FDA recall Z-1174-2018

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 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

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1174-2018