FDA Enforcement
Class II
Terminated
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.
Recall: Z-0443-2014
·
Reported December 11, 2013
Enforcement
- Recall Number
- Z-0443-2014
- Event ID
- 66632
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Cincinnati Sub-Zero Products Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 11, 2013
- Initiation Date
- May 15, 2013
- Classification Date
- December 4, 2013
- Termination Date
- May 13, 2014
- Address
- 12011 Mosteller Rd, N/A, Cincinnati, OH, 45241-1528, United States
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
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.
Code Info
Product/Part #86127, Catalog #USB-127, Lot #00554
Distribution
Worldwide Distribution - US Distribution including the following states AK, CO, FL, MA, MI, and NC. and Internationally to Canada, Germany and United Kingdom.
Quantity
12 Units