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    The Routine Service Kit #082395-00 or Part #030500-00 for HLD SYSTEM and it is labeled in part: "HLD SYSTEMS ***FOR SALES.SERVICE.SUPPLIES CALL***Cenorin*** Kent, WA 98032***P:800.426.1042***F: 253.395.2650***www.cenorin.com". Service Kit P/N: 082395-00 Series 500 Water Level Switch Upgrade Kit: The purpose of this service kit was to provide replacement parts for customers who had HLD Systems that were manufactured prior to 3/22/07.These systems were manufactured with old, old switches that have been obsolete and discontinued. Part P/N: 030500-00 Switch, Liquid Level: This part was sold by itself to a foreign consignee in Japan for inventory purposes only for regularly scheduled maintenance of a device or replacement of parts at the end of their normal life expectancy.

    FDA Recall
    Terminated ·Cenorin·Product code LDS·June 7, 2010

    VisuaLine Tricyclic Antidepressants: Six Dip (COC-THC-OPI-MET-BZD-OXD); Six Dip (COC-THC-OPI-MET-PCP-OXD); Eight DIP (COC-THC-OPI-MET-AMP-BAR-BZD-OXD); Nine Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-TCA); Ten Dip X (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-MTD-TCA); Ten Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-MTD-OXD); Ten Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-TCA-OXD); Five Dip (COC-THC-OPI-BZD-OXD); and Six Dip (CPC-THC-OPI-MET-AMP-OXD). Product is intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse.

    FDA Recall
    Terminated ·Sun Biomedical Laboratories, Inc.·Product code DJR·May 28, 2008

    HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer.

    FDA Enforcement
    Class II ·Terminated·Cenorin, LLC·July 16, 2014

    HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer.

    FDA Recall
    Terminated ·Cenorin, LLC·Product code LDS·January 24, 2013

    DrugCheck 8 Test Cup AMP/COC/OPI/THC/MET/BZD/BAR/PCP Product Code 60800

    FDA Recall
    Terminated ·Drug Free Enterprises Inc·Product code DIO·March 20, 2003

    DrugCheck 9 Test Cup AMP/COC/OPI/THC/MET/BZD/BAR/PCP/TCA Product Code 60900

    FDA Recall
    Terminated ·Drug Free Enterprises Inc·Product code DIO·March 20, 2003

    DrugCheck 9 Test Cup AMP/COC/OPI/THC/MET/BZD/BAR/PCP/MTD Product Code 60925

    FDA Recall
    Terminated ·Drug Free Enterprises Inc·Product code DIO·March 20, 2003

    HLD Systems 600 Series Washer/Pasteurizer, UDI (01) 0085249007009 (11) 160929 (21) 61160; Model 610HT, 115V & Model 610HT, 230V Product Usage: Clean and thermally disinfect medical devices using full immersion pasteurization

    FDA Enforcement
    Class II ·Terminated·Cenorin, LLC·July 4, 2018

    HLD Systems 600 Series Washer/Pasteurizer, UDI (01) 0085249007009 (11) 160929 (21) 61160; Model 610HT, 115V & Model 610HT, 230V Product Usage: Clean and thermally disinfect medical devices using full immersion pasteurization

    FDA Recall
    Terminated ·Cenorin, LLC·Product code LDS·April 9, 2018

    TiLite ZR and ZRA Series 2 are mechanical wheelchairs. Devices are sold under brand name TiLite. The TiLite ZR had a model catalog number of Z2FS1. The TiLite ZRA has a model catalog number of Z2FS2. Provide mobility for physically impaired individuals.

    FDA Recall
    Terminated ·TiSport, Llc·Product code IOR·July 5, 2011

    HLD SYSTEM 520 is a two-tank Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers). Each unit has a metal serial tag that is riveted to the enclosure of the unit and it is labeled in part: "HLD SYSTEMS 520***FOR SALES.SERVICE.SUPPLIES CALL***Cenorin*** Kent, WA 98032***P:800.426.1042***F: 253.395.2650***www.cenorin.com". Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers) are intended to use at healthcare provide clinical areas such as sleep labs, central services, sterile processing, respiratory care departments. The system is used to clean and high level disinfecting medical devices. They are designed to automate the pre-washing and rinsing of critical devices prior to sterilization in other devices.

