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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 Device Recall TAUT, Cholangiogram Catheter Intraducer see related information
Date Initiated by Firm July 20, 2012
Date Posted August 10, 2012
Recall Status1 Terminated 3 on February 12, 2015
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 NC 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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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