Z-2669-2017 Class II Terminated
FDA device recall Z-2669-2017 was initiated by Sterilmed Inc on May 8, 2017 and is designated Class II. 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… The recall status is terminated (terminated May 22, 2018). Affected quantity: 963 devices.
Recall Details
- Product Type
- Devices
- Report Date
- July 12, 2017
- Initiation Date
- May 8, 2017
- Termination Date
- May 22, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 963 devices
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.
Distribution Pattern
US Distribution to the states of : AL, AR, CO, FL, IL, MI, MO, MS, MT, NC, OH, PA, TN, TX, VA WI and WV.
Code Information
all lots