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U.S. Department of Health and Human Services

Safety

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Enforcement Report for February 1, 2006

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.

February 1, 2006
06-05

 RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

______________________________
PRODUCT
Oxygen Compressed USP, size M6, D, E, C, M, and MN cylinders, Recall # D-144-6
CODE
All lots
RECALLING FIRM/MANUFACTURER
Tri State Incorporated, Wauseon, OH, by visit on December 9, 2005. Firm initiated recall is ongoing.
REASON
cGMP deviations: FDA inspection of the recalling firm found that the Auto HP computerized filling system is not validated and there is no way to verify the automated vent and vacuum purge step during the prefill cycle.
VOLUME OF PRODUCT IN COMMERCE
359 cylinders
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

______________________________
PRODUCT
Tylenol Severe Sinus Congestion Caplets with Instant Coolburst Senstation, (Acetaminophen 325mg and Guaifenesin HCl 30mg), 48 caplets blister package, Daytime, Non-Drowsy, Recall # D-139-6
CODE
Lot number LCM138, Exp. 1/07
RECALLING FIRM/MANUFACTURER
McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil - PPC, Inc., Fort Washington, PA, by letter dated September 19, 2005. Firm initiated recall is ongoing.
REASON
Product intended for destruction due to preheater temperature (for foil backing) below validated range was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide

______________________________
PRODUCT
St. Joseph Enteric-coated Tablets, (Aspirin), 81mg, 180 count bottles, Recall # D-140-6
CODE
Lot number JPM036, Exp. 9/06
RECALLING FIRM/MANUFACTURER
McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil - PPC, Inc., Fort Washington, PA, by letter dated September 19, 2005. Firm initiated recall is ongoing.
REASON
cGMP Deviations; Product intended for destruction due to incorrect set up/filler slats and scales, resulting in short counts was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Children's Motrin Suspension, (Ibuprofen), in each 5mL 100mg, 1 fl oz (30mL) bottle, Grape Flavor, Pain Reliever/Fever Reducer, Recall # D-141-6
CODE
Lot number LDM026, Exp. 3/08
RECALLING FIRM/MANUFACTURER
McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil - PPC, Inc., Fort Washington, PA, by letter dated September 19, 2005. Firm initiated recall is ongoing.
REASON
Short Fill: Product intended for destruction was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Paclitaxel Injection, 30mg/5ml (6mg/mL), 5mL Multiple-Dose Vial, Must be Diluted Prior to IV Use, Rx only, NDC 55390-114-05, Recall # D-142-6
CODE
Lot number 779946, expiration date 03/07
RECALLING FIRM/MANUFACTURER
Bedford Laboratories, Bedford, OH, by letter, dated December 21, 2005. Firm initiated recall is ongoing.
REASON
Labeling Illegible: Unit carton may contain double embossing of the correct lot number and expiration date and an incorrect lot number and expiration date.
VOLUME OF PRODUCT IN COMMERCE
Approximately 1,592 vials
DISTRIBUTION
Nationwide and PR

______________________________
PRODUCT
Sterile Multiple-Dose Vial * Allergenic Extract * Box Elder * Acer Negundo * 1:10 W/V * Rx Only * Product is packed in Type 1 glass vials, stoppered with latex stoppers, and sealed with aluminum crimp caps, Recall # D-143-6
CODE
Item number 82A01, Lot number 34795, 1:10 W/V, 50 mL; Item number 82A03, Lot number 36613, 1:10 W/V, 10 mL and Item number 82A06, Lot number 36730, 20, 000 PNU/ mL 30 mL
RECALLING FIRM/MANUFACTURER
Greer Laboratories, Inc., Lenior, NC, by telephone on January 4, 2006 and by letter dated January 10, 2006. Firm initiated recall is ongoing.
REASON
Mislabeling: Products were labeled with an incorrect PNU value.
VOLUME OF PRODUCT IN COMMERCE
19 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Clindamycin Hydrochloride Capsules USP, 150mg, Rx only, NDC 0591-5708-01, Recall # D-145-6
CODE
P05F0323, P05G0332, P05G0333, and P05G0334
RECALLING FIRM/MANUFACTURER
Recalling Firm: Watson Laboratories, Inc., Corona, CA, by letter on December 9, 2005.
Manufacturer: Watson Laboratories, Inc., Humacao, PR. Firm initiated recall is ongoing.
REASON
Contamination: Four lots are being recalled due to a slight possibility of contamination with Trazadone.
VOLUME OF PRODUCT IN COMMERCE
38,825 bottles
DISTRIBUTION
Nationwide and PR

