Events

Rappel de Device Recall ABGHM1 Hummi Micro Draw Blood Transfer Device

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
    72350
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1636-2016
  • Date de mise en oeuvre de l'événement
    2015-10-01
  • Date de publication de l'événement
    2016-05-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-01-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140711
  • 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 abg-hm-1 hummi micro draw blood transfer because the connection between the "hummi" y connector and the yellow cannula hub may not be sufficiently secure enough and could separate while in use.
  • Action
    On 10/01/15 the firm sent out customer notification letters. The letter states for the following actions to be taken: 1. Customers using the Hummi Micro Draw device are recommended not to use the identified lot. 2. A local distributor/sales representative will be contacting customers to arrange a return of the identified lot for credit and arrangement of replacement. 3. Replacement product should be available within 10 days of 10/30/15. 4. During the period of product unavailability customers might want to choose to temporarily to return their previous method for blood drawing. The firm requests a Reply Form be completed and returned via fax at 949-583-2775 or email to JorgeHaider@hummingbirdmed.com. On 11/19/2015 the firm sent out a second notification letter involving additional recall lots. The firm provided the same instructions to customers as their previous notification; however stated replacement product should be available by mid December 2015.

Device

Device Recall ABGHM1 Hummi Micro Draw Blood Transfer Device
  • Modèle / numéro de série
    Lot 15180, 15286, 15287, 15300, 15305
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Distributed in the states of CA, KY, MD, GA, and IL.
  • Description du dispositif
    ABG-HM-1 Hummi Micro Draw Blood Transfer Device || Product Usage: || It is 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