Reported Apr 9, 2014 · Terminated

3M" Steri-Vac" Gas Sterilizer/Aerators, Model #'s 4XL,5XL, 8XL The 3M" Steri-Vac" Gas Sterilizer/Aerator is a compact…

3M Company - Health Care Business

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: 3M Company - Health Care Business · 3M Center 2510 Conway Ave , B# 275-5-W-6 · Saint Paul, MN · 55144

Is this the product you have?

  • 3M" Steri-Vac" Gas Sterilizer/Aerators, Model #'s 4XL,5XL, 8XL The 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.
Lot codes and dates
  • Model SKU Starting S/N Ending S/N
    • 5XL
    • 70-2007-2303-2
    • 721115
    • 721309
    • 5XL
    • 70-2007-2304-0
    • 820174
    • 820201
    • 5XL
    • 70-2007-2575-5
    • 780066
    • 780102
    • 8XL
    • 70-2006-8493-7
    • 350136
    • 350268
    • 8XL
    • 70-2006-8498-5
    • 450016
    • 450027
    • 4XL
    523122, 522205, 522502, 522287, 522655.
Amount recalled
73 US, 346 OUS

Where it was sold

Why it was recalled

Recently, 3M received a single report of a potential exposure to Ethylene Oxide (EO) at a hospital installation involving 3M" Steri-Vac" Gas Sterilizers. The cause was traced to a rare situation involving a failure of the EO cartridge puncture assembly. This assembly was only in production during the period November 10, 2006 through December 14, 2007 and in service during the period February 7, 20

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 22, 2015 · Data as of Sep 19, 4:48 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.