ICU Medical IV Connector Extension Set Recalled for Manufacturing Defect
ICU Medical is recalling intravascular administration set connectors due to a manufacturing defect that creates a visible gap in the connector housing. The defect affects approximately 5.8 million units distributed nationwide and internationally.
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 involving a manufacturing defect in a critical component of intravenous administration systems. No illnesses or injuries have been reported; the hazard is the potential risk posed by the connector defect. Per the rubric, this qualifies as High because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
ICU Medical, Inc. is recalling approximately 5.8 million intravascular administration set connectors. The recalled product is a 6.5-inch (17 cm) extension set with a 4-way stopcock and Clave connector, designed for use with intravenous lines.
The manufacturer identified a manufacturing defect that results in a visible gap between the connector's top and bottom housing. This defect in the connector assembly could compromise the integrity of intravenous administration.
The affected units have Product Number CH3771 and Lot Number 5782919. These connectors have been distributed throughout the United States, including all states and U.S. territories (Alaska, Hawaii, Guam, and Puerto Rico), as well as internationally to 27 countries including Canada, the United Kingdom, Austria, Belgium, Germany, France, Italy, Spain, Japan, and others.
Healthcare providers and consumers who have received these connectors should examine them for visible gaps between the connector housing. Healthcare facilities should review their inventory and follow appropriate procedures for managing the recalled devices.
The recalled product
- Product
- 6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for intravascular administration set.
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 5,795,989
Distribution
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.
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