The Recall Desk
HighFDA (Devices)·Z-1724-2022·Announced 2022-09-21

ICU Medical Trifuse Extension Set Recalled for Connector Housing Gap

ICU Medical is recalling 5.8 million Trifuse Extension Sets due to a manufacturing defect that creates a visible gap between the connector's housing parts. The gap could lead to disconnection or fluid leakage during infusion.

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: This is an FDA Class II medical device recall affecting 5.8 million units with a manufacturing defect that could compromise infusion line integrity. However, the source text does not report any adverse events, injuries, or deaths. Per the rubric, Class II recalls with no reported harm score at most 3 (High).

Plain-English summary

ICU Medical, Inc. is recalling approximately 5.8 million units of its 6-inch Smallbore Trifuse Extension Sets worldwide. The affected sets include multiple product numbers and lot numbers identified by UDI codes. These are medical devices used in infusion therapy to connect intravenous (IV) lines.

The recall was initiated due to a manufacturing defect in which a visible gap exists between the top and bottom housing of the connector. This gap could potentially allow the connector to separate during use or permit fluid leakage, potentially compromising the integrity of the infusion line.

The affected products have been distributed throughout the United States (all states plus Guam and Puerto Rico) and internationally to 27 countries including Canada, the United Kingdom, Japan, Germany, and others. Healthcare facilities and patients using these extension sets may be affected.

The FDA has classified this as a Class II recall. Patients and healthcare providers should stop using the affected lots and contact ICU Medical or their healthcare provider for replacement units. Product identification information including lot numbers and UDI codes is available from the FDA.

The recalled product

Product
6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check Valve, 3 Clamps, Rotating Luer;
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Infusion/IV Extension Set
Hazard
Affected units
5,795,989

Distribution

Distributed in 53 states:

Part of a larger recall action

This product is one of 6 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 6 products in this recall →

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