, 2004. Firm initiated recall is ongoing.
REASON
Radiation treatment software could potentially cause a healthcare practitioner to apply incorrect treatment regimen to patients undergoing brachytherapy.
VOLUME OF PRODUCT IN COMMERCE
203.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) Baxter System 1000 Single Patient Hemodialysis Delivery
System; Model SYS1000; all series 1000 instruments
labeled as System 1000, AltraTouch 1000.
Recall # Z-0583-04;
b) Baxter Arena Hemodialysis Delivery System.
Recall # Z-0584-04.
CODE
a) Serial numbers 1001S to 1142S; 50001 to 52109; 01001 to
26231;
b) Serial numbers 300001 through 300147.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Renal Div., McGaw Park, IL, by letters dated February 20, 2004. Firm initiated recall is ongoing.
REASON
These devices have the potential to overheat in the absence of a Ground Fault Circuit Interrupter (GFCI). This heater system failure could result in a fire.
VOLUME OF PRODUCT IN COMMERCE
28,435 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) BD First PICC Introsyte-N, 1.9Fr. x 50cm Single Lumen
Procedure Kit. Catalog Number 384224. Recall Z-0586-04;
b) BD Introsyte-N Precision Introducer in 1.9Fr. Bulk,
Non-sterile. Catalog Number 380402. Recall # Z-0587-04.
CODE
a) Lot Number 3349840;
b) Lot Numbers 3356877, 3356485, 3352218.
RECALLING FIRM/MANUFACTURER
Becton Dickinson Infusion Therapy, Sandy, UT, by telephone and letter on February 3, 2004. Firm initiated recall is ongoing.
REASON
Splittable catheter introducer may not fully split or may separate non-uniformly.
VOLUME OF PRODUCT IN COMMERCE
1,560 kits, 12,000 bulk units.
DISTRIBUTION
Nationwide, Australia and Brazil.
 

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
Magnetic Resonance Imaging, System: Flexart, Visart and Excelart Models. Recall # Z-0546-04.
CODE
Flexart systems with software V3.51*R534 to V4.10*R551. Visart systems with software V3.51*R234 to V4.10*R251. Excelart systems with software V4.04*R251 to V4.10*R271.
RECALLING FIRM/MANUFACTURER
Toshiba American Med Sys., Inc., Tustin, CA, by letters on January 28, 2004. Firm initiated recall is ongoing.
REASON
Software anomally causes image slices to be in incorrect order.
VOLUME OF PRODUCT IN COMMERCE
24.
DISTRIBUTION
Nationwide and PR.

_______________________________
PRODUCT
Stayfuse brand intramedullary bone screw; MID 3.8x6 mm.
Zimmer part number 00-2227-003-001. Recall # Z-0561-04.
CODE
Lot 77097300.
RECALLING FIRM/MANUFACTURER
Pioneer Surgical Technology, Marquette, MI, by letter dated January 20, 2004. Firm initiated recall is ongoing.
REASON
Product labeled as size 3.8x6 mm implant may actually be size 4.3x6 mm implant.
VOLUME OF PRODUCT IN COMMERCE
318.
DISTRIBUTION
Nationwide, Australia, Canada, Germany and United Kingdom.

_______________________________
PRODUCT
Bardia® Complete Foley Kit, Single use only, Do not resterilize, For urological use only, Reorder: 800518, 18 Fr., Inflate with 10ml sterile water, Contents:

  • 5cc Silicone Elastomer-Coated Foley Catheter,
  • Waterproof underpad,
  • Synthetic Vinyl Gloves (2),
  • Lubricant,
  • 10cc Syringe (prefilled with sterile water to inflate Foley catheter),
  • Povidone-Iodine swabs (3),
  • CSR Wrap,
  • Plastic Tray. Catalog Number: 800518. Recall # Z-0562-04.

