Sutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile, Rx only, Product Usage: Non-absorbable polypropylene surgical suture is a monofilament, Non-absorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation.
Recall
- Recall Number
- Z-1294-2014
- Event Number
- 67733
- Firm
- Teleflex Medical
- FEI Number
- 3005747797
- Product Code
- GAT
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- March 11, 2014
- Posted
- March 26, 2014
- Terminated
- August 15, 2017
- Address
- 2917 Weck Dr., Research Triangle Park, NC, 27709
Description
Sutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile, Rx only, Product Usage: Non-absorbable polypropylene surgical suture is a monofilament, Non-absorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation.
The products are being recalled because they did not meet minimum needle attachment strength requirements.
Teleflex sent an Urgent Medical Device Recall Notification letter dated March 11, 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to return all affected product to Teleflex Medical per the instructions provided in the letter. Customers were asked to complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service. For questions contact your local sales representative or Customer Service at 1-866-246-6990
Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland
Total 32,271 ea.