BEUDAMED
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    PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL - Product Usage: used for the removal of SDS and other inhibitors from samples collected using DNA Genotek oral sample collection kits.

    FDA Recall
    Terminated ·DNA Genotek Inc. 3000-500 Palladium Dr Kanata Canada·Product code PPM·June 24, 2020

    Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF C74339 Access SARS-CoV-2 IgG (1st IS) Calibrators, REF C74340 Access SARS-CoV-2 (1st IS) Quality Control (QC), REF C74341

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code QKO·August 5, 2021

    5 Hole Locking 1st Tarsometatarsal Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: 5 Hole Locking 1st Tarsometatarsal Plate... REF 70-0007-S... LOT W58115".

    FDA Recall
    Terminated ·Acumed LLC·Product code HWC·February 14, 2008

    4 Hole Locking 1st Tarsometatarsal Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: 4 Hole Locking 1st Tarsometatarsal Plate... REF 70-0008-S... LOT W58116".

    FDA Recall
    Terminated ·Acumed LLC·Product code HWC·February 14, 2008

    Left Locking Dorsal 1st MTP Fusion Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Left Locking Dorsal 1st MTP Fusion Plate... REF 70-0012-S... LOT W58120".

    FDA Recall
    Terminated ·Acumed LLC·Product code HWC·February 14, 2008

    Left Locking 1st MTP Revision Fusion Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Left Locking 1st MTP Revision Fusion Plate... REF 70-0018-S... LOT W58121".

    FDA Recall
    Terminated ·Acumed LLC·Product code HWC·February 14, 2008

    Right Locking 1st MTP Revision Fusion Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Right Locking 1st MTP Revision Fusion Plate... REF 70-0019-S... LOT W58122".

    FDA Recall
    Terminated ·Acumed LLC·Product code HWC·February 14, 2008

    Left Locking 2st MTP/MPJ Combo Fusion Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Left Locking 2st MTP/MPJ Combo Fusion Plate... REF 70-0036-S... LOT W58123".

    FDA Recall
    Terminated ·Acumed LLC·Product code HWC·February 14, 2008

    Right Locking 1st MTP/MPJ Combo Fusion Plate. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Right Locking 1st MTP/MPJ Combo Fusion Plate... REF 70-0037-S... LOT W58148".

    FDA Recall
    Terminated ·Acumed LLC·Product code HWC·February 14, 2008

    Portex 1st Response Adult Manual Resuscitators Ref: 8500P

    FDA Recall
    Terminated ·Sims Portex Inc.·Product code BTM·November 15, 2002

    Portex 1st Response Adult Manual Resuscitators Ref: 8503P

    FDA Recall
    Terminated ·Sims Portex Inc.·Product code BTM·November 15, 2002

    Portex 1st Response Adult Manual Resuscitators Ref: 8506P

    FDA Recall
    Terminated ·Sims Portex Inc.·Product code BTM·November 15, 2002

    Integra Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536 The Advansys plates are intended for bone fixation such as: Arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus, Lisfranc arthrodesis, Mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HRS·February 9, 2012

    Tarsys 1st Generation Seating System - an optional accessory for the Powered Wheelchairs.

    FDA Recall
    Terminated ·Invacare Corp·Product code ITI·March 10, 2003

    GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System

    FDA Recall
    Open, Classified ·GRAMERCY EXTREMITY ORTHOPEDICS·Product code HRS·April 4, 2023

    Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.

    FDA Recall
    Open, Classified ·Treace Medical Concepts, Inc.·Product code HRS·June 2, 2024

    Zimmer Periarticular Locking Plate System Distal Radial Volar Plate Lateral Column (1st generation stainless steel only). Orthopedic fixation plate. For temporary internal fixation and stabilization of osteotomies and fractures.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code HRS·June 10, 2014

    Gas Delivery Engine (GDE)-1st Generation, 16222-001-99 A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.

    FDA Recall
    Terminated ·Carefusion 211 Inc dba Carefusion·Product code CBK·May 17, 2016

    Inquiry Steerable Diagnostic Catheter, REF: IBI-87002 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at the high right atrium, right ventricular apex, and HIS bundle.

    FDA Recall
    Terminated ·Irvine Biomedical Inc, a St. Jude Medical Co.·Product code DRF·August 24, 2020

    Inquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at the high right atrium, right ventricular apex, and HIS bundle.

    FDA Recall
    Terminated ·Irvine Biomedical Inc, a St. Jude Medical Co.·Product code DRF·August 24, 2020