Device product

STRADIS HEALTHCARE, pack Item No.40788SMS, oral surgery tray

Z-0491-2023

November 02, 2022

Class II

Product summary

Firm: Stradis Medical, LLC dba Stradis Healthcare
Event: Event 91124
Status: Ongoing
Classification: Class II
Quantity: 6 units
Official record key: device-enforcement:Z-0491-2023

Official wording

Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.

Code information: UDI/DI (case) M75240788SMS1, UDI/DI (kit)M75240788SMS0, Serial/Lot Numbers: 22234489435

Distribution pattern: US nationwide distribution, and Canada.

Derived failure modes

Labeling or packaging
reason.labeling_packaging · v1.0.0

bag being incompletely sealed, which may result in a breach
Sterility assurance
reason.sterility_assurance · v1.0.0

bag being incompletely sealed, which may result in a breach in the sterility