FDAFDA · Food and drugs·Recall number Z-0319-2025
Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
Published November 13, 2024 · Recall initiated: September 25, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ethicon, Inc.
- Distributor
- International distribution to the country of China.
- Lot
- UDI-DI: 10705031237308 (each); 30705031237302 (box); Lot Number: QP2AJM
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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