B. Braun Introcan Safety IV catheters distributed without FDA approval in the US are recalled. Affected units have specific product codes and lot numbers. Consumers should contact the manufacturer for details.
Distribution of B.Braun Introcan Safety IV catheters without a 510(k) within the United States by JTG.
B. Braun Introcan Safety IV catheters with certain product codes and lot numbers were distributed without FDA approval in the US. This recall affects patients receiving IV treatments who may have these specific catheters.
The catheters were distributed without FDA approval, which means they may not meet safety standards. This could lead to potential risks during IV treatments, though the exact hazard is not specified in the recall notice.
Patients receiving IV treatments in the US who have the recalled catheters are most at risk. The recall applies to specific product codes and lot numbers distributed by Janus Trade Group.
Check the product codes listed in the recall notice (e.g., REF 4252500-01) and lot numbers (e.g., 18L23G8271) on the catheter packaging. The recall covers specific batches distributed by Janus Trade Group.
Review the product codes and lot numbers on the catheter packaging to determine if it is affected.
The recall is due to distribution without FDA approval in the US, which may not meet safety standards.
Check the product codes (e.g., REF 4252500-01) and lot numbers (e.g., 18L23G8271) on the catheter packaging.
Contact Janus Trade Group directly for instructions on how to return or replace the catheter.
We’ve drafted a message you can send B. Braun to request your refund or repair — edit it as you like.
Subject: Recall Z-0509-2021 — B. Braun B. Braun Hello, I own a B. Braun that is covered by recall Z-0509-2021 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.
