Events

Rappel de 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 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
    79890
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1961-2018
  • Date de mise en oeuvre de l'événement
    2018-04-11
  • Statut de l'événement
    Open, Classified
  • 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=163841
  • 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
    Product sterility may be compromised due to unsealed packaging.
  • Action
    On April 11, 2018 Arrow International mailed Urgent Medical Device Recall notifications to affected customers. Customers were instructed to take the following actions: 1. If you have affected stock, immediately discontinue use and quarantine any products with the product codes and lot numbers listed above, so that the affected products can be returned to Arrow. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Arrow International. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document your receipt of this letter. Customers with questions may contact your local sales representative or Customer Service at (866)246-6990.

Device

Epidural Needle
  • Modèle / numéro de série
    Lot Numbers:  Product code AN-05501:  13F17A0211 13F17B0082 13F17C0378 13F17D0082 13F17E0023 13F17E0329 13F17E0838 13F17F0432 13F17F0813 13F17G0333 13F17H0059 13F17J0002 13F17L0598 Product code AN-05505:  13F17A0213 13F17C0109 13F17C0479 13F17E0208 13F17F0254 13F17F0727 13F17G0357 13F17J0161 13F17J0274 13F17L0441
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM
  • Description du dispositif
    Epidural Needle; Product Codes: AN-05501 and AN-05505
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc
  • Adresse du fabricant
    Arrow International Inc, 2400 Bernville Rd, Reading PA 19605-9607
  • Société-mère du fabricant (2017)
    Teleflex Incorporated
  • Source
    USFDA