Medical procedure trays recalled for incomplete outer bag sealing
Stradis Medical recalls Henry Schein temp stimulator supplies due to incomplete outer bag sealing that may compromise kit sterility. Affected units should not be used until reviewed.
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 FDA recall of medical devices with potential sterility compromise due to incomplete sealing. No illnesses or injuries have been reported, and the hazard is theoretical risk of sterility breach rather than confirmed harm. The score reflects the risk-of-harm nature of surgical procedure trays combined with the absence of reported adverse events.
Plain-English summary
Henry Schein Temp Stimulator Supplies (Item No. 570-2883) manufactured by Stradis Medical, LLC dba Stradis Healthcare are being recalled due to manufacturing defects that may result in incompletely sealed outer bags on medical and surgical procedure trays and kits.
An incomplete seal on the outer bag may compromise the sterility of the kit, creating a potential risk if the products are used without verification of seal integrity.
This recall affects units distributed nationwide in the United States and Canada, with lot/serial number 22229489323 identified in the recall notice.
Healthcare facilities and users in possession of affected units should stop use and contact Stradis Medical, LLC or Henry Schein directly for guidance on the recall and replacement procedures.
The recalled product
- Product
- HENRY SCHEIN, TEMP STIMULATOR SUPPLIES, Item No.570-2883
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Hazard
- sterility-breach
- incomplete-seal
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) H65857028831
- UDI/DI (kit)M75257028831
- Serial/Lot Numbers: 22229489323
Distribution
Distributed nationwide across the United States.
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