Recall Z-2312-2026 · FRN Pump, Infusion
ICU Medical, Inc.
Plum Duo Infusion Pump, 40002-0401
| Date | Jun 5, 2026 (initiated Apr 29, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software Design Change |
| Action | On April 29, 2026, the firm notified consignees via letters titled "URGEND MEDICAL DEVICE CORRECTION." Customers were instructed to identify all affected pumps in their possession and ensure all users or potential users of the pumps are immediately made aware of the notification. During bolus programming, clinicians should check whether the soft limit override icon is displayed next to the bolus dose entry field on the programming screen. If the pump displays the icon, the clinician should review the program and make any necessary adjustments before confirming the program. The firm is devel |
| Quantity | 13,613 |
| Distribution | Worldwide - US Nationwide distribution in the states of ID, IL, IN, KS, MA, MD, NM, NY, PA, TN, TX and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223607 | Plum Duo Infusion System Icu Medical, Inc., Aug 24, 2023 |