Z-1598-2011

Hospira Plum XL Micro/Macro Infusion Pump, Single Channel, with a 0.1-999 mL/hr flow rate range; list number...

Name: Z-1598-2011 Hospira Plum XL Micro/Macro Infusion Pump, Single Channel, with a 0.1-999 mL/hr flow rate range; list number...
Creator: Hospira Inc.
Published: 2011-02-14
License: https://open.fda.gov/license/

Abbott Medical / initiated 2011-02-14 / Terminated / root cause: labeling and UDI

FDA source

Hospira Inc. began a recall of Hospira Plum XL Micro/Macro Infusion Pump, Single Channel, with a 0.1-999 mL/hr flow rate range; list number 11846 on 2011-02-14. The reason FDA records is "Hospira has received reports of the Plum XL, XLM and XLD Infusion Pumps with no audible alarm at the low audio level setting". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1598-2011
Status: Terminated
Initiated: 2011-02-14
Posted: 2011-03-08
Terminated: 2016-11-07
Recalling firm: Abbott Medical
Product: Hospira Plum XL Micro/Macro Infusion Pump, Single Channel, with a 0.1-999 mL/hr flow rate range; list number 11846
Product code: FRN Pump, Infusion
Reason for recall: Hospira has received reports of the Plum XL, XLM and XLD Infusion Pumps with no audible alarm at the low audio level setting.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Hospira sent Urgent Device Recall letters dated February 14, 2011 to their customers on the same date, informing them that Hospira had received complaints of the Plum XL, XLM and XLD infusion pumps in which the audible alarm failed. If the audible alarm fails and the user does not notice the visual alert, the user may not be aware of the change in pump status such as air-in-line or occlusion. This may result in a delay or interruption of therapy which may result in serious injury and/or death. 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. They were also instructed to ensure that all personnel in their facility are following Hospira's Technical Service Manual for routine decontamination of the pumps and cleaning of the buzzers during preventative maintenance, including inspection of the buzzers for leg lifting. 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 1-866-382-4228.
Quantity in commerce: 23,385 pumps
Distribution: Worldwide distribution, including United States, the U.S. Virgin Islands, Puerto Rico, Argentina, Australia, Bahamas, Bahrain, Barbados, Belgium, Bosnia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Ecuador, EI Salvador, Finland, France, Greece, Guatemala, Hong Kong, Hungary, Ireland, Israel, Italy, Jordan, Korea, Kuwait, Luxembourg, Mexico, New Zealand, Oman, Panama, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, San Marino, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Taiwan, Turkey, United Kingdom, Uruguay, United Arab Emirates and Venezuela.
Product codes and lots: list number 11846, serial numbers 0012200009 through 0097830800

Product code FRN

K952799Class IIAbbott Xl3m Infusion PumpAbbott Laboratories / cleared 1996-01-18

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)