FDA recall Z-1566-2025

Baxter Healthcare Corporation · Class II · 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.

Reason for recall

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

Distribution

Worldwide distribution.

Key facts

Status: Ongoing
Initiation date: 2025-03-21
Report date: 2025-04-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1566-2025