# FDA recall Z-2669-2017

> **Sterilmed Inc** · Class II · device recall initiated 2017-05-08.

## 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.

## 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

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

## Key facts

- **Recall number:** Z-2669-2017
- **Recalling firm:** Sterilmed Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-05-08
- **Report date:** 2017-07-12
- **Termination date:** 2018-05-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2669-2017

## Citation

> AI Analytics. FDA recall Z-2669-2017. Retrieved 2026-07-05 from https://api.ai-analytics.org/recall/Z-2669-2017. Source: US FDA. Licensed CC0.

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