Company: C. R. Bard Inc.
Date of Enforcement Report 1/19/2011
Class lll:

PRODUCT
Bard CritiCore Monitor, Software Version 2.1, Catalog number 000002N. 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. Recall # Z-0719-2011

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.

RECALLING FIRM/MANUFACTURER
Recalling Firm: C.R. Bard, Inc., Urological Division, Covington, GA, by letter on/about November 18, 2010.
Manufacturer: Dymax Corp., Warrendale, PA. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
234 units

DISTRIBUTION
Nationwide, Netherlands, and Japan