Recall Z-2669-2017— Sterilmed Inc
Class II · Terminated
Class II FDA medical device recall by Sterilmed Inc, initiated 2017-05-08, terminated 2018-05-22. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Sterilmed Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-05-08
- Terminated
- 2018-05-22
- Firm location
- Minneapolis, MN, United States
Product description
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 for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.