FDA Medical devices recall ·
Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT… recall
- Recall number
- Z-0319-2025
- Date
- (initiated September 25, 2024)
- Company / brand
- Ethicon, LLC
1000 Route 202, Raritan, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 31,032 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 10705031237308 (each); 30705031237302 (box); Lot Number: QP2AJM
Distribution
International distribution to the country of China.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0319-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.