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U.S. Department of Health and Human Services

Class 3 Device Recall RUSCH Foley Insertion Tray

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  Class 3 Device Recall RUSCH Foley Insertion Tray see related information
Date Initiated by Firm July 10, 2014
Date Posted August 06, 2014
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = ORION LIFE SYSTEMS, INC.
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