Events

Recall of Device Recall suction canister

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
    69319
  • Event Risk Class
    Class 2
  • Event Number
    Z-0097-2015
  • Event Initiated Date
    2014-08-22
  • Event Date Posted
    2014-10-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130223
  • 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
    Bottle, collection, vacuum - Product Code KDQ
  • Reason
    These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition.
  • Action
    DeRoyal sent an Urgent Voluntary Recall letter dated August 22, 2014, to all affected consignees by overnight letter or by email. DeRoyal was to follow up with non-responding accounts before October 1, 2014. Customers were instructed to check their inventory for the affected product. If they have affected product, customers were instructed to destory both the liner and the lid and dispose of it according to their facility's procedures. Customers were instructed to return the included Notice of Destruction to recalls@deroyal.com even if they no longer have affected product. Customers with questions were instructed to contact their DeRoyal Sales Representative or DeRoyal Customer Service at 1-800-251-9864. For questions regarding this recall call 865-362-2334.

Device

Device Recall suction canister
  • Model / Serial
    1) DeRoyal(R), REF 71-6510, Lot 36408631  2) NOVAPLUS(TM) Cat. No. V71-6510, Lot 36408622
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including MI, OH, IN, FL, WV, VA, MI, NC, and NY
  • Product Description
    Suction canisters labels as follows: || 1) DeRoyal(R) SUCTION CANISTER, 1000cc, SEMI-RIGID, REF 71-6510, NON-STERILE, Rx Only. || 2) NOVAPLUS(TM) SUCTION CANISTER, 1000 cc, SEMI-RIGID, Cat. No. V71-6510, NON-STERILE, Rx Only || general hospital
  • 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