Innovative Sterlization Technologies LLC recalls OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical…

Recall date

February 3, 2014

Source

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

Recall number

Z-0153-2016

FDA classification

Class II

Brand / firm

Innovative Sterlization Technologies LLC

Sold / distributed

US Nationwide Distribution in the states of IL, IN, LA, OH, PA, TX & WV.

Why it was recalled

The wrong sterilization time was on the label. The label lists Steam Gravity 10 - 34 minutes at 270 degrees F instead of Steam Gravity 17 - 34 minutes at 270 degrees F.

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

What was recalled

OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices