Events

Rappel de ThermaCare Menstrual 8 Hour Heat Wraps

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 Pfizer Global.

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
    56855
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0622-2011
  • Date de publication de l'événement
    2010-12-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-09-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94656
  • 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, disposable - Product Code IMD
  • Cause
    The chemical components contained in the heat wrap may leak directly onto the skin, which could cause skin injury, including burns.
  • Action
    Wyeth Consumer Healthcare issued an Urgent Voluntary Medical Device Recall letter dated September 24, 2010 to direct accounts, and issued a press release. The firm is removing the product in question from store shelves and asking consumers who have purchased the product to record the lot number, throw the product away in its entirety without opening the foil pouch and call 1 800 232-3383 for replacement. Direct accounts were instructed to remove the affected product from sale and return it immediately. If they further distributed the product they were instructed to notify their customers of the recall and request return of the products to them credit. Instructions were provided in the event consumers inquired about the recall. A prepaid post card was enclosed to record the quantity on hand to be returned.

Device

ThermaCare Menstrual 8 Hour Heat Wraps
  • Modèle / numéro de série
    Lot number: E06831 (Exp 8/2012); The lot number on the 3 ct cartons may be followed by an "N" or "S", for example, E06831 "N" or E06831 "S"
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution: Throughout the U.S. and Puerto Rico.
  • Description du dispositif
    ThermaCare Menstrual 8 Hour Heat Wraps, 3 count, NDC 0573-3020-02, SKU: 302002, UPC: 3-0573-3020-02-9, Wyeth Consumer Healthcare, P.O. Box 26609, Richmond, VA 23261-6609
  • Manufacturer
    Pfizer Global

Manufacturer

Pfizer Global
  • Adresse du fabricant
    Pfizer Global, 5 Giralda Farms, Madison NJ 07940
  • Société-mère du fabricant (2017)
    Pfizer
  • Source
    USFDA