Surgical procedure trays recalled due to incomplete outer bag sealing
Stradis Healthcare is recalling surgical procedure trays that may have incompletely sealed outer bags, risking sterility breach. Sixteen units were distributed nationwide and in 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 FDA Class II medical device recall involves a manufacturing defect—incomplete outer bag sealing—that may result in sterility breach. Although no injuries or illnesses are reported in the recall notice, the potential for patient harm in surgical applications makes this a risk-of-harm product scenario.
Plain-English summary
Stradis Medical, LLC (doing business as Stradis Healthcare) is recalling medical and surgical procedure trays and kits, including the STRADIS HEALTHCARE Breast model (Item No. 693-276). The outer bags of the affected units may be incompletely sealed due to manufacturing conditions, which may result in a breach of the product's sterility.
Sixteen units with Serial/Lot Number 22242490001 were distributed nationwide in the United States and in Canada. A sterility breach could allow contamination of the surgical kits, compromising their safety and effectiveness.
If you have received an affected kit, contact your healthcare provider for guidance. The FDA has classified this as a Class II recall.
The recalled product
- Product
- STRADIS HEALTHCARE, Breast, Item No.693-276,
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Hazard
- sterility-breach
- incomplete-sealing
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) M7526932761
- UDI/DI (kit)M7526932760
- Serial/Lot Numbers: 22242490001
Distribution
Distributed nationwide across the United States.
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