Recall Z-3086-2026
Fresenius Medical Care Renal Therapies Group, LLC · initiated August 10, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
Codes / lots: Lots 25JR01801 25KR01225 25KR01251 25NR01016 25NR01265 UDI-DI 00840861102532
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.
FDA-determined cause: Component change control
Action taken
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.
Details
- Recall number
- Z-3086-2026
- Initiated
- August 10, 2026
- Posted by FDA
- September 2, 2026
- Product code
- KOC – Accessories, Blood Circuit, Hemodialysis
- Quantity
- 18,600
- Distribution
- 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.
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC, Waltham, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3084-2026 Class II | 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line… | 08/10/2026Open, Classified |
| Z-3085-2026 Class II | 5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line… | 08/10/2026Open, Classified |
| Z-3087-2026 Class II | 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line… | 08/10/2026Open, Classified |