PlainRecalls
FDA Devices Moderate Class II Terminated

MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H 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 who

Reported: April 4, 2018 Initiated: February 23, 2018 #Z-1176-2018

Product Description

MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H 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.).

Reason for Recall

Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure

Details

Recalling Firm
ConMed Corporation
Units Affected
18,720 units in total
Distribution
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).
Location
Utica, NY

Frequently Asked Questions

What product was recalled? ▼
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H 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.).. Recalled by ConMed Corporation. Units affected: 18,720 units in total.
Why was this product recalled? ▼
Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 4, 2018. Severity: Moderate. Recall number: Z-1176-2018.

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