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    Roche/Hitachi ALT (ALAT/GPT) Reagent Kit for use on the Roche/Hitachi MODULAR ANALYTICS P Module; Catalog number 1877470 (11877470216).

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code CKH·August 20, 2004

    Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical powered. Surgical powered Laser instruments.

    FDA Recall
    Terminated ·China Daheng Group Inc. # A9 Shangdi Xinxilu Haidian District Beijing China·Product code LYB·July 15, 2013

    The GSP 2021-0010 (Genetic Screening Processor) instrument is a fully automated, high through put batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The chemistries running on the GSP instrument are used to test blood specimens dried on filter paper as an aid in screening newborns for congenital disorders.

    FDA Recall
    Terminated ·PerkinElmer LAS, Inc·Product code JLW·October 24, 2011

    Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH00002T The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an exothermic chemical reaction, warming the pouch, which is then applied to the heel of an infant to aid in blood draws

    FDA Recall
    Terminated ·Cardinal Health·Product code MPO·June 9, 2021

    Infant Heel Warmer without Attachment Tab, Nonsterile, Active Product SKU MH00002N The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an exothermic chemical reaction, warming the pouch, which is then applied to the heel of an infant to aid in blood draws

    FDA Recall
    Terminated ·Cardinal Health·Product code MPO·June 9, 2021

    Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.

    FDA Enforcement
    Class II ·Terminated·Sentinel CH SpA·November 4, 2015

    MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems The product is a medical device (chemistry reagent) and is intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems. The kit is provided as a ready to use liquid material consisting in two components: Reagent 1 and Reagent 2. According to the catalogue number, the kit is composed of three vials of 48 ml for Reagent 1 and three vials of 18 ml for Reagent 2 in the configuration 8L24-31. The configuration 8L24-41 consists in ten vials of 90 ml for Reagent 1 and ten vials of 34 ml for Reagent 2

    FDA Enforcement
    Class II ·Terminated·Sentinel CH SPA·August 9, 2017

    Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 08P5320

    FDA Enforcement
    Class II ·Terminated·Sentinel CH SpA·October 2, 2019

    MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 8L25-30

    FDA Enforcement
    Class II ·Terminated·Sentinel CH SpA·October 2, 2019

    Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer.

    FDA Enforcement
    Class III ·Terminated·Sentinel CH SpA·October 13, 2021

    Dale Medical Stabilock Endotracheal Tube Holder Product # 270 The Dale Stabilock Endotracheal Tube Bolder 270 is a 2 piece device consisting of an adhesive base, Dale product number 273, that attaches to the patient's skin and a cushioned neckband with tube channel that attaches with hook & loop closures. The 270 is used to secure and stabilize endotracheal tubes, preventing unnecessary movement which can help prevent accidental .extubation

    FDA Recall
    Terminated ·Dale Medical Products, Inc.·Product code CBH·March 24, 2017

    Portex HEPA Bacterial /Viral Filter, Non-Latex Ref: 002890

    FDA Recall
    Terminated ·Smiths Medical International Ltd Reachfields Boundry Road Hythe United Kingdom·Product code CAH·June 7, 2005

    PALL Medical Breathing Circuit Filter, REF BB50T and BB50T-BULK , Rx ONLY Single use, bi-directional bacterial/viral removal filter. The filters are individually packaged in a clear, plastic pouch with black writing - 50 per case, or in bulk packaged 100 filters/bag and two bags per shipper for a total of 200 filters/shipper.

