Agency classClass IIOur severity:High FDA (Devices)·Z-0705-2021·Announced 2020-12-30

ICU Medical Recalls 30-inch IV Administration Sets Due to Molding Defect

ICU Medical is recalling 325 units of 30-inch IV administration sets because a molding defect in the male luer may cause fluid leaks, potentially leading to infusion delays or contamination.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a defect that poses a risk of harm (contamination, exposure to hazardous medications, blood loss) but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

ICU Medical, Inc. is recalling 325 units of 30-inch (76 cm) IV administration sets, reference number CH3286. The affected lots are 4727479 and 4784305. These products were distributed nationwide in the United States and internationally to numerous countries including Canada, the United Kingdom, Germany, and Australia.

The recall is due to a molding defect in the spinning versions of the male luer, which may exhibit leaks. This defect could potentially cause a delay in infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.

Healthcare facilities and consumers who have these specific administration sets should stop using them and contact ICU Medical for instructions on how to return or dispose of the product.

The recalled product

Product: 30" (76 cm) Appx 5.5 mL 20 Drop Admin Set w/Integrated Clave Drip Chamber, 1.2 Micron Filter, Spiros, Bag Hanger, REF: CH3286
Manufacturer: ICU Medical, Inc.
Category: Medical Device — IV Administration Sets
Hazard: fluid-leakage
contamination
exposure-to-hazardous-medications
blood-loss
Affected units: 325

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Lots: 4727479
4784305

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

Part of a larger recall action

This product is one of 13 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 13 products in this recall →

Same manufacturer · ICU Medical, Inc.

See all →

High
ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
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High
ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
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High
ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
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Moderate
ICU Medical Recalls IV Administration Sets with Drip Chamber Specks
FDA (Devices) · 2026-09-23
Moderate
ICU Medical Recalls Oncology Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23

Same hazard · fluid leakage