Recall Z-3093-2026
- Recall number
- Z-3093-2026
- Event number
- 99543
- Firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Firm FEI
- 3001451489
- Product code
- KPO
- Status
- Open, Classified
- Initiated
- 2026-07-14
- Posted
- 2026-09-03
- Root cause
- Material/Component Contamination
- 510(k) numbers
- K192017, K212620, K864942, K823103, K922990, K052393, K120005, K013448, K990507, K980659, K800624, K171750, K901473, K033386, K233213, K810925, K901471, K041428, K851431, K000792, K233950, K162887, K171015, K810527, K012328, K993212, K034066, K872857, K131611, K160847
Product#
Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA; Liquid Acid Concentrate for Bicarbonate Hemodialysis
Reason for Recall#
Complaints of blue-green discoloration in product