Philips HEARTSTART Electrode Pads Recalled for Incompatibility with AEDs
Covidien is recalling Philips HEARTSTART Multifunction Electrode Pads 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
Covidien LLC is recalling 151,210 pairs of Philips HEARTSTART Multifunction Electrode Pads, Part Number M3718A. 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), Puerto Rico, Canada, Greece, Israel, Belgium, Finland, France, Germany, Great Britain, Ireland, Italy, Norway, Poland, Portugal, Spain, Sweden, Switzerland, Brazil, Chile, Philippines, Taiwan, Australia, and New Zealand. All lot codes are affected.
Users should stop using these electrode pads with Philips FR3 or FRx AEDs and contact the manufacturer for instructions on replacement or return.
The recalled product
- Product
- Philips HEARTSTART Multifunction Electrode Pads Part Number: M3718A
- Manufacturer
- Covidien LLC
- Affected units
- 151,210
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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