Events

Rappel de Device Recall Large Bore Central Venous Catheters

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
    52376
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1671-2009
  • Date de mise en oeuvre de l'événement
    2009-05-08
  • Date de publication de l'événement
    2009-08-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-07-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82808
  • 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
    Central Venous Catheters - Product Code FOZ
  • Cause
    Wire guide can have difficulty passing through catheter juncture hub or being removed from the catheter.
  • Action
    The recalling firm issued an Urgent Medical Device Recall letter dated 5/11/09 to their customers informing them of the problem and the potential consequences. The letter asked customers to check their stock, cease use and distribution, and quarantine the affected products. They are to contact Arrow's Customer Service Department at 1-800-523-8446 for a Return Authorization Number; complete the Recall Acknowledgement & Stock Status Form and fax to 1-800-343-2935; and return any affected product. The letter states that Arrow can provide either replacement with a similar product at no charge or credit customers' accounts. Additional information or clarification can be obtained by calling Customer Service at 1-800-523-8446.

Device

Device Recall Large Bore Central Venous Catheters
  • Modèle / numéro de série
    Product number AK-12123-H - Lot numbers: RF8045004, RF8072289, RF8084254, RF8107640, RF8108841, RF8110482, RF8122717, RF9027113, RF9030981; Product number CS-12123-E - Lot numbers: RF8032041, RF8043417, RF8058142, RF8060023, RF8072220, RF8084333, RF8097145, RF8109080, RF8110116, RF9015982, ZF7126427, ZF8027168, ZF8027448, ZF8037862, ZF8048194, ZF8048672, ZF8059197, ZF8069577, ZF8090983, ZF8091196, ZF8101854, ZF8102010, ZF8112852, ZF8124161, ZF9014366, ZF9025408, ZF9035840, ZF9046856; Product number MA-12123 - Lot numbers: ZF8027407, ZF8059146, ZF8090984, ZF9014354, ZF9046854; and  Product number MC-12123 - Lot numbers: RF8057141 and RF8083743.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, Belgium, Canada, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Hungary, Indonesia, Ireland, Israel, Italy, Lithuania, Japan, Republic of Korea, Netherlands, New Zealand, Poland, Singapore, Slovakia, South Africa, Spain, Taiwan, Ukraine, and United Kingdom.
  • Description du dispositif
    12 French 3 Lumen 16 cm Large-Bore Central Venous Catheters. Product numbers AK-12123-H, CS-12123-E, MA-12123, and MC-12123. || The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration. It may be inserted into the jugular, subclavian, or femoral veins.
  • 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