Events

Recall of Device Recall InterDry Ag

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Coloplast Corp Skin Care Div.

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
    52801
  • Event Risk Class
    Class 3
  • Event Number
    Z-1996-2009
  • Event Initiated Date
    2009-07-21
  • Event Date Posted
    2009-09-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84034
  • 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
    Medical Absorbent Fiber - Product Code FRL
  • Reason
    Coloplast determined that a portion of one lot of interdry" ag lot number 1789435, did not meet the product specification for silver content. in this portion of the lot antimicrobial properties of the product could be compromised although the absorption and transportation of moisture would be as expected.
  • Action
    Consignees were faxed on 7/27/09 a Coloplast "Product Recall" letter dated July 2009. The letter addressed the problem and requested consignees to contact Coloplast Customer Service at 1-800-533-0464 to communicate the status of the product. Replacement product will be provided upon receipt of returned product. It also advised distributors to contact their customers immediately and advise them of the recall and to return the product them. Questions or concerns should be directed to the customer's customer care rep at 1-800-533-0464.

Device

Device Recall InterDry Ag
  • Model / Serial
    Lot 1789435
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including states of AL, AZ, CA, CT, FL, GA, IL, IN, IA, KY. LA, MI, MA,MO, MN, MS, MD, NE, NV, NH, NJ, NM, NY, NC, OH, OK OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI and country of CANADA.
  • Product Description
    Coloplast, InterDry Ag 10" x 144" Roll P/N 6791001400, Manufactured for Coloplast A/S DK-3050 Humlebaek, Denmark, Distributed by Coloplast Corp Minneapolis MN 55411. || InterDry" is a non-sterile, knitted, polyurethane-coated polyester textile impregnated with an antimicrobial silver complex used for the management of skin fold complications. || The textile provides moisture transportation to keep skin dry while the antimicrobial in the textile reduces odor. The textile's low friction surface acts as a lubrication aid, thereby reducing skin-to-skin friction. InterDry" provides a protective environment for the skin and an effective protection against microbial contamination in the fabric. The product reduces colonization of the following gram-negative and gram-positive bacterial as well as yeast. Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa and Candida albicans. InterDry" Ag Textile contains 0.01% silver and is a single patient use product that is custom cut from a multi-use package.
  • Manufacturer
    Coloplast Corp Skin Care Div

Manufacturer

Coloplast Corp Skin Care Div
  • Manufacturer Address
    Coloplast Corp Skin Care Div, 1940 Commerce Dr, North Mankato MN 56003-1700
  • Source
    USFDA