Device product
LOCAL PACK. Sterile Procedural Tray.
Z-1062-2023
Product summary
- Event
- Event 91386
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8 cases (200 units)
- Official record key
device-enforcement:Z-1062-2023
Official wording
Reason: Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Code information: Item Number: DYNJ34129C, Case UDI/GTIN: 40889942382300, Unit UDI/GTIN: 10889942382309, Lot Number: 22IBG550
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Derived failure modes
-
Unknown
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.