Coviden Defibrillation Electrodes Recalled for Incompatibility with Philips AEDs
Coviden LLC is recalling 9,850 pairs of Medi-Trace Cadence 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs"
Plain-English summary
Coviden LLC is voluntarily recalling 9,850 pairs of Coviden Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pre-connected (Part Number: 22660PC). 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 the United States (nationwide) and Puerto Rico, as well as 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 consumers should stop using these specific electrodes with Philips FR3 or FRx AEDs. Users should contact Coviden LLC for further instructions or a replacement.
The recalled product
- Product
- Coviden Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pre-connected Part Number: 22660PC
- Manufacturer
- Covidien LLC
- Hazard
- Affected units
- 9,850
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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