Events

Rappel de Device Recall MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE

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 Gyrus Acmi, Incorporated.

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
    65255
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1439-2013
  • Date de mise en oeuvre de l'événement
    2013-05-24
  • Date de publication de l'événement
    2013-05-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-05-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118384
  • 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
    Instrument, ent manual surgical - Product Code LRC
  • Cause
    Lack of sterility assurance.
  • Action
    Cyrus ACMI notified their direct accounts of the recall by Priority Mail with delivery confirmation on May 24, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory and immediately cease any further use of any affected product they may have, remove it from inventory, and quarantine it until they ship it back to the firm. For questions customers were instructed to contact their Olympus customer service representative at 1-800-848-9024 to obtain a Returned Goods Authorization so that they may return the product with no charge to them. Customers were asked to note on the enclosed questionnaire that they have received this information and fax it to 484-896-7128. For questions regarding this recall call 508-804-2739.

Device

Device Recall MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE
  • Modèle / numéro de série
    JC477666
  • Classification du dispositif
    Ear, Nose, and Throat Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and countries of: Canada and United Kingdom.
  • Description du dispositif
    GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104 || Disposable myringotomy knife intended to perforate the tympanic membrane to allow the placement of a bent tube or to directly provide ventilation or drainage of the middle ear.
  • Manufacturer
    Gyrus Acmi, Incorporated

Manufacturer

Gyrus Acmi, Incorporated
  • Adresse du fabricant
    Gyrus Acmi, Incorporated, 136 Turnpike Road, Southborough MA 01772-2118
  • Société-mère du fabricant (2017)
    Olympus Corporation
  • Source
    USFDA