    FDA Recall
    Terminated ·Pall Corporation·Product code CAH·June 4, 2014

    UNIVERSAL FLEX2 BREATHING CIRCUIT, Item Numbers: D460-6133Z, D390-6121Z, D390-6121Z, D495-61Z, DF4116-6121Z, D466-61Z, DFP170-6121, DF3115-6121Z, DF375-6121Z, DF3115-6121Z, DF3115-6121Z, D360-8031Z, D465-61Z, JD365-6033Z, DF370-6121Z, DF3110-61Z, DF375-17621Z, DF375-6121Z, DF475-17621Z, DF370-6121Z, DF375-6121Z, DF470-6021Z, D366-618Z, D390-60Z, D390-61Z, DP260-61, DF370-6121Z, D3120-6154Z, F95100, JD365-6033Z, DF370-61Z, DF475-61Z, DF3110-6121Z, DF3110-6121Z, DF375-6121Z, DF475-6121Z, F90755, F90798, F95368, PDP260-61, D396R-61Z, F90578, F90622Z, F94980, D360-61Z, D365-6121Z, D366-6121Z, D366-6121Z, SJDF3116-6121Z, DF375-6121Z, DF470-6121Z, DF470-61Z, DF475-6121Z, DF375-6033Z, DF375-618Z, DF470-6127Z, DF475-61Z, DF476-6121Z, F90756, PDB160-6131, PDP160-6121, PDY160-6121, D060-8021, D366-8021Z, D466-6121Z, DF370-6121Z, DF470-6121Z, DF376-6121Z, PDP160-6031, D360-8021Z, D360-80Z, D445-80Z, D465-8021Z, JD365-6033Z, D460-6131Z, D460-6133Z, DF475-6121Z, DF3116S-608Z, F90777, D360-6133Z, D365-80Z, D360-6021Z, D360-6121Z, D360-61Z, DF3110-61Z, DF370-61Z, DF375-17621Z, DF475-6121Z, D365-6121Z, D060-80, PD060-6121, PD160-6121Z, PDP160-6121, DF3115-6121Z, F90767, DF375-17621Z, DF375-6121Z, DF470-6121Z, PD260-61Z, PDY140-6133, D360-16421Z, D360-6121Z, D366-6121Z, DFP2110-6121, DF470-6121Z, D465-8021Z, DF4115-6121Z, DF370-6121Z, DF376-6121Z, PDB140-61, D365-6121Z, DF070-61, PDY160-6121, D365-61Z, D360-6121Z, D360-61Z, D460-6121Z, DF0110-6121, DF3110-61Z, DF370-61Z, DF375-6121Z, DF375-6121Z, DF475-6121Z, DF475-6121Z, DF370-6021Z, DF370-6133Z, DF375-618Z, DF475-17621Z, DFB170-61, PD040-61, PDP160-6121, PDY160-6121, D390-61Z, F94474, D460-61Z, D366-6121Z, D360-6121Z, D360-6121Z, D360-6121Z, D360-6121Z, DF0110-61, DF0110-61, DF3115-6121Z, DF3115-6121Z, DF070-6127, F90752, DF375-17621Z, DF375-61Z, DF376-17621Z, F95100, D360-6021Z, D366-6121Z, D465-8021Z, D360-61Z, DF3110-61Z, DF3110-61Z, DF3110-6121Z, PDP160-6031, D360-6121Z, D360-6121Z, D360-6121Z, D360-6121Z, D360-6121Z, D360-6121Z, D460-61Z, D3120-6121Z, D360-8021Z, D365-80Z, D395-8021Z, D460-8021Z, D465-8021Z, D495-61Z, F90577Z, DF370-6133Z, DF375-6021Z, DF376-6121Z, DF475V-6121Z, DFP170-6121, DF370-61Z, DF470-6121Z, DF470-6121Z, DF470-6121Z, DF470-6121Z, DF470-61Z, DF3115-6121Z, F90767, DF370-6121Z, DF375-6121Z, DF476-6121Z, F95407, F90556, D365V-8021Z, F95383, D460-61Z, F90777, DF370-6121Z, DF370-6121Z, DF375-17621Z, DF475-6121Z, D440-80Z, D360-6021Z, D365-6121Z, DF370-61Z, DF4116-6121Z, DF476-6121Z, F90579, D345-6121Z, D396R-61Z, D460-80Z, D465-6031Z, D465-8021Z, DP2120-61, F90578, F94795, F94980, D360-61Z D365-6121Z, D365-6121Z, D366-6121Z, D366-6121Z, D460-6121Z, D460-6121Z, D460-61Z, D360-6021Z, D360-6121Z, D366-6121Z, D366-6121Z, D060-8021, D3120-6121Z, D360-16421Z, D360-8021Z, D360-8031Z, D366-80Z, D390-61Z, D460-80Z, D465-8021Z, D465V-8021Z, PDP160-6121, DF070-6121, DF370-6021Z, DF375-61Z, DF375-61Z, DF375-61Z, DF470-6021Z, DF475-61Z, DFY170-6121, DF375-17621Z, DF375-6121Z, DF375-6121Z, DF470-6121Z, DF475-6121Z, DF475-6121Z, SJDF3116-6121Z, DF3115-6121Z, DF3116-6121Z, DF4115-6121Z, DF4116-6121Z, DF475-6121Z, DF375-6121Z, DF375-6121Z, DF470-6121Z, DF0110-618, DF370-61Z, DF375-6121Z, DF475-6121Z, DF475-6121Z, DF375-6021Z, F90798, PDP140-6121, D365V-8021Z, D366-8021Z, D445-80Z, D460-8021Z, D460-8021Z, D465-61Z, D365-61Z, DF3116S-608Z, DF370-6121Z, DF375-17621Z, DF375-6121Z, DF470-6127Z, DF475V-6121Z, DF476-6121Z, F95368, F95407, PD060-61, PDB160-6131, PDP160-6121, D460-6131Z, D360-6121Z, D360-61Z, DF370-6121Z, DF375-17621Z, DF475-6121Z, DF376-17621Z, D3120-6121Z, D466-6121Z, DF4110-6121Z, DF370-6121Z, DF376-6121Z, DF475V-6121Z, D440-80Z, DF376R-61Z, DF0110-6121, DF370-6121Z, DF470-6121Z, DF375-17621Z, DF370-6021Z, DF475-61Z, DFP170-6121, DFY270-6121, PDP264C-61, D360-8021Z, D365-8021Z, D365-80Z, D365-80Z, F90578, D360-6121Z, D360-6121Z, D360-61Z, D460-6121Z, DF3115-6121Z, DF3115-6121Z, DF4115-61Z, DFP2110-61, DF375-6121Z, DF470-6121Z, DF475-6121Z, DF476-6121Z, DF470-6121Z, DF475V-6

