Events

Rappel de Device Recall Technocut Plus,Sterile Single Use Safety Scalpel.

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 Myco Medical Supplies 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
    64434
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0891-2013
  • Date de mise en oeuvre de l'événement
    2013-02-07
  • Date de publication de l'événement
    2013-02-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-07-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116137
  • 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
    Scalpel, one-piece - Product Code GDX
  • Cause
    Pouch labeling/printing errors and defective packaging resulting in possible compromised sterility.
  • Action
    MYCO Medical sent an Advisory Notice dated February 7, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers wsere instructed to review their inventory for the affected product and immediately quarantine the affected product per their internal procedures. Customers were also instructed to complete the attached Material for Return form and return to MYCO via email QA@mycomedical.com or fax to 919-800-3919. Customers were have the returned material packaged and ready for UPS to pick up at their location. If product was shipped to other customers, customers were asked to contact a MYCO Customer Service Representative with the additional customer's contact and ship-to information. Customers with questions were instructed to call 919-460-2535. For questions regarding this recall call 919-460-2535, ext 105.

Device

Device Recall Technocut Plus,Sterile Single Use Safety Scalpel.
  • Modèle / numéro de série
    Catalogue number: 6008TR-10, 6008TR-11, 6008TR-12, 6008TR-15, 6008TR-20; Batch numbers: 1208235, 1210189, 1211305, 1208276, 1211213, 1208224, 1210105, 1212041, 1208307, 1211192, 1212052, 1210116.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including CA, FL, IL, MI, MO, NY, OH, PA, SC, TN, WI and Internationally to Canada
  • Description du dispositif
    Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medical.
  • Manufacturer
    Myco Medical Supplies Inc

Manufacturer

Myco Medical Supplies Inc
  • Adresse du fabricant
    Myco Medical Supplies Inc, 158 Towerview Ct, Cary NC 27513
  • Société-mère du fabricant (2017)
    Myco Medical Supplies Inc.
  • Source
    USFDA