Fresenius Medical Care

Fresenius Medical Care has recalled specific lots of Citrasate Liquid Acid Concentrate used in hemodialysis due to blue-green discoloration observed in the product. The discoloration may indicate a quality issue that could affect the product's safety or efficacy. No injuries have been reported.

Fresenius Medical Care is recalling specific lots of NaturaLyte Liquid Acid Concentrate used in bicarbonate hemodialysis due to reports of blue-green discoloration in the product. The affected lots were distributed nationwide in the U.S. and in Mexico.

Fresenius Medical Care has recalled certain lots of GRANUFLO Dry Acid Concentrate used in hemodialysis machines after receiving reports of blue-green discoloration in the product. The affected product numbers are 0FD2251-3B and 0FD3251-3B, with specific lot numbers listed by the FDA.

Fresenius Medical Care is recalling specific lots of the 5008X HD/HDF Twister Blood Tubing Set (Part Number 03-5350-8) because the connection between the Arterial Alpha Clip and the main line may leak during dialysis treatment. A leak could result in blood loss and low blood volume.

Fresenius Medical Care is recalling certain 5008X HD/HDF blood tubing sets (part number 03-5300-3C) due to a heightened risk of blood leaks at the connection between the Arterial Alpha Clip and the main line. Blood leaks during dialysis treatment can result in significant blood loss.

Fresenius Medical Care is recalling certain 5008X HD/HDF Standard Blood Tubing Sets due to a heightened risk of blood leaking from the connection between the Arterial Alpha Clip and the main line or pump segment. A blood leak during dialysis treatment could result in blood loss and low blood volume.

Fresenius Medical Care is recalling certain 5008X Standard HD Pre-Flush blood tubing sets due to a heightened risk of blood leaking from the connection between the Arterial Alpha Clip and the main line. A leak during dialysis treatment could result in blood loss.

Fresenius Medical Care's Bicarby Dialysate (Model RFP-400-G) has incorrect barcode labeling on some units. While the case label and printed information are correct, scanning the GTIN barcode alone could lead to identification errors. This could result in use of a dialysate with a potassium concentration different from what was prescribed.

Fresenius Medical Care is notifying users of potential leaks in Bicarby Dialysate products during setup and use. Fluid leaks from the luer-lock connection can create a slip and fall hazard on the floor where treatment is taking place.

Fresenius Medical Care identified several software problems in the 5008X CAREsystem +CLiC +CDX dialysis machine that could interfere with patient treatment. One anomaly could potentially cause the machine to stop treatment if certain conditions occur. This affects 115 units with software versions older than 4.82.4.