Events

Recall of Bard RespiShield

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

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
    33780
  • Event Risk Class
    Class 2
  • Event Number
    Z-0178-06
  • Event Date Posted
    2005-11-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-01-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42430
  • 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
    Catheters, Suction, Tracheobronchial - Product Code BSY
  • Reason
    Varying degrees of difficulty were encountered when opening and closing the innovalve.
  • Action
    Consignees were notified via Federal Express letter on/about 09/28/2005.

Device

Bard RespiShield
  • Model / Serial
    Catalog Number: 220059, Lot Numbers: NGPD0713, NGPD0714, NGPE11, Catalog Number: 220067, Lot Number: NGPD2781, Catalog Number: 220068, Lot Number: NGPD0855, Catalog Number: 220069, Lot Numbers: NGPD0939, NGPD1735, NGPD2015, NGPE0403, NGPE0404, Catalog Number: 220141, Lot Number: NGPE1200, Catalog Number: 220145, Lot Number: NGPD0934, Catalog Number: 220155, Lot Number: NGPD2697, Catalog Number: 220211, Lot Number: NGPE1170.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Bard RespiShield¿ * Closed Suction System with InnoValve¿ * Endotracheal Start Kit * QTY 1 Unit * 14F/4.7mm * Sterile * Rx Only * C.R.Bard, Inc., Covington, GA 30014, 800-526-4455, www. bardmedical.com * Manufactured in Mexico.
  • Manufacturer
    C.R. Bard, Inc., Urological Division

Manufacturer

C.R. Bard, Inc., Urological Division
  • Manufacturer Address
    C.R. Bard, Inc., Urological Division, 8195 Industrial Blvd Ne, Covington GA 30014-1497
  • Source
    USFDA