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U.S. Department of Health and Human Services

Class 2 Device Recall Blanketrol III Data Export Software

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 Class 2 Recall
Blanketrol III Data Export Software
see related information
Date Posted December 04, 2013
Recall Status1 Terminated on May 13, 2014
Recall Number Z-0443-2014
Recall Event ID 66632
Product Classification System, Thermal Regulating - Product Code DWJ
Product 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.
Code Information Product/Part #86127, Catalog #USB-127, Lot #00554
Recalling Firm/
Manufacturer
Cincinnati Sub-Zero Products Inc
12011 Mosteller Rd
Cincinnati, Ohio 45241-1528
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control
Action Cincinnati Sub-Zero sent a Urgent Medical Device Notification letter dated July 15, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They instructed their customers to to do the following: 1) Upon receipt of the corrected Blanketrol III Data Export Software disc, immediately collect and destroy all previous Blanketrol III Data Export Software disc from this lot # currently in possession and replace all downloaded Blanketrol III Data Export Software with the correct version provided by CSZ. 2) After the Blanketrol Data Export Software Version 1.00 have been destroyed and downloaded versions replaced with version 1.10, complete and return the enclosed response form as soon as possible to acknowledge receipt of this notification and to inform CSZ that you have performed and completed the requested actions. Return the form by fax to (513) 772-9119 scan and e-mail the information to BIIIExportSoftware@cszinc.com, or mail to: Cincinnati Sub-Zero 12011 Mosteller Road Cincinnati, OH 45241 U.S.A. For further questions please call 1-(800) 989-7373 or (513) 772-8810.
Quantity in Commerce 12 Units
Distribution Worldwide Distribution - US Distribution including the following states AK, CO, FL, MA, MI, and NC. and Internationally to Canada, Germany and United Kingdom.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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