Recall Z-1536-2021 ยท FIP Subsystem, Water Purification
Fresenius Medical Care Holdings, Inc.
AquaBplus and AquaBplus B2 Water Purification System - Product Usage: Intended for use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or related therapies. Fresenius P/N 24-2500-0 All 3 units make up the AquaBplus 2500Fresenius Part Number: G02040109-US AquaBplus 3000 - Typ USA G02040115-US AquaBplus 2500 - Typ
| Date | Mar 18, 2021 |
| Status | Terminated |
| Reason | AquaBplus HF module on the AquaBplus 2500 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may be installed in combination with an AquaBplus 2500 device. The 3-ring main and fluid fly loops the heat disinfection may not be as effective as a 2-ring main installation |
| Root cause | Labeling Change Control |
| Action | Fresenius issued Urgent Medical Device Alert (FA-2021-07-C) to customers on 03/18/2021 via First Class Mail. Letter states reason for recall, health risk and action to take: Please note that all installed AquaBplus 2500 osmosis systems are validated for chemical disinfection upon installation. You may continue to use your HF module, since the chemical disinfection remains the primary disinfection method. The system will continue to provide dialysis water that meets Association for the Advancement of Medical Instrumentation (AAMI) standards; thus, there is no risk introduced. You should contin |
| Quantity | 27 units |
| Distribution | US Nationwide distribution in the states of FL, MA, MD, MI, MO, NC, NJ, NY, PA, PR, SC, TN, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133829 | AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF Vivonic GmbH, Apr 22, 2014 |