    FDA Recall
    Terminated ·Cenorin·Product code LDS·June 7, 2010

    Access Immunoassay Systems Thyroglobulin, Part Number: 33860 This device is intended to aid in monitoring for the presence of local and metastatic thyroid tissue in patients who have had thyroid gland ablation (using thyroid surgery with or without radioactivity) and who lack serum thyroglobulin antibodies.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code MSW·October 18, 2010

    HLD SYSTEM 540 is the Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers). This device does not have the external heater unit known as High Throughput Heater. Each unit has a metal serial tag that is riveted to the enclosure of the unit and it is labeled in part: "HLD SYSTEMS 540***FOR SALES.SERVICE.SUPPLIES CALL***Cenorin*** Kent, WA 98032***P:800.426.1042***F: 253.395.2650***www.cenorin.com". Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers) are intended for use at healthcare provided clinical areas such as sleep labs, central services, sterile processing, respiratory care departments. The system is used to clean high level disinfecting medical devices. They are designed to automate the pre-washing and rinsing of critical devices prior to sterilization in other devices.

    FDA Recall
    Terminated ·Cenorin·Product code LDS·June 7, 2010

    The HLD SYSTEM 540HT is a Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers). The Model 540HT has an external heater (aka High Throughput Heater). This external heater is connected through hoses to the device and may be secured to a wall. This external heater reduces the pasteurization cycle time by heating the water to higher temperatures. Each unit has a metal serial tag that is riveted to the enclosure of the unit and it is labeled in part: "HLD SYSTEMS 540HT***FOR SALES.SERVICE.SUPPLIES CALL***Cenorin*** Kent, WA 98032***P:800.426.1042***F: 253.395.2650***www.cenorin.com". Medical Device Cleaning and High Level Disinfection Systems (Washer/Pasteurizers) are intended for use at healthcare provided clinical areas such as sleep labs, central services, sterile processing, respiratory care departments. The system is used to clean high level disinfecting medical devices. They are designed to automate the pre-washing and rinsing of critical devices prior to sterilization in other devices.

    FDA Recall
    Terminated ·Cenorin·Product code LDS·June 7, 2010

    G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06, 9180-07, 9180-17, 9101-00, 9101-06 The Opticage Expandable Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior, transforaminal or lateral approach. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had six months of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels. The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices and posterior pedicle screw and rod systems).

    FDA Enforcement
    Class II ·Terminated·Interventional Spine Inc·January 11, 2017

    MANOS EX (CAT#TY-12-101) Product Usage: Carpal Tunnel Release: as a tool for tissue release of the transverse carpal ligament in patients with Carpal Tunnel Syndrome who fail conservative therapy. Plantar Fasciotomy: as a tool for tissue recession in patients with plantar fasciitis who fail conservative therapy.

    FDA Enforcement
    Class II ·Terminated·Thayer Intellectual Property, Inc.·December 14, 2016

    Vereos PET/CT Model # 882446, computed tomography x-ray system

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 14, 2019

    IQon Spectral CT Model # 728332, computed tomography x-ray system

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 14, 2019

    Ingenuity TF PET/CT Model # 882456, computed tomography x-ray system

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 14, 2019

    CA 15-3 Calibrators, list 9C08-01; the pack contains six 4-mL bottles of 115D8:DF3 reactive determinants prediluted in TRIS buffer with protein stabilizers to yield the following assay values: A - 0 u/mL, B - 15 U/mL, C - 60 U/mL, D - 120 U/mL, E - 180 U/mL and F - 250 U/mL; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD·Product code MOI·March 4, 2003