Surgical Procedure Kits Recalled by Stradis Healthcare for Sealing Defect
Stradis Healthcare is recalling surgical procedure kits for perioral surgery due to a manufacturing defect that may result in incomplete outer bag sealing. This could compromise the sterility of the kits.
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 surgical device recall with potential sterility breach from incomplete outer bag sealing. No illnesses or injuries have been reported; the hazard is theoretical.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling its Perio Surgery surgical procedure kits and trays (Item No. 20177RPSS). The recall was initiated due to manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
The recall affects 25 units distributed throughout the United States and Canada. The affected lot is identified by Serial/Lot Number 22263491083. The affected kits have UDI/DI codes M75220177RPSS1 (case) and M75220177RPSS0 (kit).
An incomplete seal on the outer packaging could result in a breach in the sterility of the surgical procedure kit. If you have received or currently possess kits from this lot, contact Stradis Healthcare for replacement or further guidance.
The recalled product
- Product
- STRADIS HEALTHCARE, Perio Surgery, Item No. 20177RPSS
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Hazard
- 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) M75220177RPSS1
- UDI/DI (kit)M75220177RPSS0
- Serial/Lot Numbers: 22263491083
Distribution
Distributed nationwide across the United States.
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