BEUDAMED
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    CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The CIDEX OPA solution is intended for automated and manual cleaning and disinfection.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·September 5, 2012

    ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·November 13, 2013

    ISE REF Valve, Part No. MU7638 for the AU480, AU680, and AU5800 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·November 13, 2013

    CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices.

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code MED·August 10, 2015

    CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The CIDEX OPA solution is intended for automated and manual cleaning and disinfection.

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code MED·June 1, 2012

    CIDEX OPA Solution, ortho-Phthalaldehyde Solution

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code MED·April 12, 2004

    Ortho-phthaladehyde Concentration Indicator Browne CIDEX OPA Indicator

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code JOJ·September 4, 2003

    CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·September 23, 2015

    EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent (CIDEZYME Gl) to achieve cleaning and high level disinfection of heat sensitive (>60 ¿C) semi-critical endoscopes.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·June 17, 2015

    EvoTech Endoscope Cleaner & Reprocessor, Product Code 50004 Indicated for use with high level disinfectant CIDEX OPA Concentrate and an enzymatic detergent, CIDEZYME GI, to achieve cleaning and high level disinfection of heat sensitive semi-critical endoscopes.

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code FEB·February 13, 2008

    EvoTech Endoscope Cleaner and Reprocessor, Product Code 50004-002 Indicated for use with high level disinfectant CIDEX OPA Concentrate and an enzymatic detergent, CIDEZYME GI, to achieve cleaning and high level disinfection of heat sensitive semi-critical endoscopes.

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code FEB·February 13, 2008

    EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant CIDEX OPA Concentrate Solution and an enzymatic detergent (CIDEZYME XTRA) to achieve cleaning and high level disinfection of heat sensitive (>60C} semi-critical endoscopes.

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code FEB·September 27, 2016

    EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant CIDEX OPA Concentrate Solution and an enzymatic detergent (CIDEZYME XTRA) to achieve cleaning and high level disinfection of heat sensitive (>60¿C} semi-critical endoscopes.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·January 18, 2017

    EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent (CIDEZYME Gl) to achieve cleaning and high level disinfection of heat sensitive (>60 ¿C) semi-critical endoscopes.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·June 17, 2015

    EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent (CIDEZYME Gl) to achieve cleaning and high level disinfection of heat sensitive (>60 C) semi-critical endoscopes.

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code FEB·May 11, 2015

    EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent (CIDEZYME Gl) to achieve cleaning and high level disinfection of heat sensitive (>60 C) semi-critical endoscopes.

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code FEB·May 11, 2015

    Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Vinyl Olefin (EVO) and contains no BPA or latex. The bag can be supplied with tubing sets that can include, but are not limited to, the following components: EVA/PVC coextruded tubing, PVC tubing, Yconnectors, needle-free valves, female luers, male luers and/or caps

    FDA Enforcement
    Class III ·Terminated·OriGen Biomedical, Inc.·April 21, 2021

    MEGA¿ 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ MEGA¿ 7.5Fr. 40cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ MEGA¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ MEGA¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit, STATLOCK¿ & APA

    FDA Enforcement
    Class II ·Terminated·Datascope Corporation·June 15, 2016

    REF 822 IMUBIND(R) Plasma PAI-1 ELISA The intended use: Product is an enzyme-linked immunosorbent assay for the quantative measurement of human Plasminogen Activator Inhibitor Type-1 (PA-1) antigen in plasma.

    FDA Recall
    Terminated ·American Diagnostica, Inc.·Product code GGP·March 5, 2010

    MEGA 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK MEGA 7.5Fr. 40cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK MEGA 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK MEGA 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit, STATLOCK & APA

    FDA Recall
    Terminated ·Datascope Corporation·Product code DSP·May 13, 2016