Reported May 4, 2016 · Terminated

3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.

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 · 55144-0001

Is this the product you have?

    • 3M Steri-Vac Gas Sterilizer/Aerator
    • models 5XL and 8XL
Lot codes and dates
  • Model 5XL
  • Serial Numbers
    • 722612 - 722683
    • 820352 - 820360 Model 8XL
  • Serial Numbers
    • 351303 - 351399
    • 450144 - 450147
Amount recalled
74 valves

Where it was sold

Why it was recalled

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.

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 Aug 25, 2016 · Data as of Sep 19, 5:20 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.