Z-1752-2013 Class II Terminated

Recalled by Baxa Corporation — Englewood, CO

Recall Details

Product Type
Devices
Report Date
July 24, 2013
Initiation Date
June 4, 2013
Termination Date
October 16, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
753 units

Product Description

ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution.

Reason for Recall

Baxter Healthcare is recalling certain ExactaMix automated compounding devices due to the complementary metal oxide semi-conductor battery failure resulting in resetting the internal clock of the device to midnight December 31, 2010.

Distribution Pattern

Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada, Latin America, Europe/Middle East/Africa, and Taiwan.

Code Information

ExactaMix 1200 serial numbers 45004-45481 (sequentially), and ExactaMix 2400 serial numbers 40005-40335.