ICU Medical Recalls Spiros Closed Male Luer Due to Leakage Defect
ICU Medical is recalling Spiros Closed Male Luer devices 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, which typically corresponds to a moderate severity where the product may cause temporary or medically reversible health issues, such as fluid leakage, without reported serious injury or death.
Plain-English summary
ICU Medical, Inc. is recalling specific lots of Spiros Closed Male Luer devices. These medical devices are 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 is due to a molding defect that creates a potential for small amounts of leakage in the inactivated position. The affected product is identified by REF 20120-01 and Lot Number 5141416.
The devices were distributed nationwide in the United States and in several international countries, including Belgium, Canada, France, Italy, South Africa, Spain, and the United Kingdom. Users should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- REF 20120-01 Spiros" Closed Male Luer - 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 into a vein).
- 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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