Surgical Procedure Trays Recalled Over Incomplete Outer Bag Seals
Stradis Medical is recalling surgical procedure trays due to manufacturing defects that may leave outer bags incompletely sealed, potentially breaching kit sterility. No illnesses have been 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: This is an FDA Class II recall involving surgical procedure kits with a potential sterility breach hazard. The rubric classification of 'risk-of-harm products where injury has not yet been reported' applies: sterile surgical instruments are critical to prevent infection, but no illnesses or injuries have been reported and the hazard is theoretical rather than confirmed.
Plain-English summary
Stradis Medical, LLC (dba Stradis Healthcare) is recalling medical and surgical procedure trays and kits marketed as HENRY SCHEIN Vas Pack, Item No. 888-2520. The recall affects 304 units distributed nationwide in the United States and Canada (lot number 22256490684).
Certain manufacturing conditions resulted in incomplete sealing of the outer bag on these kits. An incomplete seal may allow the sterile contents to be compromised before the kit is opened for use.
Healthcare facilities and professionals who have these kits should stop using them and contact Stradis Healthcare for return or replacement instructions. No illnesses or injuries related to this recall have been reported.
The recalled product
- Product
- HENRY SCHEIN, Vas Pack, Item No.888-2520,
- 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) H65888825201
- UDI/DI (kit)M75288825200
- Serial/Lot Numbers: 22256490684
Distribution
Distributed nationwide across the United States.
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