Events

Recall of Device Recall 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
    68580
  • Event Risk Class
    Class 2
  • Event Number
    Z-1995-2014
  • Event Initiated Date
    2013-01-24
  • Event Date Posted
    2014-07-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-02-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128261
  • 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
    The temperature sensor/control system in the hld systems model 610 may provide a false temperature reading. this caused the water to remain at ambient temperature throughout the pasteurization cycle rather than using hot water.
  • Action
    Cenorin sent a Notification letter dated December 18, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated: Cenorin has developed an upgrade to mitigate this issue as well as provide additional process control and system monitoring benefits. Cenorin included a Return Response form with the recall letter to be completed and return. For questions contact HLD Systems Sales Representative for questions.

Device

Device Recall HLD Systems
  • Model / Serial
    610601, 610603, 610703, 610704, 610705, 610707, 610708, 610802, 610803, 610804, 610901, 610903, 610904, 610905, 611001, 611002, 611004, 611101, 611102, 611103, 611201, 611202, 611203, 610902L, 611204.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide): CA, DE, FL, MA, MI, NY, PA, TX, UT, WA, and WI and the countries of Uruguay and Taiwan.
  • Product Description
    HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer.
  • 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