5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8: recall status
Notice names this product. Fresenius Medical Care Renal Therapies Group’s 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8 is named in FDA Class II recall Z-3087-2026.
Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies.Agency-reported hazard: 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. Identifying details: Lots 25JR01802 25NR01017 25NR01266 UDI-DI 00840861102525. Units affected: 6,624 units. Status: Ongoing.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Product named
5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
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.
Agency product description and boundaries
5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
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 hypovol…