Agency classClass IIOur severity:High FDA (Devices)·Z-1723-2022·Announced 2022-09-21

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.

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: 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.
Category: Medical Device — Intravascular Administration / IV Connector
Hazard: manufacturing-defect
connector-gap
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 →

Same manufacturer · ICU Medical, Inc.

See all →

High
ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
High
ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
High
ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
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 · manufacturing defect