Z-1566-2025 Class II Ongoing
FDA device recall Z-1566-2025 was initiated by Baxter Healthcare Corporation on Mar 21, 2025 and is designated Class II. Reason for recall: Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. The recall status is ongoing. Affected quantity: 135 units.
Recall details
- Product Type
- Devices
- Report Date
- Apr 23, 2025
- Initiation Date
- Mar 21, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 135 units
Product description
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.
Reason for recall
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Distribution pattern
Worldwide distribution.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1566-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026