Device Recall Suture, Nonabsorbable, Synthetic, Polyethylene

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

General and Plastic Surgery Devices

2

Yes

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.

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.

Product Code: 0100019-507, Lot number: 02F1301128; Product Code: 6-511, Lot number: 02M0800561; Product Code: 6-559, Lot number: 02A0800005; Product Code: 69-403, Lot number: 02H0802530; Product Code: 7-5008M4, Lot number: 02C0900466; Product Code: 7-518, Lot number: 02E1302561; Product Code: 7-565, Lot number: 02B1100185; Product Code: 7-655A, Lot numbers: 02C0901963 & 02M0800836; Product Code: 7-740, Lot number: 02L1000536; Product Code: 833-114, Lot numbers: 02A1202112, 02C0903374 & 02D1202794; Product Code: 02F0902697, 02K1100404, 02L1202369 & 02M0802509; Product Code: E13-6351, Lot number: 02F0902446; Product Code: E13-6354, Lot number: 02F0902439; Product Code: E13-6399, Lot number: 02F0902436; Product Code: E6-545, Lot number: 02F0902443; Product Code: E7-4578, ot number: 02D0901672; Product Code: H5300, Lot number: 1450153E13; Product Code: RN6-5106M5, Lot number: 02F1003837; Product Code: RN7-536M5, Lot number: 02A0801205; Product Code: TEV100, Lot number: 02G1101500; Product Code: V-2599, Lot number: 02F0802055; Product Code: X-5424, Lot number: 02B0900765; Product Code: X6-692W, Lot number: 02C0803135; Product Code: X7-655M6A, Lot number: 02A0900806, 02A0902742, 02C0900446 & 02H1003233 and Product Code: XF7-7011, Lot numbers: 02A0901594.

General and Plastic Surgery Devices

2

Yes

Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland

Sutures, Non-absorbable, Synthetic, Polyethylene, Sterile, Rx only, || Product Usage: Non-absorbable poly(ethylene terephthalate) surgical suture is a multifilament, non-absorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation.

Product Code: 833-123, Lot numbers: 02A0902858, 02D0900775, 02G1003092, 02H1100535, 02H1100536, & 02K1102309; Product Code: 833-124, Lot numbers: 02A1200503, 02B1101450 & 02C0903400; Product Code: 02D0900010, 02D0900103, 02D1003285, 02D1003286 & 02F1302321; Product Code: 02G1000045, 02G1300348, 02G1301122, 02H1100494, & 02L0803407; Product Code: 02L1100009, 02M1002289, 02M1101933 & 02F1302322; 833-213, Lot number: 02H1100687; Product Code: D-5007K, Lot numbers: 02B1002310, 02C1103731, 02F1100069 & 02H1102294; Product Code: D-5007M4A, Lot number: 02M0902844; Product Code: D-5007M4K, Lot numbers: 02C1002252, & 02F1100124; Product Code: D-7016M4K, Lot number: 02G1301749; Product Code: D-7070K, Lot numbers: 02A1103450 & 02B1002276: Product Code: D-7070M4K, Lot numbers: 02C1103707, 02F1301100, 02G1100876 & 02G1301739; Product Code: D-7076M1K, Lot number: 02H1103237; Product Code: D-7076M4K, Lot numbers: 02F1101036, 02J1301343, and 02K0900010: Product Code:  D-7375K, Lot number: 02A1201015; Product Code: D-793M4K, Lot number: 02L1002488; Product Code: ED-6072, Lot numbers: 02C1002218, 02E1002342 & 02J0902517; Product Code: ED-6276, Lot number: 02F0902457; Product Code: ED-6896, Lot numbers: 02A0902278, 02B0900089, 02B0901762, 02C0900661, 02C1002207, 02D0900634, 02D1100186, 02E0901921, 02E0902608, 02E1301581, 02H1300608, 02J0900501, 02K0901590, 02K0902406, 02L0900676, 02M0901869, & 02G1301755; Product Code: ED-853, Lot numbers: 02G1002594, 02B0902976, 02D0902457 & 02M0901348 and Product Code: EP4049N, Lot number: 02A1003137.

General and Plastic Surgery Devices

2

Yes

Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland

Sutures, Non-absorbable, Synthetic, Polypropylene, Sterile, Rx only, || Product Usage: || Non-absorbable polypropylene surgical suture is a monofilament, Non-absorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation.