Events

Recall of Biatain Super NonAdhesive

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Coloplast Manufacturing US, LLC.

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
    69279
  • Event Risk Class
    Class 3
  • Event Number
    Z-0138-2015
  • Event Initiated Date
    2014-09-08
  • Event Date Posted
    2014-10-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-01-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130151
  • 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,occlusive - Product Code NAD
  • Reason
    Coloplast is conducting a recall for one lot (4201931) of the biatain super non-adhesive wound dressing which was mislabeled.
  • Action
    Coloplast sent an "Urgent Voluntary Recall Notification" dated September 9, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If they have further distributed the product they need to contact their customers immediately. For questions they can contact Coloplast Customer Care Representative at 800-533-0464. A second follow up "Urgent Voluntary Recall Notification" letter dated September 23, 2014 was also sent to consignees.

Device

Biatain Super NonAdhesive
  • Model / Serial
    4201931
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution to MO and RI.
  • Product Description
    Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Origin:HU. || Biatain Super Non-Adhesive dressing is primarily indicated for the treatment of high, medium and low exuding leg ulcers surrounded by fragile skin. The dressings may be used throughout the healing process to provide padding and protection for 2nd degree burns, diabetic wounds (primarily lower leg and foot), surgical wounds (left to heal by secondary intention and incisional wounds) and skin abrasions. The dressings are suitable for use under compression bandaging.
  • Manufacturer
    Coloplast Manufacturing US, LLC

Manufacturer

Coloplast Manufacturing US, LLC
  • Manufacturer Address
    Coloplast Manufacturing US, LLC, 1601 W River Rd, Minneapolis MN 55411-3431
  • Manufacturer Parent Company (2017)
    Coloplast A/S
  • Source
    USFDA