Reported May 14, 2014 · Terminated
Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Sterile, Distributed by Boston Scientific,…
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 · 4024 Stirrup Creek Dr · Durham, NC · 27703-9000
Is this the product you have?
- Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; CAPIO Green Braided Coated Polyglycolic Acid Suture, Synthetic Absorbable Surgical Suture SUP, RX Only, Teleflex; Deklene II Polypropylene Blue Monofil, Blue Monofilament Polypropylene Suture, Nonabsorbable Surgical Suture USP, Deknatel; Deklene MAXX, Blue Monofilament Polypropylene suture Nonabsorbable Surgical Suture USP, Deknatel. Indicated for use in soft tissue approximation.
- Lot codes and dates
17 of 17 products
Products covered by this recall Model / number Product as published 833-124Lot 02A0902858, 02D0900775, 02G1003092, 02H1100535, 02H1100536, 02K1102309 833-213Lot 02A1200503, 02B1101450, 02C0903400, 02D0900010, 02D0900103, 02D1003285, 02D1003286 02F1302321, 02G1000045, 02G1300348, 02G1301122, 02H1100494, 02L0803407, 02L1100009, 02M1002289, 02M1101933, 02F1302322 D-5007KLot 02H1100687 D-5007M4ALot 02B1002310, 02C1103731, 02F1100069, 02H1102294 D-5007M4KLot 02M0902844 D-7016M4KLot 02C1002252, 02F1100124 D-7070KLot 02G1301749 D-7070M4KLot 02A1103450, 02B1002276 D-7076M1KLot 02C1103707, 02F1301100, 02G1100876, 02G1301739, 02F1101036, 02J1301343, 02K0900010 D-7375KLot 02H1103237 D-793M4KLot 02A1201015 ED-6072Lot 02L1002488 ED-6276Lot 02C1002218, 02E1002342, 02J0902517 ED-6896Lot 02F0902457 ED-852Lot 02A0902278, 02B0900089, 02B0901762, 02C0900661, 02C1002207, 02D0900634, 02D1100186, 02E0901921, 02E0902608, 02E1301581, 02H1300608, 02J0900501, 02K0901590, 02K0902406, 02L0900676, 02M0901869, 02G1301755 ED-863Lot 02G1002594 — Lot 02B0902976, 02D0902457, 02M0901348. - Amount recalled
- 32,271 ea.
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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