Surgical Procedure Trays Recalled for Potential Sterility Breach
Stradis Medical recalls surgical procedure trays due to incomplete outer bag sealing that may compromise sterility. The affected products were distributed nationwide in the US and Canada.
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 an FDA Class II recall of surgical medical devices with potential sterility compromise due to manufacturing defect. As a risk-of-harm product with no reported injuries, it meets the High severity threshold per the rubric.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling the HENRY SCHEIN Basin Set, Item No. 570-1803, medical and surgical procedure trays and kits.
The recall was initiated because these products underwent manufacturing conditions that may result in the outer bag being incompletely sealed. An incomplete seal may result in a breach of the sterility of the kit, which could compromise the safety and effectiveness of the product for medical and surgical use.
The recalled product was distributed nationwide in the United States and Canada. The affected lot number is 22258490734, with 96 units identified in this recall.
Healthcare facilities and users who have received these trays should immediately stop using them and contact Stradis Medical for instructions regarding return or replacement.
The recalled product
- Product
- HENRY SCHEIN, Basin Set, Item No.570-1803
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Hazard
- incomplete-sealing
- sterility-breach
- contamination-risk
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) H65857018031
- UDI/DI (kit)M75257018030
- Serial/Lot Numbers: 22258490734
Distribution
Distributed nationwide across the United States.
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