Reported Jul 12, 2017 · Terminated
Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the…
Sterilmed Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sterilmed Inc · 5010 Cheshire Pkwy N Ste 2 · Minneapolis, MN · 55446-4101
Is this the product you have?
- 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.
- Lot codes and dates
- all lots
- Amount recalled
- 963 devices
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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