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Recall Observatory FDA recall evidence

Device 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.).

Z-1174-2018

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-1174-2018

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: Y011813-09, Y040612-16, Y061214-15, Y090712-04, Y012714-08, Y040715-02, Y06291501, Y091914-07, Y013012-04, Y04291601, Y072012-14, Y100412-08, Y020713-13, Y050313-10, Y072513-04, Y103114-03, Y022814-09, Y050412-08, Y07291601, Y110912-12, Y03151701, Y050814-15, Y08031702, Y11131501, Y031715-11, Y05251701, Y081314-03, Y112414-03, Y032513-16, Y06071601, Y08231601, Y121613-07 Y03271501, Y060812-04, Y090514-11 & Y12181501.

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