Events

Recall of Device Recall RUSCH Easy Cath

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

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
    68350
  • Event Risk Class
    Class 2
  • Event Number
    Z-1732-2014
  • Event Initiated Date
    2014-05-21
  • Event Date Posted
    2014-06-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-11-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127390
  • 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
    Catheter, urological - Product Code KOD
  • Reason
    Product was packaged with a straight catheter rather than the correct coude (curved) catheter.
  • Action
    Teleflex Medical sent an Urgent Medical Device Recall Notification dated May 21, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine any of the affected product in stock. They were to complete and return the enclosed Recall Acknowledgement Form via fax to Teleflex Medical. Upon receipt, they will be contacted by a Customer Service Representative with instructions for the return of the product to Teleflex Medical. Teleflex Medical is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.

Device

Device Recall RUSCH Easy Cath
  • Model / Serial
    Product Code: ECK103, Lot number: 02A1402484
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of CA, FL, OH and OK.
  • Product Description
    RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical, Research Triangle Park, NC 27708. || A tubular device that is inserted through the urethera and is used to pass fluids to or from urinary tracts.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Manufacturer Address
    Teleflex Medical, 2917 Weck Dr., Research Triangle Park NC 27709
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA