Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Triangle Park, NC USA Assembled in Mexico. Indicated for use in soft tissue approximation.
This recall has been terminated (originally issued May 7, 2014).
- Company
- Teleflex Medical
- Recall Initiated
- March 11, 2014
- Posted
- May 7, 2014
- Terminated
- August 14, 2017
- Recall Number
- Z-1559-2014
- Quantity
- 32,271 ea.
- Firm Location
- Durham, NC
- Official Source
- View on FDA website ↗
Reason for Recall
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
Distribution
Worldwide Distribution -- USA, including the states of AL, CA, FL, GA, IL, IN, KS, LA, ME, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, PA, RI, SC, TN, TX, UT, VA, WV, and WI; and countries of Canada, Germany, and Ireland.
Lot / Code Info
Product Code H5300 - Lot 1450153E13
Root Cause
Employee error
Action Taken
Urgent Medical Device Recall Notification letters were issued on March 11, 2014 to consignees. The letter requested that customers discontinue use and quarantine any product on hand. The attached Recall Acknowledgment Form should be completed and returned to Teleflex regardless of whether affected product is on hand or not. Once received a customer service representative will contact customers with instructions on how to return the affected product. Questions should be directed to Customer Service at 1-866-246-6990.