Medical device recalls Moderate risk

Stradis Healthcare recalls Surgical Suture Kit

Recall date
April 22, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1132-2022
FDA classification
Class II
Brand / firm
Stradis Healthcare
Sold / distributed
US Distribution to NC.

Why it was recalled

There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.

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

What was recalled

Surgical Suture Kit

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