Class II
Medical Device Recall: Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-2; 2) 44WT-3; 3) 44WT-4; 4) 44WT-6; 5) 44WT-B; 6) 44XT-2; 7) 44XT-4; 8) 44XT-6; 9) 44XT-B.
Baxter Healthcare Corporation · March 21, 2025
Reason for Recall
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Distribution
Worldwide distribution.
Quantity Affected
34187 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1565-2025
Status: ongoing
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