Reported Aug 13, 2025 · Ongoing
Plum Duo Infusion System, List Number: 400020401
ICU Medical, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ICU Medical, Inc. · 600 N Field Dr · Lake Forest, IL · 60045-4835
Is this the product you have?
- Plum Duo Infusion System
- List Number400020401
- Lot codes and dates
- UDI-DIM335400021
- Serial Numbers50
3,618 of 3,618 codes
500001245000438650006225500003005000376750006228500047195000556250001512500020635000208750000125500043875000622450001628500037685000622750004720500055665000151350002064500020915000012650004389500062235000178550003775500062185000472250005572500015145000206550002107500001275000439050006220500024615000377650006205500047255000561950001515500020665000211450000128500043915000621750002491500037855000619850004726500056395000151650002067500021205000012950004392500062155000254150003786
- Amount recalled
- 4677 units
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.
Using this product could cause serious injury, illness or death — stop using it now.
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