Events

Rappel de Device Recall Kimberly Clark Ultra 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
    57535
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0920-2011
  • Date de mise en oeuvre de l'événement
    2010-12-23
  • Date de publication de l'événement
    2011-01-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-07-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96481
  • 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
    Surgical Gown - Product Code FYA
  • Cause
    Product was not properly sterilized.
  • Action
    Kimberly-Clark contacted all ten (10) Distributors with a Distributor Recall Letter (sent FedEx Priority overnight) on 12/23/2010, as well as via telephone. This letter instructs the Distributor to extend the Recall to end-user level by notifying each of their customers of the Recall via the provided Customer Recall Letter. Both the Distributor Letter and Customer Letter include Response Sheets that allows for both Distributor and Customer (end-user) to indicate the quantity of affected product they have in their inventory or indicate whether they do not have any affected product. The Distributor is instructed to immediately cease further shipment of the product and to physically quarantine the product, and fax the completed Response Sheet to our firm's Recall Coordinator within 5 business days of receipt of the letter. The Customer is instructed to immediately cease further use of the gowns and physically quarantine the product, and fax the completed Customer Product Response Sheet to Kimberly Clark's Recall Coordinator within 5 business days of receipt of the letter. Upon receipt of the Response Sheets, the firm will provide instructions for the return of the impacted gowns for delivery to a quarantine location at our warehouse.

Device

Device Recall Kimberly Clark Ultra Surgical Gown
  • Modèle / numéro de série
    Product code (Large Surgical Gowns): 95111-35, Case Lot Numbers: AH0319YL0, AH0319YLI, AH0319YM4, AH0319YLH, AH0319YLJ, AH0319YM3, AH0320YMD, AH0320YME, AH0320YMF, AH0320YMG, AH0320YMN, AH0320YMM, AH0320YMH, AH0320YN0, AH0320YNC, AH0320YND, AH0320YNJ, AH0320YNI, AH0320YNK; Individual Unit Lot Numbers (printed on the sterile pouch): AH0319A, AH0319B, AH0319C, AH0320A, AH0320B, AH0320C.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution -- CA, CT, LA, NJ, NM, RI, CO and TX.
  • Description du dispositif
    Ultra Surgical Gown, Large with Polypropylene Fabric and Towel, Reference number 95111-35, Single use only, Sterile, Made in Honduras.
  • Manufacturer
    Kimberly-Clark Corporation

Manufacturer

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