Recall Z-0757-2007 ยท MLN Electrode, Electrocardiograph, Multi-Function
Conmed Corporation
PADPRO ADULT Radiotranslucent Pad w/Medtronic connector, REF/Catalog #2516M. RX ONLY. Defibrillation/Pacing/Cardioversion/Monitoring Electrodes. Made in USA for: CONMED CORPORATION Utica, New York, 13502.
| Date | Apr 24, 2007 (initiated Mar 8, 2007) |
| Status | Terminated |
| Reason | Firm was notified of three incidents over the past 15 months in which customers opened the pouch & found an incorrect connector. This error makes the product unusable. The Zoll and Medtronic connectors are not interchangeable and are unique to their specific device. |
| Root cause | Other |
| Action | On 3/08/07, "URGENT DEVICE RECALL" letters (dated 3/05/07) will be sent via UPS to the US distributors and direct user accounts. The letters inform them of the problem and of the recall. The letters instruct them to immediately discontinue using the affected lots, inspect their stocks, and to return them as soon as possible. The letters instruct the consignees to notify their customers of the recall of the devices to the user level if they have been distributed, and request the return of the products. Additionally, when requested, ConMed will notify distributor's customers (sub-accounts) by t |
| Quantity | 920 pairs |
| Distribution | Worldwide, including USA, Canada, Romania, Chile, and Belgium |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020203 | PADPRO MODEL #2516 Padpro, LLC, May 8, 2002 |