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I

______________________________
PRODUCT
Human Cornea Tissue, Recall # B-0342-6
CODE
05-026 OD and 05-026 OS
RECALLING FIRM/MANUFACTURER
Lions Eye Bank of NW Pennsylvania, Inc., Erie, PA, telephone on May 23, 2005, and by letters dated May 23, 2005, and May 31, 2005. Firm initiated recall is complete.
REASON
Human tissues for transplantation, procured from a donor who tested negative
for antibody to hepatitis C virus (anti-HCV), but was subsequently found to
have tested positive for the hepatitis C virus by NAT testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues
DISTRIBUTION
CA

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

_______________________________
PRODUCT
Source Plasma, Recall # B-0472-6
CODE
Units 04HPAA1043, SH050157, SH049896, SH049736, SH047954, SH047654, SH047480, SH047207, SH046991, SH046558, SH046303, SH046142, SH045838, SH045662, SH045383, SH045212, SH044926, SH044763, SH044533, SH043853, SH043573, SH043052, SH042630, SH042431, SH042199, SH041974, SH041714, SH041527, SH041217, SH041031, SH040751, SH040606, SH039804, SH039600, SH036973, SH036759, SH036462, SH036299, SH036043, SH035838, SH035576, SH035399, SH034633, SH034473, SH034204, SH034041, SH046760, SH039315, SH039137, SH038665, SH038420, SH037940, SH037419, SH035066, SH034881, SH033759, SH033564, SH038215, SH037721, SH037242, SH044322, SH044050, SH043355, SH042882, SH040288, SH040114
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Harrisburg, PA, by facsimile on July 27, 2005. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
66 units
DISTRIBUTION
NY, NC and France

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0477-6
CODE
Unit 8110973 (Part 1)
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH, by letter dated June 10, 2005. Firm initiated recall is complete.
REASON
Platelets Pheresis, with an unacceptably low volume, were distributed.      
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH

_______________________________
PRODUCT
Source Plasma, Recall # B-0563-6
CODE
Units VL184059, VL183751, VL182164, VL181886, VL181317, VL181149, VL180319, VL179796, VL179518, VL176982, VL176591, VL176228, VL175590, VL175153, VL174861, VL174286, VL174073, VL170195, VL169583, VL169286, VL167285, VL200343, VL200226, VL199778, VL199469, VL199224, VL198934, VL198609, VL198357, VL198057, VL197871, VL197530, VL197334, VL196997, VL196793, VL196097, VL195468, VL195243, VL193527, VL193313, VL192741, VL192495, VL192019, VL191805, VL184793, VL184535, VL167105, VL166766, VL166601, VL166213, VL165995, VL165675, VL165519
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services LP, Shreveport, LA, by facsimile dated May 20, 2004. Firm initiated recall is complete.
REASON
Source Plasma, collected from a previously deferred donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
53 units
DISTRIBUTION
NC

_______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0570-6
CODE
Unit 6869278
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ, by telephone on January 10, 2005. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of clotted Red Cells, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NH

_______________________________
PRODUCT
Source Plasma, Recall # B-0584-6
CODE
Units VL53767, ZZ031076, ZZ030881, ZZ03046, VL151413, VL151144, VL50837
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services LP, Shreveport, LA, by facsimile dated October 6, 2003. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor who was at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
NC

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

_______________________________
PRODUCT
Platelets, Recall # B-0478-6
CODE
Units 6726297, 1310306       
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH, by letter dated June 10, 2005. Firm initiated recall is complete.
REASON
Blood products, which were stored at unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH

_______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Irradiated, Recall # B-0496-6
CODE
Units 06KY04410
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southern California Region, Pomona, CA, by telephone on October 5, 2004, and by letter dated October 7, 2004. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with microorganisms, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0553-6
CODE
Unit 1021687
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, UC Medical Center, Cincinnati, OH, by letter dated May 19, 2005. Firm initiated recall is complete.
REASON
Red Cells, mislabeled as to S antigen phenotype, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY

_______________________________
PRODUCT
Platelets, Pheresis Leukocytes Reduced, Recall # B-0571-6
CODE
Unit GS39156
RECALLING FIRM/MANUFACTURER
Blood Bank of San Bernardino and Riverside Counties, San Bernardino, CA, by letter dated June 30, 2004. Firm initiated recall is complete.
REASON
Platelets, mislabeled as to volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

