B. Braun Medical recalls 286,400 IV administration sets used with Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump worldwide. The devices may backflow from secondary IV containers into primary containers and cannot be primed. Stop using the device immediately and follow recall instructions from the manufacturer.
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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IV administration sets connect IV bags to patients to deliver fluids and medications either by gravity or via infusion pumps. They are used widely in hospitals and clinics.
Backflow from a secondary IV container into the primary container can alter the dose delivered. Inability to prime can lead to incomplete delivery of the prescribed medication.
This recall is not described as part of a broader industry pattern.
Healthcare facilities may need to replace affected sets. The recall affects 286,400 units worldwide, potentially causing operational delays and procurement adjustments.
On device label and packaging; recall notice from FDA and manufacturer
Remedy processing commonly 4-6 weeks after submission
Preserve recall notice; Photograph catalog numbers and UDI codes; Save all correspondence and replacement receipts
Catalog Number: 354211 Primary UDI-DI: 04046964182198 Unit of Dose UDI-DI: 04046964182181 Description: IV ADM 15 DROP W/3 CARESITE N/C DUAL Quantity: 286,400 units Distribution: Worldwide; US distribution and international distribution to Canada, Germany, Guatemala and Singapore Expiration: Earliest Expiration of Component or 24 months Sold at: Unknown Price: Unknown
No injuries or incidents have been reported.
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