FDA-Device2015-10-28Class II
OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices
Innovative Sterlization Technologies LLC
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.
Sold states
US Nationwide Distribution in the states of IL, IN, LA, OH, PA, TX & WV.
Affected count
M2104 - 25 units; M2408 - 84 units
Manufactured in
7625 Paragon Rd Ste A, N/A, Dayton, OH, United States
Products
OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0153-2016Don't want to check this manually?
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