The Recall Desk
SevereFDA (Devices)·Z-0045-2015·Announced 2014-10-22

Kendall Defibrillation Electrodes Recalled for Incompatibility with Philips AEDs

FDA recalls 31,590 pairs of Kendall defibrillation electrodes because they are not compatible with Philips FR3 or FRx AEDs.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as an FDA Class I recall, which mandates a minimum severity score of 4 per the rubric, indicating a reasonable probability of serious adverse health consequences.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling 31,590 pairs of Covidien Kendall Adult Multi-Function Defibrillation Electrodes, Part Number 20660. The recall was initiated because these specific electrodes are not compatible for use with Philips model FR3 or FRx Automated External Defibrillators (AEDs). The agency has classified this recall as Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death.

The affected products were distributed worldwide, including nationwide in the United States (including Puerto Rico) and in Canada, Greece, Israel, Belgium, Finland, France, Germany, Great Britain, Ireland, Italy, Norway, Poland, Portugal, Spain, Sweden, Switzerland, Brazil, Chile, the Philippines, Taiwan, Australia, and New Zealand. All lot codes are affected by this recall.

Healthcare facilities and users should stop using these specific electrodes with Philips FR3 or FRx AEDs. Users should contact the manufacturer or their supplier for instructions on how to return the product or obtain a replacement.

The recalled product

Product
Covidien Kendall Adult Multi-Function Defibrillation Electrodes Part Number: 20660
Manufacturer
Covidien LLC
Affected units
31,590

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Al lot codes

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 6 recalled by Covidien LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →