Events

Recall of HLD Systems 600 Series Washer/Pasteurizer

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
    80295
  • Event Risk Class
    Class 2
  • Event Number
    Z-2288-2018
  • Event Initiated Date
    2018-04-09
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=165073
  • 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
    There is a supplier quality issue with the terminal blocks which may cause the terminal block to overheat, char and/or burn.
  • Action
    On April 9, 2018, Cenorin telephoned customers and then followed-up with a formal letter titled URGENT MEDICAL DEVICE RECALL via email. To mitigate this quality issue, Cenorin has a Corrective Kit available to replace the existing terminal blocks in the Washer/Pasteurizer as the long-term solution. In the meantime, here is how you can help with the recall process: 1. Please immediately examine your inventory for the recalled Washer/Pasteurizers listed and quarantine them to prevent further distribution. In addition, if you have further distributed this product, please notify your customers immediately using the enclosed notice. 2. If the Washer/Pasteurizers does not exhibit any of the symptoms of failure as noted, continue to use the Washer/Pasteurizers as normal until the service can be completed. If the Washer/Pasteurizers exhibit any of the symptoms of failure, immediately cease its use and contact Cenorin immediately at recall@cenorin.com or call Technical Support at 800-426-1042 ext. 224. 3. Complete the Recall Acknowledgement & Response Form and return to Cenorin as noted on form via email to recall@cenorin.com within 5 business days. Response is required. Customers with questions, please email Cenorin at recall@cenorin.com or call 253-395-2400 or toll-free 800-426-1042, extension 236 during the hours of business Monday through Friday, 7:30AM to 4:30PM, Pacific Standard Time.

Device

HLD Systems 600 Series Washer/Pasteurizer
  • Model / Serial
    Serial Numbers: 611503, 611504, 611505, 611506, 611601, 611602, 611603, 611604, 611605, 611606, 611607, 611608, 611609 & 611610
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of CA, FL, IN, NC, NE, UT & WV; and countries of Malaysia and Taiwan
  • Product Description
    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
  • Manufacturer
    Cenorin, LLC

Manufacturer

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