Events

Recall of Device Recall Rusch, Sure Seal Golden Drain, One Piece Urinary Incontinence Device

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
    59184
  • Event Risk Class
    Class 2
  • Event Number
    Z-2831-2011
  • Event Initiated Date
    2011-06-27
  • Event Date Posted
    2011-07-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101559
  • 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
    Sheath, Corrugated rubber, for nonindwelling catheter - Product Code NNY
  • Reason
    The kit contains skin-prep protective wipes that were manufactured by the triad group and are being recalled by smith & nephew, due to possible bacterial contamination.
  • Action
    Teleflex Medical sent an "Urgent Medical Device Recall Notification" dated June 27, 2011 to all affected customers. The firm provided recommendations including all affected product be discontinued and quarantined. A Recall Acknowledgement Form was provided to be completed and returned. If the product was further distributed, they were urged to contact their customers and communicate the recall. For additional information please contact Customer Service at 866-246-6990 or your local sales representative.

Device

Device Recall Rusch, Sure Seal Golden Drain, One Piece Urinary Incontinence Device
  • Model / Serial
    Catalog number: A1300VA, Lot number: 02E1002552   Catalog number: A1300, Lot number: 02F1001467, 02F1002271, 02F1003283, 02G1000845 and 02G1001302.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution (USA) including the states of FL, GA, OH and SC.
  • Product Description
    Rusch, Sure Seal Golden Drain, One Piece Urinary Incontinence Device, Teleflex Medical. || Used for urine collection.
  • 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