Physio-Control, Inc.: Device Recall

Recall #Z-1102-2025 · 01/21/2025

Class II: Risk

Recall Details

Recall Number: Z-1102-2025
Classification: Class II
Product Type: Device
Recalling Firm: Physio-Control, Inc.
Status: Ongoing
Date Initiated: 01/21/2025
Location: Redmond, WA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 245 units

Reason for Recall

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

Product Description

LIFEPAK 35 ECG cable REF 11111-000041

Distribution Pattern

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.

Other Recalls by Physio-Control, Inc.

Class II: Risk 07/22/2025

Due to required inspections not being performed on products/units that have gone through servicing.
Class II: Risk 07/22/2025

Due to required inspections not being performed on products/units that have gone through servicing.
Class II: Risk 07/22/2025

Due to required inspections not being performed on products/units that have gone through servicing.
Class II: Risk 02/03/2025

Incorrect keypad was incorrectly installed onto a defibrillator/monitor.
Class II: Risk 01/21/2025

Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system.

View all recalls by Physio-Control, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.