Reported Nov 13, 2024 · Ongoing
Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
Ethicon, Inc.
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: Ethicon, Inc. · 1000 Route 202 · Raritan, NJ · 08869-1425
Is this the product you have?
- Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
- Lot codes and dates
- UDI-DI
10705031237308 (each)30705031237302 (box)
- Lot NumberQP2AJM
- UDI-DI
- Amount recalled
- 31,032 units
Why it was recalled
Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package.
This product could cause temporary or reversible health problems — stop using it.
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