Events

Rappel de Device Recall AirLife(TM) Arterial Blood Gas (ABG) Sampling Kit

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 Vyaire Medical.

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
    77845
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3080-2017
  • Date de mise en oeuvre de l'événement
    2017-07-18
  • Date de publication de l'événement
    2017-08-28
  • 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=158028
  • 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
    Arterial blood sampling kit - Product Code CBT
  • Cause
    Lot #0001047501 of the 9025rhtr abg sampling kits have been manufactured containing the incorrect sub-assembly which includes a larger needle (23 gage, 1" needle), larger syringe (3ml), and larger amount of heparin (113iu), than what is intended for the kit.
  • Action
    The firm, Vyaire Medical, sent an "URGENT RECALL NOTIFICATION" letter dated 07/18/2017 to its consignees. The letter described the product, problem and actions to be taken. Thee consignees were directed to inspect their current inventory and remove the recalled lot. Distributors and direct consignees were instructed to complete the Customer Response Form and return to GMB-GLB-ALFieldActions and destroy the product. If you wish to obtain credit/replacement contact Vyaire Customer Support at (800) 323.9008 (option #1) Monday-Friday 8:00am CST - 5:oopm CST. Distributors were instructed to notify their customers and have them respond directly to the distributor. For any additional questions and support concerning this voluntary Recall, please contact Clinical Risk Coordinator, at (224)706-6830 or Lindy.Schenning@Vyaire.com.

Device

Device Recall AirLife(TM) Arterial Blood Gas (ABG) Sampling Kit
  • Modèle / numéro de série
    Lot Number 0001047501
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution- Nationwide distribution to states of: FL, OK, VA, MI, TH, NM, MA, MO, WA, AND country of: Australia.
  • Description du dispositif
    AirLife(TM) Reduced Heparin ARTERIAL BLOOD SAMPLER, REF 9025RHTR, 1ML SYRINE 25G 5/8", LUER SLIP PROTECTIVE SHEATH, 3.2 IU, STERILE R, Rx ONLY, CAREFUSION || Lot #0001047501 of the 9025RHTR ABG sampling kits have been manufactured containing the incorrect sub-assembly which includes a larger needle (23 Gage, 1" needle), larger syringe (3mL), and larger amount of heparin (113IU), than what is intended for the kit.
  • Manufacturer
    Vyaire Medical

Manufacturer

Vyaire Medical
  • Adresse du fabricant
    Vyaire Medical, 75 N Fairway Dr, Vernon Hills IL 60061-1845
  • Société-mère du fabricant (2017)
    Vyaire Holding Company
  • Source
    USFDA