Class 1 Recall: Baxa Corporation Exacta-Mix™ 2400 Operating Software Version 1.07 Pharmacy Compound System

June 27, 2007

Exacta-Mix™ 2400 Operating Software version1.07, Model No. 8300-0073, Pharmacy Compound System

From June 4, 2007 through June 25, 2007, Baxa distributed 32 units to 14 U.S. customers and to one foreign customer.

The device is a compounding system that can be used in pharmacies to add and mix various ingredients into one intravenous (IV) solution.

A software failure allowed up to 50mL extra volume of an ingredient to be added to the IV solution that can be life-threatening, particularly in newborns.

All customers were notified by telephone on June 27, 2007 with a follow-up of a FAXed/email letter detailing the software error. They were given instructions to follow to prevent the problem from occurring until the software could be replaced with version 1.06. An additional copy of the recall letter was sent by FedEx. All customers now have the affected software replaced by version 1.06.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

• Online: www.fda.gov/MedWatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
  Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• FAX: 1-800-FDA-0178