Recall Z-2312-2026
- Recall number
- Z-2312-2026
- 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
- K223607, K024056, K912914, K982170, K030576, K924868, K894506, K843331, K771664, K070235, K013776, K161469, K910024, K893769, K210073, K070718, K760718, K922909, K091386, K912928, K900057, K873522, K962709, K242735, K952794, K022869, K953731, K032789, K872741, K852965
Product#
Plum Duo Infusion Pump, 40002-0401
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.