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Sterilmed Inc recalls Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and th
Recalled July 12, 2017 · FDA recall Z-2669-2017 · Sterilmed
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. · FDA Class II
Units
963 devices
Sold at
US Distribution to the states of : AL, AR, CO, FL, IL, MI, MO, MS, MT, NC, OH, PA, TN, TX, VA WI and WV.
Description
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.
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.
Manufacturer(s)
Sterilmed Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →