Recall Z-1175-2018 ยท MKJ Automated External Defibrillators (Non-Wearable)
ConMed Corporation
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 pac
| Date | Feb 23, 2018 |
| Status | Terminated |
| Reason | Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure |
| Root cause | Process design |
| Action | The firm, ConMed,issued an "URGENT: DEVICE RECALL" notice dated 2/28/2018 and business reply forms to customers on 2/28/2018 via courier service. The notice described the product, problem and actions to be taken. The Customers were instructed to do the following: Step 1: Review your inventory for any of the devices with the lot codes listed on the notice. Customers are encouraged to contact all of those departments within your facility and any other facilities within your organization that may have received affected products. It is imperative that all end users of these devices receive this |
| Quantity | 18,720 units in total |
| Distribution | 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). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002280 | PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602 Medical Devices, Inc., Feb 5, 2001 |