Surgical Procedure Kits Recalled for Potential Sterility Seal Defect
Stradis Medical is recalling Henry Schein breast procedure kits distributed nationwide in the US and Canada due to incomplete outer bag sealing that may compromise sterility. No illnesses 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: FDA Class II recall of medical procedure kits with potential sterility breach from manufacturing defect. No illnesses or injuries reported; hazard is theoretical, not confirmed, placing this at Score 3 per rubric criteria.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling Henry Schein Breast Pack surgical procedure trays and kits distributed nationwide in the US and Canada.
The kits may have incomplete sealing of the outer bag due to certain manufacturing conditions. This defect may result in a breach in the kit's sterility, which is essential for safe medical and surgical procedures.
No illnesses or injuries have been reported in connection with this recall. Affected consumers and healthcare facilities should contact the recalling firm for additional information about the recalled products.
The recalled product
- Product
- HENRY SCHEIN, BREAST PACK, Item No.570-2397
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 8
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) H65857023971
- UDI/DI (kit)M75257023970
- Serial/Lot Numbers: 22235489451
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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