ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk
ICU Medical is recalling Sapphire Microbore Infusion Sets because fluid may leak from the inline filters. The recall covers 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 involves a medical device with a risk of fluid leakage, which 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 Sapphire Microbore Infusion Sets with Inline Filters, specifically the Sapphire Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch. 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 240130401 and Lot numbers 885585H and 925855H. The recall covers units distributed nationwide to all 50 states, DC, Puerto Rico, and the U.S. Virgin Islands, as well as 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 infusion sets and contact ICU Medical Inc for instructions on return or replacement.
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, PAV, 123 Inch. 1 unit per pouch; 50 pouches per case
- Manufacturer
- ICU Medical Inc
- Category
- Medical Device — Infusion Sets
- Hazard
- Affected units
- 50
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: 240130401
- Lot number (UDI Number): 885585H (20887787009266
- 10887787009269)
- 925855H (20887787009266
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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