FDA recall Z-1102-2025

Physio-Control, Inc. · Class II · device

Product

LIFEPAK 35 ECG cable REF 11111-000041

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.

Key facts

Status
Ongoing
Initiation date
2025-01-21
Report date
2025-02-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Redmond, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1102-2025