BEUDAMED
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    Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060-1834 USA www.steris.com. The intended use of the REPS is washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-resistant, semi-critical devices.

    FDA Recall
    Terminated ·Steris Corporation·Product code NZA·August 29, 2013

    RELISA ENA Multiparameter Antibody Screening test, enzyme immunoassay test system, manufactured by Immuno Concepts N.A. Ltd., Sacramento, CA.

    FDA Recall
    Terminated ·Immuno Concepts Inc·Product code LLL·November 25, 2008

    Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System

    FDA Enforcement
    Class II ·Terminated·Smith & Nephew Inc.·March 5, 2014

    Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)

    FDA Enforcement
    Class II ·Terminated·Abaxis Inc·June 24, 2020

    Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System

    FDA Recall
    Terminated ·Smith & Nephew Inc.·Product code OMP·November 14, 2013

    Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.

    FDA Recall
    Terminated ·Accelerate Diagnostics Inc·Product code PRH·March 14, 2018

    Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.

    FDA Enforcement
    Class II ·Terminated·Accelerate Diagnostics Inc·May 2, 2018

    ANA Fluorescent Test System and ANA Colorzyme Test System, Sub assembly catalog number SA 2013, Kit Catalog Numbers, 2000, 2002, 2003, 2004, 2005, 2100, 2200, 4000, 4200, 8024.1, and 8060, manufactured by Immuno Concepts N.A. Ltd, Sacramento, CA. The device is used in the screening and titration of circulating antinuclear antibodies by means of an immunofluoresence test. Products are to be used as an aid in the detection of antibodies associated with systemic rheumatic disease.

    FDA Recall
    Terminated ·Immuno Concepts Inc·Product code DHN·December 4, 2008

    Boston Scientific Super Sheath and Super Sheath R/O Introducer Sheaths, Sterile EO, Manufactured by Togo Medikit Co., Ltd. 17148-6 Aza Kamekawa, Oaza Hichiya, Hyuga City, Miyazaki Prefecture 883-0062, Japan, Distributed by Boston scientific Corporation One Boston Scientific Place, Natick, MA 01760-1537 USA. Super Sheath 8F x 11 cm ,038 with Guide Wire BX/10 UPN H7491603508B1, Catalog # 16035-08B. Batch/Lot 11B15B6, 11B23B7, 11B28B9, 11C09BA, 11C16B9, 11C30B9. Super Sheath 8F x 11 cm ,038 without Guide Wire BX/10 , U PN M00115724B1, Catalog # 15-724B1. Batch/Lot 11C07B8. Super Sheath R/O 8 F x 11 cm without Guide Wire BX/10, M00159664B1, Catalog # 15-964B, Batch/Lot 11B01B4, 11B25B6. The device is indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DRE·November 3, 2011

    Lodox Statscan digital radiographic system.

    FDA Recall
    Terminated ·Lodox Na Llc·May 10, 2004

    SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.

    FDA Recall
    Terminated ·Akita Sumitomo Bakelite Co., Ltd. 27-4, Aza Nakajimita Akita Japan·Product code KNS·September 9, 2016

    SB (Sumitomo Bakelite Co.,) Electrosurgical Knife Size: Working Length 1.8M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.

    FDA Recall
    Terminated ·Akita Sumitomo Bakelite Co., Ltd. 27-4, Aza Nakajimita Akita Japan·Product code KNS·September 9, 2016

    THREAD RETRIEVAL DRILL REF 2224

    FDA Recall
    Terminated ·Zimmer Dental Inc·Product code DZA·July 10, 2017

    Hospitak, REF 962-E, Adapter 22mm/15mm, manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico

    FDA Recall
    Terminated ·Unomedical, Inc·Product code BZA·December 2, 2004

    Hudson RICA Sheridan, EB Tube, Sher-I-Bronch, LS, 35FR, Nova Plus, 37FR, 39 FR, and 41 FR, Teleflex Medical, Research Triangle Park, NC 27709. Indicated for use in thoracic surgery, bronchospirometry, for the administration of endobronchial anesthesia and other uses commonly associated with endobronchial tubes.

    FDA Recall
    Terminated ·Teleflex Medical·Product code BZA·July 31, 2009

    ACT3020 Advanced Cutting technology (ACT) Twist Drill 3.0mm(D) X 20mm(L). BIOMET 3i 455 Riverside Drive, Palm Beach Gardens, FL 33410 USA. Made in Switzerland. Twist drill for preparation of osteotomy during dental implant surgical drilling procedure.

    FDA Recall
    Terminated ·Biomet 3i, LLC·Product code DZA·June 29, 2009

    Hudson RICA Sher-I-Swiv & Sher-I-Swiv F/O, Teleflex Medical, Research Triangle Park, NC 27709. Indicated for use in thoracic surgery, bronchospirometry, for the administration of endobronchial anesthesia and other uses commonly associated with endobronchial tubes.

    FDA Recall
    Terminated ·Teleflex Medical·Product code BZA·July 31, 2009

    Hospitak, REF CD1N4Y-E, Mapleson D. Anesthesia Non-Rebreathing Circuit, 10'', manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico

    FDA Recall
    Terminated ·Unomedical, Inc·Product code BZA·December 2, 2004

    Viasys, REF BLD-14660, Pulmanex Adult Transport Circuit w/ Exhalation Valve, Non-Heated, 60'', manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico

    FDA Recall
    Terminated ·Unomedical, Inc·Product code BZA·December 2, 2004

    Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, QTY 50 Product Usage: for use in respiratory and anesthesia circuits to connect two or more components of a breathing system.

    FDA Recall
    Terminated ·Teleflex Medical Europe Ltd Ida Business Park Athlone Ireland·Product code BZA·March 27, 2018