Recall Z-1174-2018— ConMed Corporation

Name: FDA recall Z-1174-2018
Creator: U.S. Food and Drug Administration
Published: 2018-02-23

Class II · Terminated

Class II FDA medical device recall by ConMed Corporation, initiated 2018-02-23, terminated 2020-09-17. It names one FDA 510(k) clearance: K002280. 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.).. Reason: Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure.

Recalling firm: ConMed Corporation
Classification: Class II
Status: Terminated
Initiated: 2018-02-23
Terminated: 2020-09-17
Firm location: Utica, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K002280 — PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602Medical Devices, Inc.·cleared 2001-02-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.).

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.