Reported Sep 23, 2026 · Ongoing
Plum administration sets
ICU Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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. · 951 Calle Amanecer · San Clemente, CA · 92673-6212
Is this the product you have?
- Plum administration sets
- Lot codes and dates
- All products manufactured on or before 7/4/2026
- UDI-DI
75 of 75 codes
108877091014603088770910002330887709100030108877091014773088770910004730887709100054208877870053122088778700540410887709101484308877091000922088770910011820887709100125308877091001391088770910149120887709100149208877091001562088770910016320887709100170208877091001872088770910019430887709100207208877091004602088770910080410887709101569308877091007332088770910034720887709100354208877870062342088778700622720887787006180208877870064872088778700603620887787005978208877870052371088770910086920887787005251108877091016752088778700526820887709101689208877870030112088778700535020887787008801208877870056262088778700565720887787003202208877870032332088778700572520887787008771208877870034311088770910090610887709101613108877091009202088770910088020887709101627108877091025661088770910150710887709101637208877091015112088770910164120887709101849
- Amount recalled
- 163,500,199
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
Why it was recalled
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.
This product could cause temporary or reversible health problems — stop using it.
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