FDA Device recall Z-1176-2018
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H Indicated for use in external pacing,…
- FDA Device
- Class II
- terminated
- Published 2018-04-04
On 2018-04-04 the FDA classified a Class II recall of MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H Indicated for use in external pacing,… by Conmed, citing wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1176-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-23 |
| Published | 2018-04-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Conmed |
| Distribution | US |
Product
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
Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure
Identifiers
| code_info | Lot Numbers: Y01221601, Y03241702, Y10121501, Y020713-17, Y04071501, & Y12021501. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1176-2018%22
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