Class 3 Device Recall TAUT, Cholangiogram Catheter Intraducer

• Date Initiated by Firm: July 20, 2012
• Date Posted: August 10, 2012
• Recall Status: Terminated 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: 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.