—#126127

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.

FDA product code: GAT — Suture, Nonabsorbable, Synthetic, Polyethylene
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K930738
Affected lot / code info: 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

Why it was recalled

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

Root cause (FDA determination)

Employee error

Action the firm took

Urgent Medical Device Recall Notification letters were issued on March 11, 2014 to consignees. The letter requested that customers discontinue use and quarantine any product on hand. The attached Recall Acknowledgment Form should be completed and returned to Teleflex regardless of whether affected product is on hand or not. Once received a customer service representative will contact customers with instructions on how to return the affected product. Questions should be directed to Customer Service at 1-866-246-6990.

Recalling firm

Firm: Teleflex Medical
Address: 4024 Stirrup Creek Dr, Durham, North Carolina 27703-9000

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2014-03-11
Posted by FDA: 2014-05-07
Terminated: 2017-08-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #126127. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.