FDAClass IIFebruary 12, 2020

Coated VICRYL recall

Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.

Why was Coated VICRYL recalled?

Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point.

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

lot PGZ908

Product
Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
Recalling firm
Ethicon, Inc.
Quantity
23688 units
Distribution
Domestic distribution nationwide. US and Puerto Rico only.
Recall date
February 12, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls