Mallinckrodt Manufacturing LLC is recalling 13,602 One-Way Valves (22F x 22M) used with ventilators because the valves may stick during operation. This mechanical failure can prevent or significantly reduce the flow of ventilated air or oxygen to a patient. These valves were sold individually (Part #91346) and in packs of five (Part #50412) and distributed worldwide.
If the one-way valve sticks, it can block the delivery of life-sustaining oxygen and air, potentially leading to respiratory distress, low blood oxygen levels, or other serious health complications for patients dependent on ventilator support.
Manufacturer notification and guidance
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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