_______________________________
PRODUCT
Source Plasma, Recall # B-0611-6
CODE
Unit SA128214
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, San Diego, CA, by facsimile on April 22, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documentation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

 RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

_______________________________
PRODUCT
a) GE Millennium Systems: MC, MyoSight.
Dual Head Gamma Camera. A compact
cardiac-optimized nulear imaging system.
It is comprised of 2 digital CSE (Coorelated
Signal Enhancement) detectors in variable
geometries mounted on a pass-through ring
gantry, a compact imaging table, and a GENIE
Acquisition station. Recall # Z-0413-06;
b) GE Millennium Systems: MG. Multi-Geometry
Digital CSE Dual Detector Gamma Camera.
A modular nuclear medicine imaging system.
The MG gantry allows the detectors to be
oriented in the 180-degree and 101.25-degree
orientations. The other modular core components
include a 3-axis universal imaging table, a
GENIE Acquistion station, dual Digital CSE
(Correlated Signal Enhancement) detectors and
high-performance collimators. Features optional
real-time body-contoured SPECT and whole body
scans, as well as ACuscan, an optional
transmission attenuation correction system for
SPeC and Gated SPECT scans. Recall # Z-0414-06;
c) GE Millennium Systems: MPR and MPS Digital
CSE Single Detector Gamma Camera. This system
is a multi-purpose single-head nuclear medicine
imaging system, comprised of a Digital CSE
(Correlated Signal Enhancement) multi-purpose
square detector, a pass-through counter-balanced
ring gantry, a SPECT-optimized imaging table,
and a collimator cart. Recall # Z-0415-06
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: General Electric Medical Systems LLC, Waukesha, WI, by letter on April 18, 2005.
Manufacturer: General Electric Medical Systems F.I. Haifa, Tirat Hacarmel, Israel. Firm initiated recall is ongoing.
REASON
In certain cases, one of the four collimator locking mechanisms that attach the collimator to the head may work itself free if collimator exchange has not been performed for an extended period of time. This situation, if neglected, could eventually cause the locking mechanism to unlock itself.
VOLUME OF PRODUCT IN COMMERCE
1,421 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) Roche brand Accu-Chek Aviva Care Kit;
Catalog number 04528280001. (Distributed
within the U.S.), Recall # Z-0417-06;
b) Roche brand Accu-Chek Aviva Meter Only Kit;
Catalog number 04532279001. (Distributed
within the U.S.), Recall # Z-0418-06;
c) Roche brand Accu-Chek Aviva Bonus Pack;
Catalog number 04528247001. (Distributed
within the U.S.), Recall # Z-0419-06;
d) Roche brand Accu-Chek Aviva Retail
Distributor Pack; Catalog number 04578198001.
(Distributed within the U.S.),
Recall # Z-0420-06;
e) Roche brand Accu-Chek Aviva Bonus Pack
Display; Catalog number 045659066001.
(Distributed within the U.S.)
Recall # Z-0421-06;
f) Roche brand Accu-Chek Aviva Pediatrics Kit;
Catalog number 04593839001. (Distributed
within the U.S.) Recall # Z-0422-06;
g) Roche brand Accu-Chek Aviva Meter (mg/dL);
Catalog number 03532275001. (Distributed
within the U.S.) Recall # Z-0423-06;
h) Roche brand Accu-Chek Aviva Care Kit;
Catalog number 04422058170; - Canada
Catalog number 04422058164; - Nordics
Catalog number 04422040170. (Distributed
outside of the U.S.) Recall # Z-0424-06;
i) Roche brand Accu-Chek Aviva Meter (mg/dL);
Catalog number 03532356001. (Distributed
outside of the U.S.) Recall # Z-0425-06;
j) Roche brand Accu-Chek Aviva Meter (mmol/L);
Catalog numbers 03532313001 and 03532321001.
(Distributed outside of the U.S.)
Recall # Z-0426-06
CODE
a), b), c), d),e), f), g), Aviva meter serial
numbers 52500000000 through 52510999999;
h), i) and j) Aviva meter serial numbers
52600000000 through 52610999999, 52700000000
through 52710999999 and 52800000000 through
52810999999
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letters dated November 9, 2005 and press release issued on January 17, 2006.
Manufacturer: Sanmina SCI, Huntsville, AL. Firm initiated recall is ongoing.
REASON
Incorrect patient blood glucose test results may be reported due to a software problem.
VOLUME OF PRODUCT IN COMMERCE
1,143,155 meters
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Flexible Support Arm Assembly. Breathing Tube Support. Catalog number BE 122-30, Recall # Z-0427-06
CODE
Lot numbers PO902505 and PO900805
RECALLING FIRM/MANUFACTURER
Instrumentation Industries, Inc., Bethel Park, PA, by telephone on October 14 and 17, 2005 and by letters on October 17 and 18, 2005. Firm initiated recall is ongoing.
REASON
Potential for the flexible tube portion of the assembly to become brittle and break.
VOLUME OF PRODUCT IN COMMERCE
22 units
DISTRIBUTION
FL, NY, and WV

