ICU Medical Recalls Plum Microbore Infusion Sets Due to Leakage Risk
ICU Medical Inc is recalling 7,920 units of Plum Microbore Infusion Sets because fluid may leak from the inline filters.
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 involves a medical device with a functional defect (fluid leakage) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
ICU Medical Inc is recalling 7,920 units of Plum Microbore Infusion Sets with Inline Filters. The affected products are labeled as PLUM Epidural Set with NRFit Connector Yellow-Striped Tubing, Distal Microbore Tubing, 0.2 Micron Filter, 107 Inch. The recall involves specific lot numbers: 896485H, 915625H, and 3850054.
The recall was initiated due to a potential for fluid leakage out of the air vents on the inline filters. This defect could compromise the integrity of the infusion system.
The affected products were distributed nationwide to 48 states and territories, as well as internationally to 19 countries including Canada, France, Germany, and the United Kingdom. Healthcare facilities and distributors should stop using the affected lots and contact ICU Medical Inc for instructions on return or replacement.
The recalled product
- Product
- Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PLUM Epidural Set with NRFit Connector Yellow-Striped Tubing, Distal Microbore Tubing, 0.2 Micron Filter, 107 Inch. 1 unit per pouch; 48 pouches per case
- Manufacturer
- ICU Medical Inc
- Hazard
- Affected units
- 7,920
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Product Code: 240070401
- Lot number (UDI Number): 896485H (20887787009228
- 10887787009221)
- 915625H (20887787009228
- 3850054 (20887787009228
Distribution
Part of a larger recall action
This product is one of 22 recalled by ICU Medical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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