Events

Rappel de Device Recall Hummi

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 Hummingbird Med.

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
    73461
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1908-2016
  • Date de mise en oeuvre de l'événement
    2015-03-11
  • Date de publication de l'événement
    2016-07-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-02-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144230
  • 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
    System, blood collection, vacuum-assisted, manual - Product Code KST
  • Cause
    Hummingbird med devices, inc. is recalling the hummi micro draw because of insertion difficulties.
  • Action
    The firm, Hummingbird Med Devices, Inc., sent a "Safety Alert" on March 3, 2015 and Addendum on March 11, 2015, to all affected customers. The notification sent on March 3, 2015, instructed customers that: 1) the Hummi Micro device is not recommended to be used with the Baxter Interlink device with the Hummi Micro draw blood transfer device as the Interlink T Connector septum may be damaged. 2) the use of Nexus Medical Micro-T Split Septum T Connector NMT8046 with all uses of the Hummi Micro Draw Blood Transfer device. The connector has been tested and validated for use in combination with the Ameritus Medical's Hummi Micro-Draw Blood Transfer Device. 3) Distributors of the Hummi Micro Draw Device contact and inform all Hummi Micro-Draw Blood Transfer Device users to recommend change to the Nexus Split Septum Micro-T Connector NMT8046 for all uses with the Hummi Micro Draw device. Inservice materials and training on proper Hummi Micro Draw device blunt cannula insertion into the connector's septum will be provided. 4) Distributors complete the attached form indicating hospitals and date contacted, name, and contact information of responsible person and resulting outcome. and 5) Scan and email the attached form to: jorgehaider@humigbirdmed.com or fax to: 1-949-583-2775. On March 11, 2015, the firm sent out a second email to their distributor to inform customers again that only the split septum T-Connector recommended for use with the Hummi Micro Draw is the Nexus Micro T split septum T-Connector. The Nexus Micro T-Connector is designed to provide improved insertion force and eliminate potential leaking while providing a microbial barrier when used with the Hummi Micro Draw device. The Hummi Micro device manufactured in 2015 now has improved lubrication on the blunt tube which makes insertion into smaller septum opening of the Mexud Micro T-Connector smooth and easier to accomplish. The firm states in the letter that the distributor will offer

Device

Device Recall Hummi
  • Modèle / numéro de série
    Lot Numbers: 20140510 20140513 20140516 20140519 20140603 20140606 20140609 20140612 14299
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution in the state of CA.
  • Description du dispositif
    ABG-HM-1 Hummi Micro Draw Blood Transfer Device; Used for blood transfer and collection from peripheral arterial line catheters.
  • Manufacturer
    Hummingbird Med

Manufacturer

Hummingbird Med
  • Adresse du fabricant
    Hummingbird Med, 20371 Lake Forest Dr Ste A6, Lake Forest CA 92630-8106
  • Source
    USFDA