B. Braun Medical recalled 105,550 BBraun Medical 21G X4.4CM Winged INF devices worldwide, including Texas and Costa Rica. A dull or blunt needle tip may be difficult to advance or break. Healthcare providers and patients should stop using the device and follow the manufacturer's recall instructions.
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact B Braun Medical Inc or your healthcare provider for instructions. Notification method: Letter
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Winged infusion needles are used to access a vein or subcutaneous space for injections. In this recall they are used to temporarily expand a tissue expander by percutaneous injection of air or fluids.
A dull or blunt needle tip may require more force to insert or advance, increasing tissue trauma. The needle can also break during use, posing injury risk to patients and clinicians.
This recall is not part of a broader industry pattern.
The recall covers 105,550 units distributed worldwide, including TX and Costa Rica. Immediate cessation of use is required. No injuries are reported in the data provided, but the hazard is serious for medical procedures.
FDA enforcement report Z-1481-2026 and the manufacturer’s recall notice
Refunds or replacements timelines are not specified in the provided data; typical processing may take several weeks.
Keep the recall notice, packaging, serial and lot codes, photos, and all correspondence with the manufacturer for records.
Model/Catalog Number: 7B3050 Distribution: Worldwide; US TX and Costa Rica Quantity: 105,550 units Lot numbers/Exp: 0062006430 (30APR2032); 0062006470 (30JUN2032); 0062006471 (31MAY2032); 0062014964 (31JUL2032); 0062014965 (31JUL2032); 0062014966 (30SEP2032); 0062027579 (31AUG2032) Primary-DI: 4046964341298 Unit of Use-DI: 4046964341274
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