ICU Medical Recalls Intravascular Connectors for Manufacturing Defect
ICU Medical is recalling approximately 5.8 million MicroClave Clear Connectors used in IV administration due to a manufacturing defect that creates a visible gap between the connector housing.
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 connector used in intravascular administration. Although no illnesses or injuries have been reported, the defect represents a potential risk of harm if the visible gap causes connector malfunction or failure during medical use. Per the severity rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
ICU Medical, Inc. is recalling MicroClave Clear Neutral Connectors and related connector variants used in intravascular administration sets. Approximately 5.8 million units are affected.
The connectors are being recalled due to a manufacturing defect that results in a visible gap between the connector's top and bottom housing.
The recalled connectors have been distributed throughout the United States, including all 50 states, Washington, D.C., Guam, and Puerto Rico, as well as internationally to Austria, Bahrain, Belgium, Canada, Colombia, Estonia, France, Germany, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Peru, Poland, Saudi Arabia, Slovakia, Slovenia, Spain, Sweden, Thailand, Turkey, United Arab Emirates, the United Kingdom, and Vietnam.
The recalled product
- Product
- MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroClave Clear Neutral Connector, Approx Priming Volume: 0.04 mL. Accessory for Intravascular Administration Set
- Manufacturer
- ICU Medical, Inc.
- Hazard
- connector-defect
Distribution
Distributed in 51 states:
- AK
- AL
- AR
- AZ
- CA
- CO
- CT
- DC
- DE
- FL
- GA
- HI
- IA
- ID
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- ME
- MI
- MN
- MO
- MS
- MT
- NC
- ND
- NE
- NH
- NJ
- NM
- NV
- NY
- OH
- OK
- OR
- PA
- RI
- SC
- SD
- TN
- TX
- UT
- VA
- VT
- WA
- WI
- WV
- WY
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