PlainRecalls
FDA Devices Critical Class I Terminated

CONMED PEDIATRIC R2 Multifunction Electrodes, REF/Catalog Number 3115-1750, Direct Connect to Philips Heartstart, Rx ONLY --- ASSEMBLED IN MEXICO -Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable device.

Reported: December 10, 2014 Initiated: November 6, 2014 #Z-0461-2015

Product Description

CONMED PEDIATRIC R2 Multifunction Electrodes, REF/Catalog Number 3115-1750, Direct Connect to Philips Heartstart, Rx ONLY --- ASSEMBLED IN MEXICO -Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable device.

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.

Details

Recalling Firm
ConMed Corporation
Units Affected
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.
Location
Utica, NY

Frequently Asked Questions

What product was recalled? ▼
CONMED PEDIATRIC R2 Multifunction Electrodes, REF/Catalog Number 3115-1750, Direct Connect to Philips Heartstart, Rx ONLY --- ASSEMBLED IN MEXICO -Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable device.. Recalled by ConMed Corporation. Units affected: 174,610 (168,090 US and 6,520 OUS) in total..
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 10, 2014. Severity: Critical. Recall number: Z-0461-2015.

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