Events

Rappel de RK Epidural Needle

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 Epimed International, 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
    74018
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0086-2017
  • Date de mise en oeuvre de l'événement
    2016-04-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145925
  • 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, conduction, anesthetic (w/wo introducer) - Product Code BSP
  • Cause
    There is a possibility that the needles may have the potential to skive a catheters outer coating. if this were to occur, there exists the risk that a portion of the catheter could remain in the patient, which may require otherwise unnecessary medical invention.
  • Action
    On April 22, 2016, Epimed sent an Urgent Medical Device Recall notices and Recall Return Response Forms to their customers via courier service. Customers were advised to examine all inventory and quarantine product subject to recall immediately. Once the product has been quarantined, please complete and return the enclosed response form as soon as possible by fax to: 518-725-0207, Attn: Quality Assurance. In addition, if you find any product that corresponds to the lot numbers given, please contact the Customer Service Department so that Epimed can arrange for replacement/credit (518-725-0209 or 518-514-1891). Further questions, please call (518) 725-0209.

Device

RK Epidural Needle
  • Modèle / numéro de série
    1) Spectra Lot# GC091702 (Epimed manufacturing lot # 2801501, Sterile Lot # 12157181) 2) Spectra Lot# GC101871 (Epimed manufacturing lot # 3211503, Sterile Lot # 12157445) 3) Spectra Lot# GC101897 (Epimed manufacturing lot # 3161501, Sterile Lot # 12157325)
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to the states of : AL, AK, FL, IN, TN & TX
  • Description du dispositif
    15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 || Intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia
  • Manufacturer
    Epimed International, Inc.

Manufacturer

Epimed International, Inc.
  • Adresse du fabricant
    Epimed International, Inc., 141 Sal Landrio Dr, Crossroads Business Park, Johnstown NY 12095-3835
  • Société-mère du fabricant (2017)
    Epimed International Inc
  • Source
    USFDA