Recall Z-1556-2014— Teleflex Medical

Name: FDA recall Z-1556-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-11

Class II · Terminated

Class II FDA medical device recall by Teleflex Medical, initiated 2014-03-11, terminated 2017-08-14. It names one FDA 510(k) clearance: K930738. 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, 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.. Reason: Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use..

Recalling firm: Teleflex Medical
Classification: Class II
Status: Terminated
Initiated: 2014-03-11
Terminated: 2017-08-14
Firm location: Durham, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K930738 — SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETCDeknatel, Inc.·cleared 1994-07-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.