Medical connector recalled due to manufacturing housing gap defect
ICU Medical is recalling MicroClave Clear Neutral Connectors used in intravascular catheters due to a manufacturing defect that creates a visible gap between housing parts.
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 a Class II medical device with a structural manufacturing defect that poses risk of improper function in a critical care application. The source does not report illnesses or injuries, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
ICU Medical, Inc. is recalling MicroClave Clear Neutral Connectors, bidirectional connectors used as accessories to intravascular catheters placed in veins or arteries. Approximately 5,795,989 units of affected connectors were distributed across all US states, territories, and to over 26 countries internationally.
The recall is due to a manufacturing defect resulting in a visible gap between the connector's top and bottom housing.
The affected units can be identified using the specific product numbers, lot numbers, and UDI codes provided in the official FDA recall notice.
The recalled product
- Product
- MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular catheter placed in the vein or artery.
- Manufacturer
- ICU Medical, Inc.
- Hazard
- manufacturing-defect
- connector-failure
- contamination-risk
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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