B Braun Medical recalled 41,976 IV Administration Sets sold worldwide after identifying a backflow risk. The device can allow medication to flow from secondary (piggyback) containers into the primary IV line and may not prime properly. Hospitals and healthcare providers should stop using the sets immediately and await recall instructions from B Braun Medical.
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 are used to deliver fluids and medications through IV lines in hospital and clinical settings. They connect to IV bags or pumps and are selected based on compatibility with infusion devices.
Backflow into the primary IV line can lead to medication misadministration or contamination. Inability to prime can disrupt flow and dosing.
This recall is not described as part of a broader industry pattern in the provided information.
Hospitals and clinics may need to quarantine affected lots and switch to alternatives, impacting inventory and workflow.
UDI numbers, catalog numbers, and expiration on device packaging and recall notices.
Refunds or replacements typically take 4-8 weeks after submission of the recall claim.
Keep recall notice, purchase records, batch/lot numbers, and correspondence with the manufacturer as part of the record.
Catalog Number: 490354. Primary UDI-DI: 04046964602382. Unit of Dose UDI-DI: 04046964602375. Expiration Date: Earliest Exp of Comp or 24mths. Distribution: Worldwide, including US, Canada, Germany, Guatemala, Singapore. Quantity: 41,976 units. Brand: B Braun Medical.
No injuries or incidents have been reported.
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