5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
Fresenius Medical Care Renal Therapies Group, LLC · 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 b…
Open FDA's page for this record- Cfres ID
- 221855
- Product res number
- Z-3087-2026
- Event date initiated
- 2026-08-10
- Event date posted
- 2026-09-02
- Recall status
- Open, Classified
- Res event number
- 99556
- Product code
- KOC
- Product description
- 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
- Code info
- Lots 25JR01802 25NR01017 25NR01266 UDI-DI 00840861102525
- Firm FEI number
- 3001451489
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Address 1
- 920 Winter St Bld 920
- City
- Waltham
- State
- MA
- Postal code
- 02451-1521
- Additional info contact
- Fresenius Medical Care Customer Service 800-323-5188
- Root cause description
- Component change control
- Product quantity
- 6,624 units
- 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.
- Action
On 8/10/2026, the firm began notifying consignees via URGENT MEDICAL DEVICE RECALL letters. Customers were instructed to 1. Identify any affected product on hand. 2. IMMEDIATELY segregate and discontinue use of affected lot. 3. Contact the call center at 1-888-943-4901 and reference Event 8514, between 8:00 AM 4:30 PM Eastern daily, for return of affected lots and replacement of your stock. 4, Complete and return the included reply form.
- Distribution pattern
Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IL, KY, LA, MA, MD, MN, MO, NC, NH, NH, NY, OH, PA, TN, TX, VA and the country of Lithuania.
- K numbers
- K243505
- Harmonized identifiers (openFDA)
- Device name
- Accessories, Blood Circuit, Hemodialysis
- Medical specialty description
- Gastroenterology, Urology
- Regulation number
- 876.5820
- Device class
- 2
- K number
- K822225, K002372, K760639, K830729, K082758, K823069, K971860, K822339, K152953, K831606, K760632, K832103, K770048, K972206, K801354, K761038, K852134, K895882, K935958, K141997, K810074, K831173, K831482, K821495, K840937, K761078, K925522, K950282, K822049, K926374, K823826, K822338, K955277, K920614, K830021, K760631, K844504, K002816, K941803, K822337 +142 more
- Registration number
- 3005987240, 3010202439, 3016096143, 3005162618, 1424263, 2032112, 3027859369, 3006755813, 8041145, 3006849754, 3035708507, 2029275, 3004111573, 3013557562, 1644312, 3005578748, 3043014136, 3014936217, 1625425, 1649518, 3038195011, 1225714, 1643817, 3003464075, 1932668, 3018348, 1720929, 9611824, 3012494290, 9616074, 1056186, 3014638255, 1650907, 3015335038, 3023981687, 8031561, 3043226252, 9680579, 3008252904, 3030446844 +10 more
- FEI number
- 3005987240, 1000306431, 3016096143, 3002681132, 3027859369, 3002806960, 3006755813, 3003015552, 3006849754, 3035708507, 3004111573, 3013557562, 3043014136, 3005578748, 3014936217, 1000117748, 1625425, 3003076831, 3008730267, 3038195011, 3002807721, 1643817, 3003464075, 1000132332, 1000203464, 1000126788, 1000138417, 3018348, 1720929, 3002807744, 3002974635, 3012494290, 3001451489, 3014638255, 3015335038, 3001236277, 3002807005, 3043226252, 1527681, 3001733054 +10 more