BEUDAMED
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    CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321

    FDA Recall
    Terminated ·Carolina Liquid Chemistries·Product code DIC·January 16, 2019

    Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent causes faster degradation in EtOH assay. Possible container or pitchers with some detergent residue was used while producing R2 of the defective lot.

    FDA Recall
    Terminated ·Lin-Zhi International Inc·Product code DIC·January 11, 2019

    Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an ethyl alcohol assay, IVD use.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code DIC·February 14, 2020

    TDx/TDxFLx REA Ethanol, list 9545-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD/GPRD·Product code DIC--·December 5, 2003

    CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321

    FDA Recall
    Terminated ·Carolina Liquid Chemistries·Product code DIC·January 16, 2019

    Drug Check, Distributed by Express Diagnostics Intl Inc., 1550 Industrial Drive, Blue Earth, MN 56013. Following Cup and Dip product models involved in the recall: 40900 40901 30500-A 30575 -A 30603-A 30671-A 30800-A 30802-3A 30900-A 30950-A 31102-A 40901C 60410-3A 60500-A 60505-A 60524-A 60526-A 60535-A 60600-A 60602-4A 60630-A 60635-4A 60640-4A 60705-4A 60709-A 60800-6A 60800-A 60801-A 60820-A 60903-A 60910-A 60921-A 60925-A 60930-A 61020-A 61023-A 61026-4A 61028-3A 61030-3A 61044-6A 61052-4A 61100-A 61204-A 61206-4A 61206-6A 61303-A 61401-A 61404-A 65500-4A 70410-4A 70500-3A 70500-A 70550-A 70602-3A 70604-6A 70630-3A 70640-4A 70808-6A 70910-A In Vitro immunoassay screening device for the qualitative detection of multiple drugs of substances in human urine.

    FDA Recall
    Terminated ·Express Diagnostics Int'l., Inc.·Product code DIC·November 1, 2010

    Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)

    FDA Recall
    Terminated ·Abiomed, Inc.·Product code OZD·March 1, 2021

    Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.

    FDA Recall
    Terminated ·Aesculap, Inc.·Product code JXG·April 21, 2014

    Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.

    FDA Recall
    Terminated ·Abiomed, Inc.·Product code OZD·October 10, 2023

    Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.

    FDA Recall
    Terminated ·Abiomed, Inc.·Product code OZD·October 10, 2023

    Fitness Gear Inversion table (Style STE00059FG or Style STE00118FG), Distributed by ASLI, Wilmington, DE (on carton), Paradigm Health & Wellness, Inc. (in user manuals); The products are inversion tables, which allow the user to secure his or her ankles to the table and invert. The products were intended to be fitness equipment; i.e. consumer products.

    FDA Recall
    Terminated ·Dick's Sporting Goods·Product code HST·December 29, 2014

    A-dec Decade Plus 1221 Dental Chair This chair is used for positioning dental patient prior to and during dental treatment.

    FDA Recall
    Terminated ·A-Dec Inc·Product code KLC·April 1, 2009

    Vein Irrigation Cannula with blunt tip. ASY BIC, STERILE 25/CS REF/ GTIN for Insert Label:BIC/ 00803622133091

    FDA Recall
    Terminated ·LivaNova USA Inc.·Product code DWF·April 24, 2020

    Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)

    FDA Enforcement
    Class II ·Terminated·Abiomed, Inc.·February 28, 2024

    Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.

    FDA Enforcement
    Class II ·Terminated·Abiomed, Inc.·December 13, 2023

    Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.

    FDA Enforcement
    Class II ·Terminated·Abiomed, Inc.·December 13, 2023

    Vein Irrigation Cannula with blunt tip. ASY BIC, STERILE 25/CS REF/ GTIN for Insert Label:BIC/ 00803622133091

    FDA Enforcement
    Class II ·Terminated·LivaNova USA Inc.·July 8, 2020

    Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.

    FDA Enforcement
    Class II ·Terminated·Aesculap, Inc.·June 11, 2014

    Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.

    FDA Recall
    Terminated ·Aesculap, Inc.·Product code JXG·November 11, 2014

    The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.

    FDA Recall
    Terminated ·Aesculap, Inc.·Product code JXG·October 24, 2014