Fresenius—Various Products: May Have Been Exposed to Freezing Temperatures

July 28, 2021 | Strategic Insights for Health System


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Problem: ​​FDA's Center for Devices and Radiological Health (CDRH) states that the above products may have been exposed to freezing temperatures because of refrigerated truck malfunctions that occurred during storms in Texas in February 2021. Affected product was exposed to freezing temperatures for approximately three hours. The solutions inside the products are not affected; Fresenius has freeze/thaw studies that prove this. However, because of the freezing temperatures, the packaging may become compromised and may exhibit leaks. FDA's CDRH also states that the manufacturer initiated a recall by telephone call on April 28, 2021. Fresenius states that only a subset of the above lot numbers were on trucks affected by the storms, so not all product within the lots is affected. Fresenius has contacted...

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