Sage Products Inc. is recalling 174,960 units of the stryker Sage PrimaFit External Urine Management System for the Female Anatomy due to a labeling error. A small percentage of devices in three specific lots contain a tape made with natural rubber latex adhesive that is not disclosed on the product packaging. Consumers who have an allergy or sensitivity to latex should not use the affected products, as exposure could cause serious allergic reactions.
The product contains natural rubber latex adhesive that is not declared on the label, which can trigger potentially life-threatening allergic reactions in individuals with latex sensitivities.
Consult healthcare provider or manufacturer
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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