3M Company - Health Care Business recalls 3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.

Recall date

January 22, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1563-2016

FDA classification

Class II

Brand / firm

3M Company - Health Care Business

Sold / distributed

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.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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