Events

Recall of Device Recall Custom Procedural Trays

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Merit Medical Systems, 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
    62749
  • Event Risk Class
    Class 2
  • Event Number
    Z-0464-2013
  • Event Initiated Date
    2012-06-08
  • Event Date Posted
    2012-12-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-12-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111628
  • 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 procedural trays contain stryker hytrel togas which are being recalled because the clear tape that is intended to aid in the prevention of patient's fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process.
  • Action
    The firm, Merit Medical, sent an "URGENT PRODUCT RECALL NOTICE" letter dated June 8, 2012 to its customers by letter sent by US Postal Service - Certified Mail Receipt describing the problem, instructions as to actions that need to be taken, and requesting the customer to complete and sign the Customer Response Form and immediately fax a copy to this form to 1-804-416-1031. Customers were instructed to mail the completed original Customer Response Form using the provided postage-paid, self-addressed envelope to Merit. Should the customer choose to return the product for rework, they are to return the affected products by shipping them back to Merit Medical Systems via Federal Express 2nd Day Air (Acct #1129-5275-6) to: RGA Department RGA #NC-53417, Merit Medical Systems, Inc., Attn: Manager of Quality Assurance and Regulatory Affairs, 12701 Kingston Ave., Chester, VA 23836. For questions customers were instructed to contact Manager of Quality Assurance and Regulatory Affairs at 1-804-416-1048 or email: jbraxton@merit.com.

Device

Device Recall Custom Procedural Trays
  • Model / Serial
    Merit's Custom Total Hip Pack, K12T-05537, Lot numbers T320054, T331364, T335090; Merit's Total Knee Pack, K12T05538, Lot numbers T320059, T331365, T335092
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: US including states of: NE and SD.
  • Product Description
    Custom Procedural Trays: Merit's Custom Total Hip Pack, K12T-05537, Merit's Total Knee Pack, K12T05538 || A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses.
  • Manufacturer
    Merit Medical Systems, Inc.

Manufacturer

Merit Medical Systems, Inc.
  • Manufacturer Address
    Merit Medical Systems, Inc., 12701 N Kingston Ave, Chester VA 23836-2700
  • Manufacturer Parent Company (2017)
    Merit Medical Systems Inc
  • Source
    USFDA