Medical Insertion Tray Recalled for Incomplete Sterile Bag Sealing
Stradis Medical is recalling Henry Schein ILR Insertion Trays due to incomplete outer bag sealing that may compromise sterility. No illnesses have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall for a risk-of-harm product (surgical procedure tray) where a manufacturing defect may compromise sterility. No illnesses or injuries have been reported, making this a theoretical hazard. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Stradis Medical, LLC is recalling the Henry Schein ILR Insertion Tray (Item No. 570-3131) due to a manufacturing defect. During production, the outer bag of these medical procedure trays may be incompletely sealed, which could compromise the sterility of the kit.
The recall involves 140 units distributed nationwide in the United States and Canada. The affected lot number is 22257490596. Hospitals and healthcare facilities should identify any of these trays in inventory and segregate them from use.
Healthcare providers with affected inventory should contact Stradis Medical for return or replacement instructions. No illnesses or injuries have been reported to date.
The recalled product
- Product
- HENRY SCHEIN, ILR Insertion Tray, Item No.570-3131
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 140
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI/DI (case) H65857031311
- UDI/DI (kit)M75257031310
- Serial/Lot Numbers: 22257490596
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 78 recalled by Stradis Medical, LLC dba Stradis Healthcare under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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