Events

Rappel de Device Recall TEG Haemonetics System Level II Control

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 Haemonetics Corporation.

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
    70352
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1130-2015
  • Date de mise en oeuvre de l'événement
    2015-01-26
  • Date de publication de l'événement
    2015-02-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-06-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133242
  • 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, multipurpose for in vitro coagulation studies - Product Code JPA
  • Cause
    Specific lots of level ii control kits produce high maximum amplitude (ma) results, which are outside of the manufacturer's expected quality control range for ma parameter.
  • Action
    Haemonetics issued on 1/26/15, an Urgent Medical Device Recall to consignees The letter identified the affected product, the reason for the recall, as well as the risk to health. It instructs consignees to inspect their stock and determine if they have any of the affected lots. Customers are to immediately discontinue use and discard as instructed any affected product. The attached customer acknowledgment form should be completed and returned whether or not customers have any affected product. Customers are to contact their local service representative at 1-800-537-2802 if replacement product is needed. If any affected product has been forwarded to other locations, customers are to inform them of the recall. Please call the Technical Support team at 1-800-438-2834, with questions about this action.

Device

Device Recall TEG Haemonetics System Level II Control
  • Modèle / numéro de série
    Lot numbers: HMO 9200  HMO 9217  HMO 9226  HMO 9232  HMO 9276  HMO 9285  HMO 9292 Exp. Date 1/2017
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US, Canada, Czech Republic, Denmark, Great Britain, and Sweden.
  • Description du dispositif
    Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. || Level II Control is a biological control for use with the Thrombelastograph (TEG) Hemostasis System.
  • Manufacturer
    Haemonetics Corporation

Manufacturer

Haemonetics Corporation
  • Adresse du fabricant
    Haemonetics Corporation, 400 Wood Rd, Braintree MA 02184-2412
  • Société-mère du fabricant (2017)
    Haemonetics Corporation
  • Source
    USFDA