Recall Z-3086-2026
- Recall number
- Z-3086-2026
- Event number
- 99556
- Firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Firm FEI
- 3001451489
- Product code
- KOC
- Status
- Open, Classified
- Initiated
- 2026-08-10
- Posted
- 2026-09-02
- Root cause
- Component change control
- 510(k) numbers
- K243505, K760626, K760935, K760640, K823069, K925522, K950282, K823707, K761051, K770048, K230514, K811457, K832666, K770383, K761082, K831175, K172238, K913361, K924436, K830231, K831482, K941803, K844185, K760042, K831338, K790591, K831433, K833252, K834596, K823791
Product#
5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
Reason for Recall#
Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.