Device product
Sterile Procedural Trays, labeled as the following: a. PELVISCOPY PACK b. D-PELVISCOPY
Z-1090-2023
Product summary
- Event
- Event 91386
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 109 cases (316 units)
- Official record key
device-enforcement:Z-1090-2023
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: a. PELVISCOPY PACK, Item Number: DYNJ82555, Case UDI/GTIN: 40195327198252, Unit UDI/GTIN: 10195327198251, Lot Number: 22HBQ035; b. D-PELVISCOPY, Item Number: DYNJ900628I, Case UDI/GTIN: 40195327224142, Unit UDI/GTIN: 10195327224141, Lot Number: 22JDB340;
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.