BBraun Medical recalled 12,700 ADDitIV gravity IV sets distributed worldwide. The sets can backflow medication from piggyback containers into primary IV containers and cannot be primed. Healthcare providers and patients should stop using the sets immediately and follow the recall instructions from BBraun 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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ADDitIV gravity IV sets are used to deliver medications via gravity-fed IV therapy. They connect piggyback containers to primary IV lines in clinical care. Users rely on proper priming to ensure accurate dosing.
Backflow can cause medications to mix improperly between containers, potentially delivering an incorrect dose. An occlusion can prevent proper flow of IV fluids, delaying treatment.
This recall is not described as part of a broader industry pattern.
Healthcare settings may need to switch to alternative IV sets. Hospitals and clinics should review inventory and affected lots to prevent medication errors.
Manufacturer recall letters and the FDA enforcement report provide identification details.
Recall actions typically run 4-8 weeks for replacement or corrective actions. Hospital procurement may coordinate direct replacements.
Keep a copy of recall communications, models, lot numbers, and any replacement orders. Maintain logs of any adverse events.
Catalog Number: 352062 Primary UDI-DI: 04046964181160 Unit of Use UDI-DI: 04046964181153 Quantity: 12,700 units Distribution: Worldwide distribution, including the US and international distribution to Canada, Germany, Guatemala and Singapore Sold since: Unknown Price: Unknown
No injuries or incidents have been reported.
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