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Recall Observatory FDA recall evidence

Device product

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

Z-0153-2016

February 03, 2014

Class II

Product summary

Firm
Innovative Sterlization Technologies LLC
Event
Event 72011
Status
Terminated
Classification
Class II
Quantity
M2104 - 25 units; M2408 - 84 units
Official record key
device-enforcement:Z-0153-2016

Official wording

Reason: 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.

Code information: M2104 Lot # 044305, 044379, 044380 & 044418. M2408 Lot # 044296, 022304, 044381, 044420, 044421 & 044422.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.