Defibrillation Electrodes Recalled for Incompatibility with Philips AEDs
FDA recalls 317,550 pairs of defibrillation electrodes because they are not compatible with Philips FR3 or FRx AEDs.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class I recall for 317,550 pairs of Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, Radiotransparent (Part Number: 22660R). The recall was initiated because the electrodes are not compatible for use with Philips model FR3 or FRx AEDs Defibrillators.
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 lots of the product are included in this recall.
Healthcare facilities and users should stop using these specific electrodes with Philips FR3 or FRx AEDs. Consumers and medical professionals should contact the recalling firm, Covidien LLC, for further instructions on how to return or replace the affected units.
The recalled product
- Product
- Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, Radiotransparent Part Number: 22660R
- Manufacturer
- Covidien LLC
- Hazard
- Affected units
- 317,550
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)
- All lots
Distribution
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.
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