The Recall Desk
HighFDA (Devices)·Z-2243-2018·Announced 2018-06-27

C.R. Bard Recalls CritiCore Automated Urine Output and Temperature Monitor

C.R. Bard is recalling CritiCore Automated Urine Output and Temperature Monitors due to measurement errors and undesired alarms.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with measurement errors and undesired alarms, which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

C.R. Bard, Inc. is recalling the CritiCore Automated Urine Output and Temperature Monitor. The recall was initiated because of issues identified with the monitor, including urine output measurement errors, temperature measurement errors, and undesired alarms.

The affected units were distributed in the following states: AR, AZ, CA, FL, GA, HI, IN, JP, KS, LA, MD, MN, MO, MS, NC, NJ, OH, OK, TN, TX, VA, WA, WI, and WY. The source text does not specify the total number of units recalled or the specific dates of distribution.

Healthcare facilities and users should stop using the affected monitors and contact C.R. Bard, Inc. for further instructions on the recall. The source text does not report any specific injuries or illnesses associated with the use of these devices.

The recalled product

Product
CritiCore Automated Urine Output and Temperature Monitor
Manufacturer
C.R. Bard, Inc.

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • DYZIAA003
  • DYAPAA017
  • DYARAA002
  • DYARAA047
  • DYBPAA012
  • DYBRAA022
  • DYBSAA022
  • DYBSAA067
  • DYZIAA004
  • DYAPAA018
  • DYARAA003
  • DYARAA048
  • DYBPAA013
  • DYBRAA023
  • DYBSAA023
  • DYBSAA068
  • DYZIAA005
  • DYAPAA019
  • DYARAA004
  • DYARAA049

Distribution