Events

Rappel de Device Recall Medical Action Industries Inc. Blue OR Towel Non XRay Detectable (6 Towels per Pack)

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 Medical Action Industries 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
    80147
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2043-2018
  • Date de mise en oeuvre de l'événement
    2017-12-11
  • 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=164683
  • 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
    Fiber, medical, absorbent - Product Code FRL
  • Cause
    Product sterility potentially compromised.
  • Action
    On December 11, 2017, the firm sent letters to their consignee informing them to: Immediately examine your inventory and quarantine all product subject to this recall notification. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Replacement product should be available within the next two weeks. Should you have immediate replacement needs in the interim, we do have sufficient inventory of AVID265, Blue OR Towel Non X-Ray Detectable (4 Towels per Pack), available for immediate distribution. Your assistance is appreciated and necessary to prevent any unintended use of affected product. Please complete and return the enclosed response form as soon as possible. For further questions, please call (828_ 338-7604.

Device

Device Recall Medical Action Industries Inc. Blue OR Towel Non XRay Detectable (6 Towels per Pack)
  • Modèle / numéro de série
    Item Code #AVID266, Lot No. 231479, Exp. Date 08/31/2021 and Item Code #AVID266, Lot No. 232564, Exp. Date 11/06/2021.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to the states of : CO, KS, MN, NY, RI, TX, and WA and Internationally to Canada
  • Description du dispositif
    Medical Action Industries Inc. Blue OR Towel Non X-Ray Detectable (6 Towels per Pack) / product # AVID266 Sterile || This OR towel product is intended for external use only. These towels are intended to be used as absorbent towels for hand drying, cleanup, and to provide increased absorbency of blood and bodily fluids. There are no instruction catalogues or manuals included with the product as these are intended to be used in accordance with hospital protocol.
  • Manufacturer
    Medical Action Industries Inc

Manufacturer

Medical Action Industries Inc
  • Adresse du fabricant
    Medical Action Industries Inc, 25 Heywood Rd, Arden NC 28704-9302
  • Société-mère du fabricant (2017)
    Owens & Minor Inc
  • Source
    USFDA