Company: Mediware Information Systems, Inc.
Date of Enforcement Report: 1/23/02
Class: III
PRODUCT
Hemocare Blood Bank Data Management System, Recall # B-0669-2.
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 Nov. 23,
Dec. 7 and 14, 1999 and Jan. 5, March 18 and May 18, 2000. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
272 distributed.
DISTRIBUTION
Nationwide and Internationally