Events

Recall of Device Recall Tegaderm

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
    73237
  • Event Risk Class
    Class 2
  • Event Number
    Z-1036-2016
  • Event Initiated Date
    2016-02-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-06-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143609
  • 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
    Dressing, wound, drug - Product Code FRO
  • Reason
    Misbranding; due to the presence of chg in the tegaderm picc/cvc dressing change convenience kit, which is not identified on the exterior labeling.
  • Action
    Medical Action Industries, Inc. sent an Urgent Medical Device Recall letter dated February 3, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to immediately examine their inventory and quarantine all product subject to this recall. Consignees were also instructed if product was further distributed to identify their consignees and notify them at once of this product recall. Recalled product should be returned to Medical Action Industries for credit or replacement by contacting quality@owens-minor.com . Consignees were asked to complete and return the enclosed response form. Consignees with questions were instructed to call 828-338-7630.

Device

Device Recall Tegaderm
  • Model / Serial
    Kit #73775, Lot 213403
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Nationwide distribution to MO, NE and TX .
  • Product Description
    PICC/CVC Secure Dressing Change kit, Ref: 73775, Lot 213403, Sterile Single Use, Medical Action Industries, Inc., Arden, NC. || This kit is used by clinicians to change dressings
  • 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