B. Braun Medical recalls universal fill kits (REF 7M2804) for tissue expander inflation due to potential leakage causing infection or delayed therapy. Affected units include specific lot numbers.
Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.
B. Braun Medical is recalling all universal fill kits (REF 7M2804) for tissue expander inflation because they may leak, which could delay treatment, cause infections, or lead to serious health issues. This recall affects healthcare providers using these kits for medical procedures.
The kits may leak due to a manufacturing issue, which can delay therapy, increase the risk of bloodstream infections, and expose patients and healthcare workers to hazardous medication. In severe cases, this leakage could cause life-threatening situations requiring additional medical intervention.
Healthcare providers using the recalled universal fill kits for tissue expander inflation are most at risk. Patients receiving these treatments may also be affected if the kits are used improperly.
Check for the product name 'ALLERGAN UNIVERSAL FILL KIT' with reference number 7M2804. Affected units include lot numbers 0061745499, 0061745500, 0061745501, and 0061792770.
Look for the reference number 7M2804 and affected lot numbers on the kit packaging.
The kits may leak due to a manufacturing issue, which could delay therapy, increase infection risk, and expose patients and healthcare workers to hazardous medication.
Leakage could delay treatment, cause bloodstream infections, and lead to life-threatening situations requiring additional medical intervention.
Check for the reference number 7M2804 and affected lot numbers: 0061745499, 0061745500, 0061745501, 0061792770.
We’ve drafted a message you can send B. Braun to request your refund or repair — edit it as you like.
Subject: Recall Z-0134-2024 — B. Braun B. Braun Hello, I own a B. Braun that is covered by recall Z-0134-2024 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.
