Z-0601-06

Hospira LifeCare PCA3 Infusion System Software, versions 4.08 and 4.09

Name: Z-0601-06 Hospira LifeCare PCA3 Infusion System Software, versions 4.08 and 4.09
Creator: Hospira Inc
Published: 2005-11-02
License: https://open.fda.gov/license/

Abbott Medical / initiated 2005-11-02 / Terminated

FDA source

Hospira Inc began a recall of Hospira LifeCare PCA3 Infusion System Software, versions 4.08 and 4.09 on 2005-11-02. The reason FDA records is "Incorrect values for dosage, dose limit, concentration or rate of delivery may display on screen". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0601-06
Status: Terminated
Initiated: 2005-11-02
Posted: 2006-03-09
Terminated: 2006-08-11
Recalling firm: Abbott Medical
Product: Hospira LifeCare PCA3 Infusion System Software, versions 4.08 and 4.09
Product code: MEA Pump, Infusion, Pca
Reason for recall: Incorrect values for dosage, dose limit, concentration or rate of delivery may display on screen.
FDA root 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.
Product codes and lots: List numbers 12384-04, software version 4.08 and 4.09

Product code MEA

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)