Events

Rappel de MicroCool Breathable Impervious Surgical Gown

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 Kimberly-Clark 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
    62451
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2017-2012
  • Date de mise en oeuvre de l'événement
    2009-09-17
  • Date de publication de l'événement
    2012-07-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110687
  • 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
    Gown, surgical - Product Code FYA
  • Cause
    Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough and fibers falling off the gowns.
  • Action
    Kimberly Clark sent an Urgent Medical Device Recall letter dated September 17, 2009. to all affected consignees. The Recall notification of the expanded recall was sent to consignees on November 17, 2009. Customers were instructed to destroy all affected product remaining in their inventory. For questions regarding this recall call 770-587-7400.

Device

MicroCool Breathable Impervious Surgical Gown
  • Modèle / numéro de série
    Product Code: 92340 (Large), Lot #AH9103, AH9110, AH9139, AH9140, AG9154, AH9155 and AH9160; Product Code: 92342 (X-Large), Lot #AH9116, AH9142, AH9143, AH9145, AH9150, AH9151, AH9155, AH9157, AH9159, AH9160, AH9166, AH9168 and AH9076. Customers were notified to include Lot range AH9076xxx to AH9175xxx. On November 17, 2009 the recall was expanded to include the following: Product number 92340 (Large), Lot numbers: AH9072, AH9073, AH9074, AH9103, AH9140 and AH9146; Product number: 92342 (X-Large), Lot numbers: AH9073, AH9074, AH9112, AH9158, AH9160, AH9163, AH9165, AH9167 and AH9168; Product number: 92344 (XX-Large), Lot numbers: AH9074, AH9139, AH9152, AH9153, and AH9155; Product number: 92353 (X-Large Specialty), Lot numbers: AH9143, AH9146 and AH9160 and Product number: 92357 (XX-Large Specialty), Lot number range AH9072xxx to AH9175xxx.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including AL, FL, GA, KY, LA, MS, NC, OH, SC, TN, and VA
  • Description du dispositif
    MicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile, Made in Honduras. || The Kimberly Clark Micro COOL Surgical Gowns are sterile single use surgical apparel intended to be worn by heathcare professionals to help protect the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter.
  • Manufacturer
    Kimberly-Clark Corporation

Manufacturer

Kimberly-Clark Corporation
  • Adresse du fabricant
    Kimberly-Clark Corporation, 1400 Holcomb Bridge Rd, Roswell GA 30076
  • Source
    USFDA