BEUDAMED
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    Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the system calibration of Na, K, Cl, Urea N, Urea, Glucose Creatine, Ca, CO2, and P in UniCel DxC Systems.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc·July 19, 2017

    Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the system calibration of Na, K, Cl, Urea N, Urea, Glucose Creatine, Ca, CO2, and P in UniCel DxC Systems.

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code JIX·May 15, 2017

    Spectrum Medical Quantum Standard heat exchanger

    FDA Enforcement
    Class II ·Terminated·QURA S.R.L.·August 18, 2021

    Hudson RCI AQUA+ Flex, Hygroscopic Condenser Humidifier, HCH Tidal Volume Range 300-1500mL, ICU/Anesthesia Adult/Child, Catalog number 1570, Distributed by Teleflex Medical. The Aqua+ Flex is a passive humidifier indicated for use on patients under anesthesia and intensive care to effectively warm and humidify the inspired air.

    FDA Recall
    Terminated ·Teleflex Medical·Product code BTT·March 19, 2010

    Toshiba DUA-450F Kalare Radiographic Tilting Table.

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code IXR·July 15, 2010

    Aqua 540 SW, 540 w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.

    FDA Recall
    Terminated ·Teleflex Medical·Product code BTT·June 5, 2014

    Cosmetic color soft contact lenses. Multiple colors which include Blue, Green, Aqua, Brown, Grey. BesCon (brand)

    FDA Recall
    Terminated ·My Cosmetics Inc·Product code LPL·November 13, 2002

    Aqua 540 SW, 540 w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·July 16, 2014

    X-Ray High Voltage Generator, Model KXO-80G used on Image Intensified Fluoroscopoc X-Ray System DUA-450D

    FDA Recall
    Terminated ·Toshiba American Med Sys Inc·Product code rad·September 7, 2004

    SYNCHRON Systems Modular Creatinine (CREm) Reagent Kit, Part Number: 472525 Systems AQUA CAL 1 and 2, is intended for the quantitative determination of creatinine concentration in human serum, plasma or urine. CREm reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 800 System and SYNCHRON Systems AQUA CAL 1 and 2, is intended for the quantitative determination of creatinine concentration in human serum, plasma or urine.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CGX·August 2, 2010

    ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800 Systems), Part No. A28937, A28945, 467935, 467915. Product Usage: ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems AQUA CAL 1, 2 and 3, are intended for the quantitative determination of potassium concentration in human serum, plasma or urine.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·August 21, 2013

    AQUA 540 SW, 540 W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·February 18, 2015

    Spectrum Medical Quantum Standard heat exchanger

    FDA Recall
    Terminated ·QURA S.R.L. Via Di Mezzo·Product code KFM·March 22, 2021

    Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. The product is contained within prefilled, labeled syringes in a transparent plastic container identified with an aqua, red, orange, blue and black label with black and blue print writing. Product code: 5135, 872.3200 KLE, liquid and powder mixture is a syringe-in-a-syringe delivery system. The product is used for most bonding needs in restorative dentistry. Bonds chemical cure luting and chemical cure composites, namely PermaFlo DC. Peak SE does not require a separate etching step for quality adhesion. Peak SE is also conducive for bonding to: Dentin and enamel, porcelain, metal and composite.

    FDA Enforcement
    Class II ·Terminated·Ultradent Products, Inc.·June 27, 2012

    Penner Patient Stretcher/Transfer Lift System Models 391000-1 and 392000-1 The Pacific Stretcher/Transfer Lift is used with Whirlpool or Aqua-Aire (air bubbling) bathing system intended for use in nursing homes, hospitals, and assisted living facilities to transfer and/or lift patients under the direct supervision of trained staff. Model 392000-1 is equipped with a scale.

    FDA Recall
    Terminated ·Penner Mfg Inc·Product code MMP·January 30, 2015

    AQUA 540 SW, 540 W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

    FDA Recall
    Terminated ·Teleflex Medical·Product code BTT·January 14, 2015

    Insulia Diabetes Management Companion

    FDA Recall
    Terminated ·Voluntis 22 Quai Gallieni Suresnes France·Product code NDC·October 8, 2018

    ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800 Systems), Part No. A28937, A28945, 467935, 467915. Product Usage: ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems AQUA CAL 1, 2 and 3, are intended for the quantitative determination of potassium concentration in human serum, plasma or urine.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CEM·September 22, 2010

    ADVIA Centaur PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code LTJ·August 9, 2016

    Penner Patient Stretcher/Transfer Lift System Models 391000-1 and 392000-1 The Pacific Stretcher/Transfer Lift is used with Whirlpool or Aqua-Aire (air bubbling) bathing system intended for use in nursing homes, hospitals, and assisted living facilities to transfer and/or lift patients under the direct supervision of trained staff. Model 392000-1 is equipped with a scale.

    FDA Enforcement
    Class II ·Terminated·Penner Mfg Inc·April 1, 2015