ICU Medical Recalls Plum Administration Sets Due to Drip Chamber Discoloration
ICU Medical is recalling Plum administration sets because drip chambers may contain black specks or discolored PVC material. The presence of particulate matter in the fluid path has not been ruled out.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential particulate matter in the fluid path of a medical device, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
ICU Medical, Inc. is recalling 163,500,199 units of Plum administration sets. The recall is due to a potential defect in the intravascular administration tubing set drip chambers, which may contain black specks. This discoloration is potentially caused by the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall.
The source text notes that the presence of discoloration and particulate matter in the fluid path has not been ruled out. The affected products were manufactured on or before July 4, 2026. The recall covers products distributed worldwide, including nationwide distribution in the United States and specific countries such as Pakistan, the Philippines, Malaysia, and Germany.
Healthcare facilities and consumers should check their inventory for Plum administration sets manufactured on or before July 4, 2026, and discontinue use of any affected units. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Plum administration sets
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 163,500,199
Distribution
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