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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The 21GA Winged Infusion Set is used for subcutaneous procedures to facilitate percutaneous injections in tissue expansion contexts. It is typically used by healthcare providers in clinical settings.
A dull or blunt needle tip can impede safe needle advancement and may break, increasing the risk of tissue injury or improper delivery.
This recall is not described as part of a broader industry pattern in the notice.
The recall affects a sizable batch of devices used in medical settings. Consumers and healthcare providers should halt use immediately to avoid injury and follow the manufacturer’s recall instructions.
Refer to the FDA enforcement report at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1483-2026
The notice does not specify a refund or replacement timeline. Follow manufacturer instructions for remedy processing.
Keep the recall letter, note the device model and lot numbers, log dates of contact with manufacturer, preserve any unused devices and packaging for reference
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).
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