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    Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIPL), and Pseudocholinesterase (PCHE) methods on the Dimension Vista System.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JIX·January 6, 2014

    Arterial Line Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation or to other small vessels.

    FDA Recall
    Terminated ·Arrow International Inc·Product code DQX·August 8, 2016

    Radial Artery Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation. The safety feature is intended to help minimize the risk of sharps injuries when using the device.

    FDA Recall
    Terminated ·Arrow International Inc·Product code DQX·August 8, 2016

    AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, Ab PLATE 1 X ! Plate, IgM Sample DIL 1 x 100 mL, ENZ CONJ CONC 1 x 1.5 mL, Calibrators A-C 3 x 1.2 mL, CONJ DIL 1 X 12 mL, Stop SOLN 1 X 12 mL, TMB SOLN 1 X 12 mL, WASH CONC A 1 X 60 mL, (01)00853592008219 - Product Usage: intended for the qualitative detection of IgM antibodies in serum collected from the individuals suspected with signs and symptoms of COVID-19 infection by their healthcare provider.

    FDA Recall
    Terminated ·Ansh Labs, LLC·Product code QKO·December 18, 2020

    Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code CCK·July 1, 2019

    Bubble Sensor (REF: 70105.5720)

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTQ·December 28, 2023

    CareFusion V.Mueller GENESIS QTR-LENGTH CONTAINER 12 X 8" (30.3X20.3CM) 4" (10.2CM) DEEP STERRAD COMPATIBLE, REF CD0-4ST

    FDA Recall
    Open, Classified ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code KCT·September 26, 2022

    CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD2-4ST

    FDA Recall
    Open, Classified ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code KCT·September 26, 2022

    CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD3-6ST

    FDA Recall
    Open, Classified ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code KCT·September 26, 2022

    CareFusion V.Mueller GENESIS LARGE, SHALLOW CONT. 28 X 11" (71.1 X 27.9CM) 3" (7.6CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD5-3ST

    FDA Recall
    Open, Classified ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code KCT·September 26, 2022

    CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD1-6ST

    FDA Recall
    Open, Classified ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code KCT·September 26, 2022

    CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD1-4ST

    FDA Recall
    Open, Classified ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code KCT·September 26, 2022

    CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 7" (17.8CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD3-7ST

    FDA Recall
    Open, Classified ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code KCT·September 26, 2022

    CareFusion V.Mueller GENESIS MINI CONTAINER 10-1/2 X 7-1/2" (26.7X19.0CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD0-3ST

    FDA Recall
    Open, Classified ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code KCT·September 26, 2022

    CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 8" (20.3CM) DEEP STERRAD COMPATIBLE, REF CD2-8ST

    FDA Recall
    Open, Classified ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code KCT·September 26, 2022

    CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD2-5ST

    FDA Recall
    Open, Classified ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code KCT·September 26, 2022

    CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD1-5ST

    FDA Recall
    Open, Classified ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code KCT·September 26, 2022

    CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD2-6ST

    FDA Recall
    Open, Classified ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code KCT·September 26, 2022

    CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD3-5ST

    FDA Recall
    Open, Classified ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code KCT·September 26, 2022

    CareFusion V.Mueller GENESIS SMALL, SHALLOW CONT. 21 X 7" (53.3 X 17.8CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD4-3ST

    FDA Recall
    Open, Classified ·Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845·Product code KCT·September 26, 2022