FDA-Device2025-12-10Class II

Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn Two-Piece Blood Pressure Cuff.

Baxter Healthcare Corporation
Hazard

Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits.

Sold states
US Nationwide distribution in the states of California, Colorado, Ohio, and Utah.
Affected count
118 units
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn Two-Piece Blood Pressure Cuff.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0847-2026

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