MINI INFANT < recalled over sterility concerns

Recall date

February 23, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

ConMed Corporation recalls MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control¿ Quik-Combo" Connector, REF/Catalog Number 2602M Indicate…

Recall number

Z-1177-2018

FDA classification

Class II

Brand / firm

ConMed Corporation

Sold / distributed

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).

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control¿ Quik-Combo" Connector, REF/Catalog Number 2602M 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.).