Class II

Medical Device Recall: LIFEPAK 35 ECG cable REF 11111-000041

Physio-Control, Inc. · January 21, 2025

Reason for Recall

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

Distribution

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.

States Affected

NATIONWIDE

Quantity Affected

245 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1102-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Physio-Control, Inc. Medical Device Recall: LIFEPAK 35 ECG cable REF 11111-000041 | SafeCheck