B. Braun recalls Outlook IV Set 15Drop W/2 CareSite (model 35421: lots after Aug 1, 2023) due to potential backflow of medication causing patient injuries.
Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.
B. Braun is recalling Outlook IV Set 15Drop W/2 CareSite sets used with infusion pumps. The risk of backflow could cause medication to flow backward into the patient's IV line, leading to adverse reactions or medication loss.
The backcheck valve might malfunction, allowing medication from secondary IV containers to flow back into the primary IV container. This could cause medication to be lost or lead to adverse reactions in patients.
Healthcare professionals using these IV sets with electric infusion pumps. Patients receiving IV treatments are at risk if the backflow occurs.
Check for model number 354212 or UDI-DI 04046964293832. All units distributed after August 1, 2023, are affected.
Identify the model number (354212) and UDI-DI (04046964293832) to confirm if your set is affected.
Reach out to your healthcare provider to discuss potential replacement or corrective action for the affected IV set.
The model number is 354212 with UDI-DI 04046964293832.
All lots distributed after August 1, 2023, are affected.
The recall record does not specify a fix or remedy.
We’ve drafted a message you can send B. Braun to request your refund or repair — edit it as you like.
Subject: Recall Z-2376-2024 — B. Braun B. Braun Hello, I own a B. Braun that is covered by recall Z-2376-2024 from B. Braun. 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.
