Events

Recall of Device Recall SSCOR Powered Suction Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by S S C O R 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
    30845
  • Event Risk Class
    Class 2
  • Event Number
    Z-0416-05
  • Event Initiated Date
    2005-01-06
  • Event Date Posted
    2005-01-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36698
  • 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
    Pump, Portable, Aspiration (Manual Or Powered) - Product Code BTA
  • Reason
    Reports from medical professionals that sscor suction device has not performed as intended. firm's investigation disclosed that the condition in questions is caused by cracked regulators that result in inadequate suction.
  • Action
    SSCOR Powered Suction Device not performing as intended.

Device

Device Recall SSCOR Powered Suction Device
  • Model / Serial
    Serial Number: L00396 - L00425
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, FL, IA, IL, IN, KY, MO, NC, NJ, NY, OH, France, New Zealand, Singapore, United Kingdom
  • Product Description
    SSCOR Suction Device Model 2315
  • Manufacturer
    S S C O R Inc

Manufacturer

S S C O R Inc
  • Manufacturer Address
    S S C O R Inc, 11064 Randall St, Sun Valley CA 91352-2621
  • Source
    USFDA