B Braun Medical recalls specific IV administration sets used with gravity and pump systems due to potential backflow of medication and inability to prime. Affected units include those with catalog number 354211.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
B Braun Medical is recalling certain IV administration sets used with gravity and pump systems because they can cause medication to flow backward into the main container and fail to prime properly. This could lead to incorrect dosing or infection risks if the sets are used without proper checks.
The IV sets can allow medication from secondary containers to flow back into the primary container, which may cause incorrect dosing or contamination. They also may not prime correctly, leading to blockages or incomplete medication delivery.
Healthcare professionals using these IV sets with gravity or pump systems, particularly those administering medications via piggyback infusions. Patients receiving IV treatments with these sets are at risk if the sets malfunction.
Check for the catalog number 354:211 on the set or the label indicating it was used with B Braun's Infusomat Space, Outlook, or Vista Basic pumps. The expiration date is typically 24 months from manufacturing.
Look for the catalog number 354211 or the specific UDI-DI codes listed on the product.
Reach out to B Braun Medical for guidance on whether the set is affected and next steps.
The catalog number is 354211, and the product is labeled for use with B Braun's Infusomat Space, Outlook, or Vista Basic pumps.
Check for the catalog number 354211 on the set or the label indicating it was used with B Braun's Infusomat Space, Outlook, or Vista Basic pumps.
The recall does not require immediate discontinuation; however, affected sets should be checked and contacted for guidance.
We’ve drafted a message you can send B Braun Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0683-2026 — B Braun Medical B Braun Medical Hello, I own a B Braun Medical that is covered by recall Z-0683-2026 from B Braun Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.