# FDA recall Z-1175-2018

> **ConMed Corporation** · Class II · device recall initiated 2018-02-23.

## 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 for recall

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

## 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).

## Key facts

- **Recall number:** Z-1175-2018
- **Recalling firm:** ConMed Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-02-23
- **Report date:** 2018-04-04
- **Termination date:** 2020-09-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Utica, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1175-2018

## Citation

> AI Analytics. FDA recall Z-1175-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1175-2018. Source: US FDA. Licensed CC0.

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