Events

Recall of Device Recall Suture Set

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medical Action 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
    68564
  • Event Risk Class
    Class 2
  • Event Number
    Z-1952-2014
  • Event Initiated Date
    2014-06-12
  • Event Date Posted
    2014-07-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-02-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128220
  • 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
    Suture kit - Product Code OVN
  • Reason
    Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.
  • Action
    Consignees were notified via E-Mails, Certified Letters and Telephone on 06/12/2014.

Device

Device Recall Suture Set
  • Model / Serial
    Model number: 58468B, Lot number: 187203, Exp. Date: 11/1/2016.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of AR, AZ, FL, GA, IA, IL, KY, MA, MN, NC, NY, OH, TN, TX, and VA.
  • Product Description
    Suture Set, Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
  • Manufacturer
    Medical Action Industries Inc

Manufacturer

Medical Action Industries Inc
  • Manufacturer Address
    Medical Action Industries Inc, 25 Heywood Rd, Arden NC 28704-9302
  • Manufacturer Parent Company (2017)
    Owens & Minor Inc
  • Source
    USFDA