Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data Export Software is intended for use in the elec

FDA device recall Z-0443-2014 · posted 2013-12-04 · Terminated

Recall details

Recalling firm

Cincinnati Sub-Zero Products Inc

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.

Action taken

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.

Root cause

Software Manufacturing/Software Deployment

Status

Terminated

Product code

DWJ

Quantity affected

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.

Date initiated

2013-05-15

Date posted

2013-12-04

Date terminated

2014-05-13

Location

Cincinnati, OH