FDA (Devices) recall action 69257
The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.
Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs
Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs Defibrillators
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
The FDA is recalling 330 pairs of MediChoice Multifunction Electrodes because they are not compatible with certain Philips AED models.
Covidien is recalling Philips HEARTSTART Multifunction Electrode Pads because they are not compatible with Philips FR3 or FRx 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.
FDA recalls 31,590 pairs of Kendall defibrillation electrodes because they are not compatible with Philips FR3 or FRx AEDs.
FDA recalls 133,930 pairs of Kendall defibrillation electrodes because they are not compatible with specific Philips AED models.
FDA recalls 317,550 pairs of defibrillation electrodes because they are not compatible with Philips FR3 or FRx AEDs.