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Recall Observatory FDA recall evidence

Device product

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.).

Z-1177-2018

February 23, 2018

Class II

Product summary

Firm
ConMed Corporation
Event
Event 79337
Status
Terminated
Classification
Class II
Quantity
18,720 units in total
Official record key
device-enforcement:Z-1177-2018

Official wording

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

Code information: 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

Distribution pattern: 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).

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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