Events

Rappel de Device Recall InterDry Ag

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Coloplast Corp Skin Care Div.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    52801
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1996-2009
  • Date de mise en oeuvre de l'événement
    2009-07-21
  • Date de publication de l'événement
    2009-09-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-01-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84034
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Medical Absorbent Fiber - Product Code FRL
  • Cause
    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
  • Modèle / numéro de série
    Lot 1789435
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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
  • Adresse du fabricant
    Coloplast Corp Skin Care Div, 1940 Commerce Dr, North Mankato MN 56003-1700
  • Source
    USFDA