[Recalled] OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices — The wrong sterilization time was on the label | FDA 2014-02-03
A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.
Recall details
| Product | OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices |
|---|---|
| Brand / manufacturer | Innovative Sterlization Technologies LLC |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0153-2016 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 03 February 2014 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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 Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.