The Recall Desk
ModerateFDA (Devices)·Z-1569-2021·Announced 2021-05-19

ICU Medical Recalls Spinning Spiros Closed Male Luer Due to Leakage

ICU Medical is recalling certain lots of Spinning Spiros Closed Male Luer devices 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, and the source text describes a potential for small amounts of leakage without reporting any specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of REF Spinning Spiros Closed Male Luer devices. These medical devices are 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 being conducted due to a molding defect. This defect creates a potential for small amounts of leakage in the inactivated position of the device. The affected products were distributed worldwide, including nationwide in the United States and in Belgium, Canada, France, Italy, South Africa, Spain, and the United Kingdom.

Healthcare facilities and consumers should check their inventory for the specific lot numbers and REF codes listed in the 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 recalled product

Product
REF Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Infusion Components
Hazard

Distribution

Distributed nationwide across the United States.

The notice also names 39 states specifically:

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

Same manufacturer · ICU Medical, Inc.

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Same hazard · leakage

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