Events

Rappel de Device Recall Connecting Tube Female to Male Luer Lock

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 Cook 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
    79789
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1755-2018
  • Date de mise en oeuvre de l'événement
    2018-03-29
  • 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=163457
  • 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
    Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass - Product Code DTL
  • Cause
    Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube.
  • Action
    On March 29, 2018, the recalling firm mailed recall notifications to affected customers. Customers were informed that the affected devices may have been manufactured with equipment that was out of calibration, which could result in the cap-adapter assembly of the device not being adequately tightened. Customers were advised of potential adverse events. Customers were instructed to 1) Examine inventory immediately to determine if they have affected product, and quarantine affected product. Immediately cease all distribution and use of the recalled lots. 2) Return the affected product to the recalling firm with a copy of the Acknowledgement and Receipt Form to receive a product credit. 3) Complete the Acknowledgement and Receipt Form even if the customer does not have affected products on hand. 4) Immediately report adverse events to the recalling firm. Customers with further questions were directed to contact Cook Medical Customer Relations at 800-457-4500 or 812-339-2235.

Device

Device Recall Connecting Tube Female to Male Luer Lock
  • Modèle / numéro de série
    Lots NS7835000, NS7835001, NS7846433, NS7853877, NS7853880, NS7866660, NS7875342, NS7898129, NS7898130, NS7898131, NS7928009, NS7928014, NS7940349
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed to accounts in 7 states: AL, CA, GA, NE, NV, NY, and TX. International distribution to Japan, Korea, and Taiwan.
  • Description du dispositif
    Connecting Tube - Female to Male Luer Lock, HPCT8.8-100-M-FM || Product Usage: || The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.
  • Manufacturer
    Cook Inc.

Manufacturer

Cook Inc.
  • Adresse du fabricant
    Cook Inc., 750 N Daniels Way, Bloomington IN 47404-9120
  • Société-mère du fabricant (2017)
    Cook Group Incorporated
  • Source
    USFDA