ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk
ICU Medical Inc 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 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 Sapphire Microbore Infusion Sets with Inline Filters, specifically those labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. The recall involves 120 units, identified by Product Code 240119201 and Lot number 916205H.
The recall was initiated because of a potential for fluid leakage out of the air vents on the inline filters. The source text notes that these specific units were not distributed in the U.S., despite the distribution pattern listing various U.S. states and international locations for the product line generally.
Healthcare facilities and distributors should stop using the affected infusion sets and contact ICU Medical Inc for further instructions. Consumers are advised to check their inventory for the specific product code and lot number listed in this notice.
The recalled product
- Product
- Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. 1 unit per blister; 40 blisters per case. Not distributed in…
- Manufacturer
- ICU Medical Inc
- Hazard
- Affected units
- 120
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: 240119201
- Lot number 916205H
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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