BEUDAMED
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    Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. Part Number: 823087

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code JXG·December 14, 2020

    Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting cerebrospinal fluid (CSF) Part Number: 823073

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code JXG·December 14, 2020

    Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up, Model Numbers: 869810, 869820, 869830

    FDA Recall
    Terminated ·Product code ITJ·March 6, 2020

    Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code FAD·November 16, 2020

    KWIK-STI(TM), GBS QC Set (Live Culture), REF 0243U. Specifically affected component: KWIK-STIK(TM), Lactobacillus acidophilus derived from ATCC(R) 4356(TM)

    FDA Recall
    Terminated ·Microbiologics Inc·Product code JTR·December 16, 2020

    Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code FAD·November 16, 2020

    Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049

    FDA Recall
    Terminated ·Remel Inc·Product code JSI·December 10, 2020

    COHERENCE Oncologist, Model Nos. 07333680 & 07351898

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·January 16, 2020

    Merit Medical Cultura Collection and Transport System, 3 mL Viral Transport Medium, Ref: VCTS100, Single Use, IVD, for the following unit counts: 1 Unit - (01)00884450499917, 50 Units - (01)10884450499914, 200 units - (01)20884450499911

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code JSM·September 16, 2020

    MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the following unit count:1 unit - (01)00884450491102, 25 unit - (01)10884450491109, 100 unit - (01)20884450491106

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code KXG·September 16, 2020

    Hurricane RX Biliary Balloon Dilatation Catheter Catalog REF No. M00545890; M00545900; M00545910; M00545920; M00545930; M00545940; M00545950; M00545960 The device is a double lumen catheter with a balloon mounted at the distal tip. Dilatation balloon catheters are used to exert radial force to dilate narrow duct segments, as well as the Sphincter of Oddi.

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code FGE·September 16, 2020

    CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector

    FDA Recall
    Terminated ·Avanos Medical, Inc.·Product code KNT·October 16, 2020

    Merit Medical Cultura Collection and Transport System, Ref CFTS100, Single Use, IVD, for the following unit counts: 1 Unit - (01)00884450492123, 50 Units - (01)10884450492120, 200 units - (01)20884450492127

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code JSM·September 16, 2020

    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 right, Sterile, Catalog # 504-02-64E-R, UDI (01)07613327012460(17)

    FDA Recall
    Terminated ·Howmedica Osteonics Corp.·Product code LPH·April 16, 2020

    K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM.

    FDA Recall
    Open, Classified ·Helena Laboratories, Corp.·Product code JPA·November 9, 2020

    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Left, Sterile, Catalog # 504-02-58D-L, UDI (01)07613327012385(17)

    FDA Recall
    Terminated ·Howmedica Osteonics Corp.·Product code LPH·April 16, 2020

    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 left, Sterile, Catalog # 504-02-68F-L, UDI (01)07613327012521(17)

    FDA Recall
    Terminated ·Howmedica Osteonics Corp.·Product code LPH·April 16, 2020

    REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the peritoneal cavity.

    FDA Recall
    Open, Classified ·Medtronic Neurosurgery·Product code JXG·December 16, 2020

    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Right, Sterile, Catalog # 504-02-58D-R, UDI (01)07613327012446(17)

    FDA Recall
    Terminated ·Howmedica Osteonics Corp.·Product code LPH·April 16, 2020

    KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO DISK, Catalog #0894L; Microsporum canis derived from ATCC 36299.

    FDA Recall
    Terminated ·Microbiologics Inc·Product code JTR·December 16, 2020