______________________________
PRODUCT
a) The AIRIS MR System is an imaging device
and is intended to provide the physician
with physiological and clinical information,
obtained non invasively and without the use
of ionizing radiation. The MR system produces
transverse, coronal, sagital, oblique, and
curved cross-sectional images that display
the internal structure of the head, body, and
extremities. The images produced by the MR
system reflect the spatial distribution of
protons (hydrogen nuclei) exhibiting magnetic
resonance. The NMR properties that determine
the image appearance and proton density,
spin-lattice relaxation time (T1) and
spin-spin relaxation time (T2) and flow.
When interpreted by a trained physician,
these images provide information that can be
useful in diagnosis determination. Recall
# Z-0428-06;
b) The AIRIS II MR System is an imaging device
and is intended to provide the physician with
physiological and clinical information, obtained
non invasively and without the use of ionizing
radiation. The MR system produces transverse,
coronal, sagital, oblique, and curved cross-
sectional images that display the internal
structure of the head, body, and extremities.
The images produced by the MR system reflect
the spatial distribution of protons (hydrogen
nuclei) exhibiting magnetic resonance. The NMR
properties that determine the image appearance
and proton density, spin-lattice relaxation time
(T1) and spin-spin relaxation time (T2) and flow.
When interpreted by a trained physician, these
images provide information that can be useful in
diagnosis determination. Recall # Z-0429-06
CODE
a) Serial numbers A305 thru A341;
b) Serial numbers C048 thru C788
RECALLING FIRM/MANUFACTURER
Hitachi Medical Systems America, Inc., Twinsburg, OH, by letter, dated December 1, 2005. Firm initiated recall is ongoing.
REASON
The bolts holding the lift mechanism may be damaged causing them to fail and the table top to drop several inches.
VOLUME OF PRODUCT IN COMMERCE
702 devices
DISTRIBUTION
Nationwide, PR, and Virgin Islands

______________________________
PRODUCT
BDT PhoenixSpecT Calibrator Kit, consisting of 3 tubes identified as 0.25, 1.0 and 4.0 McFarland unit calibrators, Recall # Z-0430-06
CODE
Lot 5075281 Exp 2/14/06*** Lot 5115146 Exp 2/14/06
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Co., Sparks, MD, by telephone, fax and email on December 1, 2005.
Manufacturer: GFS Chemicals Inc., Columbus, OH. Firm initiated recall is ongoing.
REASON
A calibrator for an in vitro diagnostic kit is not standarized correctly and may cause a calibration error when measuring microbiological cultures for turbidity.
VOLUME OF PRODUCT IN COMMERCE
145 kits
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
LifeScan One Touch Ultra Test strips, part number 020-245-07, Recall # Z-0435-06
CODE
Lot number 2528640, Expiration date April 2006
RECALLING FIRM/MANUFACTURER
Lifescan, Inc., Milpitas, CA, by letter on November 21, 2005. Firm initiated recall is ongoing.
REASON
Product may be defective and may give low inaccurate glucose results.
VOLUME OF PRODUCT IN COMMERCE
29,284 vials (7,321 boxes of 100 count test strips)
DISTRIBUTION
CA, PA, IL, WI, MN, SD, OK, CO, MA, MI

