Topic archive
MedTech Current publications and recall entries tagged Infusion, Renal & Respiratory Therapy.
FDA has expanded the Class I recall involving BD Alaris Pump Infusion Sets used with the Alaris Pump Module Model 8100 after updated testing showed that some sets may perform substantially worse than previously disclosed at low flow rates and low bolus volumes.
Losing CGM connectivity changes how the insulin pump operates: users must manage delivery in manual mode without the app’s glucose values or automated control. For connected-device teams, the failure links release controls and sensor-compatibility testing to the ability to restore a working production version quickly.
FDA has classified the recall of Draeger VentStar Resus Neo disposable breathing circuits as Class I after cracks were found in the hose, creating a risk of leakage or disconnection that may restrict ventilation or delay therapy in infants.
Oxygen readings guide respiratory care, so affected sensors need to be identified before replacement. Clinical engineering and respiratory teams also need to coordinate with distributors on response forms and the timing of sensor changes.
FDA classified BD's correction of specified dialysis convenience kits and procedure trays as Class I because they contain sodium chloride ampules affected by a separate recall over product-quality and sterility-assurance concerns.
FDA has classified the recall of specified CooperSurgical INCA Infant and Neonatal Nasal CPAP sets as Class I because a loose connection between the Stay-Flex tubing and nasal cannula may cause loss of CPAP pressure and reduced oxygenation.
Hemodialysis blood tubing is part of an extracorporeal blood circuit, so connection integrity and preparation steps have direct clinical and workflow importance. The event is notable because the field action focuses on reinforcing correct use rather than removing product, placing much of the immediate burden on training, setup verification, and clinical practice.
Blood-circuit leakage during hemodialysis has direct treatment and patient-safety implications and can require immediate inventory segregation across dialysis programs. The event also demonstrates why quantity aggregation must respect FDA's stated units: otherwise a seemingly simple total can introduce unsupported assumptions into an otherwise evidence-based recall summary.
Infusion-pump software behavior during syringe changes can affect medication-delivery workflow at the bedside, making the event particularly relevant to clinical engineering and medication-safety teams. The correction also depends on users following a specific compatible-syringe workflow until the underlying software behavior is addressed.
Dialysate concentrate is a core treatment input, so visible product contamination or discoloration requires rapid inventory control in dialysis operations. The event is also a practical example of why grouped recall entries should preserve incompatible units instead of converting or summing them in ways the FDA record does not support.
Hemodialysis machines support ongoing therapy, so recurring flow, water, or temperature alarms can impose immediate operational burden on clinics even when a machine remains usable without error messages. The correction also requires facilities to coordinate backup-machine use and field replacement according to each affected system's condition.
These circuits support neonatal and infant respiratory care, so a connector failure can create both immediate clinical-management needs and broad inventory work. The recall also illustrates how one failure mode may span several FDA product classifications and catalog families while still representing a single underlying field action.
A potential sterilization underdose in products used to administer fluids into the vascular system has direct clinical and operational significance. The event also creates broad inventory work because facilities must locate specified lots across storage and use locations, discontinue affected product, and manage destruction, quarantine, replacement, and downstream notification.