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.

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.

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