Z-0443-2014 Class II Terminated
FDA device recall Z-0443-2014 was initiated by Cincinnati Sub-Zero Products Inc on May 15, 2013 and is designated Class II. 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. The recall status is terminated (terminated May 13, 2014). Affected quantity: 12 Units.
Recall Details
- Product Type
- Devices
- Report Date
- December 11, 2013
- Initiation Date
- May 15, 2013
- Termination Date
- May 13, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 Units
Product Description
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.
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.
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.
Code Information
Product/Part #86127, Catalog #USB-127, Lot #00554