ICU Medical Recalls Bag Spike Adapters Due to Molding Defect
ICU Medical is recalling specific lots of Bag Spike Adapters 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 is a potential for small amounts of leakage due to a molding defect, which is a functional defect without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
ICU Medical, Inc. is recalling specific lots of REF CH3034 5" (13 cm) Bag Spike Adapters with Spiros and Red Cap, Vented Cap. The recall is due to a molding defect that creates a potential for small amounts of leakage in the inactivated position of certain spinning and non-spinning Spiros male luers.
The affected 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 covers worldwide distribution, including nationwide distribution 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 5125305. Users should check their inventory for this lot number and stop using the affected devices if found.
The recalled product
- Product
- REF CH3034 5" (13 cm) Bag Spike Adapter w/Spiros" w/Red Cap, Vented Cap - 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.
- 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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