Events

Rappel de Device Recall Arrow Nerve Block Component, Product Code: AB18040N

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 Arrow 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
    69740
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0573-2015
  • Date de mise en oeuvre de l'événement
    2014-11-10
  • Date de publication de l'événement
    2014-12-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-09-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131448
  • 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
    Anesthesia conduction kit - Product Code CAZ
  • Cause
    Arrow is recalling certain lots of the continuous nerve block component, product code: ab-18040-n, due to a labeling inconsistency. the product lidstock incorrectly identifies the needle in the finished good as 17ga rather than the correct 18ga. the product included in the package is the correct 18ga size. no injuries or illnesses have been reported.
  • Action
    An urgent medical device recall notification, dated November 11, 2014, was sent to consignees which identified the product, problem, and action to be taken. Customers with affected stock were asked to immediately discontinue use and quarantine any products with the catalog and lot number. To return product, the Recall Acknowledgement Form should be completed and faxed to 1-855-419-8507 Attn: Customer Service or email it to recalls@teleflex.com. A customer service representative will be in contact to provide instructions for the return of product. All customers were asked to complete the Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to recalls@teleflex.com.

Device

Device Recall Arrow Nerve Block Component, Product Code: AB18040N
  • Modèle / numéro de série
    Product Number: AB-18040-N;  Lot Number:  RF2096425,  RF2010131,  RF1057898,  RF0074365,  RF0035689
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution.
  • Description du dispositif
    Arrow Nerve Block Component, Product Code: AB-18040-N: Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or || analgesia techniques for periods not exceeding 72 hours.
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc
  • Adresse du fabricant
    Arrow International Inc, 2400 Bernville Road, Reading PA 19605
  • Société-mère du fabricant (2017)
    Teleflex Incorporated
  • Source
    USFDA