Fresenius Medical Care Holdings, Inc. - GranuFlo products (3 in total, all under K192209: item numbers 0FD22513B; 0FD32513B; 0FD32513B) - Class 2 Recall

Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. Both concentrates are formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis.
Source: Medical Device Recalls - Category: Medical Devices Source Type: alerts