The Recall Desk
HighFDA (Devices)·Z-0206-2021·Announced 2020-10-28

ICU Medical Recalls Smallbore Trifuse Extension Sets Due to Seal Defect

ICU Medical is recalling specific lots of Smallbore Trifuse Extension Sets because a manufacturing defect may prevent the NanoClave from sealing properly.

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 may compromise the sterile seal, posing a risk of harm to patients, but the source text does not report any specific injuries or illnesses.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of 60-inch Smallbore Trifuse Extension Sets. The recall involves a total of 304,735 units distributed nationwide in the United States and in several international countries, including Canada, Mexico, and various nations in Europe and Asia.

The recall was initiated due to a potential manufacturing defect on the internal surface of the NanoClave component. This defect may inhibit a proper seal with the NanoClave spike. The affected products are identified by lot numbers 4514845, 4549102, and 4730714.

These devices are single-use, sterile, non-pyrogenic intravascular administration sets used to provide access for the administration of fluids from a container to a patient's vascular system. Healthcare facilities and distributors should stop using the affected lots and contact the manufacturer for instructions on return or replacement.

The recalled product

Product
60" (152 cm) Appx 1.0 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, NanoClave, 0.2 Micron Filter, 1.2 Micron Filter, 4 Clamps (2 Blue, Yellow, White), Rotating Luer; 1 unit per pouch, 50 multivac pouches per case UDI:(01)10887709083889(17)241201(30)50(10)4514845; (01)1088
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Intravascular Administration Set
Hazard

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 (3)

  • Lot Number:4514845
  • 4549102
  • 4730714.

Distribution

Distributed nationwide across the United States.

The notice also names 37 states specifically:

Part of a larger recall action

This product is one of 99 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 99 products in this recall →

Related recalls

Same manufacturer · ICU Medical, Inc.

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Same hazard · seal defect

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