B Braun Medical Inc. recalls 43,900 ADDitIV gravity and pump administration sets. The recall covers catalog numbers V1443, V1447, V1448, and V1484. The issue is backflow of medication from secondary IV containers into primary containers and inability to prime the line. Patients and healthcare providers should stop using these devices immediately 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
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ADDitIV sets are used in IV therapy to deliver medications via gravity or pump systems. They are intended for hospital and clinical use.
Backflow from piggyback containers into primary IV lines can lead to incorrect dosing or contamination. Inability to prime increases risk of underdelivery.
This recall is not part of a broader industry pattern.
High-risk medical devices with potential to compromise IV therapy accuracy and safety; may require stock withdrawal and replacement.
Refer to FDA recall page Z-0603-2026 and BBMI recall notices.
Refunds or replacements via manufacturer coordination; typical timelines span weeks to months.
Keep recall notice, lot numbers, UDIs, purchase records, and communications with supplier for records.
Brand: B Braun Medical. Product: ADDitIV gravity IV administration sets and pump administration sets. Catalog numbers: V1443, V1447, V1448, V1484. UDI-DI: see individual entries. Sold worldwide; US and international distribution to Canada, Germany, Guatemala, Singapore. Recall date: 2025-10-29. Report date: 2025-12-03. Quantity: 43,900 units.
No injuries or incidents have been reported in the provided data.
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