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FDAFebruary 3, 2014device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

innovative sterlization technologiesinnovativeinnovative sterlization

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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