Events

Recall of Device Recall Merit Medical

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
    53619
  • Event Risk Class
    Class 2
  • Event Number
    Z-0413-2010
  • Event Initiated Date
    2009-05-19
  • Event Date Posted
    2009-11-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86098
  • 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
    Convenience Kits containing recalled surgical gloves - Product Code KDD
  • Reason
    Surgical gloves in hospital convenience kits may be degraded and tear during use.
  • Action
    Merit Medical Systems notified customers by phone, fax, or visit by sales representatives on 05/19/09. The notification advised of the convenience kit correction due to the recall of the Derma Prene Ultra Surgical Gloves, and that use of the product should cease immediately. Sales representatives were instructed to provide replacement gloves and "warning" stickers to be placed on identified kits in inventory. The warning stickers advise the customer to discard the surgical gloves in the kit and replace. Customers were requested to verify product disposition by signing a response form.

Device

Device Recall Merit Medical
  • Model / Serial
    Lots: V705949, Exp 2010-05 V698581, Exp 2010-04 V700586, Exp 2012-04 V707921, Exp 2012-04
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA distribution: nine hospitals in Texas and Colorado.
  • Product Description
    Merit Medical Systems, Inc., Convenience Trays, custom packaged under the following Merit Medical¿ labels: (1) Prentice PICC Kit, Catalog number K12T-03698; (2) Insertion Kit, catalog number K12T-03050C; and (3) Angio Procedure Pack, catalog number K09T-09530A.
  • Manufacturer
    Merit Medical Systems, Inc.

Manufacturer

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