Events

Rappel de Device Recall Bipolar Forceps

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 Stingray Surgical Products, LLC.

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
    62024
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2011-2012
  • Date de mise en oeuvre de l'événement
    2012-05-23
  • Date de publication de l'événement
    2012-07-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-08-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109874
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Cause
    On 05/23/2012, stingray surgical products, llc., boca raton, fl initiated a recall initiated due to "instructions for use" of bipolar forceps not being cleared by fda and incorrect "instructions for use" . the sterilization instructions have been altered without the clearance of the fda.
  • Action
    Stingray Surgical Product sent an URGENT Instructions for Use Recall letter dated Mary 23, 2012, to all distributors. The letter identified the product, the problem, and the action to be taken by the client. Distributers were requested to convey the recall to their users along with fowarding copies of the firm's recall notification letter. IFU's will be destroyed or discarded by either user or distributor since returns will not be necessary. Distributors were asked to complete the form at the bottom of the letter and return via e-mail or fax. For questions clients were instructed to call 561-210-7582. For questions regarding this recall call 561-210-7582.

Device

Device Recall Bipolar Forceps
  • Modèle / numéro de série
    Bipolar Forceps model number: S02-XXX, S03-XXX, P02-XXX, and P03-XXX. "Instructions For Use" (QF7.5.1A.R01 thru QF7.5.1A.R06 Care and Handling of Bipolar Forceps.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide)
  • Description du dispositif
    Bipolar Forceps model number: S02-XXX, S03-XXX, P02-XXX, and P03-XXX. "Instructions For Use" (QF7.5.1A.R01 thru QF7.5.1A.R06 Care and Handling of Bipolar Forceps. || Bipolar Forceps designed to grasp, manipulate and coagulate selected tissue for use in general surgical procedures powered by a high frequency generator.
  • Manufacturer
    Stingray Surgical Products, LLC

Manufacturer

Stingray Surgical Products, LLC
  • Adresse du fabricant
    Stingray Surgical Products, LLC, 156 Nw 16th St, Boca Raton FL 33432-1607
  • Société-mère du fabricant (2017)
    Stingray Surgical Products Llc
  • Source
    USFDA