BEUDAMED
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    Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.

    FDA Recall
    Terminated ·Ormco/Sybronendo·Product code DZC·November 4, 2015

    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

    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 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

    Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: a. VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); b. VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); c. VEN LP, PU, 1.9MM, UL, 6 FR/INTRO, VALVED (1/EA); d. DL, LP, PU, 2.2MM, WING-LOCK, 7FR, INTRO (1/EA); e. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO (1/EA); f. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO, VALVED (1/EA); g. DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO, VALVED (1/EA)

    FDA Recall
    Terminated ·Smiths Medical ASD Inc.·Product code LJT·December 4, 2017

    HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine Samaritan Public Access Defibrillator models: 350P/360P/450P/500P

    FDA Recall
    Open, Classified ·HeartSine Technologies Ltd 207 Airport Road West Belfast United Kingdom·Product code MKJ·April 26, 2023

    Alinity i Estradiol Reagent Kit, List Number 07P5020

    FDA Recall
    Terminated ·Abbott Ireland Diagnostics Division Lisnamuck Co. Longford Ireland·Product code CHP·November 21, 2018

    Alinity i Free T4 Reagent Kit, List Number 07P7030

    FDA Recall
    Terminated ·Abbott Ireland Diagnostics Division Lisnamuck Co. Longford Ireland·Product code CEC·November 21, 2018

    EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respiratory usage.

    FDA Recall
    Terminated ·Nephron Pharmaceuticals Corp.·Product code CCQ·April 30, 2013

    Alinity i Progesterone Reagent Kit, List Number 08P3620

    FDA Recall
    Terminated ·Abbott Ireland Diagnostics Division Lisnamuck Co. Longford Ireland·Product code JLS·November 21, 2018

    EZ Breathe Medication Cup. For the delivery of liquid medications for respiratory usage.

    FDA Recall
    Terminated ·Nephron Pharmaceuticals Corp.·Product code CCQ·April 30, 2013

    Alinity i TSH Reagent Kit, List Number 07P4830

    FDA Recall
    Terminated ·Abbott Ireland Diagnostics Division Lisnamuck Co. Longford Ireland·Product code JLW·November 21, 2018

    AsthmaNefrin Starter Kit contains ten (10) AsthmaNefrin vials and one (1) EZ Breathe Atomizer. For the delivery of liquid medications for respiratory usage.

    FDA Recall
    Terminated ·Nephron Pharmaceuticals Corp.·Product code CCQ·April 30, 2013

    Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532

    FDA Recall
    Terminated ·Abbott Ireland Diagnostics Division Lisnamuck Co. Longford Ireland·Product code MRG·November 21, 2018

    Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121

    FDA Recall
    Terminated ·Abbott Ireland Diagnostics Division Lisnamuck Co. Longford Ireland·Product code DHA·November 21, 2018

    3M Durapore Surgical Tape, Catalog Number 1538-118

    FDA Recall
    Open, Classified ·3M Company Health Care Business 3m Center·Product code KGX·March 20, 2024

    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