Baxa Corporation

Repeater Pump model #s 095, 099, and 099R.

General Hospital and Personal Use Devices

2

No

Worldwide Distribution-USA (nationwide) and the countries of Argentina, Australia, Brazil, Canada, Columbia, Guam, Japan, Malaysia, Mexico, Panama, Puerto Rico, Taiwan, UK, and Venezuela.

Repeater Pump, Class II device used for facilitating repeatable drug dosage distribution and reconstitution in hospital pharmacies. The device are Fluid Transfer Tube Sets, Sterile/EO, Std Volume Trifurcated, BAXA Corporation, Englewood, CO. || The Repeater Pump is a device that provides a peristaltic pump driven fluid transfer that facilitates repeatable drug dosage distribution and reconstitution in hospital pharmacies. The device is for use with IV bags, syringes, elastomeric infusers, and other drug administration containers.

Model 071B-RS232, all serial numbers

General Hospital and Personal Use Devices

2

No

Nationwide, including military facilities in CA, FL, HI, MS, NC, TX, VA and VA facilities in NY, OR, SC, UT. Foreign distribution to Australia, Canada, China and New Zealand.

Exacta-Mix 600 Pharmacy Compounding System is used in the pharmacy to compound multiple source ingredients into on final solution based on user-specified sequences and volumes.

Models 2400-D, 2400-M, 2400-L, all serial numbers

General Hospital and Personal Use Devices

2

No

Nationwide, including military facilities in CA, FL, HI, MS, NC, TX, VA and VA facilities in NY, OR, SC, UT. Foreign distribution to Australia, Canada, China and New Zealand.

Exacta-Mix 2400, Pharmacy Compounding System is used in the pharmacy to compound multiple source ingredients into on final solution based on user-specified sequences and volumes.

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.

Lot or Serial No. 785518

General Hospital and Personal Use Devices

2

No

Distributed to One Customer in NC.

Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Single Use. Product Code H93890. || Used as a needleless access device for reconstitution and drug transfer.