Medical device recalls Moderate risk

Ethicon, Inc. recalls Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile sur…

Recall date
January 3, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0989-2020
FDA classification
Class II
Brand / firm
Ethicon, Inc.
Sold / distributed
Domestic distribution nationwide. US and Puerto Rico only.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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