Class 2 Device Recall LifeCare PCA3

• Date Initiated by Firm: November 02, 2005
• Date Posted: March 09, 2006
• Recall Status: Terminated on August 11, 2006
• Recall Number: Z-0601-06
• Recall Event ID: 34053
• 510(K)Number: K022203 K043256
• Product Classification: Pump, Infusion, Pca - Product Code MEA
• Product: Hospira LifeCare PCA3 Infusion System Software, versions 4.08 and 4.09
• Code Information: List numbers 12384-04, software version 4.08 and 4.09
• Recalling Firm/ Manufacturer: Hospira Inc; 755 Jarvis Dr; Morgan Hill CA 95037-2810
• For Additional Information Contact: Willy Weinmann; 408-782-3519
• Manufacturer Reason for Recall: Incorrect values for dosage, dose limit, concentration or rate of delivery may display on screen.
• FDA Determined Cause: Other
• Action: Field corrections initiated November 2, 2005. The firm has sent notification letters to consignees via Federal Express.
• Quantity in Commerce: 10,489 units
• Distribution: Nationwide. Distributed to 544 domestic consignees, all direct users.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MEA; 510(K)s with Product Code = MEA