Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–9 of 9 recalls
Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.
Complaints of blue-green discoloration in product
Complaints of blue-green discoloration in product
Complaints of blue-green discoloration in product
Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.
Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.
Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.
Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.
Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T¿ BlueStar Hemodialysis machines.