Medical device recalls Moderate risk

Fort Defiance Industries, LLC recalls P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641

Recall date
August 19, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0121-2022
FDA classification
Class II
Brand / firm
Fort Defiance Industries, LLC
Sold / distributed
Distributed nationwide to PA, MD, TX, NJ, OH, TN, UT, VA and internationally to Canada.

Why it was recalled

The rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground.

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

What was recalled

P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641

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