Sterilmed Inc recalls Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the…

Recall date

May 8, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2669-2017

FDA classification

Class II

Brand / firm

Sterilmed Inc

Sold / distributed

US Distribution to the states of : AL, AR, CO, FL, IL, MI, MO, MS, MT, NC, OH, PA, TN, TX, VA WI and WV.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.