[pending] Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH ALLYN 2-Piece Reusable
Pending LLM rewrite. Source: FDA_DEVICE Z-1568-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
The recalled product
- 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.
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distribution scope not specified by the agency.
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