B Braun Medical recalled 18,984 IV administration sets after discovering a potential for backflow of medication from secondary IV containers into primary containers. This defect creates a high risk of medication errors and occlusion. Patients and healthcare providers should stop using these sets immediately and contact B Braun Medical for further 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 sets are used to deliver intravenous medication through gravity or pump systems. They are critical in hospital settings for treating patients with a variety of conditions. Healthcare providers use these sets to ensure accurate dosing of medications.
The IV administration sets may allow backflow of medication from secondary containers into primary IV containers. This backflow can lead to administration of incorrect dosages, potentially harming patients.
This recall is not part of a broader industry pattern.
Healthcare facilities and patients may face safety risks due to the potential for medication errors. Immediate cessation of use of these sets is necessary to mitigate these risks.
The catalog number and UDI-DI numbers are typically found on the product packaging or accompanying documentation.
Expect processing for refunds or replacements to take 4-6 weeks from the time of contact with the manufacturer.
Keep records of your purchase, any medical advice received, and communications regarding the recall for future reference.
Product: IV Administration Set Catalog Number: 490329 UDI-DI: 04046964541100, 04046964541094 Quantity Recalled: 18,984 units Distribution: Worldwide, including the US, Canada, Germany, Guatemala, and Singapore
No injuries or incidents have been reported.
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