FDA Device recall Z-1292-2014
Sutures, Non-absorbable, Synthetic, Polyethylene, Sterile, Rx only, Product Usage: Non-absorbable poly(ethylene terephthalate) surgical sut…
- FDA Device
- Class II
- terminated
- Published 2014-04-02
On 2014-04-02 the FDA classified a Class II recall of Sutures, Non-absorbable, Synthetic, Polyethylene, Sterile, Rx only, Product Usage: Non-absorbable poly(ethylene terephthalate) surgical sut… by Teleflex Medical, citing the products are being recalled because they did not meet minimum needle attachment strength requirements.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1292-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-11 |
| Published | 2014-04-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Teleflex Medical |
| Distribution | US |
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.
Reason
The products are being recalled because they did not meet minimum needle attachment strength requirements.
Identifiers
| code_info | Product Code: 0100019-507, Lot number: 02F1301128; Product Code: 6-511, Lot number: 02M0800561; Product Code: 6-559, Lo…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 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1292-2014%22
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