FDA-Device2024-11-13Class II
Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
Ethicon, Inc.
Hazard
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.
Sold states
International distribution to the country of China.
Affected count
31,032 units
Manufactured in
1000 Route 202, N/A, Raritan, NJ, United States
Products
Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0319-2025Don't want to check this manually?
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