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 recall covers 170,735 units distributed nationwide and internationally.
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, and the hazard involves a risk of harm (fluid leakage) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
ICU Medical Inc is recalling specific Plum Microbore Infusion Sets with Inline Filters. The affected products are labeled as High-Pressure Filter PRIMARY I.V. PLUMSET Convertible Pin, 104 Inch with Orange Polyethylene-Lined/Light Resistant Tubing, Prepierced Injection Site and OPTION-LOK. The recall involves 170,735 units.
The recall is being conducted 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 agency has classified this as a Class II recall.
The affected products were distributed nationwide to all 50 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands. They were also distributed internationally to Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Arabia, South Africa, Spain, Taiwan, Turkey, and the United Arab Emirates. Healthcare facilities and consumers should stop using the affected lots and contact ICU Medical for further instructions.
The recalled product
- Product
- Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as High-Pressure Filter PRIMARY I.V. PLUMSET Convetible Pin, 104 Inch with Orange Polyethylene-Lined*/Light Resistant Tubing, Prepierced Injection Site and OPTION-LOK. 1…
- Manufacturer
- ICU Medical Inc
- Category
- Medical Device — Infusion Sets
- Hazard
- Affected units
- 170,735
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 (11)
- Product Code: 118790412
- Lot number (UDI Number): 855505H (20887787009020
- 10887787009023)
- 865135H (20887787009020
- 918695H (20887787009020
- 928085H (20887787009020
- 937325H (20887787009020
- 3864774 (20887787009020
- 3935434 (20887787009020
- 4011065 (20887787009020
- 4088425 (20887787009020
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
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