The Recall Desk
ModerateFDA (Devices)·Z-1590-2021·Announced 2021-05-19

ICU Medical Recalls Spinning Spiros Male Luers Due to Leakage Defect

ICU Medical is recalling specific lots of Spinning Spiros Closed Male Luers because a molding defect 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 leakage defect without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of REF K7040-001 Spinning Spiros Closed Male Luers. 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 due to a molding defect that creates a potential for small amounts of leakage in the inactivated position. The affected lots are 5135765 and 5142935, with expiration dates of January 1, 2026. The 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 these specific lot numbers and stop using the affected devices. The source text does not specify further consumer actions or report any illnesses or injuries associated with this defect.

The recalled product

Product
REF K7040-001 Spinning Spiros Closed Male Luer - 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.
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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