ICU Medical Recalls Sprios Administration Sets Due to Molding Defect
ICU Medical is recalling specific lots of Sprios administration sets due to a molding defect that may cause leakage in the inactivated position.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a potential for small amounts of leakage without reporting any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
ICU Medical, Inc. is recalling specific lots of REF CL3028T 30-inch administration sets. These medical devices are used to provide access for the administration of fluids from a container to a patient's vascular system. The recall is due to a molding defect in certain lots of spinning and non-spinning Sprios male luers.
The defect creates a potential for small amounts of leakage in the inactivated position. The affected product is identified by REF CL3028T, UDI (01) 1 0887709 09996 5 (17) 260101 (30) 50 (10) 5125199, and Lot Number 5125199.
The product was distributed worldwide, including nationwide in the United States and in Belgium, Canada, France, Italy, South Africa, Spain, and the United Kingdom. Healthcare providers and facilities should check their inventory for this specific lot number and discontinue use if found.
The recalled product
- Product
- REF CL3028T 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, 0.2 Micron Filter, Spiros , Bag Hanger, Drop-In Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the admi
- Manufacturer
- ICU Medical, Inc.
- Hazard
Distribution
Part of a larger recall action
This product is one of 26 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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