B. Braun Medical Inc. is recalling approximately 177,850 Winged Infusion Sets because the needle tips may be dull, blunt, or difficult to advance, and in some cases, the needles may break during use. These devices are used temporarily to expand tissue expanders by injecting air or fluids under the skin. The recall includes various 21-gauge models distributed worldwide, including across the United States.
A dull or blunt needle can cause difficulty during insertion, leading to increased patient pain, tissue trauma, or failed procedures. If the needle breaks while inside the patient, it may require surgical intervention to retrieve the fragment and could cause internal injury or infection.
A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids.
A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids.
A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids.
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.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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