Recall of Spectra Optia Apheresis System - Return Line Air Detector (RLAD) Sensor Replacement
DATE NOTIFICATION INITIATED:
August 4, 2014
PRODUCT / LOT NUMBER
Spectra Optia Apheresis System
All Serial Numbers
Terumo BCT, Inc.
Terumo BCT is voluntarily recalling and replacing the Spectra Optia Apheresis System’s Return Line Air Detector (RLAD) Sensor. The RLAD sensor is present on all devices and is active during both therapeutic apheresis and cell collection procedures. The sensor’s function is to detect air in the return line of any Spectra Optia system disposable set. When air is detected by the sensor, the system alarms and advises the operator to take action to prevent the return of even very small quantities of air to the patient or donor. Terumo BCT is recalling the sensor because a small number of these components have failed either disrupting or prematurely ending an ongoing apheresis procedure. Consignees are asked to return the acknowledgement of the recall notice.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.