CareFusion Recalls SmartSite Needleless Connectors Due to Connection Issues
CareFusion is recalling SmartSite Needleless Connectors because they may unintentionally disconnect, be difficult to disconnect, or fail to disconnect from a female luer.
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: The recall is classified as FDA Class II. The hazard involves a medical device that may fail to disconnect or leak during medication administration, which poses a risk of harm, but the source text does not report specific injuries or illnesses.
Plain-English summary
CareFusion 303, Inc. is recalling the SmartSite Needleless Connector, model number 2000E, due to connection issues. The affected connectors are sterile, individually packaged devices used to administer fluids and medications into a primary line without the use of a needle.
The recall is being issued because the affected lots may unintentionally disconnect from a female luer, may be difficult to disconnect from a female luer, or may fail to disconnect from a female luer once attached. Leakage may also be observed if the connector disconnects from the female luer during use.
Approximately 3,500,000 units were distributed worldwide, including 2,136,200 units in the United States (nationwide, including Puerto Rico) and 1,404,700 units in Australia, Canada, and New Zealand. The recall covers specific lot numbers listed in the official FDA notice. Healthcare facilities and consumers should stop using the affected connectors and contact CareFusion for further instructions.
The recalled product
- Product
- SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile, individually packaged connectors. The connectors are used to administer fluid and medications. The needle free connector allows the user to add medication into the primary line…
- Manufacturer
- CareFusion 303, Inc.
Distribution
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