Z-0438-05

The Hospira Plum A+ I.V. Infusion pump is a cassette-based, multi-function fluid delivery infusion system...

Name: Z-0438-05 The Hospira Plum A+ I.V. Infusion pump is a cassette-based, multi-function fluid delivery infusion system...
Creator: Hospira Inc
Published: 2004-09-08
License: https://open.fda.gov/license/

Abbott Medical / initiated 2004-09-08 / Terminated

FDA source

Hospira Inc began a recall of The Hospira Plum A+ I.V. Infusion pump is a cassette-based, multi-function fluid delivery infusion system, consisting of pumping module and assortment of IV... on 2004-09-08. The reason FDA records is "The batteries in Plum A+ and Plum A+3 I.V. infusion pumps may fail prematurely when the pump is operating solely on battery power". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0438-05
Status: Terminated
Initiated: 2004-09-08
Posted: 2005-01-27
Terminated: 2005-09-20
Recalling firm: Abbott Medical
Product: The Hospira Plum A+ I.V. Infusion pump is a cassette-based, multi-function fluid delivery infusion system, consisting of pumping module and assortment of IV sets.
Product code: JFL Ph Rate Measurement, Carbon-Dioxide
Reason for recall: The batteries in Plum A+ and Plum A+3 I.V. infusion pumps may fail prematurely when the pump is operating solely on battery power.
FDA root cause: Other
Action: On 9/8/04, all consignees were notified via written letter sent via Federal Express, informing them of the affected products and providing instructions on the recall. The firm will follow up with phone calls to its consignees.
Quantity in commerce: The firm distributed approximately 31,914 units for all model numbers.
Distribution: The firm distributed these products to 484 consignees throughout the US, and an undetermined number of foreign consignees. The firm has distributed the product nationwide, excluding AK, HI, NV, NM, SC, and SD. The firm has sent products to Veterans Supply Office Pharmacy, Dept. of Veteran''s Affairs, Vet Admin Medical Center and US Pentitentiary-MC. Foreign countries that have received the product incluide Saudi Arabia, Canada, Puerto Rico and Taiwan.
Product codes and lots: The following LIST numbers are under recall. All lots (serial numbers) are currently under recall. LIST No. 11971-04 and LIST No. 12391-04.

Product code JFL

K021350Class IIAbbott Plum A+3 Multichannel Infusion Pump, Model 12348Abbott Laboratories / cleared 2002-05-14

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)