Events

Rappel de Continuous Peropheral Nerve Block Catheter Kit and Set

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
    66589
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0546-2014
  • Date de mise en oeuvre de l'événement
    2013-10-09
  • Date de publication de l'événement
    2013-12-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-09-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122660
  • 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
    A labeling inconsistency was discovered in which the lidstock states that the kit contains a stimulator cable with 1.5mm socket, however, the kit contains a stimulator cable with 1.5mm pin.
  • Action
    The firm, Arrow International, Inc., sent an "Urgent Medical Device Recall Notification" letter dated October 14, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use and quarantine any of listed affected products/lots you have in stock; return affected products, customer service representative will contact you with RGA# and instructions for the return of the product, and complete enclosed Recall Acknowledgement form and fax to 1-800-343-2935, Attn: Customer Service, even if you have not affected product. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-800-343-2935.

Device

Continuous Peropheral Nerve Block Catheter Kit and Set
  • Modèle / numéro de série
    Product number AB-07200 Stimulator Adapter Cable with lot numbers: RF0059570, RF2069779, RF0088984, RF2108983, RF0128588, RF3052266, RF1071764.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: US (nationwide) including states of: MA, LA, CA, GA, KS, TX, PA, NY, MO, WI, NJ, MS, CT, ID, AL, CO, and PR; and Singapore.
  • Description du dispositif
    Continuous Peripheral Nerve Block Catheter Kit and Set || Continuous Peripheral Nerve Block Catheter Kit and Set 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