______________________________
PRODUCT
Smiths Pneupac babyPAC portable ventilator, model 100. Designed for use by qualified medical caregivers, paramedics and other trained personnel, for hospital, emergency and transport ventilation of patients during respiratory distress or insufficiency. Recall # Z-0436-06
CODE
0504244, 0505158, 0506211, 0506218, 0506242, 0506248, 0506254, 0506265, 0506283, 0506289, 0506321, 0506346, 0506358, 0507127, 0507139, 0507234, 0507235, 0507236, 0507248, 0507249, 0507265, 0508173, 0508174, 0508195, 0508196, 0508197, 504227, 504254, 505139, 505142, 505145, 505257, 505271, 505276, 505286, 506155, 506158, 506169, 506171, 506194, 506233, 506241, 506343, 507317
RECALLING FIRM/MANUFACTURER
Smiths Medical PM, Inc., Waukesha, WI, by a Safety Action Bulletin, number 05-SAB05, dated 12/05/05. Firm initiated recall is ongoing.
REASON
A potential safety related problem associated with the Pnuepac babyPac Ventilator model 100 has been discovered in that the interface between the air input hose and the air input fitting may leak, and if tightened too much, the air input fitting may loosen when trying to remove the air hose.
VOLUME OF PRODUCT IN COMMERCE
44 devices
DISTRIBUTION
CA, CO, IN, MN, NY, PA, TN, and TX
__________________________
PRODUCT
Panorama Patient Monitoring Network, Cardiac Arrhythmia Monitor, Recall # Z-0437-06
CODE
All Panorama Central Station containing software versions 8.1.6 through 8.2
RECALLING FIRM/MANUFACTURER
Datascope Corp., Mahwah, NJ, by letters on December 7, 2005. Firm initiated recall is ongoing.
REASON
Software anomaly that affects the Panorama Telepack where if communications are lost during standby, certain alarms which appear set could be actually off.
VOLUME OF PRODUCT IN COMMERCE
110 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
a) Arcadic Orbic Mobile X-Ray System, model
number 8081080, Recall # Z-0438-06;
b) Arcadis Varic Mobile X-Ray System, model
number 8080017, Recall # Z-0439-06
CODE
All units
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on December 12, 2005.
Manufacturer: Siemens Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing.
REASON
Patient information can be stored in another patient's file.
VOLUME OF PRODUCT IN COMMERCE
179 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Primus Biliary Stent and Delivery System. Balloon Expandable Stent and Delivery System. Rx only. Model BXB35-07-27-75, Recall # Z-0442-06
CODE
Lot no. 923291, 923290
RECALLING FIRM/MANUFACTURER
Ev3, Inc., Plymouth, MN, by letter on August 1, 2005. Firm initiated recall is complete.
REASON
A Primus device was labeled as a BXB 35 09-37-75 but contained a BXB35 07-27-75 stent.
VOLUME OF PRODUCT IN COMMERCE
18 devices
DISTRIBUTION
AL, AZ, FL, KS, LA, MS, NC, NE, NY, TX

_______________________________
PRODUCT
BMT PhoenixSpecT Nephelometer, Catalog # 440910. Recall # Z-0443-06
CODE
All codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Co., Sparks, MD, by letter on January 17, 2006.
Manufacturer: Hach Chemical Company, Loveland, CO. Firm initiated recall is ongoing.
REASON
A operator's manual for a diagnostic test kit is incorrect and may cause inaccurate results for bacterial identification and antibiotic susceptibility in patient samples.
VOLUME OF PRODUCT IN COMMERCE
488 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
Depuy Mitek Fastin RC Anchor with Panacryl (2) strands Size 2 Panacryl Poly ***braided absorbable suture Reference Number: 222740, Recall # Z-0446-06
CODE
Lot Number:1270449
RECALLING FIRM/MANUFACTURER
Recalling Firm: Depuy Mitek, a Johnson & Johnson Co., Raynham, MA, by letter on October 27, 2005.
Manufacturer: Ethicon SARL, Neuchatel, Switzerland. Firm initiated recall is complete.
REASON
The device may contain one strand of suture instead of two strands.
VOLUME OF PRODUCT IN COMMERCE
19 boxes (5 pieces/box)
DISTRIBUTION
CA, IA, FL, MI, MO, OR, TX, Australia, Brazil, and Sweden

