Medical device recalls Moderate risk

Physio-Control, Inc. recalls LIFEPAK 35 ECG cable REF 11111-000041

Recall date
January 21, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1102-2025
FDA classification
Class II
Brand / firm
Physio-Control, Inc.
Sold / distributed
U.S. Nationwide distribution in the states of CA, FL, GA, IA, IN, KY, MD, MI, MO, NE, NV, NY, OH, OR, SC, TN, TX, and WI.

Why it was recalled

Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions

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

What was recalled

LIFEPAK 35 ECG cable REF 11111-000041

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