B. Braun Medical Inc. recalls 31,392 IV administration sets used with Infusomat Space and other pumps worldwide. The device may allow backflow from piggyback containers into primary IV lines and cannot be primed. Hospitals and healthcare providers should stop using the device 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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The IV administration set is used to deliver IV medications through gravity or pump-assisted systems in clinical settings. It connects to IV containers and pumps to control fluid flow.
A backflow path from secondary piggyback lines into the primary IV line, plus an occlusion that prevents priming, could compromise medication delivery and patient safety.
This recall is not described as part of a broader industry pattern in the provided data.
Hospitals and clinics may need to replace affected lots, re-train staff on priming procedures, and review pump configurations to prevent interruptions in therapy.
Recall details and instructions are available on the FDA enforcement page linked in the notice
Refund or replacement information will be provided by the manufacturer through the recall notification; expect 4-6 weeks for processing
Keep a copy of the recall notice, inventory records showing affected lots, correspondence with BBraun, and photographs of the affected packaging.
Catalog Number 490301. Primary UDI-DI 04046964716867. Unit of Dose UDI-DI 04046964716850. Expiration Date: 36 months from Start Date. Sold worldwide with US and international distribution to Canada, Germany, Guatemala, and Singapore. Quantity: 31,392 units.
No injuries or incidents have been reported.
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