Events

Rappel de GSK

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 GSK Consumer Healthcare.

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
    74030
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-2148-2016
  • Date de mise en oeuvre de l'événement
    2016-04-25
  • Date de publication de l'événement
    2016-07-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-07-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146010
  • 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
    Breathing - Nasal Strips - Product Code N/A
  • Cause
    Some cartons used in the secondary packaging of breathe right clear, large, 30 ct. nasal strips were incorrectly labeled for cartons intended for the au/nz market.
  • Action
    GSK Consumer Healthcare sent an Urgent - Product Recall Letter dated April 4, 2016, to all affected customers and an updated recall letter dated April 25, 2016, via FedEx. The recall letters identified the product and problem. The April 25, 2016, was sent to further clarify, the lot number on the Breathe Right carton. The customers were asked to immediately examine their inventory, quarantine and cease distribution of the specific lot of the affected product. Customers were asked to carry out a physical count and record the data on the response form. The response form should be returned to GSK within five (5) business days, even if you do not have the recalled lot. The response form should be faxed to (336) 499-8795. If customer needs shipping assistance or questions about the recall process, they can call 1-844-722-2104, and refer to Event Number 535STRIPS16. If any customer has questions, they can direct them to GSK Consumer Healthcare Consumer Relations team at 800-858-6673.

Device

GSK
  • Modèle / numéro de série
    Shipper case lot #8008580, Retal Carton Lot #4543U8008580
  • Distribution
    US Nationwide
  • Description du dispositif
    Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)
  • Manufacturer
    GSK Consumer Healthcare

Manufacturer

GSK Consumer Healthcare
  • Adresse du fabricant
    GSK Consumer Healthcare, 184 Liberty Corner Rd Ste 200, Warren NJ 07059-6868
  • Société-mère du fabricant (2017)
    Glaxosmithkline Plc
  • Source
    USFDA