The Recall Desk
ModerateFDA (Devices)·Z-1589-2021·Announced 2021-05-19

ICU Medical Recalls IV Administration Sets Due to Molding Defect

ICU Medical is recalling specific lots of IV 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 CH3762 35" (89 cm) IV administration sets. The recall is due to a molding defect that may cause small amounts of leakage in the inactivated position of certain Sprios male luers.

The affected product is an IV administration set used to provide access for the administration of fluids from a container to a patient's vascular system. The specific lot number is 5135759, with an expiration date of January 1, 2026. The product was distributed nationwide in the United States and in Belgium, Canada, France, Italy, South Africa, Spain, and the United Kingdom.

Healthcare providers and consumers should stop using the affected lots immediately and contact ICU Medical for further instructions or a replacement.

The recalled product

Product
REF CH3762 35" (89 cm) Appx 3.9 ml, 10 Drop Admin Set w/Integrated Clave" Drip Chamber, Clave", Spiros" w/Red Cap, Bag Hanger - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle
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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