Events

Recall of Device Recall 3M SteriVacGas Sterilizer/Aerator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by 3M Company - Health Care Business.

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
    73117
  • Event Risk Class
    Class 2
  • Event Number
    Z-1563-2016
  • Event Initiated Date
    2016-01-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143088
  • 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
    Sterilizer, ethylene-oxide gas - Product Code FLF
  • Reason
    3m discovered a valve with incorrectly labeled "input" and "output" orientation. this defect can result in the valve being installed backwards, creating a remote possibility of valve failure. a failure may result in eo being vented outside the sealed chamber during a limited period in the eo injection phase of the cycle.
  • Action
    3M sent an Urgent Medical Device Field Correction letter to customers beginning 01/22/2016. The letter identified affected product, and stated that a 3M Service representative will contact the consignee to inspect the sterilizer. Questions can be directed to 3M Health Care Service Line at 1-800-228-3957.

Device

Device Recall 3M SteriVacGas Sterilizer/Aerator
  • Model / Serial
    Model 5XL, Serial Numbers: 722612 - 722683, 820352 - 820360  Model 8XL, Serial Numbers: 351303 - 351399, 450144 - 450147
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL, CO, CT, FL, GA, IN, NC, NJ, NY, OK, OR, PA, RI, VA, WI, and OUS to include: Argentina, Canada, Chile, China, Columbia, El Salvador, Germany, India, Indonesia, Japan, Korea, Mexico, Peru, Philippines, South Africa, Switzerland, Thailand, Trinidad, Turkey, United Arab Emirates, Vietnam.
  • Product Description
    3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.
  • Manufacturer
    3M Company - Health Care Business

Manufacturer

3M Company - Health Care Business
  • Manufacturer Address
    3M Company - Health Care Business, 3m Center 2510 Conway Ave , B# 275-5-W-6, Saint Paul MN 55144-0001
  • Manufacturer Parent Company (2017)
    3m Company
  • Source
    USFDA