B Braun Medical recalled 19,320 Anesthesia IV Sets on October 29, 2025. The recall follows reports of potential backflow of medication from secondary IV containers. Patients and healthcare providers must stop using the device immediately.
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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The recalled product includes Anesthesia IV Sets with Catalog Number 490476. These devices were distributed worldwide, including the United States, Canada, Germany, Guatemala, and Singapore.
The Anesthesia IV Set poses a high hazard risk due to the potential for medication backflow from secondary IV containers into primary containers. This could lead to medication errors and patient harm.
Currently, there are no reported injuries or incidents related to this recall. However, the nature of the hazard presents a serious risk to patient safety.
Patients and healthcare providers should stop using the Anesthesia IV Sets immediately. Contact B Braun Medical Inc or your healthcare provider for further instructions and follow recall guidelines.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0613-2026 or contact B Braun Medical Inc.
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