ConMed Corporation: Medical Device Recall in 2014 - (Recall #: Z-0461-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class I

Date Initiated: November 6, 2014

Date Posted: December 10, 2014

Recall Number: Z-0461-2015

Event ID: 69752

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.

Status: Terminated

Product Quantity: 174,610 (168,090 US and 6,520 OUS) in total.

Code Information:

All Lot Codes

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated