FDAFDA · Food and drugs·Recall number Z-1567-2025
Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff labeled as: 1) WELCH ALLYN DURASHOCK Aneroid Gauge Sets with a Reusable Blood Pressure Cuff, Product Code Part Numbers: 5098-02, 5098-23, 5098-27, 5098-28, 5098-29, 5098-30, 5098-33, 5098-42, DS44-09, DS44-11, DS44-11C, DS44-MC, DS45-11, DS45-11C, DS45-12, DS45-MC, DS58-11, DS58-MC, DS58-PD, DS58-ST; 2) WELCH ALLYN Gauge Sets with a Reusable Blood Pressure Cuff, Product Code/Part Number 407637; 3) WELCH ALLYN 767 Gauge Sets with a Reusable Blood Pressure Cuff, Product Code/Part Number 7670-10.
Published April 23, 2025 · Recall initiated: March 21, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- Worldwide distribution.
- Lot
- 1) Product Code/Part # 5098-02, UDI/DI 00732094110128; Product Code/Part # 5098-23, UDI/DI 00732094109900; Product Code/Part # 5098-27, UDI/DI 00732094109856; Product Code/Part # 5098-28, UDI/DI 00732094109801; Product Code/Part # 5098-29, UDI/DI 00732094109764; Product Code/Part # 5098-30, UDI/DI 00732094109726; Product Code/Part # 5098-33, UDI/DI 00732094109658; Product Code/Part # 5098-42, UDI/DI 00732094109603; Product Code/Part # DS44-09, UDI/DI 00732094085884; Product Code/Part # DS44-11, UDI/DI 00732094085631; Product Code/Part # DS44-11C, UDI/DI 00732094085617; Product Code/Part # DS44-MC, UDI/DI 00732094084924; Product Code/Part # DS45-11, UDI/DI 00732094084610; Product Code/Part # DS45-11C, UDI/DI 00732094084498; Product Code/Part # DS45-12, UDI/DI 00732094084429; Product Code/Part # DS45-MC, UDI/DI 00732094083965; Product Code/Part # DS58-11, UDI/DI 00732094083385; Product Code/Part # DS58-MC, UDI/DI 00732094083347; Product Code/Part # DS58-PD, UDI/DI 00732094083309; Product Code/Part # DS58-ST, UDI/DI 00732094083170; 2) Product Code/Part Number 407637, UDI/DI 00732094046755; 3) Product Code/Part Number 7670-10,UDI/DI 00732094071511; Lot Number 24-314 & lower
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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