B Braun Medical Inc device recall (Cls II)

Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version: N/A Product Description: 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. Component: N/A — Reason: The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. — Status: Ongoing