Events

Recall of Device Recall DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution

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
    72098
  • Event Risk Class
    Class 2
  • Event Number
    Z-0240-2016
  • Event Initiated Date
    2015-08-31
  • Event Date Posted
    2015-11-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-04-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139865
  • 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 (kit) - Product Code LRO
  • Reason
    Custom sterile surgical kits contain 3m duraprep (tm) surgical solution, catalog number 8630, lot number 2016-09ee which was recalled due to unintended exposure to the sterilant during package sterilization.
  • Action
    DeRoyal initiated their recall on 08/31/2015 to the end-user level by sending overnight letters to its direct accounts and hospitals. Distributors were asked to put the product in quarantine, place the provided labels on the products and complete and return the spreadsheet of how many they labeled. They were asked to return the spreadsheet even if they did not have inventory. Hospitals were provided with labels to affix to the kits with direction to discard the recalled component and notice of destruction forms to be completed and returned.

Device

Device Recall DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution
  • Model / Serial
    REF 89-4561.11, Lot numbers: 38198163, 38276045, 38276045; REF 89-4562.12, Lot Number 38345071; REF 89-3101.04, Lot Number 38276230; REF 89-7744.03, Lot Number 38229177;  REF 89-8194.02, Lot Number 38245020; REF 89-8439.01, Lot Number 38317548; REF 50-12160.17, Lot Number 38247391; REF 50-12602.09, Lot Number 38345266; REF 89-8381.01, Lot Number 38085071
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    SC, FL, OH, NJ, OK, MN, AR
  • Product Description
    DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE: || TOTAL KNEE A & B, REF 89-4561.11; TOTAL HIP A & B, REF 89-4562.12; PODIATRY TRAY, REF 89-3101.04; KNEE SCOPE PACK, REF 89-7744.03; || KNEE PACK, REF 89-8194.02; BEACH CHAIR PACK, REF 89-8439.01; || TOTAL JOINT, REF 50-12160.17; BACK TRAY, REF 50-12602.09; || PACEMAKER PACK, REF 89-8381.01;
  • 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