Plum Duo Precision IV Pump, 40002-0403
FDA device recall Z-2313-2026 · posted 2026-06-05 · Open, Classified
Recall details
- Recalling firm
- ICU Medical, Inc.
- 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.
- Action taken
- 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 developing a software update to correct the issue and will notify customers when it is available.
- Root cause
- Software Design Change
- Status
- Open, Classified
- Product code
- FRN
- Quantity affected
- 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.
- Date initiated
- 2026-04-29
- Date posted
- 2026-06-05
- Location
- Lake Forest, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Plum Duo™ Precision IV Pump (K242115) | Icu Medical, Inc. | 2025-04-02 |