Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
FDA Recall #Z-0319-2025 — Class II — September 25, 2024
Product Description
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.
Recalling Firm
Ethicon, Inc. — Raritan, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
31,032 units
Distribution
International distribution to the country of China.
Code Information
UDI-DI: 10705031237308 (each); 30705031237302 (box); Lot Number: QP2AJM
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated