Recall Z-1529-2020 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Fresenius Medical Care Holdings, Inc.
Honeywell Pressure Transducer- Part Number: 370506-22. It is a component used in 2008T, Common Name: Hemodialysis Delivery System; 2008T HD SYS. BLUE STAR; 2008K2, Common Name: Hemodialysis Delivery Equipment; 2008K@home, Common Name: Hemodialysis Delivery System
| Date | Jan 29, 2020 |
| Status | Terminated |
| Reason | The firm is replacing pressure transducers with an improved design due to an increase in customer complaints regarding lower long-term reliability of the part. |
| Root cause | Component design/selection |
| Action | Starting October 7, 2019, the firm began implementing the improved Pressure Transducers into machine production. On January 29, 2020, the firm's Technical Services began contacting clinics via phone call on to set up appointments for transducer replacements for 2008T and 2008T Blue Star machines affected by the recall. Customers may also contact FMCRTG Technical Service at 800-227-2572. |
| Quantity | 3561 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |