Events

Rappel de Device Recall Zero

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 Ansell Healthcare Products LLC.

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
    64246
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0838-2013
  • Date de mise en oeuvre de l'événement
    2013-01-14
  • Date de publication de l'événement
    2013-02-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-08-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115660
  • 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
    Condom - Product Code HIS
  • Cause
    Out of an abundance of caution, ansell is implementing a voluntary recall of the zero latex condom (regular) product. the condom has met or exceeded test and quality standards required by the food and drug administration. however, we are experiencing a number of complaints concerning the difficulty in unrolling and subsequent breakage, and so we are asking to have all products returned.
  • Action
    Ansell HealthCare Product LLC sent an Recall letter dated January 14, 2013, via registered mail to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The recall notification informs customers about the problem with the affected product and provides instructions to the customers on how to handle affected product. Customers are asked to complete the Response Form and return via fax (1-800) 722-8155. If you have further questions, please contact our Customer Service Department at 1-800-952-9916.

Device

Device Recall Zero
  • Modèle / numéro de série
    Zero Regular 10-Ct: SKU# 0-70907-20510-5 Master Case: 30070907205106.
  • Classification du dispositif
    Obstetrical and Gynecological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    .Nationwide Distribution including the states of AL, AZ, CA, CO, DE, FL, GA, IA, IN, IL, KS, KY, LA, MI, MN, MO.MS, NC, NH, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA, WI and UT.
  • Description du dispositif
    LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC, Dothan, AL 96303. || A sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections).
  • Manufacturer
    Ansell Healthcare Products LLC

Manufacturer

Ansell Healthcare Products LLC
  • Adresse du fabricant
    Ansell Healthcare Products LLC, 111 Wood Ave S, Suite 210, Iselin NJ 08830-2700
  • Société-mère du fabricant (2017)
    Ansell Ltd.
  • Source
    USFDA