Events

Recall of GeoMed, TURP/CYSTO PACK

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
    74927
  • Event Risk Class
    Class 2
  • Event Number
    Z-2678-2016
  • Event Initiated Date
    2016-08-11
  • Event Date Posted
    2016-08-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148840
  • 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
    General surgery tray - Product Code LRO
  • Reason
    The firm is recalling two custom surgical kits containing the bard(tm) toomey irrigation syringe 70cc with resectoscope tip, catheter tip, luer adapter and cap. the bard(tm) component is being recalled for a possible slit defect on the package that may affect the component's sterility.
  • Action
    DeRoyal issued their recall on 08/11/2016 to the end-user level by sending overnight letters to its direct accounts. The customers were asked to identify the affected trays, place them in quarantine and return them to DeRoyal for replacement or credit.

Device

GeoMed, TURP/CYSTO PACK
  • Model / Serial
    Lot Number 40259236
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in LA and TN.
  • Product Description
    Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, || Custom surgical kit.
  • 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