Z-0389-06

Hospira brand Plum A+I.V. Infusion Pump, List No. 11971-04; Hospira brand Plum A+I.V. Infusion Pump, List No...

Name: Z-0389-06 Hospira brand Plum A+I.V. Infusion Pump, List No. 11971-04; Hospira brand Plum A+I.V. Infusion Pump, List No...
Creator: Hospira Inc
Published: 2005-05-18
License: https://open.fda.gov/license/

Abbott Medical / initiated 2005-05-18 / Terminated

FDA source

Hospira Inc began a recall of Hospira brand Plum A+I.V. Infusion Pump, List No. 11971-04; Hospira brand Plum A+I.V. Infusion Pump, List No. 12391-04; Hospira brand Plum A+3 I.V. Infusion... on 2005-05-18. The reason FDA records is "The pump may shut-off prematurely during battery operation without providing adequate response time when 'E320' service warning message appears". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0389-06
Status: Terminated
Initiated: 2005-05-18
Posted: 2006-01-12
Terminated: 2006-12-21
Recalling firm: Abbott Medical
Product: Hospira brand Plum A+I.V. Infusion Pump, List No. 11971-04; Hospira brand Plum A+I.V. Infusion Pump, List No. 12391-04; Hospira brand Plum A+3 I.V. Infusion Pump, List No. 12618-04; Hospira brand Plum A+3 I.V. Infusion Pump, List No. 12348-04; Infusion pump is a multi-function fluid delivery infusion system, consisting of pumping module and assortment of IV sets. Product is manufactured and distributed by Hospira Inc., 755 Jarvis Dr., Morgan Hill, CA
Product code: FRN Pump, Infusion
Reason for recall: The pump may shut-off prematurely during battery operation without providing adequate response time when 'E320' service warning message appears.
FDA root cause: Other
Action: On 5/18/05, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected products and providing instructions on the recall.
Distribution: Product was distributed nationwide to 746 domestic consignees. Product was distributed internationally to the following countries: Puerto Rico, Canada, Saudi Arabia, Taiwan, Australia, Italy, Jordan, New Zealand, Spain, Turkey, and United Arab Emirates.
Product codes and lots: List No. 11971-04 Plum A+ I.V. Infusion Pump; List No. 12391-04 Plum A+ I.V. Infusion Pump; List No. 12618-04 Plum A+3 I.V. Infusion Pump; List No. 12348-04 Plum A+3 I.V. Infusion Pump. List Numbers: 12618-04; List Numbers: 11971-36; (shipped 12391-04; (shipped 11971-04; domestically) 11971-04; internationally) 12391-04; 12348-04; 12348-04; 12391-13; 12391-1312391-1 12618-04. All serial numbers of the above list numbered product are included in this correction.

Product code FRN

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)