The Recall Desk
ModerateFDA (Devices)·Z-1567-2021·Announced 2021-05-19

ICU Medical Recalls Spiros Administration Sets Due to Molding Defect

ICU Medical is recalling specific lots of Spiros administration sets 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 hazard involves a potential leakage defect without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of REF 20124-01 30-inch Spiros administration sets. The recall is due to a molding defect that may cause small amounts of leakage in the inactivated position of the male luer.

The affected product is used to provide access for the administration of fluids from a container to a patient's vascular system. The recall covers Lot 5142971, which was distributed nationwide in the United States and in several international countries including Belgium, Canada, France, Italy, South Africa, Spain, and the United Kingdom.

Healthcare facilities and consumers should stop using the affected administration sets and contact ICU Medical for further instructions or a replacement.

The recalled product

Product
REF 20124-01 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger LOT 5142971 - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or c
Manufacturer
ICU Medical, Inc.
Category
Medical Device — IV Administration Sets
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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