Avanos Medical, Inc. is recalling 4,730 cases (totaling 94,600 units) of its BALLARD Closed Suction System for Adults (14 Fr, DSE, MDI) because the products were incorrectly labeled as not being made with the phthalate Di(2-ethylhexyl) phthalate (DEHP). Although the labels claimed the device was DEHP-free, the manufacturer determined that the internal tubing components do contain this chemical. This suction system is used to clear secretions from the airways of adult patients who are on mechanical ventilation.
Patients using these devices may be unintentionally exposed to DEHP, a chemical plasticizer that can leach from the tubing during use. This poses a particular risk to sensitive populations where long-term phthalate exposure may lead to adverse health effects.
Contact manufacturer for instructions regarding labeling error.
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.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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