Recall Z-1568-2025
Baxter Healthcare Corporation · initiated March 21, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 1) Product Code/Part # 47-15-389, UDI/DI 00732094002423; Product Code/Part # 47-22-189, UDI/DI 00732094002379; Product Code/Part # 47-23-189, UDI/DI 00732094002362; Product Code/Part # 5082-01, UDI/DI 00732094113723; Product Code/Part # 5082-01H, UDI/DI 00732094113693; Product Code/Part # 5082-02, UDI/DI 00732094113679; Product Code/Part # 5082-03, UDI/DI 00732094113648; Product Code/Part # 5082-07, UDI/DI 00732094113631; Product Code/Part # 5082-08, UDI/DI 00732094113600; Product Code/Part # 5082-11, UDI/DI 00732094113327; Product Code/Part # 5082-16, UDI/DI 00732094113105; Product Code/Part # 5082-21, UDI/DI 00732094112344; Product Code/Part # 5082-22, UDI/DI 00732094112290; Product Code/Part # 5082-22H, UDI/DI 00732094112276; Product Code/Part # 5082-23, UDI/DI 00732094112245; Product Code/Part # 5082-23H, UDI/DI 00732094112221; Product Code/Part # 5082-24, UDI/DI 00732094112207; Product Code/Part # 5082-25, UDI/DI 00732094111996; Product Code/Part # 5082-26, UDI/DI 00732094111897; Product Code/Part # 5082-42, UDI/DI 00732094111873; Product Code/Part # 5082-43, UDI/DI 00732094111842; Product Code/Part # 5082-44, UDI/DI 00732094111811; Product Code/Part # 5082-45, UDI/DI…
Reason for recall
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
FDA-determined cause: Device Design
Action taken
Baxter issued an Urgent Medical Device Recall notice to its consignees on 03/21/2025 via USPS First Class Mail. The notice explained the issue, hazard involved, and requested the following: Actions to be Taken by Customers 1. Immediately locate the impacted products (see Attachment A for details) at your facility that are unopened. 2. If you received this communication directly from Baxter, acknowledge receipt by following the instructions on the enclosed Reply Form Instruction Sheet, even if you have no remaining inventory. 3. If you purchased this product from a distributor or wholesaler, please contact your supplier to arrange for the return and exchange of the affected product. Please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to them according to their instructions. 4. Please forward a copy of this communication to the Director of Nursing, and any other departments within your institution who unpack the affected product. 5. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) and you have an affected product please do not distribute. Contact Baxter Technical Support for additional instructions. 6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please conduct a consumer-level recall of the affected product that you distributed to customers and check the associated box on the customer portal. For general questions regarding this communication, please contact Baxter Technical Support between the hours of 8:00 am and 8:00 pm Eastern Time, Monday through Friday at 800-535-6663. Press option 2, then select option 1 or 2 for language preference, then press option 2.
Details
- Recall number
- Z-1568-2025
- Initiated
- March 21, 2025
- Posted by FDA
- April 15, 2025
- Product code
- DXQ – Blood Pressure Cuff
- Quantity
- 76407 units
- Distribution
- Worldwide distribution.
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1562-2025 Class II | Welch Allyn Connex Integrated Wall System, Product Code/Part Numbers: 1) 84MTVE2-4; 2)…Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure… | 03/21/2025Open, Classified |
| Z-1563-2025 Class II | Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1) 73WT-B; 2)…Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure… | 03/21/2025Open, Classified |
| Z-1564-2025 Class II | Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Product…Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure… | 03/21/2025Open, Classified |
| Z-1565-2025 Class II | Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-2; 2)…Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure… | 03/21/2025Open, Classified |
| Z-1566-2025 Class II | Welch Allyn Green Series 777 Wall System, Product Code/Part Numbers: 1) 77791-2MP2X; 2)…Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure… | 03/21/2025Open, Classified |
| Z-1567-2025 Class II | Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff labeled as:…Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure… | 03/21/2025Open, Classified |