Recall Z-0454-2015
ConMed Corporation · initiated November 6, 2014
Class I – dangerous or defective products that could cause serious health problems or death
Product
ADULT Radiotransparent Electrode, REF/Catalog Number 2001H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable device.
Codes / lots: All Lot Codes
Reason for recall
Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death or serious injury.
FDA-determined cause: Device Design
Action taken
ConMed sent an Urgent Device Correction letter dated November 16, 2014, to all affected consignees via UPS Next Day Air. The letter instructed consignees to notify all end users of the correction. For questions or additional information, consignees were instructed to contact ConMed at 1-727-399-5276 or by e-mail at multifunctionelectrodes@conmed.com. International notices were sent via UPS Priority or equivalent by November 19, 2014.
Details
- Recall number
- Z-0454-2015
- Initiated
- November 6, 2014
- Posted by FDA
- December 4, 2014
- Terminated
- October 30, 2017
- Product code
- MKJ – Automated External Defibrillators (Non-Wearable)
- Quantity
- 174,610 (168,090 US and 6,520 OUS) in total.
- Distribution
- Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to Bosnia, Herzegovina, Brazil, Canada, Great Britain, Israel, Italy, Republic of Korea, Norway, Portugal, Saudi Arabia, and Spain.
- Recalling firm
- ConMed Corporation, Utica, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0455-2015 Class I | ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-C, Rx ONLY --- COMPARABLE TO…Philips Healthcare made changes to the design of the connection between multifunction electrodes and their… | 11/06/2014Terminated |
| Z-0456-2015 Class I | ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-PC, Rx ONLY --- COMPARABLE TO…Philips Healthcare made changes to the design of the connection between multifunction electrodes and their… | 11/06/2014Terminated |
| Z-0457-2015 Class I | ADULT Radiotransparent Electrode, REF/Catalog Number 2516H, Rx ONLY --- COMPARABLE TO…Philips Healthcare made changes to the design of the connection between multifunction electrodes and their… | 11/06/2014Terminated |
| Z-0458-2015 Class I | ADULT Radiotransparent Electrode, REF/Catalog Number 2516H-PC, Rx ONLY --- COMPARABLE TO…Philips Healthcare made changes to the design of the connection between multifunction electrodes and their… | 11/06/2014Terminated |
| Z-0459-2015 Class I | PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2603H, Rx ONLY --- COMPARABLE…Philips Healthcare made changes to the design of the connection between multifunction electrodes and their… | 11/06/2014Terminated |
| Z-0460-2015 Class I | MINI PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2602H, Rx ONLY ---…Philips Healthcare made changes to the design of the connection between multifunction electrodes and their… | 11/06/2014Terminated |
| Z-0461-2015 Class I | CONMED PEDIATRIC R2 Multifunction Electrodes, REF/Catalog Number 3115-1750, Direct…Philips Healthcare made changes to the design of the connection between multifunction electrodes and their… | 11/06/2014Terminated |
| Z-0462-2015 Class I | CONMED ADULT R2 Multifunction Electrodes, REF/Catalog Number 3115-1751, Direct Connect…Philips Healthcare made changes to the design of the connection between multifunction electrodes and their… | 11/06/2014Terminated |