Recall archive
81 recalls · page 4 of 4
Reported Apr 23, 2014
SmartSite Extension Set, Model No. 20029E, intravascular administration set.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — Disconnections and leakages at the connection of the smallbore tubing and the SmartSite Y-port.
FDA (openFDA device enforcement)
Reported Feb 12, 2014
SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile, individually packaged…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand · Reason for recall — CareFusion is recalling the SmartSite Needlefree Connector, model number 2000E, because of connection issues. The affected SmartSite connector lots…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 1, 2014
Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600. Product…
High riskUsing this product could cause serious injury, illness or death — stop using it now.CareFusion 303, Inc.
Matched: Brand · Reason for recall — CareFusion is recalling the Alaris PC unit (model 8000 and 8015) because the Alaris PC unit will produce an audible alarm and the Alaris PC unit will…
FDA (openFDA device enforcement)
Reported Dec 11, 2013
VersaSafe Extension Set, Model No. 21000M-007
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand · Reason for recall — CareFusion is recalling the VersaSafe Extension Intravascular Administration Set because it may have excessive adhesive which will prevent the male…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 2, 2013
SmartSite Low Sorbing Infusion Set, Model#72313E The SmartSite Low Sorbing Infusion Sets are used to administer fluid…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand · Reason for recall — CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model 72313E, Lot Number 13016314, because of an incorrect filter was assembled on…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 14, 2013
Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part number TC10006584. The…
High riskUsing this product could cause serious injury, illness or death — stop using it now.CareFusion 303, Inc.
Matched: Brand · Reason for recall — CareFusion is recalling the Alaris PC units model 8015 (PC unit), version 9.12, because it is operating at an incorrect voltage and it could…
FDA (openFDA device enforcement)
Reported Aug 29, 2012
Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent Product Code: FPA. The Pump module is intended…
High riskUsing this product could cause serious injury, illness or death — stop using it now.CareFusion 303, Inc.
Matched: Brand · Reason for recall — The recall was initiated because Carefusion has identified a potential risk associated with the Alaris Pump module model 8100. The pump module door…
FDA (openFDA device enforcement)
Reported Aug 22, 2012
Alaris Pump Module model 8100. Subsequent product code: FPA The Pump module is intended for facilities that utilize…
High riskUsing this product could cause serious injury, illness or death — stop using it now.CareFusion 303, Inc.
Matched: Brand · Reason for recall — The recall was initiated because Carefusion identified a potential risk associated with the Alaris Pump module model 8100. Carefusion has received…
FDA (openFDA device enforcement)
Reported Aug 1, 2012
Alaris PC unit model 8015 Product Usage: The device is labeled for prescription use only.
High riskUsing this product could cause serious injury, illness or death — stop using it now.CareFusion 303, Inc.
Matched: Brand — The recall was initiated because the Alaris PC unit model 8015 has a component on the PC unit power supply board that is causing an error…
FDA (openFDA device enforcement)
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