Events

Rappel de Sterile gowns and towels in packages. || LINEN PACK I - contains 12 towels, 1 each large single-ply scrub nurse gown/towel, 1 each large single-ply surgeons gown, 2 36'' re-usable wrappers, 1 24'' re-usable wrappers. || Surgical gown packs, inside double wrappers, for use in surgery and operating rooms. Packs include gowns and towels. || Packages are labeled ''STERILE SURGICAL SYSTEMS, LLC ** Tumwater, Washington ** Catalog # ** Quantity ** MFG Date ** Order No. ** Contents ** Contents of the unopened, undamaged package are sterile. Do not resterilize***''.

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 Sterile Surgical Systems Llc.

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
    25118
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0439-03
  • Date de mise en oeuvre de l'événement
    2002-06-04
  • Date de publication de l'événement
    2003-01-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2003-01-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25229
  • 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
    An indicator inside the package did not change to indicate gowns were sterilized.
  • Action
    The firm telephoned it's two customers on 6/4/02 and offered to have product returned or provide documentation that the sterlizing indicators were defective, and theoretically the gown packs were sterilized.

Device

Sterile gowns and towels in packages. || LINEN PACK I - contains 12 towels, 1 each large single-p...
  • Modèle / numéro de série
    Manufacturing dates on the label: MFG Dates: 5/24/02, 5/28/02, 5/29/02, 5/30/02, 5/31/02, 6/3/02
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The firm distributed to two hospitals located in the greater Seattle, WA area.
  • Description du dispositif
    Sterile gowns and towels in packages. || LINEN PACK I - contains 12 towels, 1 each large single-ply scrub nurse gown/towel, 1 each large single-ply surgeons gown, 2 36'' re-usable wrappers, 1 24'' re-usable wrappers. || Surgical gown packs, inside double wrappers, for use in surgery and operating rooms. Packs include gowns and towels. || Packages are labeled ''STERILE SURGICAL SYSTEMS, LLC ** Tumwater, Washington ** Catalog # ** Quantity ** MFG Date ** Order No. ** Contents ** Contents of the unopened, undamaged package are sterile. Do not resterilize***''.
  • Manufacturer
    Sterile Surgical Systems Llc

Manufacturer

Sterile Surgical Systems Llc
  • Adresse du fabricant
    Sterile Surgical Systems Llc, 2757 29TH AVENUE S.W., Tumwater WA 98512
  • Source
    USFDA