Events

Rappel de Red Head 2

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 Miami Fat Supply, 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
    74156
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1957-2016
  • Date de mise en oeuvre de l'événement
    2016-04-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-12-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146527
  • 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
    System, suction, lipoplasty - Product Code MUU
  • Cause
    During an fda inspection it was found that the products are marketed without a cleared 510k, nor is approved for multiple use.
  • Action
    Customers were sent an Urgent: Medical Device Recall/Correction letter, dated 04/19/2016, on 04/21/2016 that served as a notification of the Red Head 2 voluntary recall. Customers were informed that there were previous complaints of compromised product integrity and performance following sterilization. Lids are subject to fracture and fail after steam sterilization. Customers were advised to destroy used product and to ship unused product back to the manufacturer. Customers were to return an acknowledgement form to confirm their notification of the voluntary recall.

Device

Red Head 2
  • Modèle / numéro de série
    Lots 1165 and 1271.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US, including the states of AL, AZ, CA, CO, FL, GA, IL, MD, MI, MO, NM, NY, OH, TX, UT, and VA; and, the country of Dominican Republic.
  • Description du dispositif
    The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile. || Intended for use in aspirating subcutaneous fatty tissue in patients desiring aesthetic body contouring and autologous fat collection.
  • Manufacturer
    Miami Fat Supply, Inc

Manufacturer

Miami Fat Supply, Inc
  • Adresse du fabricant
    Miami Fat Supply, Inc, 1510 Max Hooks Rd Ste F, Groveland FL 34736-8032
  • Société-mère du fabricant (2017)
    Miami Fat Supply
  • Source
    USFDA