Events

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
    Recall
  • Event ID
    59356
  • Event Risk Class
    Class 2
  • Event Number
    Z-2943-2011
  • Event Initiated Date
    2011-06-30
  • Event Date Posted
    2011-08-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102364
  • 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

Device

Device Recall RUSCH
  • Model / Serial
    Product number: 238500220, Lot numbers: 108305, 140250, 142683, 153802, 276286, 359988, 370083, 375047 and 378586.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution and (USA) Nationwide Distribution.
  • Product Description
    RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 22 Fr. 40 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
    Teleflex Medical

Manufacturer

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