Teleflex Medical Recalls Surgical Sutures Due to Needle Detachment Risk
Teleflex Medical is recalling specific lots of nonabsorbable surgical sutures because the needles may detach from the suture during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect (needle detachment) that poses a risk of harm during surgical use, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Teleflex Medical is recalling 32,271 units of various nonabsorbable surgical sutures, including Tevdek II, Silky II Polydek, Polylene, and Bard FIXT. These products are indicated for use in soft tissue approximation and were distributed worldwide, including in the United States, Canada, Germany, and Ireland.
The recall was initiated because the product does not meet minimum needle attachment strength requirements. This defect creates a risk that the needle can become detached from the suture during use.
Healthcare providers and consumers should stop using the affected lots immediately. The specific product codes and lot numbers are listed in the official recall notice. Users should contact Teleflex Medical or their distributor for further instructions on how to return or dispose of the recalled products.
The recalled product
- Product
- 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, Impregn
- Manufacturer
- Teleflex Medical
- Affected units
- 32,271
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Product Code 0100019-507 -Lot 02F1301128
- Product Code 6-511 - Lot 02M0800561
- Product Code 6-559 - Lot 02A0800005
- Product Code 69-403 - Lot 02H0802530
- Product Code 7-5008M4 - Lot 02C0900466
- Product Code 7-518 - Lot 02E1302561
- Product Code 7-565 - Lot 02B1100185
- Product Code 7-655A - Lot 02C0901963
- Product Code 7-655A - Lot 02M0800836
- Product Code 7-740 - Lot 02L1000536
- Product Code 833-114 - Lot 02A1202112
- 02C0902841
- 02C0903374
- 02D1202794
- 02F0902697
- 02K1100404
- 02L1202369
- 02M0802509
- Product Code E13-6351 - Lot 02F0902446
- Product Code E13-6354 - Lot 02F0902439
Distribution
Part of a larger recall action
This product is one of 7 recalled by Teleflex Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
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