Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
Reported: November 13, 2024 Initiated: September 25, 2024 #Z-0319-2025
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.
Details
- Recalling Firm
- Ethicon, Inc.
- Units Affected
- 31,032 units
- Distribution
- International distribution to the country of China.
- Location
- Raritan, NJ
Frequently Asked Questions
What product was recalled? ▼
Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H. Recalled by Ethicon, Inc.. Units affected: 31,032 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 13, 2024. Severity: Moderate. Recall number: Z-0319-2025.
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