Events

Recall of Various DeRoyal Surgical Kits

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
    72574
  • Event Risk Class
    Class 2
  • Event Number
    Z-0363-2016
  • Event Initiated Date
    2015-09-10
  • Event Date Posted
    2015-12-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141577
  • 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
    These custom sterile surgical kits contain the component, ecolab ors fluid warming and slush drape, which was recalled due to the possibility that the sterile packaging may contain small channels in the seal of the pouch.
  • Action
    DeRoyal issued their recall on 09/10/2015 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. Hospitals were provided with labels to affix to the kits with the direction to discard the recalled component and notice of destruction forms to be completed and returned.

Device

Various DeRoyal Surgical Kits
  • Model / Serial
    Ref 89-7859.01: Lot numbers: 27369748, 27469087, 27964707, 28167081, 28207599, 28712544;  Ref 89-7859.02: Lot numbers: 35947501, 35550352, 38844461 Ref 89-7750.02: Lot numbers: 29929171, 30474952 Ref 89-7750.03: Lot numbers: 30984021, 31210924 Ref 89-8514.02: Lot numbers: 37392319, 37078506, 37109721, 36974376, 37057289, 36813530, 37086725, 37099609, 37253124, 37325378, 37401318, 37413132 Ref 89-5792.10: Lot numbers: 39821181, 39507167, 39072116, 39863866 Ref 89-7626.02: Lot numbers: 36068496, 359097163, 35543822, 35328356, 35428242, 35549693, 34939471, 33091009, 34952712 Ref 89-7626.03: Lot numbers: 39301960, 36660692, 37008882, 37210095, 37915491, 37217991, 40101164, 37519742, 38455852, 38756495, 39417057, 39714051, 39913835 Ref 89-8440.01: Lot numbers: 36674648, 36612412 Ref 89-8440.02: Lot number: 36987476
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in MO, MA, NC, CT, Kuwait.
  • Product Description
    DeRoyal sterile custom surgical kits: || 1) Emergency CABG Pack Pgybk, ref 89-7859.01 || 2) Emergency CABG Pack Pgybk, ref 89-7859.02 || 3) Open Heart Pack A&B; Pgybk, ref 89-7750.02 || 4) Open Heart Pack A&B; Pgybk, ref 89-7750.03 || 5) Intl-Cardiac Surgery Pack A&B; Pgybk, ref 89-8514.02 || GEO-MED sterile custom surgical kits: || 1) Open Heart Pack Pgybk, ref 89-5792.10 || 2) Open Heart A&B; Pgybk, ref 89-7626.02 || 3) Open Heart A&B; Pgybk, ref 89-7626.03 || 4) Open Heat Pack A&B; Pgybk, ref 89-8440.01 || 5) Open Heart Pack A&B; Pgybk, ref 89-8440.02
  • 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