Blood Pressure Cuff Kits Recalled for Undeclared Natural Rubber
Baxter Healthcare is recalling Welch Allyn reusable blood pressure cuff kits worldwide. Certain configurations contain an undeclared natural rubber band in the packaging.
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: FDA Class II recall for undeclared natural rubber (a common allergen) in blood pressure cuff kit packaging; no reported illnesses or injuries.
Plain-English summary
Baxter Healthcare Corporation is recalling Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits worldwide due to an undeclared natural rubber band in the packaging of certain configurations. Approximately 76,407 units have been distributed.
The affected products include multiple part numbers spanning several product lines, including 410519, 5090-41, and 5098-20 (Lot 24-314 and lower). The complete list of affected product codes and UDI/DI identifiers is available on the FDA website and from Baxter Healthcare Corporation.
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
- Hazard
- allergen-rubber
- labeling
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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