46 results
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Sources: EU EUDAMED, US FDA
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BIO-RAD 425-2020 Autoimmune EIA Anti-Cardiolipin IgM, 96 Tests...2010 02 16...Lot CL-863. Positive Control included in lot is identified as "REF 425-2025" and "LOT CPM-591". in vitro diagnostic.
FDA Recall
Terminated
·Bio-Rad Laboratories Inc·Product code DHC·July 14, 2009
Kit BD Max GC RT PCR Assay; Catalog # 443486
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·August 28, 2019
Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD, CVM Transport Media is provided in plastic centrifuge tubes and is used for the collection and transport of clinical specimens for the recovery of viral agents
FDA Enforcement
Class II
·Terminated·Hardy Diagnostics·December 30, 2020
TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) and PN-004 075 (GTIN 07640157990040) - Product Usage: is a multi-electrode irrigated catheter with a deflectable tip designed to allow electrophysiological mapping of the heart and, when connected to an RF generator, to deliver radiofrequency current to the catheter tip electrode for the purpose of ablation.
FDA Enforcement
Class II
·Terminated·Abbott·July 15, 2020
E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit
FDA Enforcement
Class I
·Terminated·E25Bio, Inc.·February 16, 2022
XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded with individual compressed cellulose sponges. Upon contact with blood or exudate, the sponges expand, thus increasing the dressing's capacity to absorb fluids. XGAUZE is packed in a pre-formed sterile barrier system (pouch sealed on three sides); one side is a PET/foil/PE film, and the other side is a PET/aluminum oxide/PE film. Packages are vacuum sealed and terminally sterilized via gamma radiation.
FDA Enforcement
Class II
·Terminated·Revmedx Inc·September 23, 2015
Sterile Custom Packs to be used in surgical procedures.
FDA Enforcement
Class II
·Terminated·American Contract Systems·June 10, 2020
TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The function of the 24Fr ProtekSolo Venous Cannula is to provide a conduit for blood to travel from the patient s venous system when connected to accessory extracorporeal equipment. The Venous Cannula is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support. These devices are to be used by a trained physician only.
FDA Enforcement
Class II
·Terminated·Cardiac Assist, Inc·February 19, 2020
B. Braun Introcan Safety IV Catheters, Product codes REF 4252500-01 4252519-01 4252535-01 4252560-01 4252586-01 4251890-01 4252535-01 4252586-01 4251644-01
FDA Recall
Terminated
·Janus Trade Group·Product code FOZ·March 23, 2020
Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy. It is indicated for DBS treatment for Parkinson s disease, essential tremor, dystonia, obsessive-compulsive disorder, and epilepsy.
FDA Recall
Terminated
·Medtronic Neuromodulation·Product code MHY·November 19, 2020
Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
FDA Recall
Terminated
·Exactech, Inc.·Product code PHX·September 25, 2020
Equinoxe Platform Fracture Stem, 6.5mm, Right - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
FDA Recall
Terminated
·Exactech, Inc.·Product code PHX·September 25, 2020
Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle, Ref: 112852 Sterile EO, RxOnly
FDA Recall
Terminated
·Acutus Medical Inc·Product code DYB·February 25, 2020
Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Dilator/Transseptal Needle, REF: 122852, SterileEO RxOnly
FDA Recall
Terminated
·Acutus Medical Inc·Product code DYB·February 25, 2020
Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 g/cm, Nominal Everolimus Content: 209 g; Lot number 903224A,
FDA Recall
Terminated
·Abbott Vascular·Product code NIQ·March 25, 2020
Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 122852, Sterile EO, RxOnly
FDA Recall
Terminated
·Acutus Medical Inc·Product code DYB·February 25, 2020
Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxOnly
FDA Recall
Terminated
·Acutus Medical Inc·Product code DYB·February 25, 2020
SOBEL WESTEX Disposable Isolation Gown Made in China RN#71273 SBPP non woven laminate with PE Film - Product Usage: use in patient/healthcare personnel interactions. AAMI Level II isolation gowns are intended for relatively low risk procedures, including blood draws, lab work, or similar.
FDA Recall
Terminated
·Sobel Westex·Product code OEA·August 13, 2020
VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
FDA Recall
Terminated
·Ortho Clinical Diagnostics·Product code KLI·March 10, 2020
HEMO-10 Hemospray Endoscopic Hemostat
FDA Recall
Terminated
·Wilson-Cook Medical Inc.·Product code QAU·February 4, 2020