Class 3 Device Recall RUSCH Foley Insertion Tray

• Date Initiated by Firm: July 10, 2014
• Date Posted: August 06, 2014
• Recall Status: Terminated on November 25, 2015
• Recall Number: Z-2154-2014
• Recall Event ID: 68746
• 510(K)Number: K901185
• Product Classification: Urinary Catheter insertion kit - Product Code FCM
• Product: RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product Code: 76730.
• Code Information: Product Code: 76730, Lot number: 307505.
• Recalling Firm/ Manufacturer: Teleflex Medical; 4024 Stirrup Creek Dr; Durham NC 27703-9000
• For Additional Information Contact: Michael T. Taggart; 919-433-4940
• Manufacturer Reason for Recall: Labeling error: The manufacturing date is the same as the expiration date. The manufacturing date is correct, however the expiration date incorrectly indicates that the product is expired.
• FDA Determined Cause: Process control
• Action: Consignees were notified via letter on/about 07/10/2014.
• Quantity in Commerce: 720
• Distribution: Nationwide distribution in CA, CT, FL, MA, MO, NJ, OH, OR and TX.
• 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.

• 510(K) Database: 510(K)s with Product Code = FCM