Device product
TRACH PACK. Sterile Procedural Tray.
Z-1061-2023
Product summary
- Event
- Event 91386
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 28 cases (112 units)
- Official record key
device-enforcement:Z-1061-2023
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: DYNJ46518G, Case UDI/GTIN: 40195327009169, Unit UDI/GTIN: 10195327009168, Lot Number: 22JMB321, 22JMA904, 22HMD287
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.