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U.S. Department of Health and Human Services

Class 3 Device Recall TAUT, Cholangiogram Catheter Intraducer

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 Class 3 Recall
TAUT, Cholangiogram Catheter Intraducer
see related information
Date Posted August 10, 2012
Recall Status1 Open
Recall Number Z-2186-2012
Recall Event ID 62598
Product Classification Catheter, Peritoneal - Product Code GBW
Product TAUT, Cholangiogram Catheter Intraducer, Peritoneal Catheter, Teleflex Medical, Research Triangle Park, NC. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body.
Code Information Catalog number: PI-128, Lot number: 01C200424, 01C1200425 and 01C1200426.
Recalling Firm/
Manufacturer
Teleflex Medical
2917 Weck Dr.
Research Triangle Park, North Carolina 27709
For Additional Information Contact Michael Taggart
919-433-4940
Manufacturer Reason
for Recall
Product is missing the label on the internal packaging.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action Consignees were notified by letter on 07/20/2012.
Quantity in Commerce 611 units
Distribution AK, AL, AZ, CA, CO, FL, GA, IA, IL, IN, KS, LA, MA, MI, MO, MS, NC, NY, OH, PA, SD, TX, UT, VA, WI, WV.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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