Device product
Sterile Procedural Trays, labeled as the following: GENERAL ENDOSCOPY
Z-1075-2023
Product summary
- Event
- Event 91386
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 48 cases (96 units)
- Official record key
device-enforcement:Z-1075-2023
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: DYNJ903826D, Case UDI/GTIN: 40195327177790, Unit UDI/GTIN: 10195327177799, Lot Number: 22IBR004;
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.