Reported Feb 7, 2024 · Ongoing
Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT…
Covidien LP
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: Covidien LP · 15 Hampshire St · Mansfield, MA · 02048-1113
Is this the product you have?
- Surgilon Braided Nylon sutures88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-71 SURGILON* 1 BLK 7X75CM PCT
- Lot codes and dates
5 of 5 products
Products covered by this recall Model / number Barcodes Product as published 88861919-311088452107172820884521071725SURGILON* 4-0 BLK 7X75CMPCT UDI-DI 10884521071728, 20884521071725 Lots D1L1929RY D2B2243RY 88861919-411088452107174220884521071749SURGILON* 3-0 BLK 7X75CMPCT UDI-DI 10884521071742, 20884521071749 — Lot D2B0176RY 88861919-511088452107176620884521071763SURGILON* 2-0 BLK 7X75CMPCT UDI-DI 10884521071766 Lots D2D2437RY UDI-DI 20884521071763 Lots D2D2437RY D2E0905RY D2E0916RY 88861919-7120884521071794SURGILON* 1 BLK 7X75CM PCT UDI-DI 20884521071794 Lots D1M0640RY D1M1494RY - Amount recalled
- 46,812 US; 68,976 OUS
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level.
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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