Device product
Sterile Procedural Trays, labeled as the following: LS MS PACK
Z-1085-2023
Product summary
- Event
- Event 91386
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 159 cases (159 units)
- Official record key
device-enforcement:Z-1085-2023
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: DYNJ81738, Case UDI/GTIN: 40195327138258, Unit UDI/GTIN: 10195327138257, Lot Number: 22IBO057
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.