Company: Hospira Inc.,
Date of Enforcement Report:3/15/2006
Class:lI
PRODUCT
Hospira LifeCare PCA3 Infusion System Software, versions 4.08 and 4.09, Recall # Z-0601-06
REASON
Incorrect values for dosage, dose limit, concentration or rate of delivery may display on screen.
CODE
List numbers 12384-04, software version 4.08 and 4.09
RECALLING FIRM/MANUFACTURER
Hospira, Inc., Morgan Hill , CA , by letters on November 2, 2005 , firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
10,489 units
DISTRIBUTION
Nationwide
