Welch Allyn Connex Spot Monitor Recalled for Undeclared Latex in Packaging
Baxter Healthcare is recalling certain Welch Allyn Connex Spot Monitor configurations due to undeclared natural rubber in packaging. Approximately 70,627 units distributed worldwide are affected. Natural rubber presents a latex allergen hazard.
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: This recall meets the High (3) severity criterion for allergen mislabeling on a common allergen (latex from natural rubber) without reported illnesses or injuries. An undeclared allergen in product packaging poses a direct risk to consumers with latex sensitivities.
Plain-English summary
Baxter Healthcare Corporation is recalling certain configurations of the Welch Allyn Connex Spot Monitor blood pressure cuff system. The recall affects 23 product configurations with lot number 24-314 and lower, totaling approximately 70,627 units distributed worldwide.
The reason for the recall is the presence of an undeclared natural rubber band within the packaging of certain configurations. Natural rubber contains latex, a common allergen. The undeclared presence in packaging creates a hazard for consumers with latex sensitivities.
The recalled product
- Product
- Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1) 73WT-B; 2) 74CE-B; 3) 74CT-B; 4) 74CX-B; 5) 74ME-B; 6) 74MT-B; 7) 74MX-B; 8) 74RE-B; 9) 74RT-B; 10) 75CE-B; 11) 75CT-B; 12) 75CT-BR; 13) 75CX-B; 14) 75-HCA-CTB; 15) 75-HCA-M
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- allergen-latex
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 # 73WT-B
- UDI/DI 00732094210033
- 2) Product Code/Part # 74CE-B
- UDI/DI 00732094209921
- 3) Product Code/Part # 74CT-B
- UDI/DI 00732094209860
- 4) Product Code/Part # 74CX-B
- UDI/DI 00732094209792
- 5) Product Code/Part # 74ME-B
- UDI/DI 00732094209716
- 6) Product Code/Part # 74MT-B
- UDI/DI 00732094209679
- 7) Product Code/Part # 74MX-B
- UDI/DI 00732094209624
- 8) Product Code/Part # 74RE-B
- UDI/DI 00732094335781
- 9) Product Code/Part # 74RT-B
- UDI/DI 00732094335712
- 10) Product Code/Part # 75CE-B
- UDI/DI 00732094209570
Distribution
Distribution scope not specified by the agency.
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