ICU Medical Recalls Admin Sets Due to Potential Leakage Defect
ICU Medical is recalling specific lots of REF 011-CH3967 Admin 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. The hazard involves a potential for small amounts of leakage due to a molding defect, which is a functional defect without reported injuries or fatalities, fitting the criteria for a moderate severity recall.
Plain-English summary
ICU Medical, Inc. is recalling specific lots of REF 011-CH3967 Admin Sets with Clave and Spiros components. 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 inserted into a vein.
The recall is due to a molding defect in certain lots of spinning and non-spinning Spiros male luers. This defect creates a potential for small amounts of leakage in the inactivated position of the device.
The affected products were distributed worldwide, including nationwide distribution in the United States and in Belgium, Canada, France, Italy, South Africa, Spain, and the United Kingdom. The specific lot number is 5125174. Healthcare facilities and consumers should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- REF 011-CH3967 Admin Set w/ClaveTM, SpirosTM - 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.
- Category
- Medical Device — Infusion Sets
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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