ICU Medical Recalls Plum Microbore Infusion Sets Due to Leakage Risk
ICU Medical is recalling specific Plum Microbore Infusion Sets because fluid may leak from the inline filter air vents.
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 without reported injury.
Plain-English summary
ICU Medical Inc is recalling 1,536 units of Plum Microbore Infusion Sets with Inline Filters. The specific product is labeled as Primary PLUM Set Yellow Striped Tubing, Distal Microbore Tubing, 0.2 Micron Filter, Secure Lock, 107 Inch. The product code is 149530489 and the lot number is 925155H.
The recall is being issued because of a potential for fluid leakage out of the 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, and the United Kingdom. Healthcare facilities and consumers who possess these specific infusion sets should stop using them 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 Yellow Striped Tubing, Distal Microbore Tubing, 0.2 Micron Filter, Secure Lock, 107 Inch. 1 unit per pouch; 48 pouches per case
- Manufacturer
- ICU Medical Inc
- Hazard
- Affected units
- 1,536
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 (3)
- Product Code: 149530489
- Lot number (UDI Number): 925155H (20887787003226
- 10887787003229)
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.
See all 22 products in this recall →Related recalls
Same manufacturer · ICU Medical Inc
See all →- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- ModerateICU Medical Recalls IV Administration Sets with Drip Chamber Specks
FDA (Devices) · 2026-09-23
- ModerateICU Medical Recalls Oncology Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
Same hazard · fluid leakage
See all →- HighCardinal Health Recalls Presource Packs with Leaking Handpieces
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Presource Packs Due to Potential Handpiece Leakage
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Gynecological Laparoscopy Kits Due to Handpiece Leakage
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Stryker StrykeFlow PS and AHTO Tube Set Kits
FDA (Devices) · 2026-10-07
- HighHalyard STANDARD LINE INSERTION PACK Recall for Silicone Seal Defect
FDA (Devices) · 2026-07-29
Similar recalls
- HighICU Medical Recalls I.V. Infusion Sets with Potential Leak
FDA (Devices) · 2016-04-06
- HighICU Medical Recalls IV Infusion Sets with Potential ChemoLock Port Leak
FDA (Devices) · 2016-04-06
- HighICU Medical Recalls ChemoLock IV Administration Sets Due to Leak Risk
FDA (Devices) · 2016-04-06
- HighICU Medical Recalls Plum Administration Sets Due to Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- ModerateICU Medical Recalls Smallbore Intravascular Administration Sets Due to Filter Assembly Error
FDA (Devices) · 2021-02-17
- HighICU Medical Recalls Smallbore Pressure Infusion Extension Sets
FDA (Devices) · 2020-10-28