B.Braun Medical S.A.S. has recalled 58 units of the CELSITE Babyport Set (PUR 4,5F IV USA), a medical device used for long-term intravenous access in pediatric patients. The recall was initiated because of a potential for the device to cause minor injuries, such as damage or tearing to the vessel wall during medical procedures. Healthcare providers and clinical staff should immediately stop using the affected units and follow return instructions provided by the manufacturer.
Using the affected Babyport set may result in the tearing or damage of blood vessel walls. While no specific incidents were detailed in the initial notification, this failure poses a risk of internal injury to patients during port insertion or use.
The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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