Medical device recalls Moderate risk

Safeguard US Operating LLC recalls HAWK Advanced Hypothermia Management Set, Item Number: 59-320

Recall date
August 27, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-3182-2024
FDA classification
Class II
Brand / firm
Safeguard US Operating LLC
Sold / distributed
US Nationwide distribution in the states of AK, CA, CO, DC, GA, IL, NC, NM, NY, OK, OR, RI, TX, VA, WA, WI.

Why it was recalled

Incorrect expiration date.

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

What was recalled

HAWK Advanced Hypothermia Management Set, Item Number: 59-320

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