Welch Allyn Spot Vital Signs 4400 Device Blood Pressure Cuff Recall
Baxter Healthcare Corporation is recalling certain Welch Allyn Spot Vital Signs 4400 blood pressure cuff devices due to undeclared natural rubber bands in the packaging, which poses an allergy risk.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving allergen mislabeling (undeclared natural rubber). No illnesses or injuries have been reported. The hazard is allergen exposure for susceptible individuals, which is a known risk but has not resulted in reported harm, placing it in the Moderate category per the rubric.
Plain-English summary
Baxter Healthcare Corporation is recalling certain configurations of reusable blood pressure cuffs that are part of the Welch Allyn Spot Vital Signs 4400 Device system. The recall affects 34,187 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 is a known allergen, and the lack of declaration on the product labeling creates a risk for individuals with latex or natural rubber allergies.
Affected product code/part numbers are: 44WT-2, 44WT-3, 44WT-4, 44WT-6, 44WT-B, 44XT-2, 44XT-4, 44XT-6, and 44XT-B, with lot number 24-314 and lower. Consumers who have this device should contact Baxter Healthcare Corporation or their healthcare facility for instructions on how to proceed. If you have a known natural rubber or latex allergy, inform your healthcare provider immediately.
The recalled product
- Product
- Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-2; 2) 44WT-3; 3) 44WT-4; 4) 44WT-6; 5) 44WT-B; 6) 44XT-2; 7) 44XT-4; 8) 44XT-6; 9) 44XT-B.
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 34,187
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 (19)
- 1) Product Code/Part # 44WT-2
- UDI/DI 00732094309461
- 2) Product Code/Part # 44WT-3
- UDI/DI 00732094309454
- 3) Product Code/Part # 44WT-4
- UDI/DI 00732094309447
- 4) Product Code/Part # 44WT-6
- UDI/DI 00732094309423
- 5) Product Code/Part # 44WT-B
- UDI/DI 00732094309409
- 6) Product Code/Part # 44XT-2
- UDI/DI 00732094309386
- 7) Product Code/Part # 44XT-4
- UDI/DI 00732094309362
- 8) Product Code/Part # 44XT-6
- UDI/DI 00732094309348
- 9) Product Code/Part # 44XT-B
- UDI/DI 00732094309324
- Lot Number 24-314 & lower
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 7 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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