Recall archive
136 recalls · page 5 of 6
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 Jun 3, 2015
CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator (respirator), intended to mechanically…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Carefusion 211 Inc. dba Carefusion
Matched: Brand · Product · Product details — A pressure transducer failure can develop, activating a false Extended High Ppeak or Circuit Occlusion Alarm. The Safety Valve will open to ambient…
FDA (openFDA device enforcement)
Reported May 6, 2015
CareFusion Vital Signs LightWand Stylet. A device inserted into an endotracheal tube to aid in the intubation procedure.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Vital Signs Colorado Inc.
Matched: Product · Product details · Reason for recall — Vital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3910 and 3960 due to a potential patient safety risk…
1 more product in this recall
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 Dec 17, 2014
Scrub Care Chlorhexidine Gluconate Solution, 4% Surgical Hand Scrub, OTC, CareFusion, Vernon Hills, IL 60061 NDC…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.CareFusion 213, LLC
Matched: Brand · Product · Product details — Does Not Meet Monograph: Chlorhexidine Gluconate Surgical Scrub Brush is being recalled due to higher concentrations of available chlorhexidine…
FDA (openFDA drug enforcement)
Reported Dec 17, 2014
A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus sold under the CareFusion,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Instrumed International, Inc.
Matched: Product · Product details — The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976,…
27 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 1, 2014
CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on patients who require…
High riskUsing this product could cause serious injury, illness or death — stop using it now.CareFusion 203, Inc.
Matched: Brand · Product · Product details · Reason for recall — CareFusion has identified a potential for damage to the power connector on the EnVe and ReVel ventilators due to misconnection by the operator. The…
FDA (openFDA device enforcement)
Reported Oct 1, 2014
CareFusion AirLife Heated Infant Breathing Circuit Product Usage: Respiratory breathing circuits are used with a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carefusion 2200 Inc.
Matched: Brand · Product · Product details · Reason for recall — The CareFusion AirLife Heated Infant Breathing Circuit is being recalled due to a regulatory compliance risk involving a material change. The changes…
FDA (openFDA device enforcement)
Reported Jul 23, 2014
ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 213, LLC
Matched: Brand · Product details — Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed.
FDA (openFDA drug 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 Jun 11, 2014
CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 9% Povidone-iodine (USP) Surgical Hand Scrub;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carefusion 2200 Inc.
Matched: Brand · Product · Product details · Reason for recall — Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner. The available iodine in the product is…
1 more product in this recall
FDA (openFDA drug 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)
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 9, 2013
Product Name: AVEA¿ Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Carefusion 211 Inc. dba Carefusion
Matched: Brand · Reason for recall — CareFusion has identified a potential risk associated with AVEA¿ ventilators when used at higher altitudes. A proactive complaint review identified…
FDA (openFDA device enforcement)
RecallNow is not a government agency. Every notice above is published by the FDA, USDA FSIS, or CPSC and links back to its source. Back to the look-up