Events

Recall of Device Recall RUSCH Foley Insertion Tray

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
    68746
  • Event Risk Class
    Class 3
  • Event Number
    Z-2154-2014
  • Event Initiated Date
    2014-07-10
  • Event Date Posted
    2014-08-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-11-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128594
  • 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
    Urinary Catheter insertion kit - Product Code FCM
  • Reason
    Labeling error: the manufacturing date is the same as the expiration date. the manufacturing date is correct, however the expiration date incorrectly indicates that the product is expired.
  • Action
    Consignees were notified via letter on/about 07/10/2014.

Device

Device Recall RUSCH Foley Insertion Tray
  • Model / Serial
    Product Code: 76730, Lot number: 307505.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution in CA, CT, FL, MA, MO, NJ, OH, OR and TX.
  • Product Description
    RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product Code: 76730.
  • 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