ICU Medical Recalls Sapphire Microbore Infusion Sets Due to Leakage Risk
ICU Medical is recalling Sapphire Microbore Infusion Sets because fluid may leak from the inline filter air vents. The product was distributed in the U.S. 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 involves a medical device with a risk of fluid leakage, which is a risk-of-harm product 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 the SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. The recall is due to a potential for fluid leakage out of the air vents on the inline filters. The affected product is identified by Product Code 163633155 and Lot numbers 937585H and 3959758.
The recall covers 400 units of the infusion sets. Although the product description notes it was not distributed in the U.S., the distribution pattern indicates nationwide distribution to multiple U.S. states and territories, as well as international distribution to numerous countries including Canada, the United Kingdom, and Germany.
Healthcare providers and facilities should stop using the affected infusion sets immediately. Users should contact ICU Medical Inc for further instructions on how to return or dispose of the product. No specific instructions for individual consumers are provided in the source text, as this is a medical device distributed to professional settings.
The recalled product
- Product
- Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. 1 unit per blister; 40 blisters per case . Not distributed in the U.S.
- Manufacturer
- ICU Medical Inc
- Hazard
- Affected units
- 400
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: 163633155
- Lot number 937585H
- 3959758
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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