Z-0011-2012

Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list 11005

Name: Z-0011-2012 Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list 11005
Creator: Hospira Inc.
Published: 2011-09-16
License: https://open.fda.gov/license/

Abbott Medical / initiated 2011-09-16 / Terminated / root cause: software

FDA source

Hospira Inc. began a recall of Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list 11005 Product Usage: The Plum A+ Hyperbaric Infusion System is... on 2011-09-16. The reason FDA records is "Hospira has received reports of continuous recycling and/or rebooting of Plum A+ infusion pumps when the backlight intensity and/or display contrast settings for the LED display has been adjusted from the original...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0011-2012
Status: Terminated
Initiated: 2011-09-16
Posted: 2011-10-04
Terminated: 2016-11-07
Recalling firm: Abbott Medical
Product: Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list 11005 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace and multiplace chambers.
Product code: FRN Pump, Infusion
Reason for recall: Hospira has received reports of continuous recycling and/or rebooting of Plum A+ infusion pumps when the backlight intensity and/or display contrast settings for the LED display has been adjusted from the original default setting. This condition could cause a delay in therapy if the clinician is unable to start the device due to the continuous recycling and/or rebooting.
Root cause tag: software
FDA root cause: Software design
Action: The firm, Hospira sent "URGENT DEVICE RECALL" letters dated September 16, 2011 to all affected customers. The letters identified the products, problem and action(s) to be taken. The customers were instructed to read the information provided carefully, complete the attached Reply Form and return it to Hospira via fax at 1-888-345-5358. The letter states that a software upgrade to address the issue is currently being developed. Customers were instructed to notify their consignees if they have further distributed the affected product. The customers were requested to contact Hospira Advanced Knowledge Center at 1-800-241-4002, option 4, for technical assistance. *** Follow-up letters dated June 26, 2012 were sent to the accounts listing the device modules with software versions v13.2, v13.3, v13.40 and v13.5 that will require the software upgrade. ***
Quantity in commerce: 120 pumps
Distribution: Worldwide Distribution - USA (nationwide) including Puerto Rico and the US Virgin Islands, and countries of: Argentina, Australia, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Ecuador, France, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Libya, Malaysia, Mexico, Netherlands, New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United kingdom, United Arab Emirates, Uruguay and Vietnam.
Product codes and lots: list 11005, serial numbers 0016792207 through 0018807700

Product code FRN

K081412Class IIPlum a+ Hyperbaric Infusion System with Hospira Mednet SoftwareHospira, Inc. / cleared 2008-12-17

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)