FDA recall Z-1568-2025

Baxter Healthcare Corporation · Class II · device

Product

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.

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-1568-2025