Events

Recall of Device Recall DeRoyal Surgical Kits and Vital Signs Anesthesia Circuits

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

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
    59854
  • Event Risk Class
    Class 2
  • Event Number
    Z-0016-2012
  • Event Initiated Date
    2011-08-23
  • Event Date Posted
    2011-10-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-01-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103872
  • 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
    Anesthesia breathing circuit kit (adult & pediatric) - Product Code OFD
  • Reason
    The firm manufactured kits containing a hch device, manufactured by vital signs, that was subsequently recalled because the product may have an occlusion that could prevent proper flow of medical gases or oxygen to the patient.
  • Action
    The firm, DeRoyal, sent a "URGENT: MEDICAL DEVICE RECALL" letter dated September 13, 2011 to its customers. The letter describes product, problem, and actions to be taken. Customers are instructed to identify inventory being recalled and place in quarantine to prevent further use. Constomers were asked to return affected product they have in inventory. DeRoyal will replace this product free of charge. Customers were asked to complete the attached Recall Response Spreadsheet and return as per the instructions. Constomers were asked to return affected product they have in inventory. DeRoyal will replace this product free of charge. Distributors were instructed to perform a sub-recall to their customers. Customers with questions should call 865-362-1037 between 9am and 5pm EST or email recalls@deroyal.com.

Device

Device Recall DeRoyal Surgical Kits and Vital Signs Anesthesia Circuits
  • Model / Serial
    Lot Numbers: 25402698, 25834829
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationawide Distribution USA - including the states of: CA, FL, GA, NJ, and WA.
  • Product Description
    DeRoyal (R) Heat/Moist Exchange, REF 83-000042, Rx Only, NON-STERILE, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA: || Intended Use: Varies by kit; an anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.
  • Manufacturer
    Deroyal Industries, Inc. Lafollette

Manufacturer

Deroyal Industries, Inc. Lafollette
  • Manufacturer Address
    Deroyal Industries, Inc. Lafollette, 1501 East Central Ave, La Follette TN 37766-2892
  • Manufacturer Parent Company (2017)
    Deroyal Industries Inc.
  • Source
    USFDA