Events

Recall of Device Recall SureStep Tray, with AddaFoley

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by C.R. Bard, Inc..

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
    74610
  • Event Risk Class
    Class 3
  • Event Number
    Z-2333-2016
  • Event Initiated Date
    2016-06-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-12-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148028
  • 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
    Collector, urine, (and accessories) for indwelling catheter - Product Code KNX
  • Reason
    Labeling problem.
  • Action
    Bard Medical sent an Urgent Medical Device Product Recall letter dated June 29, 2016. The letter identified the product, the problem, and the action to be taken by the customer. The letter requested that customers examine their inventory and quarantine the product. The letter also requested a sub-recall. The letter included a reply form which is to be returned to Bard. Customers were also instructed if product was further distributed they identify customers and notify them at once. Customers with questions should contact the BMD Recall Coordinator at 1-800-793-8110.

Device

Device Recall SureStep Tray, with AddaFoley
  • Model / Serial
    Lot Number NGZG1722
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to CA, FL, IL, IA, KY, NC, MN, NC, OR, RI, SD, TX, UT, and WA.
  • Product Description
    SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization || The product is a urine collection system that includes a STATLOCK Foley Stabilization Device
  • Manufacturer
    C.R. Bard, Inc.

Manufacturer

C.R. Bard, Inc.
  • Manufacturer Address
    C.R. Bard, Inc., 8195 Industrial Blvd NE, Covington GA 30014-1497
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA