FDA Device recall Z-2669-2017
Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number…
- FDA Device
- Class II
- terminated
- Published 2017-07-12
On 2017-07-12 the FDA classified a Class II recall of Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number… by Sterilmed, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2669-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-08 |
| Published | 2017-07-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Sterilmed |
| Distribution | AL, AR, CO, FL, IL, MI, MO, MS, MT, NC, OH, PA, TN, TX, VA, WI, WV |
Product
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.
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.
Identifiers
| code_info | all lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2669-2017%22
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