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Smartsite Needleless Connector (2014-01-22)
- Starting date:
- January 22, 2014
- Posting date:
- March 18, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-38313
Recalled Products
Smartsite Needleless Connector
Reason
Potential risks have been identified with model code 2000E due to connection issues. The affected Smartsite connector lots may unintentionally disconnect from a female luer, may be difficult to connect to a female luer or may fail 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 infusion. An inability to disconnect may require replacement of the IV line. The recall only affects standalone smartsite connector. Devices bonded to IV sets are not affected.
Affected products
Smartsite Needleless Connector
Lot or serial number
More than 10 serial numbers, contact manufacturer
Model or catalog number
2000E
Companies
- Manufacturer
-
Carefusion Switzerland 317 Sarl
A-One Business Centre, Zone D'Activites, Vers-La-Piece No 10
Rolle
CH-1180
SWITZERLAND