Z-0153-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 28, 2015
- Initiation Date
- February 3, 2014
- Termination Date
- February 4, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- M2104 - 25 units; M2408 - 84 units
Product Description
OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices
Reason for Recall
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.
Distribution Pattern
US Nationwide Distribution in the states of IL, IN, LA, OH, PA, TX & WV.
Code Information
M2104 Lot # 044305, 044379, 044380 & 044418. M2408 Lot # 044296, 022304, 044381, 044420, 044421 & 044422.