ICU Medical Recalls Oncology Kits Due to Molding Defect
ICU Medical is recalling specific lots of REF CL3538 Oncology Kits because a molding defect may cause small amounts of 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 for small amounts of leakage without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
ICU Medical, Inc. is recalling specific lots of REF CL3538 Oncology Kits. These kits include a 5-inch (13 cm) Add-On Set with a ChemoLock Additive Port, Vented Cap, and Spinning Spiros with a Red Cap. The product is used to provide access for the administration of fluids from a container to a patient’s vascular system through an administration set’s needle or catheter.
The recall is due to a molding defect. This defect creates a potential for certain lots of spinning and non-spinning Sprios male luers to exhibit small amounts of leakage in the inactivated position. The affected lot number is 5125294.
The products were distributed worldwide, including nationwide distribution in the United States and in Belgium, Canada, France, Italy, South Africa, Spain, and the United Kingdom. Healthcare providers and consumers should stop using the affected products and contact ICU Medical for further instructions.
The recalled product
- Product
- REF CL3538 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle
- 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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