Device product
Sterile Procedural Trays, labeled as the following: a. ENDOSCOPY-LF b. SEPTO/ENDO
Z-1076-2023
Product summary
- Event
- Event 91386
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 20 cases (72 units)
- Official record key
device-enforcement:Z-1076-2023
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. ENDOSCOPY-LF, Item Number: DYNJ22890M, Case UDI/GTIN: 40193489766487, Unit UDI/GTIN: 10193489766486, Lot Number: 22JBM081; b. SEPTO/ENDO, Item Number: DYNJ902831D, Case UDI/GTIN: 40193489231671, Unit UDI/GTIN: 10193489231670, Lot Number: 22JBP701;
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.