Events

Recall of HYDROTEMP(R) Neonatal Temperature Skin Sensor

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

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
    72454
  • Event Risk Class
    Class 2
  • Event Number
    Z-0345-2016
  • Event Initiated Date
    2015-10-14
  • Event Date Posted
    2015-11-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141078
  • 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
    Warmer, infant radiant - Product Code FMT
  • Reason
    Deroyal manufactured four lots of hnicu-32, hydro-temp(r) neonatal temperature skin sensor incorrectly. the pins contained in the probe were soldered incorrectly. when probe is connected to the proper port, this defect results in the inability to read or display temperatures on the infant warming system.
  • Action
    DeRoyal issued their recall on 10/14/2015 to the end-user level by sending overnight letters to its direct accounts and hospitals. The consignees were instructed to destroy and discard the units. In the case of further distribution, the firm requested that the consignee either notify its customers of the recall or to submit a customer list for DeRoyal to contact them.

Device

HYDROTEMP(R) Neonatal Temperature Skin Sensor
  • Model / Serial
    Lot Numbers: 39098746, 39655101, 39985370, 40067795
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of VA, AL, FL, and CA.
  • Product Description
    HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only.
  • Manufacturer
    DeRoyal Industries Inc

Manufacturer

DeRoyal Industries Inc
  • Manufacturer Address
    DeRoyal Industries Inc, 200 Debusk Ln, Powell TN 37849-4703
  • Manufacturer Parent Company (2017)
    Deroyal Industries Inc.
  • Source
    USFDA