Topic archive
MedTech Current publications and recall entries tagged BD.
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.
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 BD Intraosseous Vascular Access System Needle Set lots as Class I after out-of-tolerance dimensions were linked to difficulty removing the obturator and potential delays in therapy; the FDA recall database lists Bard Access Systems, Inc. as the recalling firm.
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.