FDA Medical Device Recalls (openFDA)
Hospira Inc.: Hospira Plum XL Micro/Macro Infusion Pump, Single Channel, with a 0.1-999 mL/hr flow rate range; list number 11846
- Recall number
- Z-1598-2011
- Recalling firm
- Hospira Inc.
- Product
- Hospira Plum XL Micro/Macro Infusion Pump, Single Channel, with a 0.1-999 mL/hr flow rate range; list number 11846
- Status
- Terminated
- Initiated
- 2011-02-14
- Posted
- 2011-03-08
- Terminated
- 2016-11-07
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- list number 11846, serial numbers 0012200009 through 0097830800
- 510(k) numbers
- ["K952799"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 3013319212
- Firm city
- Lake Forest
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28