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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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
The device has a needle tip that can be dull or blunt. It may be difficult to advance. It can also break during use.
1. Stop using the product immediately. 2. Follow the recall instructions provided by the manufacturer. 3. Contact B. Braun Medical Inc or your healthcare provider for instructions. 4. Retain packaging and labeling for reference until told to discard. 5. For refunds or replacements, follow the manufacturer’s guidance in the recall notice.
Manufacturer contact information is not provided in the recall notice. See the FDA enforcement page Z-1481-2026 for official guidance.
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