B. Braun Medical recalls 51,300 units of its 21GA Winged Infusion Set, model 7M2802, distributed worldwide including Texas and Costa Rica. The device’s needle tip can be dull or break, making advancement difficult. Stop using the device immediately and contact the manufacturer or your healthcare provider for 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: 7M2802. Sold worldwide, with US distribution in Texas and in Costa Rica. Price not disclosed. Quantity: 51,300 units. Lot numbers and expirations include: 0062003864 (EXP 30APR2032), 0062004133 (EXP 30JUN2032), 0062006454 (EXP 31JUL2032), 0062028929 (EXP 31AUG2032), 0062037141 (EXP 30SEP2032), 0062037691 (EXP 30SEP2032).
The needle tip may be dull or blunt, may be difficult to advance, and could break. This can complicate percutaneous use and pose a risk of tissue injury or misdelivery during subcutaneous procedures.
1. Stop using the product. 2. Follow the manufacturer’s recall instructions. 3. Contact B. Braun Medical Inc or your healthcare provider for guidance. 4. Check your device lot numbers against the listed lots. 5. If instructed, participate in the recall remedy or replacement program.
Manufacturer guidance and recall notices are available at the FDA enforcement page cited in the notice. Direct manufacturer contact details are not provided in the summary here; refer to the recall letter and FDA page for instructions.
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