FDA Medical Device Recalls (openFDA)
ICU Medical Inc: Plum 360 Infusion System, List number 30010.
- Recall number
- Z-0101-2018
- Recalling firm
- ICU Medical Inc
- Product
- Plum 360 Infusion System, List number 30010.
- Status
- Terminated
- Initiated
- 2017-10-30
- Posted
- not on file
- Terminated
- 2019-08-28
- Reason
- (1) Under certain conditions, if a malfunction alarm occurs while the pump is in the "Paused" state waiting for the distal pressure to decrease, the pump cannot be turned off and delivery cannot be restarted until the battery is discharged or is disconnected; and (2) when the user accesses the Preventive Maintenance Screen in Service/Biomed Mode with a Total Delivery Time >1,500 hours, the user will not be able to interact with the device and the device must be power cycled.
- Root cause
- Under Investigation by firm
- Action
- The recalling firm issued letters dated 10/30/2017 via UPS on 10/30/2017 notifying their customers of the two issues.
- Quantity
- 21,461 devices
- Distribution
- Distribution was nationwide to medical facilities. Foreign distribution was made to Canada and Australia. Government and military distribution was also made.
- Lot, serial or model codes
- All devices with software v15.10.00.010
- 510(k) numbers
- ["K161469"]
- 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