Welch Allyn DuraShock Aneroid Gauge Sets Reusable Blood Pressure Cuff Recall
Baxter Healthcare Corporation is recalling certain Welch Allyn DuraShock Aneroid Gauge Sets with reusable blood pressure cuffs due to undeclared natural rubber band in the packaging. This poses a risk to individuals with rubber allergies.
What this means for you
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 an allergen labeling/disclosure issue. The hazard is allergen-related (natural rubber latex) but the source text explicitly addresses an undeclared item in packaging rather than direct contamination of the device itself, which is a labeling/packaging concern. No illnesses or injuries are reported in the source text.
Plain-English summary
Baxter Healthcare Corporation is recalling certain Welch Allyn DuraShock Aneroid Gauge Sets with reusable blood pressure cuffs. The recalled products contain an undeclared natural rubber band within the packaging of certain configurations of the reusable blood pressure cuff.
The undeclared natural rubber band poses a hazard to individuals with natural rubber latex allergies. The recalled product includes multiple part numbers and configurations distributed worldwide, including Product Code Part Numbers 5098-02, 5098-23, 5098-27, 5098-28, 5098-29, 5098-30, 5098-33, 5098-42, DS44-09, DS44-11, DS44-11C, DS44-MC, DS45-11, DS45-11C, DS45-12, DS45-MC, DS58-11, DS58-MC, DS58-PD, DS58-ST, as well as Product Code/Part Number 407637 and 7670-10 (Lot Number 24-314 & lower).
Consumers should stop using the affected blood pressure cuff sets and contact Baxter Healthcare Corporation for further instructions or return information. Healthcare providers and patients with natural rubber latex allergies should be particularly cautious with these recalled products.
The recalled product
- Product
- Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff labeled as: 1) WELCH ALLYN DURASHOCK Aneroid Gauge Sets with a Reusable Blood Pressure Cuff, Product Code Part Numbers: 5098-02, 5098-23, 5098-27, 5098-28, 5098-29, 5098-30, 5098-33, 5098-42, DS44-
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- allergen-latex
- 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 (20)
- 1) Product Code/Part # 5098-02
- UDI/DI 00732094110128
- Product Code/Part # 5098-23
- UDI/DI 00732094109900
- Product Code/Part # 5098-27
- UDI/DI 00732094109856
- Product Code/Part # 5098-28
- UDI/DI 00732094109801
- Product Code/Part # 5098-29
- UDI/DI 00732094109764
- Product Code/Part # 5098-30
- UDI/DI 00732094109726
- Product Code/Part # 5098-33
- UDI/DI 00732094109658
- Product Code/Part # 5098-42
- UDI/DI 00732094109603
- Product Code/Part # DS44-09
- UDI/DI 00732094085884
- Product Code/Part # DS44-11
- UDI/DI 00732094085631
Distribution
Distribution scope not specified by the agency.
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