47 results
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21ms
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Sources: EU EUDAMED, US FDA
Vitros Chemistry *** GLU (glucose) DT Slides ***25 slides per box *** CAT 153 2316 *** Ortho-Clinical Diagnostics Inc. , 100 Indigo Creek Dr., Rochester, NY 14626. [NOTE: product has a 24-month shelf life.]
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code CGA·July 28, 2003
Vitros Chemistry *** GLU (glucose) Slides *** 5 cartridges each containing 60 slides for a total of 300 tests per box *** REF 170 7801 *** Ortho-Clinical Diagnostics Inc., 100 Indigo Creek Drive, Rochester, NY 14626. [NOTE: product has an 18 month shelf life.]
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code CGA·July 28, 2003
Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose 200pk Cool Mint: Enamelast 5% Sodium Fluoride Unit Dose 200pk Kit - Cool Mint REF/UP 4352 Rx CONTENTS: 200 x 0.4 ml Unit Dose Label Enamelast Unit Dose 50pk Cool Mint: Enamelast 5% Sodium Fluoride Unit Dose 50pk Kit - Cool Mint REF/UP 4353 Rx CONTENTS: 50 x 0.4 ml Unit Dose Manufactured by Ultradent Products Inc. ****Label Enamelast Unit Dose 200pk Variety Pack - The Variety Pack (PN#4368) includes four 50 packs of different Enamelast flavors, including Orange Cream, Bubblegum, Walterberry, and Cool Mint: Enamelast 5% Sodium Fluoride Unit Dose 50pk Kit - Variety Pack REF/UP 4353 Rx CONTENTS: 50 x 0.4 ml Unit Dose Product Usage: Description: Enamelast Fluoride Varnish is a flavored, xylitol-sweetened 5% sodium fluoride in a resin carrier delivered in a 0.4 ml unit dose blister pack. Indications for Use: Enamelast Fluoride Varnish is 5% sodium fluoride in a varnish carrier which produces a mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity.
FDA Recall
Terminated
·Ultradent Products, Inc.·Product code LBH·July 12, 2018
Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code QKO·May 7, 2021
Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code QKO·May 7, 2021
Access Immunoassay Systems Assay Protocol File (APF) Software versions for UniCel DxC 600i Systems. Part Number: A54378, UniCel DxC 600i APF, Part Number: A54379, UniCel DxC 600i AAF. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentration found in human body fluids.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JJE·September 11, 2008
Access Immunoassay Systems Assay Protocol File (APF) Software versions for Synchron LXI 725. Part Number: A54376, Synchron LXi 725 APF, Part Number: A54377, Synchron LXi 725 AAF. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentration found in human body fluids.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JJE·September 11, 2008
X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures.
FDA Recall
Terminated
·X-NAV Technologies, LLC·Product code PLV·February 23, 2016
Lodox Statscan digital radiographic system.
FDA Recall
Terminated
·Lodox Na Llc·May 10, 2004
Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.
FDA Recall
Terminated
·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·Product code CAF·September 5, 2017
ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of aerosolized medications from metered dose inhaler canisters and with mechanically ventilated patients.
FDA Recall
Terminated
·Smiths Medical ASD Inc.·Product code CAF·March 31, 2021
Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vials, Rx Only, NDC 0487-9007-60. A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indicated. For respiratory therapy, Solium Chloride Inhalation Solution USP, 3% is used in conjunction with a nebulizer
FDA Recall
Terminated
·Nephron Pharmaceuticals Corp.·Product code CAF·November 16, 2015
Sunset Compressor Nebulizer, Model NEB100 - Product Usage: The Sunset Compressor Nebulizer is an AC-powered air nebulizer compressor system intended to provide a source of compressed air for medical purposes for use in home healthcare. It is to be used with a nebulizer kit to produce medicated aerosol particles for respiratory therapy for both children and adults.
FDA Recall
Terminated
·SANRAI INTERNATIONAL LLC·Product code CAF·August 29, 2018
The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.
FDA Recall
Terminated
·Aerogen Ltd. Galway Business Park Dangan Galway Ireland·Product code CAF·September 2, 2014
Roscoe Mini Neb Compressor User Manual for the NEB-ROS Product Usage: Inhaler therapy that converts liquid medicine into a fine mist that is easily inhaled.
FDA Recall
Terminated
·Compass Health Brands·Product code CAF·April 20, 2015
Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.
FDA Recall
Terminated
·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·Product code CAF·September 5, 2017
Portex 1000 ml Sterile Water USP Pour Bottle
FDA Recall
Terminated
·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·Product code CAF·September 5, 2017
Medline Prefilled 350 ml Sterile
FDA Recall
Terminated
·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·Product code CAF·September 5, 2017
Intermed 550 ml Sterile Water Humidifier w/5psi Adapt.
FDA Recall
Terminated
·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·Product code CAF·September 5, 2017
AirLife MiniSpacer MDI Dispenser Adapter. Dual-Spray MiniSpacer Metered Dose Inhaler (MDI) Dispenser/Adapter with 15 mm connections. The 15 mm Dual Spray MiniSpacer is a Metered Dose Inhaler (MDI) Dispenser. It is a non-sterile, single-use item, intended to dispense aerosolized medication into a breathing circuit or ancillary circuits. MINISPACER adapters are indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. The 15 mm device is installed and operated by licensed healthcare practitioners in clinical settings. The MiniSpacer is not a metering valve, and does not measure the amount of medication dispensed. The device may also be used in conjunction with a resuscitator bag or in-line with cool or heated humidification, oxygen enriched T-pieces (blow-by) systems connected to tracheal/endotracheal tube. Environments of use include short and long term critical care settings. The 15 mm Dual Spray MiniSpacers design provides standard dimension connectors (15 mm outer diameter x 15 mm inner diameter) for connection to the ventilator circuit. The device design incorporates a dual spray nozzle that allows a path for the medication to travel through the stem and directs it through the dual orifices into the airstream. Principles of Operation A healthcare practitioner installs the 15 mm MiniSpacer MDI adapter in the breathing circuit, according to facility procedures or as ordered by a physician or other licensed health care practitioner. To dispense the prescribed medication, the healthcare practitioner inserts the MDI canister stem into the devices actuator port and manually depresses the MDI canister. The MDI canisters metering valve releases the combination of medication and propellant through the valve stem and out of the devices dual spray nozzle. The plume is simultaneously ejected through upstream and downstream spray orifices along the longitudinal axis of the device. The practitioner administers the medication as prescribed, caps the MiniSpacer device, and monitors the patient response. The devices are packaged in cardboard corrugated cartons that are rated to meet burst testing up to 200 pounds per square inch. Each carton contains 30 devices; each device is packaged in a polybag with the instructions for use. These devices are sold non-sterile.
FDA Recall
Terminated
·Thayer Medical Corporation·Product code CAF·June 6, 2012