FDAFDA · Food and drugs·Recall number Z-0443-2014
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.
Published December 11, 2013 · Recall initiated: May 15, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cincinnati Sub-Zero Products Inc
- Distributor
- Worldwide Distribution - US Distribution including the following states AK, CO, FL, MA, MI, and NC. and Internationally to Canada, Germany and United Kingdom.
- Lot
- Product/Part #86127, Catalog #USB-127, Lot #00554
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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