Events

Recall of HLD Systems

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cenorin, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    68237
  • Event Risk Class
    Class 2
  • Event Number
    Z-1729-2014
  • Event Initiated Date
    2014-04-24
  • Event Date Posted
    2014-06-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127201
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Device, pasteurization, hot water - Product Code LDS
  • Reason
    Cenorin llc is voluntarily recalling hld systems model 610 washer/high level disinfector due to a potential risk of the system not injecting the proper amount of cleaning fluid during the wash cycle and not achieving the desired level of debris reduction.
  • Action
    Cenorin sent a letter on April 24, 2014 informing their customers of the potential failure of the pump. This letter also explains the customer's option of upgrading their entire HLD System to the new cleaning fluid delivery system or to continue purchasing a six month PM kit that has a replacement pump added. Customers are instructed to complete and return an enclosed response form within 15 days and to email Jamie Wright at jwright@cenorin.com or call 800-426-1042, extension 224 for questions.

Device

HLD Systems
  • Model / Serial
    610601, 610603, 610703, 610704, 610705, 610707, 610708, 610802, 610803, 610804, 610901, 610903, 610904, 610905, 610902, 611001, 611002, 611004, 611102, 611103, 611201, 611202, 611203, 610902L, 611204.  First two digits (61)  refer to model number 610 for the HLD system Second two digits - two digit year of manufacture Last two digits  sequentially numbered as they receive orders.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution USA Nationwide
  • Product Description
    HLD Systems Model 610 Washer/High Level Disinfector. || Maximum weight of the Model 610 when filled with water is approximately 450 pounds. The dimensions of the system are: Width: 26.5" (67 cm); Depth: 33" (83 cm); Height: 46.5" (118 cm) to top of control panel; 64" (162.6 cm)- height clearance with lid open. || Product Usage: Usage: || This device washes reusable medical devices and disinfects them with high temperature hot water (pasteurization). The devices are washed with a cleaning solution (containing NaClO (sodium hypochlorite), surfactants, and detergents) to aid in the removal of debris and visible stains. Next, the medical devices and rinsed two times with water. The final, disinfection step uses only hot water at 160 F ¿ 2 F for 30 minutes.
  • Manufacturer
    Cenorin, LLC

Manufacturer

Cenorin, LLC
  • Manufacturer Address
    Cenorin, LLC, 6324 S 199th Pl Ste 107, Kent WA 98032-2135
  • Manufacturer Parent Company (2017)
    Cenorin L.L.C.
  • Source
    USFDA