_______________________________
PRODUCT
a) Wahl 2-Speed All-Body Massager,
model 4120-1; therapeutic massager;
made in China; Please note: Wahl sells
these massagers under other model numbers
based on the packaging configuration.
All packages contain the model 4120-1
massager, with various attachments.
These package models include 4120-200
and 4120-217, Recall # Z-0447-06;
b) Wahl 2-Speed All-Body Massager with Heat
and Discovery Channel brand 8-Way Massager
with Heat, model 4196-1; therapeutic
massager; made in China; Please note:
Wahl sells these massagers under other
model numbers based on the packaging
configuration. All packages contain the
model 4196-1 massager, with various
attachments. These package models include
4196-500, 4196-517 and 4196-519,
Recall # Z-0448-06
CODE
All units with a white electrical cord
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wahl Clipper Corporation, Sterling, IL, by letters dated October 31, 2005.
Manufacturer: Wahl Clipper Ningbo Ltd, Zhejiang, China. Firm initiated recall is ongoing.
REASON
The massager may develop a crack in the cord insulation where it exits out of the strain relief. A crack in the insulation may expose live conductors resulting in a possible electric shock and injury to the user.
VOLUME OF PRODUCT IN COMMERCE
112,414 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
PROCEED Surgical Mesh is a sterile, thin, flexible laminate mesh designed for the repair of hernias and other fascial deficiencies. The mesh product is comprised of an oxidized regenerated cellulose (ORC) fabric, and PROLENE Soft Mesh, a nonabsorbable polypropylene mesh, which is encapsulated by a polydioxanone polymer. The polypropylene mesh side of the product allows for tissue ingrowth while the ORC side provides a bioresorbable layer that physically separates the polypropylene mesh from underlying tissue and organ surfaces during the wound-healing period to minimize tissue attachment to the mesh. The polydioxanone provides a bond to the ORC layer. Recall # Z-0449-06
CODE
Product Code -- Lot:
PCDD1-- UHG068; UJG096; UJG110; UJG131; UJG149; UKG264; ULG335; ULG316; ULG313; ULG342; ULG374; ULG385; ULG409; UMG490; UMG492;
PCDM1-- UJG078; UJG082; UJG085; UJG087; UJG109; ULG103; ULG101; ULG095; ULG125; UJG128; ULG139; UJG142; UKG184; UKG183; UKG181; UKG175; UKG161; UKG187; UKG203; UKG201; UEG883; UKG231; UKG239; UKG241; UKG279; UKG253; UKG250; UKG243; UKG267; UKG266; UKG256; ULG309; ULG287; ULG328; ULG311; ULG370; ULG369; ULG340; ULG337; ULG393; ULG399; ULG400; ULG373; ULG401; ULG405; UMG424; UMG425; UMG426; UMG448; UMG449; UMG479; UMG478; UMG477; UMG473; UMG450; UMG504; UMG486;
PCDN1-- UHG056; UHG059; UHG072; UHG054; UJG075; UJG077; UJG088; UJG092; UJG099; UJG107; UJG134; UJG129; UJG122; UJG144; UJG154; UJG156; UJG160; UKG176; UKG170; UKG169; UKG166; UKG177; UKG190; UKG198; UKG215; UKG213; UKG220; UKG222; UKG225; UKG233; UKG248; UKG260; ULG308; ULG305; ULG289; ULG285; ULG281; ULG278; ULG272; ULG271; ULG269; ULG331; ULG321; ULG317; ULG315; ULG344; ULG343; ULG346; ULG352; ULG371; ULG368; ULG365; ULG361; ULG359; ULG341; ULG390; ULG392; ULG394; ULG396; UMG432; UMG427; ULG413; UMG438; UMG445; UMG472; UMG471; UMG459; UMG456; UMG455; UMG476; UMG493; UMG505; UMG509;
PCDL1-- UMG489; UMG483; UMG468; UMG451; UMG431; ULG408; UMG429; UMG430; ULG398; ULG397; ULG381; ULG339; ULG354; ULG355; ULG306; ULG319; ULG332; ULG193; ULG298; ULG279; ULG275; UKG255; UKG229; UKG227; UKG226; UKG168; UKG173; UKG178; UJG117; UJG094; UHG053; UHG069; UJG080; UHG060; UJG073;
PCDH1-- UMG475; UMG481; UMG494; UMG436; UMG437; UMG454; UMG458; UMG457; UMG423; UMG433; UMG414; UMG415; ULG375; ULG376; ULG377; ULG391; ULG406; ULG372; ULG349; ULG348; ULG336; ULG327; ULG310; ULG304; ULG300; ULG288; ULG276; UKG265; UKG252; UKG218; UKG219; UKG230; UKG217; UKG205; UKG204; UKG186; UKG174; UKG167; UKG163; UJG157; UJG145; UJG143; UJG141; UJG127; UJG100; UJG098; UJG115; UJG114; UJG108; UJG084;
PCDB1-- ULG323; ULG296; UEG886; UEG884; UJG116; UJG108; UJG104; UJG089; UJG079; UHG065; UJG076; UHG067; ULG296; UEG884; UEG886; UJG116; UJG104; UJG106; UJG089; UJG079; UHG065; UJG076; UHG067; ULG296; UEG884; UEG886; UJG116; UJG104; UJG106; UJG089; UJG079; UHG065; UJG076; UHG067; ULG323; ULG296; UEG884; UEG886; UJG116; UJG104; UJG106; UJG079; UJG089; UHG065; UJG076; UHG067;
PCDG1-- UMG482; UMG498; UMG499; UMG500; UMG441; UMG469; UMG470; UMG442; UMG447; UMG446; ULG402; UMG416; UMG419; UMG420; UMG421; UMG422; ULG384; ULG386; ULG387; ULG395; ULG356; ULG366; ULG367; ULG338; ULG329; ULG326; ULG325; ULG274; ULG334; ULG307; ULG299; ULG294; ULG288; ULG284; ULG283; UKG258; UKG259; UKG263; ULG277; UEG885; UKG234; UKG244; UKG245; UKG254; UKG196; UKG210; UKG197; UKG191; UKG193; UKG162; UKG179; UKG180; UJG146; UJG148; UJG153; UJG159; UJG132; UJG130; UJG124; UJG121; UJG105; UJG113; UJG091; UJG086; UJG083; UHG012; UHG063; UHG061; UHG047; UHG071; UHG064; UHG058; UHG055;
PCDT1-- UMG488; UMG485; UMG491; UMG452; UMG453; UMG435; ULG407; ULG410; UMG417; UMG428; UMG434; ULG363; ULG364; ULG389; ULG345; ULG357; ULG358; ULG291; ULG273; UKG257; UKG236; UKG221; UKG208; UKG209; UKG192; UKG171; UJG137; UJG111; UJG074; UHG057; UHG051;
PCDR1-- UMG487; UMG502; UMG474; UMG480; ULG333; ULG347; ULG301; ULG290; ULG282; UKG228; UKG237; UKG240; UKG195; UKG172; UJG147; UJG150; UJG140; UJG138; UJG136; UJG123; UJG102; UJG093; UJG090; UHG070; UHG062; UHG046; UHG052;
PCDW1-- UMG495; UMG496; UMG444; UMG443; ULG412; UMG418; ULG378; ULG388; ULG380; ULG379; ULG360; ULG320; ULG297; ULG292; ULG280; UKG261; UKG251; UKG247; UKG189; UEG887; UKG206; UKG202; UKG188; UJG120; UJG151; UJG133; UHG029; PCDJ1-- UMG484; UMG497; UMG439; UMG440; ULG383; ULG382; ULG403; ULG404; ULG362; ULG353; ULG350; ULG351; ULG330; ULG314; ULG312; UKG238; ULG303; ULG318; ULG270; ULG268; UKG262; UKG246; UKG235; UKG232; UKG199; UKG212; UKG211; UKG200; UKG199; UKG185; UKG194; UKG182; UKG165; UKG164; UJG155; UJG152; UJG119; UJG165; UJG118; UJG112; UJG097; UJG081; UHG066.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ethicon, Inc., Somerville, NJ, by letter on January 4, 2006.
Manufacturer: Ethicon, Inc., Cornelia, GA. Firm initiated recall is ongoing.
REASON
Lots of Proceed Surgical Mesh may delaminate from the polypropylene mesh during certain hernia repairs. Exposure of the polypropylene layer to the bowel prior to reperitonealization could increase the risk of adhesions and bowel fistulization.
VOLUME OF PRODUCT IN COMMERCE
18,270 devices
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

