Reported Apr 4, 2018 · Terminated

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

ConMed Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: ConMed Corporation · 525 French Rd · Utica, NY · 13502-5945

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.).

Lot codes and dates: Lot Numbers
Y013114-14
Y04191607
Y061413-09
Y081513-07
Y101212-03
Y020714-08
Y04201507
Y06151504
Y081712-39
Y101413-12
Y021413-09
Y042514-10
Y061914-14
Y082212-13
Y10231528
Y021712-01
Y042712-06
Y06261516
Y08281506
Y10231529
Y030113-12
Y05041703
Y071213-13
Y090313-12
Y110714-08
Y03041604
Y05081508
Y071814-11
Y091914-13
Y112414-04
Y031414-04
Y051414-07
Y07191604
Y09241503
Y112613-03
Y032513-03
Y052914-08
Y072712-03
Y092612-16
Y112912-13
Y032612-05
Y060412-05
Y07271508
Y100212-01
Y11301601
Y040314-07
Y060713-12
Y080113-05
Y100713-02
Y121714-09
Y040813-01
Y06071704
Y081114-05
Y10071602
Y121813-09
Y041712-02
Amount recalled: 18,720 units in total

The agency filed one notice per product. You are reading one of them; the other 4 are below.

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

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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23 in total.