B Braun Medical recalls sterile saline bags with potential contamination risk if foil is removed. Affected lots expire April 2028. Stop using if you have these specific lot numbers.
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
B Braun Medical is recalling 3000mL sterile saline irrigation bags due to a risk of contamination after the foil cover is removed. This could lead to infections if the solution becomes unsterile.
The bags may leak from the diaphragm port once the foil cover is removed, potentially allowing contamination. This could cause infections if the sterile solution is exposed to unsterile conditions.
Healthcare professionals and patients using these saline bags for medical procedures. Those with the specific lot numbers listed in the recall are most at risk.
Check for lot numbers J5E226-J5E245 and J5H151-J5H155 on the bag. These bags expire by April 2028 and are labeled as '0.9% Sodium Chloride Irrigation, USP, 3000mL, Rx only, Sterile.'
Look for lot numbers J5E226-J5E245 and J5H151-J5H155 on the bag's label.
If you have the recalled lot numbers, stop using the saline bags immediately to avoid potential contamination.
The recall is due to a risk of contamination after the foil cover is removed, which could lead to infections if the solution becomes unsterile.
If you have the recalled lot numbers, stop using them immediately and contact B Braun Medical for further instructions.
No, the recalled bags pose a risk of contamination after the foil cover is removed, so they should not be used.
We’ve drafted a message you can send B Braun to request your refund or repair — edit it as you like.
Subject: Recall D-0497-2026 — B Braun B Braun Hello, I own a B Braun that is covered by recall D-0497-2026 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.
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