Device product
Welch Allyn Green Series 777 Wall System, Product Code/Part Numbers: 1) 77791-2MP2X; 2) 77791-2MP2XL; 3) 77791-2MPX; 4) 77791-2MPX-HS; 5) 77791-2MPXL; 6) 77796-2MPX; 7) 77796-2MPXL.
Z-1566-2025
Product summary
- Event
- Event 96364
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 135 units
- Official record key
device-enforcement:Z-1566-2025
Official wording
Reason: Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Code information: 1) Product Code/Part # 77791-2MP2X, UDI/DI 00732094066890; 2) Product Code/Part # 77791-2MP2XL, UDI/DI 00732094201833; 3) Product Code/Part # 77791-2MPX, UDI/DI 00732094066876; 4) Product Code/Part # 77791-2MPX-HS, UDI/DI 00732094231045; 5) Product Code/Part # 77791-2MPXL, UDI/DI 00732094201826; 6) Product Code/Part # 77796-2MPX, UDI/DI 00732094066289; 7) Product Code/Part # 77796-2MPXL, UDI/DI 00732094184013; Lot Number 24-314 & lower
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Unknown
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.