Recall of Device Recall RUSCH

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed.
  • Action
    Teleflex Medical sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated June 30, 2011 to all affected consignees. The letter described the product, problem and actions to be taken. The letter instructs the customers to discontinue use and quarantine any of the affected products. Customers were asked to complete the attached Recall Acknowledgement Form and return as per the instructions. A separate letter was sent to distributors instructing them to communicate the recall to any of their customers who may have receive the affected products, using the recall letter and form as a template. For questions, contact your local sales representative or call Customer service at 1-866-246-6990


  • Model / Serial
    Product Number: 238300080, Lot Numbers: 082827-1, 120007, 122274, 122275, 123171, 124446, 129582, 130627, 142572, 318007, 322167, 335514,338383, 340211, 342044, 350053, 350054, 350055, 359272, 359989 and 405523.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution and (USA) Nationwide Distribution.
  • Product Description
    RUSCH, GB: Female Catheter, All Purpose PVC, 08 Fr. 18 cm, Distributed by Teleflex Medical, Research Triangle Park, NC || Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract.
  • Manufacturer


  • Manufacturer Address
    Teleflex Medical, 4024 Stirrup Creek Dr, Durham NC 27703-9000
  • Manufacturer Parent Company (2017)
  • Source