Recall Z-1292-2014
Teleflex Medical · initiated March 11, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Sutures, Non-absorbable, Synthetic, Polyethylene, Sterile, Rx only, Product Usage: Non-absorbable poly(ethylene terephthalate) surgical suture is a multifilament, non-absorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation.
Codes / lots: Product Code: 0100019-507, Lot number: 02F1301128; Product Code: 6-511, Lot number: 02M0800561; Product Code: 6-559, Lot number: 02A0800005; Product Code: 69-403, Lot number: 02H0802530; Product Code: 7-5008M4, Lot number: 02C0900466; Product Code: 7-518, Lot number: 02E1302561; Product Code: 7-565, Lot number: 02B1100185; Product Code: 7-655A, Lot numbers: 02C0901963 & 02M0800836; Product Code: 7-740, Lot number: 02L1000536; Product Code: 833-114, Lot numbers: 02A1202112, 02C0903374 & 02D1202794; Product Code: 02F0902697, 02K1100404, 02L1202369 & 02M0802509; Product Code: E13-6351, Lot number: 02F0902446; Product Code: E13-6354, Lot number: 02F0902439; Product Code: E13-6399, Lot number: 02F0902436; Product Code: E6-545, Lot number: 02F0902443; Product Code: E7-4578, ot number: 02D0901672; Product Code: H5300, Lot number: 1450153E13; Product Code: RN6-5106M5, Lot number: 02F1003837; Product Code: RN7-536M5, Lot number: 02A0801205; Product Code: TEV100, Lot number: 02G1101500; Product Code: V-2599, Lot number: 02F0802055; Product Code: X-5424, Lot number: 02B0900765; Product Code: X6-692W, Lot number: 02C0803135; Product Code: X7-655M6A, Lot number: 02A0900806, 02A0902742…
Reason for recall
The products are being recalled because they did not meet minimum needle attachment strength requirements.
FDA-determined cause: Employee error
Action taken
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
Details
- Recall number
- Z-1292-2014
- Initiated
- March 11, 2014
- Posted by FDA
- March 26, 2014
- Terminated
- August 15, 2017
- Product code
- GAT – Suture, Nonabsorbable, Synthetic, Polyethylene
- Quantity
- Total 32,271 ea.
- Distribution
- Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland
- Recalling firm
- Teleflex Medical, Research Triangle Park, NC
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1291-2014 Class II | Suture, Non-absorbable, Synthetic, Polyamide, Sterile, Rx only, Product Usage:…The products are being recalled because they did not meet minimum needle attachment strength requirements. | 03/11/2014Terminated |
| Z-1293-2014 Class II | Sutures, Non-absorbable, Synthetic, Polypropylene, Sterile, Rx only, Product Usage:…The products are being recalled because they did not meet minimum needle attachment strength requirements. | 03/11/2014Terminated |
| Z-1294-2014 Class II | Sutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile, Rx only, Product Usage:…The products are being recalled because they did not meet minimum needle attachment strength requirements. | 03/11/2014Terminated |
| Z-1295-2014 Class II | Sutures, Non-absorbable, Steel, Monofilament and Multifilament, Sterile, Rx only…The products are being recalled because they did not meet minimum needle attachment strength requirements. | 03/11/2014Terminated |
| Z-1296-2014 Class II | Sutures, Non-absorbable, Silk, Sterile, Rx only, Product Usage: Natural non-absorbable…The products are being recalled because they did not meet minimum needle attachment strength requirements. | 03/11/2014Terminated |