Recall archive
136 recalls · page 4 of 6
Reported Sep 11, 2019
Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand · Product · Product details — Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of…
FDA (openFDA device enforcement)
Reported Jul 24, 2019
Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin. The following…
High riskUsing this product could cause serious injury, illness or death — stop using it now.CareFusion 303, Inc.
Matched: Brand — The bezel manufacturing process for the FR-110 plastic may have resulted in its weakening. A bezel with weakened plastic may, over time, lead to…
FDA (openFDA device enforcement)
Reported Jul 24, 2019
Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column: a) REF…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Teleflex Medical
Matched: Product details — Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal ConchaSmart Breathing Circuit.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 14, 2018
Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris Pump Module/Medley Pump Module/Gemini…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CareFusion 303, Inc.
Matched: Brand · Product details — Complaints where users were unable to prime the administration set.
FDA (openFDA device enforcement)
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 Apr 25, 2018
Manometer, 550 ml three-Way Stopcock; STERILE;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carefusion 2200 Inc.
Matched: Brand — The integrity of the sterile packaging is potentially compromised.
5 more products in this recall
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 Nov 1, 2017
ChloraPrep OneStep (Clear) (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 3 mL applicator,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Product details — Labeling; Label Mixup; the immediate package is labeled incorrectly as Chloroprep Onestep (Clear), however, the correct label should be Chloroprep…
FDA (openFDA drug 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 Sep 6, 2017
AirLife(TM) Reduced Heparin ARTERIAL BLOOD SAMPLER, REF 9025RHTR, 1ML SYRINE 25G 5/8", LUER SLIP PROTECTIVE SHEATH, 3.2…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Vyaire Medical
Matched: Product details — Lot #0001047501 of the 9025RHTR ABG sampling kits have been manufactured containing the incorrect sub-assembly which includes a larger needle (23…
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 Sep 28, 2016
Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK, Product Code 7700RAW2
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carefusion 2200 Inc.
Matched: Brand — The Oral Airway pouch within the PINK/RED Oxygen Delivery Module, 7700RAW, was incorrectly packaged with the 8 cm Berman Oral Airway. The pouch…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 7, 2016
The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health
Matched: Reason for recall — Arterial Blood Gas (ABG) Kit- Missing Safety Component. The ABG Kit(s) have been identified as missing the locking clasp component. CareFusion/BD has…
FDA (openFDA device enforcement)
Reported Aug 3, 2016
DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Carefusion 2200 Inc.
Matched: Brand · Reason for recall — BD, formerly CareFusion, has identified a potential risk associated with a weld failure which could result in the wire protruding thru the tip of the…
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 Jun 22, 2016
AVEA Comprehensive ventilator, 17310-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or…
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 Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer…
11 more products in this recall
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)
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