    FDA Recall
    Terminated ·King Systems Corp. dba Ambu, Inc.·Product code CAH·March 15, 2017

    ViroMax viral/bacterial filter. The filter reduces the risk of infection due to cross-contamination between patients For use on all patient populations in conjunction with other respiratory devices containing standard 15mm and/or 22mm fittings (such as breathing circuits) to filter respiratory gases where infection from airborne bacteria and viruses is a concern. Disposable, for single patient use only.

    FDA Recall
    Terminated ·A M Systems Inc·Product code CAH·March 31, 2010

    Vital Signs Anesthesia Circuits The Ventilator Circuit is intended for use as an interface between a ventilator dependent patient and a ventilator. The Anesthesia Circuit is intended to administer medical gases to a patient during anesthesia. The CPAP Circuit is intended to increase the airway pressure of a patient.

    FDA Recall
    Terminated ·Vital Signs Colorado Inc.·Product code CAH·December 26, 2013

    Dale 240 Blue (Adults) Tracheostomy Tube Holder, Product Number: H84102401, Dale Medical Products, Inc., Plainville, MA 02762

    FDA Recall
    Terminated ·Dale Medical Products, Inc.·Product code CBH·September 27, 2007

    Dale Medical Stabilock Endotracheal Adhesive Base Product # 273 The Dale Stabilock Endotracheal Tube Bolder 270 is a 2 piece device consisting of an adhesive base, Dale product number 273, that attaches to the patient's skin and a cushioned neckband with tube channel that attaches with hook & loop closures. The 270 is used to secure and stabilize endotracheal tubes, preventing unnecessary movement which can help prevent accidental .extubation

    FDA Recall
    Terminated ·Dale Medical Products, Inc.·Product code CBH·March 24, 2017

    Xenon Diagnostic Circuit Kits labeled as "Xenon Diagnostic Circuit", "Xenon Circuit", and Needleless Xenon Diagnostic Circuit" Manufactured for RAF MEDICAL, INC., (Model number's RAF2306, RAF2304, RAF2380, RAF2300, RAF2370, RAF2372, RAF2350, RAF2341, RAF2302, RAF2340 RAF2306, RAF2304, RAF2361), or Medico-Mart, Inc. ("Xenon Curcuit" Model number's 2304, 2306). Xenon Diagnostic Circuit Kit: Used in specific Nuclear Medicine Procedures. ViroMax: For use on all patient populations, in conjunction with other respiratory devices containing standard 15 mm and/or 22 mm fittings (such as breathing circuits and the like) to filter respiratory gases where infection from airborne bacteria and viruses is a concern.

    FDA Recall
    Terminated ·Continental Medical Labs, Inc·Product code CAH·April 16, 2010

    Dale 242 Blue (Neonate, Infants and Small Children) Tracheostomy Tube Holder, Product Number: H84102421, Dale Medical Products, Inc., Plainville, MA 02762

    FDA Recall
    Terminated ·Dale Medical Products, Inc.·Product code CBH·September 27, 2007