device · product 1 of 5
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.).
- Recall number
- Z-1174-2018
- Initiated
- February 23, 2018
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- ConMed Corporation
- Quantity
- 18,720 units in total
App-derived interpretation
Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure
Official device-enrichment evidence · Sourced
Process design
Inspect official wording and provenance
Reason for recall
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).