Belzer UW Cold Storage SolutionRecalls & reported problems across all models

We found 2 models of Belzer UW Cold Storage Solution by Preservation Solutions Inc in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.

2 FDA recall records 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

Belzer UW Cold Storage Solution 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. Jun 10, 2019Terminated

   Lack of package integrity may compromise sterility

   Z-2237-2019 · Root cause: Package design/selection · Recall details · FDA record ↗

2. Feb 26, 2018Terminated

   Bags of solution may have a small leak at the base of the injection port where the port is welded into the body of the bag..

   Z-1387-2018 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Belzer UW Cold Storage Solution models

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

• Belzer UW Cold Storage Solution BUW-500

  System, Perfusion, Kidney
  1 recall0 reports
• Belzer UW Cold Storage Solution BUW-002

  System, Perfusion, Kidney
  1 recall0 reports