B. Braun Medical is recalling 21,000 21GA Winged Infusion Sets (Single Pack) distributed worldwide, including Texas and Costa Rica, catalog 7A3842. The needle tip can be dull or blunt, may be difficult to advance, or break. Clinicians and patients should stop using the device and await manufacturer 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 sets are used to access veins and deliver injections or draw blood. In this recall, the devices are used to subcutaneously expand an implanted tissue expander via percutaneous injection of air or fluids in medical procedures.
A dull or blunt needle tip can hinder insertion, require extra force, and may break. Breakage can cause tissue injury or incomplete delivery of intended fluid.
This recall is not described as part of a broader industry pattern in the provided information.
Hospitals and clinics may need to halt use of affected lots, source replacements, and manage inventory disruption. There may be delays in procedures that rely on these sets.
Recall notices and manufacturer instructions are available via the FDA enforcement page for Z-1482-2026 and B. Braun Medical’s recall communications.
Typically 4-8 weeks for replacement or remediation communications after a recall notice is issued.
Keep the recall notice, packaging labels, lot numbers, and all correspondence with the manufacturer. Photograph affected lots and maintain a log of actions taken.
Model/Catalog Number: 7A3842; Primary-DI: 4046964338434; Unit of Use-DI: 4046964338410; Lot numbers: 0062004706, 0062005799, 0062006415, 0062006416, 0062023397, 0062024887; Exp dates: 31MAR2032, 30JUN2032, 31JUL2032; Quantity: 21000 units; Distribution: Worldwide, including US (TX) and Costa Rica; Sold at: Unknown; Price: Unknown.
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