CLASS II Device recall · Reported 4 Apr 2018 · FDA Enforcement Report
Mini Infant <, Radiotranslucent Electrode, Zoll¿ Connector recalled
ConMed is recalling Mini Infant <, Radiotranslucent Electrode, Zoll¿ Connector, distributed nationwide in the US. The recall was initiated on 23 Feb 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1178-2018
- FDA event ID
- 79337
- Recalling firm
- ConMed, Utica, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Feb 2018
- FDA classified
- 24 Mar 2018
- Reported
- 4 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Pacemakers & Defibrillators
Timeline
| 23 Feb 2018 | Recall initiated by company | |
| 24 Mar 2018 | Classified by FDA | +29 days |
| 4 Apr 2018 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.).
Where it was distributed
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).
Questions about this recall
Why was it recalled?
Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure
Which lots are affected?
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.
Where was it sold?
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).
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 79337This product is part of a recall event; the main page for the event is Mini Infant <, Radiotranslucent Electrode recalled by ConMed.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Mini Infant <, Radiotranslucent Electrode recalled by ConMed | ConMed | Device Malfunction | Nationwide | |
| CLASS II | Mini Infant <, Radiotranslucent Electrode recalled by ConMed | ConMed | Device Malfunction | Nationwide | |
| CLASS II | Mini Infant <, Radiotranslucent Electrode recalled by ConMed | ConMed | Device Malfunction | Nationwide | |
| CLASS II | Mini Infant <, Radiotranslucent Electrode recalled by ConMed | ConMed | Device Malfunction | Nationwide |
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