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Recall Observatory FDA recall evidence

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

March 21, 2025

Class II

Product summary

Firm
Baxter Healthcare Corporation
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

    reason.no_named_rule · v1.0.0

    Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.