CODE
Lot Number: 76IN0317.
RECALLING FIRM/MANUFACTURER
C. R. Bard, Inc., Urological Division, Covington, GA, by letter on February 10, 2004. Firm initiated recall is ongoing.
REASON
The Foley trays contain a 16 French catheter instead of an 18 French catheter as specified by the product insert/labeling.
VOLUME OF PRODUCT IN COMMERCE
1,100 units (110 cases).
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Wallstent Rx Biliary Endoprosthesis with Unistep Plus
Delivery System 8 Fr, 10mm x 60mm, Catalog Number: 6965.
Recall # Z-0563-05.
CODE
Lot Number: 6023979.
RECALLING FIRM/MANUFACTURER
Boston Scientific Corporation, Natick, MA, by letter on January 28, 2004. Firm initiated recall is ongoing.
REASON
Incorrect label states stent covered with "Permalume Covering", product is uncovered.
VOLUME OF PRODUCT IN COMMERCE
12 units.
DISTRIBUTION
CA, GA, MD, NY, OR, ND, PA, and the Netherlands.

_______________________________
PRODUCT
a) Cordis Endomyocardial Biopsy Forceps 7F 104 cm Standard,
Product Number 504300L. Recall # Z-0564-04;
Cordis Biopsy Forceps 7F 104 cm Standard,
b) Product Number 504300L. Recall # Z-0564-04
CODE
a) and b) Lot Number 70403255.
RECALLING FIRM/MANUFACTURER
Cordis Corporation, Miami Lakes, FL, by Firm representatives visits the week of August 25, 2003, and by letters on August 29, 2003. Firm initiated recall is complete.
REASON
Some devices may have incorrect inner label which shows Product # 504302L with a length of 50cm, while the outer label is correctly labeled as Product # 504300L with the length of 104mm.
VOLUME OF PRODUCT IN COMMERCE
220.
DISTRIBUTION
Nationwide, Netherlands, Canada and Mexico.

_______________________________
PRODUCT
Portex Tracheal Tube Guide 15 Fr, non-sterile, Catalog Number: 153013. Recall # Z-0572-04.
CODE
Lot Number: K221961.
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc., Keene, NH., by letter dated January 26, 2004. Firm initiated recall is ongoing.
REASON
Tracheal tube guide mislabeled as a 15 Fr instead of a 10 Fr.
VOLUME OF PRODUCT IN COMMERCE
230 units.
DISTRIBUTION
CA, CO, FL, GA, IN, MA, MD, MI, NH, NC, NY, TX, and WA.

_______________________________
PRODUCT
Cruciform Slit Valve. Recall # Z-0585-04.
CODE
UbaV/V020/07-2003.
RECALLING FIRM/MANUFACTURER
Phoenix Biomedical, Norristown, PA, by letters on January 6, 2004. Firm initiated recall is complete.
REASON
Mislabeled: Product actually Single Valve.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
CA, and AZ.
 

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II

_______________________________
PRODUCT
a) Smell Tamers. Rawhide dog chews, for dogs under 20 lbs.
The product is sold in jars containing 100 pieces. The
Product is packaged as a display box containing 6 jars,
and shipped as either a display box, as individual
units, or as a 3 box combination display package (1 jar
of each size - item 68009). Recall # V-109-4;
b) Smell Tamers. Rawhide dog chews, for dogs 20-50 lbs.
The product is sold in jars containing 40 pieces.
The product is packaged as a display box containing 6
jars, and shipped as either a display box, as individual
units, or as a 3 box combination display package (1 jar
of each size - item 68009). Recall # V-110-4;
c) Smell Tamers. Rawhide dog chews, for dogs over 50 lbs.
The product is sold in jars containing 36 pieces.
The product is packaged as a display box containing 6
jars, and shipped as either a display box, as individual
units, or as a 3 box combination display package (1 jar
of each size - item 68009). Recall # V-111-4.
CODE
a) Item 68000;
b) Item 68020;
c) Item 68040.
RECALLING FIRM/MANUFACTURER
The Leathercraft Company, Inc., Conshohocken, PA, by recall notice dated August 21, 2003. FDA initiated recall is complete.
REASON
Product contains microorganism.
VOLUME OF PRODUCT IN COMMERCE
4,950 jars.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
BIODINE 110 TEAT Dip. Active Ingredient - Iodine 1%. Recall # V-112-4.
CODE
7-30-C.
RECALLING FIRM/MANUFACTURER
Artco Chemicals, Inc., Glenmont, NY, by telephone on August 29, 2003. Firm initiated recall is complete.
REASON
Product fails to meet potency specifications.
VOLUME OF PRODUCT IN COMMERCE
30/50-gallon drums and 25/5-gallon pails.
DISTRIBUTION
NY.

END OF ENFORCEMENT REPORT FOR MARCH 10, 2004

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