ICU Medical Recalls Oncology Kits Due to Molding Defect and Leakage
ICU Medical is recalling specific lots of Oncology Kits due to a molding defect that may cause 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, and the defect involves a potential for leakage without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
ICU Medical, Inc. is recalling REF CH3397 Oncology Kits with Spiros, Red Cap, Bag Spike w/Clave Additive Port, specifically Lot 5118610. These kits are used for the preparation and patient administration of cytotoxic medications.
The recall is due to a molding defect that creates a potential for small amounts of leakage in the inactivated position of certain lots of spinning and non-spinning Spiros male luers.
The affected products were distributed nationwide in the United States and in Belgium, Canada, France, Italy, South Africa, Spain, and the United Kingdom. Users should stop using the affected lots and contact the manufacturer for instructions.
The recalled product
- Product
- REF CH3397 Oncology Kit w/Spiros¿, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Infusion Kits
- 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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