Z-1176-2018 Class II Terminated
FDA device recall Z-1176-2018 was initiated by ConMed Corporation on Feb 23, 2018 and is designated Class II. Reason for recall: Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure The recall status is terminated (terminated Sep 17, 2020). Affected quantity: 18,720 units in total.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 4, 2018
- Initiation Date
- Feb 23, 2018
- Termination Date
- Sep 17, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18,720 units in total
Product Description
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H 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
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).
Code Information
Lot Numbers: Y01221601, Y03241702, Y10121501, Y020713-17, Y04071501, & Y12021501.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1176-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026