Recall Z-0565-2018
C.R. Bard, Inc. · initiated November 10, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
BARD(R) CRITICORE(R) MONITOR, Model: 000002N Series The CritiCore(R) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature.
Codes / lots: CritiCore(R) Monitor Affected Serial Numbers DYZIAA001 DYAPAA015 DYAQAA040 DYARAA045 DYBPAA010 DYBRAA020 DYBSAA020 DYBSAA065 DYZIAA002 DYAPAA016 DYARAA001 DYARAA046 DYBPAA011 DYBRAA021 DYBSAA021 DYBSAA066 DYZIAA003 DYAPAA017 DYARAA002 DYARAA047 DYBPAA012 DYBRAA022 DYBSAA022 DYBSAA067 DYZIAA004 DYAPAA018 DYARAA003 DYARAA048 DYBPAA013 DYBRAA023 DYBSAA023 DYBSAA068 DYZIAA005 DYAPAA019 DYARAA004 DYARAA049 DYBPAA014 DYBRAA024 DYBSAA024 DYBSAA069 DYZIAA006 DYAPAA020 DYARAA005 DYARAA050 DYBPAA015 DYBRAA025 DYBSAA025 DYBSAA070 DYZIAA007 DYAQAA001 DYARAA006 DYARAA051 DYBPAA016 DYBRAA026 DYBSAA026 DYBSAA071 DYZIAA008 DYAQAA002 DYARAA007 DYARAA052 DYBPAA017 DYBRAA027 DYBSAA027 DYBSAA072 DYZIAA009 DYAQAA003 DYARAA008 DYARAA053 DYBPAA018 DYBRAA028 DYBSAA028 DYBSAA073 DYZIAA010 DYAQAA004 DYARAA009 DYARAA054 DYBPAA019 DYBRAA029 DYBSAA029 DYBSAA074 DYZJAA001 DYAQAA005 DYARAA010 DYARAA055 DYBPAA020 DYBRAA030 DYBSAA030 DYBSAA075 DYZKAA001 DYAQAA006 DYARAA011 DYARAA056 DYBQAA001 DYBRAA031 DYBSAA031 DYBSAA076 DYZKAA002 DYAQAA007 DYARAA012 DYARAA057 DYBQAA002 DYBRAA032 DYBSAA032 DYBSAA077 DYZKAA003 DYAQAA008 DYARAA013 DYARAA058 DYBQAA003 DYBRAA033 DYBSAA033 DYBSAA078 DYZKAA004 DYAQAA009 DYARAA014…
Reason for recall
BMD has identified that some lots of CritiCore(R) monitors may experience failures involving urine output volume measurement fluctuations, core bladder temperature measurement fluctuations and alarm errors.
FDA-determined cause: Software design
Action taken
Bard Medical sent an Urgent Medical Device Product Recall letter dated November 10, 2017. Action required: "Immediately examine your inventory and quarantine product subject to this recall. Please refer to CritiCore Monitor Affected Serial Numbers (Attachment 2) to help you locate the affected product serial number. Do not use or further distribute any affected product. "Please complete and return the accompanying Recall & Effectiveness Check Form (Attachment 1) attached to this letter regardless of whether you have any of the affected product. Additional instructions for product return are contained on the form. "If you have further distributed any units with the referenced serial numbers, please identify your customers and notify them at once of this product recall: Your notification should include a copy of this letter and the accompanying enclosures. This recall should be carried out to the user level." For further questions, please call (770) 784-6120
Details
- Recall number
- Z-0565-2018
- Initiated
- November 10, 2017
- Terminated
- September 22, 2021
- Product code
- EXS – Urinometer, Electrical
- Quantity
- 343 units
- Distribution
- US Distribution and Internationally to Japan
- Recalling firm
- C.R. Bard, Inc., Covington, GA