Reported Apr 2, 2014 · Terminated
Sutures, Non-absorbable, Synthetic, Polypropylene, Sterile, Rx only, Product Usage: Non-absorbable polypropylene…
Teleflex Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teleflex Medical · 2917 Weck Dr. · Research Triangle Park, NC · 27709
Is this the product you have?
- Sutures, Non-absorbable, Synthetic, Polypropylene, Sterile, Rx only
- Product UsageNon-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
- Lot codes and dates
18 of 18 products
Products covered by this recall Model / number Product as published 833-123Lot numbers: 02A0902858, 02D0900775, 02G1003092, 02H1100535, 02H1100536, & 02K1102309 833-124Lot numbers: 02A1200503, 02B1101450 & 02C0903400 02D090001002D0900103, 02D1003285, 02D1003286 & 02F1302321 02G100004502G1300348, 02G1301122, 02H1100494, & 02L0803407 02L110000902M1002289, 02M1101933 & 02F1302322 — 833-213, Lot number: 02H1100687 D-5007KLot numbers: 02B1002310, 02C1103731, 02F1100069 & 02H1102294 D-5007M4ALot number: 02M0902844 D-5007M4KLot numbers: 02C1002252, & 02F1100124 D-7016M4KLot number: 02G1301749 D-7070M4KProduct Code: D-7070K, Lot numbers: 02A1103450 & 02B1002276: , Lot numbers: 02C1103707, 02F1301100, 02G1100876 & 02G1301739 D-7076M1KLot number: 02H1103237 D-7375KProduct Code: D-7076M4K, Lot numbers: 02F1101036, 02J1301343, and 02K0900010: , Lot number: 02A1201015 D-793M4KLot number: 02L1002488 ED-6072Lot numbers: 02C1002218, 02E1002342 & 02J0902517 ED-6276Lot number: 02F0902457 ED-6896Lot numbers: 02A0902278, 02B0900089, 02B0901762, 02C0900661, 02C1002207, 02D0900634, 02D1100186, 02E0901921, 02E0902608, 02E1301581, 02H1300608, 02J0900501, 02K0901590, 02K0902406, 02L0900676, 02M0901869, & 02G1301755 EP4049NProduct Code: ED-853, Lot numbers: 02G1002594, 02B0902976, 02D0902457 & 02M0901348 and , Lot number: 02A1003137. - Amount recalled
- Total 32,271 ea.
This recall covers 21 products
The agency filed one notice per product. You are reading one of them; the other 20 are below.
8 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
The products are being recalled because they did not meet minimum needle attachment strength requirements.
This product could cause temporary or reversible health problems — stop using it.
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