MINI INFANT < 3KG — Class II medical device recall Z-1174-2018
Terminated recall by ConMed Corporation, reported 2018-04-04, distributed nationwide. Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity
| Recall number | Z-1174-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ConMed Corporation, Utica, NY, United States |
| Recall initiated | 2018-02-23 |
| Classified | 2018-03-24 |
| Reported by FDA | 2018-04-04 |
| Terminated | 2020-09-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CH, NZ, SA, UY |
| Quantity | 18,720 units |
| Lot numbers | Y011813-09, Y012714-08, Y013012-04, Y020713-13, Y022814-09, Y03151701, Y031715-11, Y032513-16, Y03271501, Y040612-16, Y040715-02, Y04291601, Y050313-10, Y050412-08, Y050814-15, Y05251701, Y06071601, Y060812-04, Y061214-15, Y06291501, Y072012-14, Y072513-04, Y07291601, Y08031702, Y081314-03, Y08231601, Y090514-11, Y090712-04, Y091914-07, Y100412-08, Y103114-03, Y110912-12, Y11131501, Y112414-03, Y121613-07, Y12181501 |
| Model numbers | 2602 |
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.).
Reason for recall
Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1174-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.