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PRODUCT
Vysis LSI p16 (9p21)/CEP 9 (9p11-q11) Dual Color Probe Set; a locus specific identifier DNA probe consisting of a mixture of the LSI p16 probe labeled with a SpectrumOrange and the CEP 9 probe labeled with a SpectrumGreen fluorophore, accompanied with LSI/WCP Hybridization Buffer; 20 evaluations; order number 32-190078, Recall # Z-0416-06
CODE
Lots 42919, 45942, 53417, 57026, 59938, 60858
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Molecular, Des Plaines, IL, by letters on October 28, 2005.
Manufacturer: Vysis Inc., Downers Grove, IL. Firm initiated recall is ongoing.
REASON
The DNA-Probe has a target size of ~300 Kb region instead of the labeled ~190 Kb region.
VOLUME OF PRODUCT IN COMMERCE
741 sets
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
Selector Ultrasonic Integra Ultrasonic Aspirator System, Selector 24kHz Microsurgical Sterile Tip Set. Recall # Z-0431-06
CODE
Lot 050678 and Lot 050575
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integra LifeSciences Corpoation, Plainsboro, NJ, by letters on November 28, 2005. Manufacturer: Integra Neurosciences Ltd., Andover, United Kingdom. Firm initiated recall is ongoing.
REASON
Additional Model 24kHz Tip Sets were inadvertently packaged with the incorrect 35kHz Neuro Flues.
VOLUME OF PRODUCT IN COMMERCE
536 units
DISTRIBUTION
Nationwide

