This recall was updated on January 8, 2015.
Recall Class: Class I
Date Recall Initiated: September 18, 2014
- Covidien electrodes – All Lot Numbers
- 22660R - Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes Radiotransparent
- 22660PC - Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes Pre-connect
- 20660 - Kendall Adult Multi-Function Defibrillation Electrodes
- 40000006 - Kendall 1710H Multi-Function Defibrillation Electrodes
- Electrodes produced by Covidien and distributed under the following brands also have the same connector compatibility issue - All Lot Numbers
- MC1710H - MediChoice Multifunction Electrode
- M3718A – Philips HEARTSTART Multifunction Electrode Pads
Manufacturing and Distribution Dates: September 1, 2012 to August 24, 2014
NOTE: These electrodes work with the appropriate Philips AEDs.
Use: These electrodes are connected to AEDs. An AED analyzes the heart rhythm in cardiac arrest patients and delivers an electrical shock to restore normal heart rhythm. The primary users of AEDs are first responders and hospital health care providers.
15 Hampshire Street
Mansfield, Massachusetts 02048
Reason for Recall:
These defibrillation electrodes have been recalled due to a connector compatibility issue with Philips FR3 and FRx Defibrillators.
Use of these electrodes could cause a delay in delivering electrical therapy that is needed to revive patients. Additionally, their use could lead to severe health problems such as stroke, organ failure, or death if alternative defibrillator electrodes are not readily available.
Covidien received two reports of injuries. There was a delay in resuscitating one patient which may have contributed to the subsequent death of the patient.
Customers who need additional information or to report a problem, contact Covidien Quality Assurance at 1-800-962-9888, option 8, extension 2500, Monday through Friday, 8 a.m. to 5 p.m., Eastern Time or email Mansfield.email@example.com.
FDA District: New England District Office
More Information about this Recall:
Covidien sent customers an Urgent Field Safety Notice on September 18, 2014. The notice advised customers take the following actions:
- Do not use the recalled Covidien electrodes with Philips FR3 and FRx AEDs.
- Review the use of Covidien defibrillation electrodes in your facility to assure that Covidien electrodes are not provided with Philips model FR3 or FRx AEDs.
- Only use Philips FR3 and FRx AEDs with Philips electrodes as specified in the equipment manual.
- Complete and return the notification tracking form attached to the Urgent Field Safety Notice.
- Inform others in your facility about this recall.
- Inform other persons or facilities if your facility distributed any of the listed Covidien defibrillation electrodes and forward a copy of the Urgent Field Safety Notice to them.
About Class I Recalls
Class I recalls are the most serious type of recall. They involve situations when it is likely that use of these devices will cause serious health problems or death.
Health care professionals and consumers can report bad reactions or quality problems they had using the device to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.
- Firm Press Release
- Medical Device Recall: CONMED Corporation, PadPro and R2 Multi-Function Defibrillation Electrodes