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
    58966
  • Event Risk Class
    Class 2
  • Event Number
    Z-2672-2011
  • Event Initiated Date
    2011-06-02
  • Event Date Posted
    2011-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-04-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100736
  • 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
    Bag, urine collection, leg, for external use, sterile - Product Code FAQ
  • Reason
    Sterile integrity cannot be guaranteed.
  • Action
    Teleflex Medical sent an " URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated June 2, 2011. The letter identified the product, the problem and the actions needed to be taken. The customers were instructed to immediately discontinue distribution, quarantine any affected products, communicate this recall to any of their customers using the provided customer letter, and complete and fax the enclosed Recall Acknowledgement Form to Customer Service at 1-866-804-9881. Once the fax is received instructions for product return will be provided to customers. In the event that an alternative approach is needed, customers are instructed to contact Teleflex Medical Customer Service at 1- 866-246-6990. For further questions contact your sales representative or Customer Service at 1-866-246-6990. The recall was expanded and an additional letter was sent out on July 20, 2011 to the affected consignees with the above instructions. *****RECALL EXPANDED***** Product 2. Teleflex sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter dated July 20, 2011, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. On July 19, 2011 this recall was expanded to include additional product. Please see above strategy information for details

Device

Device Recall RUSCH
  • Model / Serial
    Catalogue number: 390060, Lot number: 20100515 & 20100501; Catalogue number: 452919, Lot number: 20100405.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution: AZ, CA, FL, GA, IL, KS, KY, LA, MA, MS, NC, NJ, NM, NY, OH, OK, PA, TN, TX, VA, WI including Puerto Rico.
  • Product Description
    RUSCH Urinary Drainage Bag, 2000 ml || Product Usage: For one time use per the Directions for Use with urinary catheter for drainage of urine.
  • 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