Kendall Defibrillation Electrodes Recalled for Incompatibility with Philips AEDs
FDA recalls 133,930 pairs of Kendall defibrillation electrodes because they are not compatible with specific Philips AED models.
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 source metadata explicitly identifies this as an FDA Class I recall, 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 133,930 pairs of Covidien Kendall 1710H Multi-Function Defibrillation Electrodes, Part Number 40000006. The recall is due to the electrodes not being compatible for use with Philips model FR3 or FRx Automated External Defibrillators (AEDs).
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.
Healthcare facilities and users should stop using these specific electrodes with Philips FR3 or FRx AEDs. The recall is classified as Class I because the use of incompatible electrodes with these specific AED models could result in a failure to deliver a defibrillation shock, which is a serious health hazard.
The recalled product
- Product
- Covidien Kendall 1710H Multi-Function Defibrillation Electrodes Part Number: 40000006
- Manufacturer
- Covidien LLC
- Affected units
- 133,930
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
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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