Z-0319-2025 Class II Ongoing
FDA device recall Z-0319-2025 was initiated by Ethicon, Inc. on Sep 25, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 31,032 units.
Recall details
- Product Type
- Devices
- Report Date
- Nov 13, 2024
- Initiation Date
- Sep 25, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31,032 units
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.
Distribution pattern
International distribution to the country of China.
Code information
UDI-DI: 10705031237308 (each); 30705031237302 (box); Lot Number: QP2AJM
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0319-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026