FDA recall Z-0319-2025

Ethicon, Inc. · Class II · device

Product

Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H

Reason for recall

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.

Distribution

International distribution to the country of China.

Key facts

Status
Ongoing
Initiation date
2024-09-25
Report date
2024-11-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Raritan, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0319-2025