Reported May 14, 2014 · Terminated
Teleflex Medical, Research Triangle Park, NC, Braided Polyester Rx Only, Sterile, Distributed by Boston Scientific,…
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 · 4024 Stirrup Creek Dr · Durham, NC · 27703-9000
Is this the product you have?
- Teleflex Medical, Research Triangle Park, NC, Braided Polyester Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; Tevdek II, Green Braided PTFE Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP Sterile, Deknatel; Tevdek II, White Braided PTFE, Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP, Sterile, Deknatel; Silky II Polydek White Braided PTFE, Impregnated Polyester Fiber, Nonabsorbable surgical Suture, USP, Sterile, Deknatel; Silky II Polydek, Green Braided PTFE, Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP, Sterile, Deknatel; Polylene Green Braided Polyester Suture Nonabsorbable surgical Suture, USP, Deknatel; Bard FIXT Braided Polyester, Green PTFE Rx Only, Teleflex Research Triangle Park, NC USA, Assembled in Mexico. Indicated for use in soft tissue approximation.
- Lot codes and dates
23 of 23 products
Products covered by this recall Model / number Product as published 6-559Lot 02M0800561 69-403Lot 02A0800005 7-5008M4Lot 02H0802530 7-518Lot 02C0900466 7-565Lot 02E1302561 7-655ALot 02B1100185 7-655ALot 02C0901963 7-740Lot 02M0800836 833-114Lot 02L1000536 E13-6351Lot 02A1202112, 02C0902841, 02C0903374, 02D1202794, 02F0902697, 02K1100404, 02L1202369, 02M0802509 E13-6354Lot 02F0902446 E13-6399Lot 02F0902439 E6-545Lot 02F0902436 E7-4578Lot 02F0902443 RN6-5106M5Lot 02D0901672 RN7-536M5Lot 02F1003837 TEV100Lot 02A0801205 V-2599Lot 02G1101500 X-5424Lot 02F0802055, 02F0802055 X6-692WLot 02B0900765 - Amount recalled
- 32,271 ea.
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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