ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk
ICU Medical is recalling Sapphire Microbore Infusion Sets with inline filters due to a potential for fluid leakage out of 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 risk of harm (fluid leakage) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
ICU Medical Inc is recalling Sapphire Microbore Infusion Sets with Inline Filters, specifically the SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, 293 cm / 8.1 mL. The recall involves 5,443 units distributed nationwide to 50 states and territories, as well as internationally to 18 countries. The product is identified by Product Code 163459255 and Lot numbers 855755H, 876275H, and 905975H.
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 set during use. The source text does not report any illnesses or injuries associated with this recall.
Healthcare facilities and consumers should stop using the affected infusion sets immediately. Users should check their inventory for the specific product code and lot numbers listed above. For further information or to arrange for a return, contact ICU Medical Inc.
The recalled product
- Product
- Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, 293 cm / 8.1 mL. 1 unit per pouch; 1 unit per blister; 40 blisters per case. Not distributed in the…
- Manufacturer
- ICU Medical Inc
- Category
- Medical Device — Infusion Sets
- Hazard
- Affected units
- 5,443
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 (4)
- Product Code: 163459255
- Lot number 855755H
- 876275H
- 905975H
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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