Recall archive
136 recalls · page 6 of 6
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 Sep 18, 2013
*** 1) Cat. 4341B; Qty. 10; Thoracentesis Tray; With Catheter; Sterile; CareFusion; 1500 Waukegan Road; McGaw Park, IL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carefusion 2200 Inc.
Matched: Brand · Product · Product details — Catheters included in Thoracentesis Tray and Safe-T Thoracentesis Tray - Drug Free may occlude, preventing drainage of excessive fluid from the…
FDA (openFDA device enforcement)
Reported Aug 21, 2013
1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) Adult Manual Resuscitator, 2K8005, 40" (1.0…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carefusion 2200 Inc.
Matched: Brand · Reason for recall — CareFusion has received four (4) customer reports of a component (oxygen connector) within the resuscitation bag being occluded which disables the…
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 May 22, 2013
Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID: 8508. IV Start Kit.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Covidien LLC
Matched: Reason for recall — On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. CareFusion is recalling a variety of OTC drug products…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 24, 2013
Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Carefusion Corporation
Matched: Brand · Reason for recall — The recall was initiated because Carefusion has received reports of a communication error on the Alaris PC unit model 8015 with software version 9.12…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 3, 2013
Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product Usage: Preoperative skin product
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.CareFusion 213, LLC
Matched: Brand · Reason for recall — An internal review of CareFusion's labeling for preoperative skin prep product codes was recently conducted. The labeling of the product codes…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 3, 2013
Pyxis Anesthesia System Model 2000 (PAS 2000) Product Usage: The PAS 2000 is an anesthesia medication dispensing device…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion Corporation
Matched: Brand · Reason for recall — The recall was initiated because Carefusion has confirmed that when the PAS 2000 drawers due to inaccessability of drawers caused by system down time…
FDA (openFDA device enforcement)
Reported Feb 27, 2013
CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carefusion 303 Inc.
Matched: Brand · Product · Product details · Reason for recall — CareFusion is recalling the SmartSite¿ Gravity Blood Set as a result of a potential for separation at the connection of the drip chamber and tubing .…
FDA (openFDA device enforcement)
Reported Oct 10, 2012
ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) Patient Preoperative Skin…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carefusion 213, LLC
Matched: Brand — Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing.
FDA (openFDA drug enforcement)
Reported Sep 26, 2012
ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, External Use Only,…
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: A customer complaint reported some units had incomplete seals (open seals) on the Individual unit packaging.
FDA (openFDA drug 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)
Reported Jul 25, 2012
CareFusion EnVe Ventilator Designed for use on patients who require respiratory support or mechanical ventilation and…
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 identified that the EnVe Ventilator may not hold the set Positive End Expiratory Pressure (PEEP) value either intermittently or…
FDA (openFDA device enforcement)
Reported Jul 11, 2012
AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated; an Rx device for single patient use;…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Carefusion 2200 Inc.
Matched: Brand · Product details — The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a…
2 more products in this recall
FDA (openFDA device enforcement)
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