Device product
Sterile Procedural Trays, labeled as the following: AMBULATORY MINI PACK
Z-1087-2023
Product summary
- Event
- Event 91386
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 36 cases (216 units)
- Official record key
device-enforcement:Z-1087-2023
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: DYNJ82579, Case UDI/GTIN: 40195327198153, Unit UDI/GTIN: 10195327198152, Lot Number: 22HBQ045
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.