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Baxter Healthcare Corporation: Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn Two-Piece Blood Press

Medical DevicesSource: FDA (device) · Date: 2025-12-10

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Baxter Healthcare Corporation
Product
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.
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of California, Colorado, Ohio, and Utah.
Recall initiated
2025-10-28
Code info
UDI- DI 00732094110845, Lot Numbers: 23-296, 23-318, 23-325, 23-353, 24-008, 24-036, 24-037, 24-138, 24-183, 25-037, 25-112, 25-119, 25-180
Product quantity
118 units
Voluntary mandated
Voluntary: Firm initiated
City
Deerfield
State
IL
Country
United States
Event id
97926
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