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U.S. Department of Health and Human Services

Class 2 Device Recall Electrophysiology catheter cables

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  Class 2 Device Recall Electrophysiology catheter cables see related information
Date Initiated by Firm May 08, 2017
Create Date July 03, 2017
Recall Status1 Terminated 3 on May 22, 2018
Recall Number Z-2669-2017
Recall Event ID 77190
Product Classification unknown device name - Product Code N/A
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.
Code Information all lots
Recalling Firm/
Manufacturer		 Sterilmed Inc
5010 Cheshire Pkwy N Ste 2
Minneapolis MN 55446-4101
For Additional Information Contact Stericycle
877-787-0369
Manufacturer 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.
FDA Determined
Cause 2		 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.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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