ClearanceBrief
Recall Z-0601-06 ยท MEA Pump, Infusion, Pca

Hospira Inc

Hospira LifeCare PCA3 Infusion System Software, versions 4.08 and 4.09

DateMar 9, 2006 (initiated Nov 2, 2005)
StatusTerminated
ReasonIncorrect values for dosage, dose limit, concentration or rate of delivery may display on screen.
Root causeOther
ActionField corrections initiated November 2, 2005. The firm has sent notification letters to consignees via Federal Express.
Quantity10,489 units
DistributionNationwide. Distributed to 544 domestic consignees, all direct users.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K022203ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384
Abbott Laboratories, Aug 1, 2002
K043256HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03
Hospira, Inc., Dec 6, 2004