Reported Oct 28, 2015 · Terminated
OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical…
Innovative Sterlization Technologies LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Innovative Sterlization Technologies LLC · 7625 Paragon Rd Ste A · Dayton, OH · 45459-4063
Is this the product you have?
- OneTray Sealed
- Sterilization Containers Product UsageA rigid sterilization container used to steam sterilize medical devices
- Lot codes and dates
M2104 Lot # 044305044379044380 & 044418. M2408 Lot # 044296022304044381044420044421 & 044422
- Amount recalled
- M2104 - 25 units; M2408 - 84 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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