Recall Z-1317-2013 ยท MKJ Automated External Defibrillators (Non-Wearable)
ConMed Corporation
PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C. The PadPro(R) Adult Radiotransparent Multifunction Electrodes with Carbon Leadwires and Medtronic(R) Connector are intended to be used in external pacing, defibrillation and monitoring applications
| Date | May 13, 2013 (initiated May 3, 2013) |
| Status | Terminated |
| Reason | ConMed was notified by the contract manufacturer that their wire/connector supplier reported damage to the connector tooling which could pinch or compress the lead wire filaments and potentially render the device incapable of delivering the appropriate energy or shock to the patient and/or could cause potential injury to user or patient. |
| Root cause | Component design/selection |
| Action | ConMed sent a URGENT: Field Safety Notice letter dated May 3, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to please review your inventory for any of the devices listed on Attachment I. Business Reply Forms were sent to the domestic and foreign consignees on May 3, 2013. The domestic notices were mailed by USP Priority Mail pouches. The recall is being conducted to the end user level. We ask that you contact all of those organizations within your facility and any other faciliti |
| Quantity | Domestic: 49,010; Foreign: 600 |
| Distribution | Worldwide distribution: USA (nationwide) and the country of: Saudi Arabia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K014209 | PADPRO MODEL 2001, 2001-S, 2001-C, 2001-EPS Padpro, LLC, Jan 18, 2002 |