Inc Class II Mediware Information Systems

Company: Mediware Information Systems, Inc
Date of Enforcement Report: 1/23/02
Class: II

PRODUCT
Hemocare Blood Bank Data Management System, Recall # B-0670-2.

REASON
Defects in the design of blood bank software programs could result in the release of unsuitable blood products.

CODE
Version 5.1, 5.2 and/or 5.2a.

RECALLING FIRM/MANUFACTURER
Mediware Information Systems, Inc., Melville, NY, by letters on September 16, 24, October 4, 1999 and May 18, 2000. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
272 distributed.

DISTRIBUTION
Nationwide and Internationally

About the author

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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Or just email training@softwarecpr.com for more info.

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