Jan

2011

Cl lll Bard CritiCore Monitor

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

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl lll Bard CritiCore Monitor

Amy Sellers

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