Events

Rappel de 17G Cryoablation Needle Holder

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 Galil Medical, 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
    61657
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1613-2012
  • Date de mise en oeuvre de l'événement
    2012-04-12
  • Date de publication de l'événement
    2012-05-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108652
  • 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
    Unit, cryosurgical, accessories - Product Code GEH
  • Cause
    Galil medical is recalling 17g cryoablation needle holder, fprpr 4014. this voluntary recall has been initiated due to the possibility of excessive bioburden on the needle holders.
  • Action
    Galil Medical sent an "Urgent Medical Device Recall" letter dated April 12, 2012 to all affected customers. The letter identified the affected product, problem, actions to be taken. The letter instructs customers to return all unused affected products, use a revised needle preparation procedure and forward and communicate this Recall Notice and instructions. Customers were instructed to complete and return the attached Response Form with returned product or fax to 1+877-510-7757. For any questions contact Galil Medical Customer Service.

Device

17G Cryoablation Needle Holder
  • Modèle / numéro de série
    N8185-001; N9438-001; N9438-003; N9438-004; N7890-003; N7975-001; N7975-002; N8185-006; N8185-007; N7729-005; N7890-004; N9438-002; N8185-005; N8185-008; N7890-005; N7975-003; N7729-001; N7729-002; N8185-009; N8185-010; N7729-003; N7729-004; N7890-001; N7890-002 ; N7975-004;N7975-005
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of CA, NY, NC, WA and the countries of CANADA, DENMARK, FRANCE, NETHERLANDS, TAIWAN and UNITED KINGDOM.
  • Description du dispositif
    Galil Medical, 17G Cryoablation Needle Holder FPRPR 4014, Rx only, Sterile EO. || Product Usage: || Galil Medicals 17G Cryoablation Needle Holder (Needle Holder) is intended for use only with a Galil Medical Needle Testing Device (NTD). The NTD, a component used when performing cryogenic destruction of tissue with a Galil Medical Cryoablation System, is intended for performing a Needle Integrity and Functionality Test in preparation for a cryoablation procedure, and also serves to organize and support the cryoablation needles and thermal sensors in a sterile environment, prior to use.
  • Manufacturer
    Galil Medical, Inc.

Manufacturer

Galil Medical, Inc.
  • Adresse du fabricant
    Galil Medical, Inc., 4364 Round Lake Rd W, Arden Hills MN 55112
  • Société-mère du fabricant (2017)
    Btg Plc
  • Source
    USFDA