Events

Recall of Device Recall HLD SYSTEM 540HT

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

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
    55802
  • Event Risk Class
    Class 2
  • Event Number
    Z-0038-2011
  • Event Initiated Date
    2010-06-07
  • Event Date Posted
    2010-10-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92351
  • 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 water level sensor switch in the medical device cleaning and high level disinfection systems (washer/pasteurizers) is sensitive to externally induced vibration noise, and it produces a false signal that the water level in the tank is full while it is only 75% full. it could present a health risk of biological hazard because the medical devices are not being adequately cleaned or pasteurized.
  • Action
    On June 7, 2010, firm, CENORIN, sent "URGENT: MEDICAL DEVICE RECALL" Initial Notification letter with Recall Response Form, Series 500 Water Level Check Instructions, and the Water Level Switch Upgrade Kit Instruction (service kit P/N # 082395-00) to their consignees. The firm also sent these documents in Spanish language to their foreign consignees. The letter describes the recall product as HLD Systems Medical Device Cleaning and High Level Disinfection Series 500 Washer/Pasteurizer-Model 540, Model 540HT and Model 520. Customers are advised to call the Customer Service at 1-800-426-1402 or e-mail the firm. The Initial Notification letter instructs consignees to conduct and quarantine the recall products and notify their sub-accounts (customers) if products have been further distributed. While waiting for a replacement kit, the consignees are asked to follow the Series 500 Water Level Check Instructions to perform a test to ensure the water tank is completely filled up the expected water level. The firm also advised the consignees to add a cautionary label on the product to avoid any sharp or bump impact that may create any externally induced vibration noise to the device. The firm is developing a replacement kit that should be ready to send out to their consignees by June 30, 2010. A response card would be also sent out with a new kit, and it is used to verify that the kit has been successfully implemented. If you have any questions, please email jbennett@cenorin.com or call 253-395-2400 or toll free: 1-800-426-1042.

Device

Device Recall HLD SYSTEM 540HT
  • Model / Serial
    Serial numbers for Model 540HT without Kits/Parts: 540911, 540910, 540909, 540908, 540907,  540906, 540905, 540904, 540903, 540902,  540901, 540709, 540707, 540708, 540715,  540714, 540713, 540712, 540711, 540723,  540727, 540726, 540725, 540724, 540805, 540804, 540803, 540802, 540801, 540810, 540809, 540808, 540807, 540806, 540912, 540914, 540913, 540917, 540916, 540915, 540607, 540701, 540706, 540918.   The firm uses a serial number as broken down in the following format AABBCC:  AA digits represent the Model Number;  BB digits represent the last two digit of the manufacturing year;  CC digits represent the unique number of the unit.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution:USA and countries including: Costa Rica, Ecuador, Japan, Mexico, and Taiwan.
  • Product Description
    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.
  • Manufacturer
    Cenorin

Manufacturer

Cenorin
  • Manufacturer Address
    Cenorin, 6324 S 199th Pl Ste 107, Kent WA 98032
  • Source
    USFDA