Agency classClass IIOur severity:High FDA (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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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.
Category: Medical Device — Patient Monitoring
Hazard: measurement-error
undesired-alarms

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

Distributed in 23 states:

Same manufacturer · C.R. Bard, Inc.

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Same hazard · measurement error