Events

Recall of Device Recall BARD Toomey Irrigation Syringe 70cc

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
    72977
  • Event Risk Class
    Class 3
  • Event Number
    Z-0812-2016
  • Event Initiated Date
    2016-01-04
  • Event Date Posted
    2016-02-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142618
  • 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
    Syringe, irrigating (non dental) - Product Code KYZ
  • Reason
    Report by a customer of an open package seal.
  • Action
    BMD sent an Urgent Medical Product Recall letter to each of the customers via FedEx with proof of delivery notice. The leter identified the affected product, problem and actions to be taken. All consignees were instructed to carry out the recall to the user level. The letter included a Recall and Effectiveness Check Form which was to be returned to Bard.

Device

Device Recall BARD Toomey Irrigation Syringe 70cc
  • Model / Serial
    Lot Number NGZE1190
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution - in the states of: AL, AZ, CA, CO, FL, GA, IL, IN, IA, KS, KY, LA, MD, MI, MS, MO, NE, NV, NJ, NM, NY, NC, OH, OK, PA, SC, TN, TX, VA, WA, WV, and Puerto Rico
  • Product Description
    REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapters, Single Use, Rx Only, Latex Free, 50 units. || Product Usage: || Product is intended for Resectoscope irrigation, catheter irrigation and Foley catheter inflation.
  • 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