FDAFDA · Food and drugs·Recall number Z-0153-2016
OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices
Published October 28, 2015 · Recall initiated: February 3, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- Innovative Sterlization Technologies LLC
- Distributor
- US Nationwide Distribution in the states of IL, IN, LA, OH, PA, TX & WV.
- Lot
- M2104 Lot # 044305, 044379, 044380 & 044418. M2408 Lot # 044296, 022304, 044381, 044420, 044421 & 044422.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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