Reported Apr 2, 2014 · Terminated
Sutures, Non-absorbable, Synthetic, Polyethylene, Sterile, Rx only, Product Usage: Non-absorbable poly(ethylene…
Teleflex Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teleflex Medical · 2917 Weck Dr. · Research Triangle Park, NC · 27709
Is this the product you have?
- Sutures, Non-absorbable, Synthetic, Polyethylene, Sterile, Rx only
- Product UsageNon-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
- Lot codes and dates
24 of 24 products
Products covered by this recall Model / number Product as published 0100019-507Lot number: 02F1301128 6-511Lot number: 02M0800561 6-559Lot number: 02A0800005 69-403Lot number: 02H0802530 7-5008M4Lot number: 02C0900466 7-518Lot number: 02E1302561 7-565Lot number: 02B1100185 7-655ALot numbers: 02C0901963 & 02M0800836 7-740Lot number: 02L1000536 833-114Lot numbers: 02A1202112, 02C0903374 & 02D1202794 02F090269702K1100404, 02L1202369 & 02M0802509 E13-6351Lot number: 02F0902446 E13-6354Lot number: 02F0902439 E13-6399Lot number: 02F0902436 E6-545Lot number: 02F0902443 E7-4578ot number: 02D0901672 H5300Lot number: 1450153E13 RN6-5106M5Lot number: 02F1003837 RN7-536M5Lot number: 02A0801205 TEV100Lot number: 02G1101500 - Amount recalled
- Total 32,271 ea.
This recall covers 21 products
The agency filed one notice per product. You are reading one of them; the other 20 are below.
8 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
The products are being recalled because they did not meet minimum needle attachment strength requirements.
This product could cause temporary or reversible health problems — stop using it.
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