Device product
Sterile Procedural Tray, labeled as the following: a. PAIN SERVICE PACK-LF; b. LOCAL BASIC
Z-1063-2023
Product summary
- Event
- Event 91386
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 12 cases (60 units)
- Official record key
device-enforcement:Z-1063-2023
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. PAIN SERVICE PACK-LF, Item Number: DYNJ0101290D, Case UDI/GTIN: 40193489345552, Unit UDI/GTIN: 10193489345551, Lot Number: 22HDC372; b. LOCAL BASIC, Item Number: DYNJ34418L, Case UDI/GTIN: 40193489969277, Unit UDI/GTIN: 10193489969276, Lot Number: 22HBQ831, 22HBO949;
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.