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PRODUCT
a) Mach 1 6F Kimny Guide Catheter. Catalog No.
34356-583. Sterilized with ethylene oxide gas.
Nonpyrogenic. Intended for one procedure use
only. Product UPN H749343565830,
Recall # Z-0432-06;
b) Mach 1 6F JR 3.5 Guide Catheter. Catalog No.
34356-685. Sterilized with ethylene oxide gas.
Nonpyrogenic. Intended for one procedure use
only. Product UPN H749343566850,
Recall # Z-0433-06
CODE
a) Lot # 6287514;
b) Lot # 6287583
RECALLING FIRM/MANUFACTURER
Boston Scientific Scimed, Maple Grove, MN, by letter on May 28, 2005. Firm initiated recall is complete.
REASON
Some Mach 1 6F Coronary Guide Catheter could be mislabeled in that a few units labeled as Mach 1 6F Kimny Curve style, could contain a Mach 1 6F JR 3.5 curve style and a few units labeled as Mach 1 6F JR 3.5 curve style, could contain a Mach 1 6F Kimny curve style.
VOLUME OF PRODUCT IN COMMERCE
20 units
DISTRIBUTION
GA, MS, NC, TN, and Internationally

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PRODUCT
Access Surgical International Reposable Metzenbaum Scissor Tips (5 EA 125382A) Non-sterile, Reusable Stainless Steel Surgical Instrument Part Number: 125382A, Recall # Z-0434-06
CODE
Lot number: 305
RECALLING FIRM/MANUFACTURER
Tnco, Inc., Whitman, MA, by telephone and letter on January 2, 2006. Firm initiated recall is ongoing.
REASON
The tip may not engage with the handle and may dislodge.
VOLUME OF PRODUCT IN COMMERCE
185 units
DISTRIBUTION
CA, CT, DC, IL, IN, FL. GA, NC, NY, UT Canada

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PRODUCT
Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. Catalog No. 38948-8607. Sterile. The Sentinol Nitinol Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy(nitinol). The stent is constrained within a 6F delivery system. The delivery system is of coaxial design with an exterior shaft to protect and constrain the stent prior to deployment. An inner shaft, with two radiopaque markers, aids in the placement of the stent. The delivery system is compatible with 0.035 in. (0.89mm) guidewires. When ready to be implanted, the stent is deployed by retracting the exterior shaft of the delivery system. As the stent is exposed to body temperature it expands to appose the duct wall. UPN # H7493894886070, Recall # Z-0440-06
CODE
Lot number: 6412353
RECALLING FIRM/MANUFACTURER
Boston Scientific Scimed, Maple Grove, MN, by letter on May 14, 2004. Firm initiated recall is complete.
REASON
One lot of one catalog number of the Sentinol Nitinol Biliary Stent System may have been packaged in a Sentinol nitinol Vascular outer carton. The product, pouch label and carton label are all correct and the correct DFU is in the package.
VOLUME OF PRODUCT IN COMMERCE
20 units
DISTRIBUTION
Nationwide and Internationally
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PRODUCT
SGD-12-70 Savary-Gilliard Dilator - Diameter: 12MM./36 FR. Length: 70 CM Reusable, Recall # Z-0441-06
CODE
Lot number: W2048624
RECALLING FIRM/MANUFACTURER
Cook Endoscopy, Winston Salem, NC, by letter on January 5, 2006. Firm initiated recall is ongoing.
REASON
The dilator size does not match the label on the product and product packaging.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
Canada and Australia

END OF ENFORCEMENT REPORT FOR FEBRUARY 1, 2006

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