Events

Rappel de THERA PEARL 3in1 BREAST THERAPY

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 Lansinoh Laboratories Inc.

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
    63390
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0784-2013
  • Date de mise en oeuvre de l'événement
    2012-08-14
  • Date de publication de l'événement
    2013-02-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-03-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115101
  • 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
    Pack, hot or cold, reuseable - Product Code IME
  • Cause
    The spanish translation on the instructions for use (ifu) insert and product package for hot and cold packs has incorrect heating instructions which would cause product to over heat.
  • Action
    Lansinoh Laboratories, Inc. sent an Urgent Product Recall letter dated August 14, 2012, to all affected customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to stop distributing and quarantine the affected product. Customers were informed that a credit would be issued for the affected product and they were asked to mail the postage paid Business Reply Card even if they do not have the affected product. If necessary call 1-877-366-1182 to arrange pickup. For questions customers were instructed to call the Customer Service Center at 1-800-292-4794. For questions regarding this recall call 703-299-6477.

Device

THERA PEARL 3in1 BREAST THERAPY
  • Modèle / numéro de série
    Lot Numbers 100/12/01, 116/12/01, 108/12/01, 109/12/01, 149/12/01
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution, including the states of TX, CA, NJ, NY, SD, RI, WV, IL PA, NC and MN.
  • Description du dispositif
    THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box. || The Thera Pearl 3-in-1 Breast Therapy is a reusable therapeutic hot and cold pack for use with pain, swelling, engorgement, plugged ducts or mastitis associated with breast feeding or to help encourage let-down while using a breast pump.
  • Manufacturer
    Lansinoh Laboratories Inc

Manufacturer

Lansinoh Laboratories Inc
  • Adresse du fabricant
    Lansinoh Laboratories Inc, 333 N Fairfax St Ste 400, Alexandria VA 22314-2632
  • Société-mère du fabricant (2017)
    Pigeon Corp.
  • Source
    USFDA