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U.S. Department of Health and Human Services

Enforcement Report - Week of December 11, 2013

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Event Detail

Event ID 66632
Product Type Devices
Status Ongoing
Recalling Firm Cincinnati Sub-Zero Products Inc
City Cincinnati
State OH
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-15
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution - US Distribution including the following states AK, CO, FL, MA, MI, and NC. and Internationally to Canada, Germany and United Kingdom.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data Export Software is intended for use in the electronic transfer of medical device data from the Blanketrol III to a computer, without controlling or altering the function or parameters of the Blanketrol III. Product/Part #86127, Catalog #USB-127, Lot #00554 Class II During a customer inquiry regarding a beta version of the Bill Data Export Software, Model USB-127, it was discovered that the wrong software version was released to a customer. 12 Units Z-0443-2014