Events

Recall of Device Recall Part : SAM XTC, Model: HiViz Blue

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by The Seaberg Company Inc.

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
    80140
  • Event Risk Class
    Class 2
  • Event Number
    Z-2228-2018
  • Event Initiated Date
    2018-05-02
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164668
  • 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
    Tourniquet, nonpneumatic - Product Code GAX
  • Reason
    Based on internal testing, results indicated a possible failure of the stitches securing the buckle to the nylon belt could occur, posing a potential risk when used on a human patient to stop arterial blood flow. there is a remote chance that a serious injury and/or death could occur as a result of the failure of the device.
  • Action
    On 05/02/2018, the firm posted a press release notifying customers of a recall of all unused SAM XT Extremity Tourniquets (SAM XT) due to a possible failure of the stitches securing the buckle to the nylon belt that could pose a potential risk when used on a human patient to stop arterial blood flow. On 05/03/2018, recall notification forms were mailed to customers via overnight mail service.

Device

Device Recall Part : SAM XTC, Model: HiViz Blue
  • Model / Serial
    Lot #: XT1808, XT1809, XT1810
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA: CA, MD, OH, FL, ID, CO, CT, OR, AZ, IL, ME, MO, NY, SC, MI, AR, MT, CT, WA, TX, KY, NC, NJ, PA OUS: Australia, Canada, China, Columbia, Costa Rica, Europe (EU), Hong Kong, Iceland, India, Iraq, Israel, Japan, Kenya, Korea, Lebanon, Malaysia, Russia, Saudi Arabia, Singapore, South Africa, Thailand, UAE
  • Product Description
    Part #: SAM XT-C, Model: Hi-Viz Blue
  • Manufacturer
    The Seaberg Company Inc

Manufacturer

The Seaberg Company Inc
  • Manufacturer Address
    The Seaberg Company Inc, 27350 SW 95th Ave Ste 3038, Wilsonville OR 97070-7709
  • Manufacturer Parent Company (2017)
    The Seaberg Company Inc
  • Source
    USFDA