ICU Medical Recalls Sprios Male Luer Administration Sets Due to Molding Defect
ICU Medical is recalling specific lots of Sprios male luer administration sets due to a molding defect that may cause leakage in the inactivated position.
What this means for you
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 defect that could lead to fluid leakage, posing a risk of harm to patients, but no injuries or illnesses have been reported in the source text.
Plain-English summary
ICU Medical, Inc. is recalling specific lots of REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line Chamber, 2 Spiros", Hanger. The recall is due to a molding defect in certain lots of spinning and non-spinning Sprios male luer components. This defect creates a potential for small amounts of leakage in the inactivated position.
The affected product is a medical device used to provide access for the administration of fluids from a container to a patient's vascular system through a needle or catheter. The recall covers Lot Number 5125290 with an expiration date of January 1, 2026. The product was distributed nationwide in the United States and in Belgium, Canada, France, Italy, South Africa, Spain, and the United Kingdom.
Healthcare facilities and consumers should stop using the affected lots immediately. Users should check their inventory for the specific lot number and reference number listed above. If the product is found, it should be quarantined and returned to ICU Medical, Inc. according to their instructions.
The recalled product
- Product
- REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line Chamber, 2 Spiros", Hanger - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted in
- 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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