Events

Recall of Device Recall Bard CritiCore

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
    57291
  • Event Risk Class
    Class 3
  • Event Number
    Z-0719-2011
  • Event Initiated Date
    2010-11-17
  • Event Date Posted
    2010-12-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95763
  • 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
    Electrical Urinometer - Product Code EXS
  • Reason
    Error can occur in the reading of the present interval output (pio) reading when the device is subjected to bumping or forceful replacement of the fluid container.
  • Action
    Consignees were notified by an Urgent: Product Advisory Letter and Medica Device Recall letter on/about November 18, 2010. The letter identified the affected product, stated the reason for recall, the interim precautions, and actions to be taken. The letter requested acknowledgement of the recall and to return the entire affected product. Each consignee that is a distributor was instructed to forward the letter to their consignees to retrieve relevant product from those locations. Affected product received by Bard Medical will be reworked with the software upgrade and place back into distribution. Consignees will either receive a software upgrade on site by a third party or replacement product with the software upgrade. For international distribution, the hospital will be informed of this issue through Bard affiliate and Notified Body Bard Europe and managed according to the requirement. If there are questions or assistance is needed, customers can contact BD at 1-770-784-6969.

Device

Device Recall Bard CritiCore
  • Model / Serial
    Catalog number 000002N, Serial numbers: DYTA0001, DYTA0002, DYTA0003, DYTA0007, DYTA0008, DYTA0011, DYTA0012, DYTA0015, DYTA0016, DYTA0017, DYTA0018, DYTA0019, DYTA0020, DYTA0021, DYTA0022, DYTA0024, DYTA0025, DYTA0027, DYTA0028, DYTA0029, DYTA0030, DYTA0031, DYTA0032, DYTA0033, DYTA0034, DYTA0036, DYTA0037, DYTA0038, DYTA0039, DYTA0040, DYTA0041, DYTA0042, DYTA0043, DYTA0044, DYTA0045, DYTA0046, DYTA0047, DYTA0049, DYTA0050, DYTA0051, DYTA0052, DYTA0053, DYTA0054, DYTA0056, DYTA0057, DYTA0058, DYTA0059, DYTA0060, DYTB0001, DYTB0003, DYTB0004, DYTB0005, DYTB0009, DYTB0010, DYTB0011, DYTB0012, DYTB0013, DYTB0015, DYTB0016, DYTB0020, DYTB0021, DYTB0022, DYTB0023, DYTB0024, DYTB0025, DYTB0026, DYTB0027, DYTB0029, DYTB0030, DYTB0031, DYTB0033, DYTB0038, DYTC0001, DYTC0004, DYTC0010, DYTC0011, DYTC0016, DYTC0017, DYTC0018, DYTC0019, DYTC0020, DYTC0021, DYTC0022, DYTC0024, DYTC0025, DYTC0026, DYTC0027, DYTC0029, DYTC0030, DYTC0031, DYTC0032, DYTC0033, DYTC0034, DYTC0035, DYTC0036, DYTC0037, DYTC0038, DYTC0039, DYTC0040, DYUC0001, DYUC0002, DYUC0004, DYUC0005, DYUC0009, DYUC0012, DYUC0014, DYUC0015, DYUC0016, DYUC0017, DYUC0018, DYUC0019, DYUC0020, DYUD0001, DYUD0002, DYUD0003, DYUD0004, DYUD0005, DYUD0006, DYUD0007, DYUD0008, DYUD0009, DYUD0011, DYUD0012, DYUD0013, DYUD0014, DYUD0015, DYUD0016, DYUD0017, DYUD0019, DYUD0020, DYUD0021, DYUD0022, DYUD0023, DYUD0026, DYUD0027, DYUD0028, DYUD0029, DYUD0030, DYUD0031, DYUD0033, DYUD0034, DYUD0035, DYUD0036, DYUD0037, DYUD0038, DYUD0039, DYUD0042, DYUD0043, DYUD0045, DYUD0046, DYUD0047, DYUD0048, DYUD0049, DYUD0050, DYUD0052, DYUD0053, DYUD0055, DYUD0057, DYUD0058, DYUD0059, DYUE0002, DYUE0007, DYUE0008, DYUE0011, and DYUE0014.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- U.S., Netherlands, and Japan.
  • Product Description
    Bard¿ CritiCore¿ Monitor, Software Version 2.1, Catalog number 000002N, C.R. Bard, Inc., Covington, GA 30014. || Intended for multiple uses as it is an electronic battery-operated monitor used in conjunction with a single-use disposable urine collection container and/or a temperature sensing Foley catheter
  • 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