ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
Summary
The FDA issued a Class II for ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 by ICU Medical, Inc.. Reason: Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The progr.
Details
Source
Device Recall
External ID
Z-1119-2026
Action Date
2026-01-28
Status
Ongoing
Category
device
Product Description
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
Lot/Code Info: 400020403 (US), Software Versions: 1.2.2; 400021003 (Philippines), Software Versions: 1.2.0
Reason for Recall
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
Distribution
Worldwide distribution - US Nationwide and the country of Philippines.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-12-15
Company
Lake Forest, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 180 device recalls issued in the same week, part of 413 device-related FDA actions this month.
ICU Medical, Inc. has 95 FDA actions in our database, including 85 recalls and 10 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ICU Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ICU Medical, Inc. have FDA actions?
ICU Medical, Inc. has 95 FDA actions in our database, including 85 recalls and 10 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1119-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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