Hospira, Inc.

Software Version 7.2.1800.3 and 7.2.1825.5

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide Distribution in states of CA, FL, IL, IN, KY, KS, MI, MO, MT, NC, NJ, NM, NV, OH, SC, SD, TN, TX, VA, WA, and WY.

EndoTool Drug Dose Calculator-Software Version 7.2.1800.3 and 7.2.1825.5

The letter was issued for all product presently in the field and product that will be released. Specific lot numbers were not indicated in the letter.

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, NK, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY and the countries of Canada, Costa Rica and the Virgin Islands.

Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-03, Hospira, Inc., Lake Forest, IL 60045. || For use with a compatible Hospira PCA pump set with injector and a compatible Hospira infusion device.