Z-0483-2013Class II

Plum A+ Single Channel Infusion Pumps with Hospira Mednet Software and a Connectivity Engine peripheral...

Name: Z-0483-2013 Plum A+ Single Channel Infusion Pumps with Hospira Mednet Software and a Connectivity Engine peripheral...
Creator: Hospira Inc.
Published: 2012-10-26
License: https://open.fda.gov/license/

Abbott Medical / initiated 2012-10-26 / Terminated / root cause: design

FDA source

Hospira Inc. began a recall of Plum A+ Single Channel Infusion Pumps with Hospira Mednet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local... on 2012-10-26. FDA classified it as Class II and gives the reason as "The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction for Loud and Quiet may be reversed. The...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0483-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-26
Posted: 2012-12-07
Terminated: 2016-11-14
Recalling firm: Abbott Medical
Product: Plum A+ Single Channel Infusion Pumps with Hospira Mednet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local area networking, allowing the MedNet software to download drug libraries to the infuser and enable the auto-programming feature; Hospira, Inc., Lake Forest, IL 60045; pump list #20679 and 20792, module list number 20677. The Plum A+ Infusion System with Hospira MedNet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local area networking, allowing the MedNet software to download drug libraries to the infuser and enable the auto-programming feature.
Product code: FRN Pump, Infusion
Reason for recall: The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction for Loud and Quiet may be reversed. The manual indicates a clockwise rotation of the knob decreases the volume; however, on some of the devices the alarm volume increases when the knob is turned clockwise.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Hospira Inc. sent "URGENT DEVICE FIELD CORRECTION" letters dated October 26, 2012 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 the firm via fax at 1-877-650-8667. The letter states that the System Operating Manual will be updated to clarify the instructions for setting the volume, and that the updated manuals will be sent as soon as they are available. 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 additional information and technical assistance.
Distribution: Worldwide Distribution - USA (nationwide) including Puerto Rico, and the countries of Australia, Bahrain, Belgium, Brazil, Canada, Chile, Colombia, Denmark, France, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Libya, Malaysia, Mexico, Netherlands, New Zealand, Oman, Pakistan, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Lavenia, South Africa, Spain, Switzerland, Taiwan, Turkey, United Kingdom, United Arab Emirates and Vietnam.
Product codes and lots: pump list numbers 20679 and 20792, and module list number 20677; all serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0483-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0481-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-19	2012-12-07
Z-0482-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-19	2012-12-07
Z-0483-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-19	2012-12-07

Product code FRN

K042081Class IIPlum a+ Infusion System with Hospira Mednet Software , and Plum A+3 Infusion System with Hospira Mednet SoftwareHospira, Inc. / cleared 2004-08-24

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)