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    Olympus OFP Flushing Pump irrigation tubing The Olympus OFP Flushing Pump is a peristaltic flushing pump intended for use with Olympus gastrointestinal videoscopes having an auxiliary water inlet as part of an Olympus endoscopic imaging system to facilitate washing of gastric and colonic mucosa to remove blood, feces and other organic matter, enabling improved visualization, diagnosis and therapy during endoscopic procedures.

    FDA Recall
    Terminated ·Olympus America Inc.·Product code FEQ·December 12, 2011

    Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440.

    FDA Enforcement
    Class II ·Terminated·Biomet Spine, LLC·September 16, 2015

    CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 Model Number(s): R2010 Intended Use: Diagnosis and treatment of non-invasive HPV-related or unrelated lesions of the lower genital tract.

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·December 3, 2014

    MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection between the endoscope's instrument channel port and the O FP-2 pump's tubing.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·October 14, 2015

    MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection between the endoscope's instrument channel port and the O FP-2 pump's tubing.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code FEQ·September 11, 2015

    Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component, Precoat, Stemmed Size 3; Lot Number:62460264. Indicated for patients with severe knee pain and disability and is intended for mating with a UHMWPE articular surface and Zimaloy Cobalt-Chromium-Molybdenum alloy femoral component to perform knee arthroplasty.

    FDA Enforcement
    Class II ·Terminated·Zimmer Manufacturing B.V.·December 30, 2015

    CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 Model Number(s): R2010 Intended Use: Diagnosis and treatment of non-invasive HPV-related or unrelated lesions of the lower genital tract.

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code HGI·October 27, 2014

    HYFRECATOR 2000 HANDPIECE SHEATH, REF/Part Number 7-796-19, Rx ONLY, STERILE, Single Patient Use -- CONMED CORPORATION, 525 FRENCH ROAD UTICA, NY 13502. --- There is no problem with the Hyfrecator 2000 Electrosurgical Units or with cases of P/N 7-796-19 sold in cases as P/N 7-796-19BX or P/N 7-796-19CS.

    FDA Enforcement
    Class II ·Terminated·ConMed Corporation·April 19, 2017

    Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component, Precoat, Stemmed Size 3; Lot Number:62460264. Indicated for patients with severe knee pain and disability and is intended for mating with a UHMWPE articular surface and Zimaloy Cobalt-Chromium-Molybdenum alloy femoral component to perform knee arthroplasty.

    FDA Recall
    Terminated ·Product code JWH·December 2, 2015

    Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 Series GI Endoscopes forCO2 Connection with Olympus OFP or Boston Scientific Endostat II Irrigation Pump Units. Contents 10. Sterile EO. of 100145CO2EXT Endo SmartCap Irrigation Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series GI Endoscopes with Extended CO2 Input - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.

    FDA Enforcement
    Class II ·Terminated·Medivators, Inc.·April 29, 2020

    Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI Endoscopes for CO2 Connection with Endogator EGP-100, Olympus OFP, Olympus AFU-100 & Erbe EIP 2 Irrigation Pump Units. Contents 10. Sterile EO. of 100145CO2EXT Endo SmartCap Irrigation Tubing for Olympus 140/160/180/190 Series GI Endoscopes with Extended CO2 Input - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.

    FDA Enforcement
    Class II ·Terminated·Medivators, Inc.·April 29, 2020

    Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI Endoscopes for CO2 Connection with Endogator EGP-100, Olympus OFP, Olympus AFU-100 & Erbe EIP 2 Irrigation Pump Units. Contents 10. Sterile EO. of 100145CO2EXT Endo SmartCap Irrigation Tubing for Olympus 140/160/180/190 Series GI Endoscopes with Extended CO2 Input - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.

    FDA Recall
    Terminated ·Medivators, Inc.·Product code FAJ·October 9, 2019

    Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 Series GI Endoscopes forCO2 Connection with Olympus OFP or Boston Scientific Endostat II Irrigation Pump Units. Contents 10. Sterile EO. of 100145CO2EXT Endo SmartCap Irrigation Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series GI Endoscopes with Extended CO2 Input - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.

    FDA Recall
    Terminated ·Medivators, Inc.·Product code FAJ·October 9, 2019

    HYFRECATOR 2000 HANDPIECE SHEATH, REF/Part Number 7-796-19, Rx ONLY, STERILE, Single Patient Use -- CONMED CORPORATION, 525 FRENCH ROAD UTICA, NY 13502. --- There is no problem with the Hyfrecator 2000 Electrosurgical Units or with cases of P/N 7-796-19 sold in cases as P/N 7-796-19BX or P/N 7-796-19CS.

    FDA Recall
    Terminated ·ConMed Corporation·Product code GEI·February 28, 2017

    Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440.

    FDA Recall
    Terminated ·Biomet Spine, LLC·Product code KWQ·August 5, 2015

    Presource PBDS, Shoulder Arthroscopy, Kit, Circulator

    FDA Recall
    Terminated ·Cardinal Health, Medical Products & Services 1430 Waukegan Road Attn V. Mueller Qa Park City IL 60085·Product code OFP·March 26, 2013

    Presource PBDS, Beaufort Memorial Hospital, Anesthesia Circuit, Kit

    FDA Recall
    Terminated ·Cardinal Health, Medical Products & Services 1430 Waukegan Road Attn V. Mueller Qa Park City IL 60085·Product code OFP·March 26, 2013

    VentStar Basic 250, Catalog Number MP00350 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets with Water trap: Breathing circuit for conveying breathing gases between an anesthesia delivery system or ventilator and a pediatric patient. Intended for single use only. Water traps are intended for collection of condensate. The standard breathing circuit is equipped with a water trap in each breathing hose limb.

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code OFP·December 21, 2018

    VentStar Watertrap (P) 180, Catalog Number MP00361 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets with Water trap: Breathing circuit for conveying breathing gases between an anesthesia delivery system or ventilator and a pediatric patient. Intended for single use only. Water traps are intended for collection of condensate. The standard breathing circuit is equipped with a water trap in each breathing hose limb.

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code OFP·December 21, 2018

    Presource PBDS, Total Knee, Kit, Circulator

    FDA Recall
    Terminated ·Cardinal Health, Medical Products & Services 1430 Waukegan Road Attn V. Mueller Qa Park City IL 60085·Product code OFP·March 26, 2013