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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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Event Detail

Event ID 62021
Product Type Biologics
Status Ongoing
Recalling Firm SCC Soft Computer
City Clearwater
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-11-11
Initial Firm Notification of
Consignee or Public
Distribution Pattern New York and Michigan

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
SoftBank II versions 23.1 and 25.1 applications are decision support software devices. SoftBank II versions 23.1 documents the receipt of inventory from an outside source, multi-side inventory control, records the confirmatory testing on the units and allows for records keeping on component preparation for transfusion. Soft Bank II versions 23.1 and 25.1 Class II Software, with a glitch or defect, was distributed. 2 products B-1162-12