Events

Rappel de Device Recall InVisionPlus CS Needleless IV Connector

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 Rymed Technologies, LLC.

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
    72997
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0676-2016
  • Date de mise en oeuvre de l'événement
    2016-01-05
  • Date de publication de l'événement
    2016-01-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-10-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142693
  • 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
    Set, administration, intravascular - Product Code FPA
  • Cause
    Potential for the female luer component of the invision-plus iv connector to crack during use.
  • Action
    The firm Ry Med Technology LLC, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated January 4, 2016 and response form to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue use and return the product to: RyMed Technologies LLC, 6000 W. William Cannon Drive, Building B, Suite 300 Austin, TX 78749; the user facilities to change the IV connectors in 24 hour when lipids are being administered; if further distributed, contact other accounts, advise of recall and return outstanding stock; complete and return the RECALL NOTIFICATION ASAP and no later than 10 business day via email to: amccutchen@rymedtech.com, fax to: 512-301-7338, Attention Recall Return Notification or mail to RyMed Technologies LLC, Attention Recall Return Notification, 6000 W. William Cannon, Building B, Suite 300 Austin, TX 78749. If you have any questions concerning the recall, contact Director of Quality Assurance/Regulatory Affairs by email to: amccutchen@rymedtech.com or call 512-301-7338x303. If you have questions about returning/replacement of product contact Logistics Specialist by email to: svara@rymedtech.com or call 512-301-7338x309.

Device

Device Recall InVisionPlus CS Needleless IV Connector
  • Modèle / numéro de série
    Catalog number RYM-7001 Lots: R01842, R01889, R01891, and R01897, Expire 03/2016.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution.
  • Description du dispositif
    InVision-Plus CS Needleless IV Connector, Catalog Number RYM-7001. Disposable, Single Use. || Products are intended for single patient use in intravenous and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.
  • Manufacturer
    Rymed Technologies, LLC

Manufacturer

Rymed Technologies, LLC
  • Adresse du fabricant
    Rymed Technologies, LLC, 6000 W William Cannon Dr Ste B300, Austin TX 78749-1991
  • Source
    USFDA