FDAFDA · Food and drugs·Recall number Z-2669-2017
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.
Published July 12, 2017 · Recall initiated: May 8, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sterilmed Inc
- Distributor
- US Distribution to the states of : AL, AR, CO, FL, IL, MI, MO, MS, MT, NC, OH, PA, TN, TX, VA WI and WV.
- Lot
- all lots
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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