B. Braun Medical recalled 15,250 PB1500 15-DROP IV SETS distributed worldwide, including the US, Canada, Germany, Guatemala and Singapore. The devices pose a backflow risk from secondary IV containers into primary containers and may fail to prime. Healthcare facilities should stop using the product and follow 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 via gravity or pump systems. This recall covers PB1500 15-DROP SETS used with Infusomat Space large-volume pumps, Outlook pumps, and Vista Basic pumps.
Backflow from secondary to primary IV containers and failure to prime could disrupt medication delivery and patient safety.
This recall is not described as part of a broader industry safety pattern in the provided data.
Hospitals and clinics may need to identify affected lots quickly, halt use, and coordinate with providers to source replacements, potentially affecting patient treatment workflows.
Recall notices are accessible via the FDA enforcement page linked in this article and through the manufacturer’s recall communications
Replacement or remediation may take 4-6 weeks in hospital settings
Keep the recall letter, serials/UDI data, purchase records, and all correspondence with the manufacturer and regulators.
Catalog Number: 490025 Primary UDI-DI: 04046964301056 Unit of Dose UDI-DI: 04046964301049 Expiration: Earliest Expiration of Component or 60 months Sold worldwide: Worldwide distribution including US, Canada, Germany, Guatemala, Singapore Quantity: 15,250 units Product: PB1500 15-DROP IV SET W/2 STOPCOCKS Hazard: Potential for backflow of medication into primary IV containers and inability to prime Recall Date: 2025-10-29 Status: ACTIVE
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