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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