Recall Z-2669-2017 ยท N/A
Sterilmed Inc
Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The cables serve two different purposes. They either serve as an extension between an EP catheter and equipment out of reach or they interface an EP catheter with the appropriate external stimulation of recording equipment.
| Date | May 8, 2017 |
| Status | Terminated |
| Reason | Sterilmed is recalling all lots of specific product codes of unexpired Sterilmed Reprocessed EP Ablation Cables because Sterilmed determined that the cables are Class III devices and thus require, but do not currently have, premarket review and approval. |
| Root cause | No Marketing Application |
| Action | Sterilmed sent an Urgent Notice Medical Device Recall letter dated April 25, 2017, to all affected customers. The letter identified affected product, stated reason for recall. Affected devices were asked to be quarantined, until returned to Stericycle, by August 31, 2017 to qualify for credit. A response form was asked to be returned. Questions can be directed to Sterilmed's Customer Care Team at 1-888-541-0078. For further questions, please call ( 877 ) 787-0369. |
| Quantity | 963 devices |
| Distribution | US Distribution to the states of : AL, AR, CO, FL, IL, MI, MO, MS, MT, NC, OH, PA, TN, TX, VA WI and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.