Events

Recall of Device Recall Electrophysiology catheter cables

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sterilmed Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77190
  • Event Risk Class
    Class 2
  • Event Number
    Z-2669-2017
  • Event Initiated Date
    2017-05-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-05-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155303
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    unknown device name - Product Code N/A
  • Reason
    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.
  • 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.

Device

Device Recall Electrophysiology catheter cables
  • Model / Serial
    all lots
  • 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 Description
    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.
  • Manufacturer
    Sterilmed Inc

Manufacturer

Sterilmed Inc
  • Manufacturer Address
    Sterilmed Inc, 5010 Cheshire Pkwy N Ste 2, Minneapolis MN 55446-4101
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA