CLASS II Device recall · Reported 14 May 2014 · FDA Enforcement Report

Research Triangle Park, NC, Braided Polyester recalled

Teleflex Medical is recalling Research Triangle Park, NC, Braided Polyester, distributed in 28 states. The recall was initiated on 11 Mar 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct 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, Product Code E13-6399 - Lot 02F0902436, Product Code E6-545 Lot 02F0902443, Product Code E7-4578 Lot 02D0901672, Product Code RN6-5106M5 - Lot 02F1003837, Product Code RN7-536M5 - Lot 02A0801205, Product Code TEV100 - Lot 02G1101500, Product Code V-2599 - Lot 02F0802055, 02F0802055, Product Code X-5424 - Lot 02B0900765, Product Code X6-692W - Lot 02C0803135, Product Code X7-655M6A - Lot 02A0900806, 02A0902742, 02C0900446, 02H1003233, Product Code XF7-7011 - Lot 02A0901594

Quantity recalled32,271 ea.

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1556-2014
FDA event ID: 67711
Recalling firm: Teleflex Medical, Durham, NC
Classification: Class II
Status: Terminated
Recall initiated: 11 Mar 2014
FDA classified: 6 May 2014
Reported: 14 May 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

11 Mar 2014	Recall initiated by company
6 May 2014	Classified by FDA	+56 days
14 May 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution -- USA, including the states of AL, CA, FL, GA, IL, IN, KS, LA, ME, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, PA, RI, SC, TN, TX, UT, VA, WV, and WI; and countries of Canada, Germany, and Ireland.

Alabama California Florida Georgia Illinois Indiana Kansas Louisiana Massachusetts Maine Michigan Minnesota Missouri Mississippi New Jersey New Mexico Nevada New York Ohio Pennsylvania

Questions about this recall

Why was it recalled?

Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.

Which lots are affected?

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, Product Code E13-6399 - Lot 02F0902436, Product Code E6-545 Lot 02F0902443, Product Code E7-4578 Lot 02D0901672, Product Code RN6-5106M5 - Lot 02F1003837, Product Code RN7-536M5 - Lot 02A0801205, Product Code TEV100 - Lot 02G1101500, Product Code V-2599 - Lot 02F0802055, 02F0802055, Product Code X-5424 - Lot 02B0900765, Product Code X6-692W - Lot 02C0803135, Product Code X7-655M6A - Lot 02A0900806, 02A0902742, 02C0900446, 02H1003233, Product Code XF7-7011 - Lot 02A0901594

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

6 other products · FDA event 67711

This product is part of a recall event; the main page for the event is Deknatel Teleflex Medical Stainless Steel recalled.

Reported	Class	Recall	Company	Reason	Where
14 May 2014	CLASS II	Deknatel Teleflex Medical Stainless Steel recalled	Teleflex Medical	Device Malfunction	28 states
14 May 2014	CLASS II	Deknatel Teleflex Medical Silk Black Braided Silk Suture recalled	Teleflex Medical	Device Malfunction	28 states
14 May 2014	CLASS II	Research Triangle Park, NC, Polypropylene recalled by Teleflex Medical	Teleflex Medical	Device Malfunction	28 states
14 May 2014	CLASS II	Nonabsorbable Surgical Suture, U.S.P., Sterile recalled	Teleflex Medical	Device Malfunction	28 states
14 May 2014	CLASS II	Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid recalled	Teleflex Medical	Device Malfunction	28 states
14 May 2014	CLASS II	Bard Fixt Suture Braided Polyester recalled by Teleflex Medical	Teleflex Medical	Device Malfunction	28 states

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