Events

Recall of 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***''.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sterile Surgical Systems Llc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    25118
  • Event Risk Class
    Class 2
  • Event Number
    Z-0439-03
  • Event Initiated Date
    2002-06-04
  • Event Date Posted
    2003-01-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-01-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25229
  • Notes / Alerts
    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.
  • Extra notes in the data
    Gown, Surgical - Product Code FYA
  • Reason
    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...
  • Model / Serial
    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
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The firm distributed to two hospitals located in the greater Seattle, WA area.
  • Product Description
    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
  • Manufacturer Address
    Sterile Surgical Systems Llc, 2757 29TH AVENUE S.W., Tumwater WA 98512
  • Source
    USFDA