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ConMed Corporation recalls MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog Number 2602 Indicated for us
Recalled April 4, 2018 · FDA recall Z-1174-2018 · ConMed
Hazard
Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure · FDA Class II
Units
18,720 units in total
Sold at
Worldwide Distribution: US (Nationwide) and countries of: New Zealand, Saudi Arabia, Switzerland, United Arab Emirates Uruguay & Republic of Macedonia (The former Yugoslav Republic of Macedonia).
Description
Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure
Product
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog Number 2602 Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).
Manufacturer(s)
ConMed Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →