Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) recall: Impurity Out of Spec
Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
Why was Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) 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 I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 10705031237308 (each); 30705031237302 (box); Lot Number: QP2AJM
- Product
- Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
- Recalling firm
- Ethicon, Inc.
- Quantity
- 31,032 units
- Distribution
- International distribution to the country of China.
- Recall date
- November 13, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)