Fresenius Medical Care Renal Therapies Group, LLC — Class II: 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
Fresenius Medical Care Renal Therapies Group has initiated a Class II recall for the 5008X HD/HDF with Twister Blood Tubing Set (Part Number 03-5350-8) due to a heightened probability of blood leaks at the connection between the Arterial Alpha Clip and the main line or pump segment.
Healthcare facilities utilizing the Fresenius 5008X HD/HDF system, clinical staff performing dialysis treatments, and quality assurance teams responsible for blood tubing set inventory.
The failure of the tubing connection presents a direct safety risk, as leaks during treatment can lead to blood loss and hypovolemia in patients. From a regulatory perspective, this suggests a need for manufacturing or design verification review of the connection integrity between the clip and the pump segment. The 'Ongoing' status indicates that the firm is currently executing its mitigation strategy and recovery of the affected lots.
Identify and quarantine all affected Twister Blood Tubing Sets (Part 03-5350-8). Update clinical training materials to emphasize monitoring for blood leaks at the Arterial Alpha Clip connection. Conduct a risk assessment to determine if current complaint handling procedures effectively captured this specific failure mode prior to the recall.
Class II. Reason: 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.. Product: 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8. Firm: Fresenius Medical Care Renal Therapies Group, LLC (Waltham MA United States). Status: Ongoing.
Open in openFDA / FDA.gov