Device product
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL¿ Connector, REF/Catalog Number 2602Z 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-1178-2018
Product summary
- Event
- Event 79337
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18,720 units in total
- Official record key
device-enforcement:Z-1178-2018
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: Y010713-02, Y03181603, Y051414-08, Y072012-12,Y09301601, Y012312-14, Y03201511, Y05151513, Y07251703, Y100314-14, Y013114-16, Y032513-17, Y052313-10, Y07271507, Y10061701, Y02151602, Y03251604, Y06011502, Y07271702, Y10071603, Y021712-02, Y03251605, Y061214-04, Y08101504, Y101413-06, Y02171701, Y032612-15, Y061412-06, Y08171703, Y101512-06, Y02261606, Y040314-08, Y06221508, Y082214-12, Y102714-11, Y022712-01, Y04041701, Y062714-10, Y08241505, Y111414-09, Y030113-13, Y041612-10, Y07061610, Y090613-11, Y11141607, Y030514-12, Y042712-07, Y07061702, Y091214-17, Y112912-14, Y030912-08, Y051013-06, Y071213-14, Y092012-28, Y120712-01, Y03181602, Y05111702, Y071814-12, Y09201703, Y121714-10 & Y121813-10.
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
Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure