ICU Medical Recalls Oncology Kits Due to Potential Leakage Defect
ICU Medical is recalling specific lots of Oncology Kits because a molding defect may cause small amounts of leakage in the inactivated position.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, but the source text explicitly states no illnesses or injuries have been reported, and the hazard is a potential leakage defect rather than a high-risk pathogen or structural failure causing immediate harm.
Plain-English summary
ICU Medical, Inc. is recalling specific lots of REF CL3960 Oncology Kits. The recall is due to a molding defect that may cause certain lots of spinning and non-spinning Spiros male luers to exhibit 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. The recall includes specific lot numbers and distribution across the United States and several international countries, including Belgium, Canada, France, Italy, South Africa, Spain, and the United Kingdom.
Healthcare providers and consumers should check their inventory for the specific lot numbers listed in the official recall notice. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. The source text does not report any illnesses or injuries associated with this defect.
The recalled product
- Product
- REF CL3960 Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros ; w/ChemoLock; Syringe Transfer Set w/MicroClave, w/ChemoLock Port - Product Usage: provides access for the administration of fluids from a container to a…
- 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.
See all 26 products in this recall →Related recalls
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