Retiro De Equipo (Recall) de Device Recall AUTOMIX

Recall

62558

Class 1

Z-2139-2012

2012-07-13

2012-08-08

Terminated

United States

2017-08-11

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110985

After fluid ingress into the keypad of the automix compounder's (automix) control module, the automix may generate an incorrect device response to an automix operator's key press. also, the automix system may experience an intermittent electrical failure, in which unexpected pump motor operations will occur. also, the automix system may intermittently experience an electrical failure where the compounder may stop compounding without an alarm and not be detected by the user.

Baxter Healthcare Corp. sent an Urgent Product Recall letters dated July 13, 2012, via first class mail to all affected customers, informing personnel that Baxter was executing a voluntary controlled product withdrawal of the Automix system from the U.S. market by June 1, 2013. Until their units can be replaced, customers were advised to exercise care when entering data, and verify the accuracy of the keypad response; to inspect the umbilical cable of the Automix for any visible cuts, nicks deformation, or physical damage to the cable, discontinuing use of the device if such damage is found; and to return the device to Baxter if the device stops compounding without an alarm and without a visible green complete light, discarding the solution bag. The customers were requested to convey this information to all users of the Automix compounders, and a wall chart was provided to hang over the device to remind users of the mitigations to take. The customers were also requested to complete the attached customer reply form listing the model and serial number of each of the Automix compounders at the facility and confirming their receipt of the letter, and fax it to Baxter at the number provided on the form. Any questions regarding the communication were directed to their local Baxter representative, and technical questions were directed to Baxter's Global Technical Services at 1-800-626-2667.