Medical device recalls Moderate risk

Anewmed Corporation recalls Various products which were contract sterilized.

Recall date
May 23, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0259-2020
FDA classification
Class II
Brand / firm
Anewmed Corporation
Sold / distributed
Nationwide distribution in the states of AL, CO, FL, IN, KY, MS, NC, OH, SC, TN, TX.

Why it was recalled

The contract sterilizer did not have adequate packaging data to support the 2-year shelf life.

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

What was recalled

Various products which were contract sterilized.

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