The Recall Desk
HighFDA (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.

What this means for you

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
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 →

Related recalls

Same manufacturer · ICU Medical, Inc.

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Same hazard · fluid leakage

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