Events

Rappel de Device Recall MERZ AESTHETICS, 27G X 1.0 " (25MM) Cannula, Sterile R, QTY 20, Model 9015M1X20, Distributed by Merz

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 Merz Aesthetics, 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
    60851
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0694-2012
  • Date de mise en oeuvre de l'événement
    2011-12-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106644
  • 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
    Needle, hypodermic, single lumen - Product Code FMI
  • Cause
    Merz aesthetics is initiating a medical device recall on tsk closed tip cannula (27ga x 25mm) due to a labeling error on the secondary (outer) packaging. the outer package label states that the carton contains cannulas that are 27ga x 25 mm in size instead of 27g x 38 mm. length of the cannula is a matter of user preference and is unlikely to impact patient safety.
  • Action
    Merz Aesthetics Inc, initially contacted customers by telephone on December 16, 2011. They were informed that the wrong size cannula were sent with their last order and would need to be returned and a replacement order would be sent. . Merz Aesthetics sent a "Urgent Medical Device Recall" letter dated January 6, 2012. The letter identified the product the problem and the action needed to be taken by the customer. In addition, if you have further distributed this product, please identify your customers and notify them of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. You may contact Merz Aesthetics Customer Service at (866) 862-1211 or (262) 835- 3333 ,for instructions regarding the return and immediate replacement of the product, or if you have any further questions or concerns..

Device

Device Recall MERZ AESTHETICS, 27G X 1.0 " (25MM) Cannula, Sterile R, QTY 20, Model 9015M1X20, D...
  • Modèle / numéro de série
    Lot #1029402
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including the states of CA, NY, OK, and TN.
  • Description du dispositif
    MERZ AESTHETICS, 27G X 1.0 " (25MM) Cannula, Sterile R, QTY 20, Model 9015M1X20, Distributed by Merz Aesthetics, In., Manufactured by TSK Laboratory. || The intended use of the Cannula is the injection of fluids into, or withdrawal of fluids from, parts of the body below the surface of the skin.
  • Manufacturer
    Merz Aesthetics, Inc.

Manufacturer

Merz Aesthetics, Inc.
  • Adresse du fabricant
    Merz Aesthetics, Inc., 4133 Courtney Rd Ste 10, Franksville WI 53126-9127
  • Société-mère du fabricant (2017)
    Merz Holding Gmbh & Co. Kg
  • Source
    USFDA