Company: Baxter Healthcare Corp.
Date of Enforcement Report 3/30/2011
Class ll:
PRODUCT
1) AUTOMIX High Speed Compounder System, product 2M8077; automated nutrition compounders; The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing. Recall # Z-1383-2011;
2) AUTOMIX Plus High Speed Compounder System, product 2M8075; automated nutrition compounders; The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing. Recall # Z-1384-2011;
3) AUTOMIX 3+3 Compounder System, product 2M8286 (115V) and 2M8286K (230V), automated nutrition compounders; The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing. Recall # Z-1385-2011;
4) AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; automated nutrition compounders; The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing. Recall # Z-1386-2011
REASON
The AUTOMIX compounder may not respond correctly to the key pressed by the operator using the keypad. The incorrect keypad response issue can occur both in manual data entry mode (STD Mode) and when entering order numbers to download from host software (MAN ID Mode). It is possible that an incorrect volume and/or an incorrect solution could be admixed into the final bag.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated January 27, 2011.
Manufacturer: Baxter Healthcare Corp., Largo, FL. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
5,166 units
DISTRIBUTION
Nationwide, and Internationally
