Recall Z-1568-2025— Baxter Healthcare Corporation

Name: FDA recall Z-1568-2025
Creator: U.S. Food and Drug Administration
Published: 2025-03-21

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2025-03-21. It names one FDA 510(k) clearance: K070060. 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: Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2025-03-21
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K070060 — WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE)Welch Allyn, Inc.·cleared 2007-12-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.