BibagRecalls & reported problems across all models

We found 2 models of Bibag by Fresenius Medical Care Holdings, Inc. in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Bibag recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Apr 28, 2021Terminated

   Exposed to freezing temperatures due to refrigerated truck malfunctions

   Z-2082-2021 · Root cause: Environmental control · names 2 of these models · Recall details · FDA record ↗

Bibag models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Bibag 08-4078-BB

  DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
  1 recall0 reports
• Bibag 08-4080-BB

  DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
  1 recall0 reports

Other Fresenius Medical Care Holdings, Inc. products

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• Crit-Line2 models · 30 reports
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