ICU Medical Recalls Sprios Administration Sets Due to Molding Defect
ICU Medical is recalling specific lots of Sprios administration sets because a molding defect 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, and the hazard involves a potential leakage defect without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
ICU Medical, Inc. is recalling specific lots of REF CL3011 30-inch administration sets with integrated ChemoLock drip chambers. The recall is due to a molding defect that may cause small amounts of leakage in the inactivated position of the Sprios male luers.
The affected product is distributed worldwide, including in the United States and in Belgium, Canada, France, Italy, South Africa, Spain, and the United Kingdom. The specific lot number identified in the recall is 5125298.
Healthcare providers and patients should stop using the affected administration sets and contact ICU Medical for instructions on how to return or replace the product.
The recalled product
- Product
- REF CL3011 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or cathe
- 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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