Physio-Control recalls LIFEPAK defibrillation electrodes (Catalog # 11101-000016) due to incorrect pad placement instructions and missing safety symbols. Affected units sold in specific model numbers.
The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type BF Patient connection and High Voltage Warning symbols.
Physio-Control is recalling LIFEPAK defibrillation electrodes because the product's artwork shows incorrect pad placement for infants and lacks critical safety symbols. This could lead to improper use during emergencies if the electrodes are used without following the correct instructions.
The electrodes have artwork that incorrectly shows how to place pads on infants, which could cause improper use during emergencies. Missing Type BF Patient connection and High Voltage Warning symbols also increase the risk of injury if the device is used without proper safety checks.
Parents or caregivers using the LIFEPAK defibrillation electrodes with infant patients are most at risk. The recall affects specific model numbers sold in the United States.
Check for the product catalog number 11101-000016 and minimum serial number 3202380-006. The electrodes are used with specific LIFEPAK defibrillators like the LIFEPAK EXPRESS AED.
Verify the catalog number 11101-000016 and minimum serial number 3202380-006 on the electrodes.
The electrodes have artwork that shows incorrect pad placement for infants and are missing Type BF Patient connection and High Voltage Warning symbols.
The official recall notice does not specify a remedy, so you should check with Physio-Control for further instructions.
These electrodes are used only with LIFEPAK EXPRESS AED, LIFEPAK CR Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED with a pink connector.
We’ve drafted a message you can send Physio-Control to request your refund or repair — edit it as you like.
Subject: Recall Z-0186-2018 — Physio-Control Physio-Control Hello, I own a Physio-Control that is covered by recall Z-0186-2018 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.
