Recall Z-2311-2026
- Recall number
- Z-2311-2026
- Event number
- 98872
- Firm
- ICU Medical, Inc.
- Firm FEI
- 3013319212
- Product code
- FRN
- Status
- Open, Classified
- Initiated
- 2026-04-29
- Posted
- 2026-06-05
- Root cause
- Software Design Change
- 510(k) numbers
- K242114, K844851, K983838, K896544, K897086, K930494, K021988, K875332, K905251, K120830, K070718, K052052, K921050, K000328, K903879, K124053, K022575, K904518, K894037, K843949, K991936, K100705, K910758, K914854, K944125, K931318, K003611, K801546, K973609, K884505
Product#
Plum Solo Precision IV Pump, 40001-0401
Reason for Recall#
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.