Events

Recall of SteriVac

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
    63214
  • Event Risk Class
    Class 2
  • Event Number
    Z-0022-2013
  • Event Initiated Date
    2012-09-13
  • Event Date Posted
    2012-10-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-01-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113036
  • 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 determined that the electrical grounding mechanism for the steri-vac 5xl and 8xl gas sterilizer/aerator did not meet all of the requirements of the standard in that the electrical wiring, which is insulated and contained within the sealed door should have a stronger connection to the protective electrical grounding mechansim.
  • Action
    3m Healthcare Service Center sent a Urgent Medical Device Field Correction letter dated September 19. 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 3M will contact you to schedule an appointment for a field correction on any unit in the range of serial numbers provided in the table. 3Ms goal is to service the affected units with minimal disruption to your facility. We apologize for any inconvenience this field correction may cause. Please be assured that 3M is committed to the highest level of safety and customer service and we are proud of our longstanding safety record for 3M" Steri-Vac" Gas Sterilizers. For Further Information If you have any questions, please contact the 3M Health Care Service Line at 1-800-688-5888 or your local 3M representative. .

Device

SteriVac
  • Model / Serial
    Model 5XL 1-door, serial numbers from 721799 - 722166.  Model 5XL 2-door, serial numbers from 820248 - 820285.  Model 8XL 1-door, serial numbers from 350608 - 350887. Model 8XL 2-door, serial numbers from 450073 - 450105
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) including the states of AL, CO, CT, GA, IN, KY, MA, MI, MN, MO, MS, NJ, OH, PA, SC, TN, VA, WA and WI., and the countries of Argentina, Barbados, Chile, China, Colombia, Costa Rica, Ecuador, Germany, India, Indonesia, Japan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Morocco, Pakistan, Paraguay, Peru, Philippines, Poland, Republic of Guinea, Russia, South Africa, Taiwan, Thailand, Trinidad, UAE, Venezuela, Vietnam and Zimbabwe.
  • Product Description
    3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. || 3M Steri-Vac Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for indoor use only.
  • 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
  • Manufacturer Parent Company (2017)
    3m Company
  • Source
    USFDA