Physio-Control recalls LIFEPAK 35 ECG cable REF 11111-000041 due to missing cleaning instructions in user manual. Affected units shipped with incorrect instructions.
Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions
Physio-Control is recalling a specific ECG cable model because the user manual does not include proper cleaning and disinfection instructions. This could lead to improper cleaning of the device, potentially causing health risks if the cable is used in medical settings.
The user manual does not include proper cleaning and disinfection instructions. This could lead to improper cleaning of the device, potentially causing health risks if the cable is used in medical settings.
Healthcare professionals using the LIFEPAK 35 ECG cable model REF 11111-000041 are most at risk. The recall affects units shipped with the incorrect user manual.
Check for the model number REF 11111-000041 on the cable. Affected units have the UDI-DI code 00883873834596 and lot/serial number 0224.
Verify if the user manual includes cleaning and disinfection instructions for the LIFEPAK 35 ECG cable.
The user manual does not include proper cleaning and disinfection instructions, which could lead to improper cleaning of the device.
Check if your cable has the model number REF 11111-000041 and the UDI-DI code 00883873834596 with lot/serial number 0224. If so, review the user manual for cleaning instructions.
The recall record does not mention a remedy or fix for this issue.
We’ve drafted a message you can send Physio-Control to request your refund or repair — edit it as you like.
Subject: Recall Z-1102-2025 — Physio-Control Physio-Control Hello, I own a Physio-Control that is covered by recall Z-1102-2025 from Physio-Control. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.