ICU Medical Recalls Plum Microbore Infusion Sets Due to Fluid Leakage Risk
ICU Medical Inc is recalling 521 units of Plum Microbore Infusion Sets because air vents on inline filters may leak fluid. The recall covers nationwide and international distribution.
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 risk of fluid leakage, which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
ICU Medical Inc is recalling 521 units of Plum Microbore Infusion Sets with Inline Filters. The specific product is labeled as Primary PLUM Set, 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock 269 cm / 14 mL. The product code is 154413190 and the lot number is 4105785.
The recall is being issued due to a potential for fluid leakage out of air vents on the inline filters. This defect could compromise the integrity of the infusion set during use.
The affected units were distributed nationwide to numerous U.S. states and territories, as well as internationally to countries including Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Arabia, South Africa, Spain, Taiwan, Turkey, United Arab Emirates, and the United Kingdom. Users should stop using the affected infusion sets and contact ICU Medical Inc for further instructions.
The recalled product
- Product
- Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set, 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure…
- Manufacturer
- ICU Medical Inc
- Category
- Medical Device — Infusion Sets
- Hazard
- Affected units
- 521
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 (2)
- Product Code: 154413190
- Lot number 4105785
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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