Device Recall ExactaMix

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

General Hospital and Personal Use Devices

2

No

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

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

model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR and 2400-DYX

General Hospital and Personal Use Devices

2

No

US Nationwide

EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200 DY Display, Replacement EM 1200 DY Display. EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR and 2400-DYX. Baxa Corporation. An automated pumping system that compounds multiple sterile ingredients into a finished solution in a single patient IV administration bag.

Version 1.07 of the EM2400 Operating Software. (Serial Numbers: 36805,36806,36356,36399,36804,36799,36797,36398,32438,36798,36460,36794,32346,36800,36801,36802,36803,(37767-36773), (36788-36793),36795 and 36796 (foreign)

General Hospital and Personal Use Devices

2

No

Class I Recall-Worldwide Distribution: USA including states of CA, CO, FL, KY, MI, NY, OH, OR, and TX and the UK

Exacta-Mix 2400, OS v1.07, Model No. 8300-0073, Pharmacy Compounding System, Baxa Corporation, Englewood, CO 80112.

2 model numbers 2400 D and 2400 M.

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - USA Nationwide including Canada.

Pharmacy compounding system . It is a twenty-four source compounder for multi-source fluid mixing of both macro and micro ingredient down to 0.2 ml quantities. || Product Usage: Pharmacy compounding System for parenteral macro and micro ingredients

Lot numbers: 738391, 738392.

General Hospital and Personal Use Devices

2

No

Worldwide distribution, including USA, Argentina, Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, Hong Kong, Japan, Malaysia, Mexico, New Zealand, Panama, Peru, Singapore, South Korea, Taiwan, and Uruguay.

Exacta Mix TPN (total parenteral nutrition) Bag, Model 738, 500mL, Baxa Corporation.