Welch Allyn Green Series 777 Wall System Cuff Recall: Undeclared Natural Rubber
Baxter Healthcare is recalling certain Welch Allyn Green Series 777 reusable blood pressure cuffs due to undeclared natural rubber in the packaging. People with latex or rubber allergies may experience allergic reactions.
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: The recall involves undeclared allergen mislabeling on a common allergen (natural rubber/latex) on a medical device. Per the severity rubric, allergen mislabeling on common allergens justifies a High score. No hospitalizations or illnesses have been reported.
Plain-English summary
Baxter Healthcare Corporation is recalling 135 units of certain configurations of the Welch Allyn Green Series 777 Wall System, reusable blood pressure cuffs, distributed worldwide. The cuffs contain an undeclared natural rubber band within the packaging.
This recall affects product code/part numbers 77791-2MP2X, 77791-2MP2XL, 77791-2MPX, 77791-2MPX-HS, 77791-2MPXL, 77796-2MPX, and 77796-2MPXL (Lot 24-314 and lower). Individuals with allergies or sensitivities to natural rubber or latex may experience allergic reactions if exposed to the undeclared material.
Consumers with affected units should stop using the product and contact Baxter Healthcare Corporation or the FDA. Do not dispose of the product; return it for inspection or replacement.
The recalled product
- Product
- Welch Allyn Green Series 777 Wall System, Product Code/Part Numbers: 1) 77791-2MP2X; 2) 77791-2MP2XL; 3) 77791-2MPX; 4) 77791-2MPX-HS; 5) 77791-2MPXL; 6) 77796-2MPX; 7) 77796-2MPXL.
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- allergen-natural-rubber
- undeclared-allergen
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 (15)
- 1) Product Code/Part # 77791-2MP2X
- UDI/DI 00732094066890
- 2) Product Code/Part # 77791-2MP2XL
- UDI/DI 00732094201833
- 3) Product Code/Part # 77791-2MPX
- UDI/DI 00732094066876
- 4) Product Code/Part # 77791-2MPX-HS
- UDI/DI 00732094231045
- 5) Product Code/Part # 77791-2MPXL
- UDI/DI 00732094201826
- 6) Product Code/Part # 77796-2MPX
- UDI/DI 00732094066289
- 7) Product Code/Part # 77796-2MPXL
- UDI/DI 00732094184013
- Lot Number 24-314 & lower
Distribution
Distribution scope not specified by the agency.
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