Z-2669-2017Class II

Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal...

Name: Z-2669-2017 Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal...
Creator: Sterilmed Inc
Published: 2017-05-08
License: https://open.fda.gov/license/

Sterilmed Inc / initiated 2017-05-08 / Terminated / root cause: sterility

FDA source

Sterilmed Inc began a recall of 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... on 2017-05-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2669-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-08
Posted: 2017-07-03
Terminated: 2018-05-22
Recalling firm: Sterilmed Inc
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.
Product code: N/A
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.
Root cause tag: sterility
FDA root cause: No Marketing Application
Action: Sterilmed sent an Urgent Notice Medical Device Recall letter dated April 25, 2017, to all affected customers. The letter identified affected product, stated reason for recall. Affected devices were asked to be quarantined, until returned to Stericycle, by August 31, 2017 to qualify for credit. A response form was asked to be returned. Questions can be directed to Sterilmed's Customer Care Team at 1-888-541-0078. For further questions, please call ( 877 ) 787-0369.
Quantity in commerce: 963 devices
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.
Product codes and lots: all lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2669-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2669-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-12	2017-07-03

Product code N/A

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)