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May 8, 2002
Company: Sigma International MedinaDate of Enforcement Report: 5/8/02 Class: II PRODUCT Sigma 8000 Volumetric Infusion Pumps with software version 3.50.01. Recall # Z-0991-2. REASON Software error: Distal occlusions may not be detected (no alarm) at rates above 550 ml/hr. CODE The following serial numbers. 49105, 49111R, 49188R, 49288R, 49289R, 49402R, 49436R, 49448R, 49454R, 49466R, 49507R,...
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