Recall archive
81 recalls · page 3 of 4
Reported Jun 13, 2018
Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications from a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — Reports of incorrect priming volume due to manufacturing with incorrect tubing.
FDA (openFDA device enforcement)
Reported Jan 17, 2018
Alaris Syringe Pump, Model 8110. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand · Product · Product details — The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 25, 2017
Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — The recalling firm has received reports of increased or decreased flows that have occurred in certain pumps.
FDA (openFDA device enforcement)
Reported Aug 23, 2017
VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200 Product Usage: Used with secondary IV sets or syringes with a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — Punctures in blister packaging that was detected during the packaging process.
FDA (openFDA device enforcement)
Reported Jul 19, 2017
Alaris Pump Module model 8100
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — There is a potential risk that could cause unintended flow in the older, centered sear door latch design in the Alaris Pump module model 8100.
FDA (openFDA device enforcement)
Reported Jul 12, 2017
Alaris PC Unit, Model 8015
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — BD initiated the recall of Alaris PC unit model 8015 after the firm identified five scenarios which can result in the occurrence of Systems Error…
FDA (openFDA device enforcement)
Reported May 3, 2017
SmartSite Add-On Bag Access Device, Model No. 10013365
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 Add-On Bag Device due to reports of separation and/or leakages between the spike port and the drip chamber…
FDA (openFDA device enforcement)
Reported Mar 29, 2017
Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — Reports where the Low Battery alarm and/or the Very Low Battery alarm are not being triggered before the battery is discharged and all infusion…
FDA (openFDA device enforcement)
Reported Mar 22, 2017
MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305
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 MaxGuard Extension Set with Injection Site and 0.2 micron filter because of reports of separation and/or leakages between…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 25, 2017
Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. The Alaris Pump module is a…
High riskUsing this product could cause serious injury, illness or death — stop using it now.CareFusion 303, Inc.
Matched: Brand — During an infusion, a false Air-in-Line (AIL) alarm would cause the infusion to be interrupted.
FDA (openFDA device enforcement)
Reported Oct 5, 2016
Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the Alaris…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — A software anomaly with the Alaris Syringe module software version 9.15 may cause an infusion to unexpectedly stop when the Syringe module is…
FDA (openFDA device enforcement)
Reported Jul 6, 2016
Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — A patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore infusions running on the Alaris LVP…
FDA (openFDA device enforcement)
Reported May 11, 2016
Alaris PC unit, Model 8015 The Alaris PC unit is the central programming, monitoring and power supply component for the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — The Alaris PC units model 8015 may display a system error code 133.6080 due to failure with the super capacitor (C245) at power up on the Alaris PC…
FDA (openFDA device enforcement)
Reported Mar 30, 2016
Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092
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 Alaris PC unit because a component on the PC unit power supply may cause a "System Error" or "Missing Battery" error code…
FDA (openFDA device enforcement)
Reported Mar 23, 2016
Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007
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 Alaris VersaSafe Infusion Set because of separation and/or leakages at the VersaSafe split septum port and tubing may…
FDA (openFDA device enforcement)
Reported Feb 24, 2016
Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. Product Usage: An accessory for the Pyxis Anesthesia…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — Customers reported issues when scanning medications with the scanners. When a user scans a medication using the affected barcode scanner, information…
FDA (openFDA device enforcement)
Reported Dec 30, 2015
Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medications through a needle or…
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 Alaris Pump Module SmartSite Infusion Set because the disconnection and leakage may occur during infusion.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 11, 2015
SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter…
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 Extension Set due to disconnection and leakage issues.
FDA (openFDA device enforcement)
Reported Aug 26, 2015
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part…
High riskUsing this product could cause serious injury, illness or death — stop using it now.CareFusion 303, Inc.
Matched: Brand — Channel Error code is displayed on the PC unit with an audio and visual alarm, and on the syringe module. After the error is cleared on the PCU, the…
FDA (openFDA device enforcement)
Reported Jun 24, 2015
Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand — An issue with the cancel functionality used during atypical infusion programming to cancel user inputted values. An infusion may start that is…
FDA (openFDA device enforcement)
Reported Apr 1, 2015
Alaris PC units, Model No. 8015. Infusion pump.
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 Alaris PC unit because of an error code. The error code may occur upon power on during the "Power-On Self Test" due to a…
FDA (openFDA device enforcement)
Reported Feb 11, 2015
SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer fluid and…
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 due to disconnection and leakage issues.
FDA (openFDA device enforcement)
Reported Jul 16, 2014
SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894 14035458
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 because they were assembled with a drip chamber that consist of a 15 micron filter.…
FDA (openFDA device enforcement)
Reported May 21, 2014
Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" Option and "Multidose"…
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 Pump model 8100 version 9.1.18 because it may have a software issue that results in situation where the pump…
FDA (openFDA device enforcement)
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