FDA-Device2025-04-23Class II

Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH ALLYN 2-Piece Reusable Blood Pressure Cuff Kits, Product Code/Part Numbers: 2. WELCH ALLYN Reusable Blood Pressure Cuff Kit, Product Code/Part Numbers: 410519, 5090-41, 5098-20.

Baxter Healthcare Corporation
Hazard

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

Sold states
Worldwide distribution.
Affected count
76407 units
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH ALLYN 2-Piece Reusable Blood Pressure Cuff Kits, Product Code/Part Numbers: 2. WELCH ALLYN Reusable Blood Pressure Cuff Kit, Product Code/Part Numbers: 410519, 5090-41, 5098-20.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1568-2025

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