B. Braun Medical recalls 7,008 IV administration sets sold worldwide, including the United States, Canada, Germany, Guatemala and Singapore. The devices may backflow from secondary to primary IV containers and may fail to prime. Hospitals and patients should stop using the sets and follow the manufacturer’s recall instructions.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
IV administration sets are used to deliver medications and fluids through intravenous therapy. They connect to bags or containers and interfaces with pumps in clinical settings.
Backflow from secondary IV containers into primary lines can alter dosing. An occlusion can prevent priming and delivery of medications, risking under- or overdosing.
This recall is not identified as part of a broader industry pattern.
The recall affects hospital and patient safety for a critical treatment pathway. No reported injuries yet, but the risk could affect patient care and require replacement stock at facilities.
Recall notice and FDA enforcement page linked in the recall press release
Refunds or replacements typically processed within 4-8 weeks after verification
Keep the recall notice, product packaging, photos of labels, and all communications with the manufacturer for records
Catalog Number: 490542. Primary UDI-DI: 04046955270187. Unit of Dose UDI-DI: 04046955270170. Expiration: Earliest Exp of Component or 36 months. Distribution: Worldwide, including US, Canada, Germany, Guatemala, Singapore. Quantity: 7,008 units.
No injuries or incidents have been reported.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
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.
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.
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.
B. Braun Medical recalled 32,500 Caresite Extension Sets used with Infusomat Space, Outlook, and Vista Basic IV pumps worldwide. The devices pose a backflow and occlusion risk in the primary IV line. Hospitals and healthcare providers should stop using the device immediately and follow the recall instructions.
B. Braun Medical Inc. recalled 19,320 Anesthesia IV Sets used with Infusomat Space Large Volume Pumps and related BBMI devices sold worldwide through healthcare facilities. The devices pose a backflow risk from secondary piggyback IV containers into the primary IV container and cannot be primed. Healthcare facilities and patients should stop using the device immediately and follow the manufacturer
B. Braun Medical recalled 129,480 IV Administration Sets sold worldwide to hospitals and clinics. The devices can backflow from secondary piggyback IV containers into primary containers and cannot be primed, risking incorrect dosing. Hospitals and healthcare providers should stop using the devices immediately and follow the recall instructions from B. Braun Medical.
B. Braun Medical recalled 10,536 Anesthesia IV Sets sold through multiple retailers worldwide after a potential backflow from piggyback to primary IV lines and occlusion. The devices are used with Infusomat Space Large Volume Pumps, Outlook Pumps, and Vista Basic Pumps. Hospitals and healthcare providers should stop using the device immediately and follow the manufacturer’s recall instructions.
B. Braun Medical recalled 48 IV Administration Sets used with Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. The devices carry a backflow and occlusion risk between secondary and primary IV containers. Healthcare providers and patients should stop using immediately and follow recall instructions. A recall letter will provide further guidance on returning or replacing the 제품