Z-1646-2011

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

Name: Z-1646-2011 Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list 11005 The Plum...
Creator: Hospira Inc.
Published: 2011-02-14
License: https://open.fda.gov/license/

Abbott Medical / initiated 2011-02-14 / Terminated / root cause: manufacturing process

FDA source

Hospira Inc. began a recall of Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list 11005 The Plum A+ Hyperbaric Infusion System is exclusively... on 2011-02-14. The reason FDA records is "Hospira has received customer reports of the Plum A+ infusion pumps with no audible alarm conditions, which have been associated with failure of the piezoelectric assembly due to component quality issues". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1646-2011
Status: Terminated
Initiated: 2011-02-14
Posted: 2011-03-14
Terminated: 2016-11-08
Recalling firm: Abbott Medical
Product: Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list 11005 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 customer reports of the Plum A+ infusion pumps with no audible alarm conditions, which have been associated with failure of the piezoelectric assembly due to component quality issues.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Hospira, sent "URGENT DEVICE RECALL" letters dated February 14, 2011 to their customers on the same date. The letter described the product, problem and action to be taken by the customers. The Customer/Clinicians were instructed to weigh the risk associated with continued use of the device versus removal from service. If they elect to continue the devices, they were provided with instructions to perform alarm tests prior to each clinical use (during their pump cleaning process). If the alarm is not audible, they were instructed to discontinue use of the pump and contact Hospira Global Product Safety and Complaints at 1-800-441-4100. The customers were requested to contact Hospira Advanced Knowledge Center at 1-800-241-4002 for technical assistance. The accounts were also requested to complete the attached Reply Form and return it to Hospira via fax at 1-888-216-7330.
Quantity in commerce: 98 pumps
Distribution: Worldwide distribution: United States including the U.S. Virgin Islands and Puerto Rico, and countries including: Argentina, Australia, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, 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, Uruguay, United Arab Emirates and Vietnam.
Product codes and lots: list 11005, serial numbers 0016792201 through 0018807578

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)