OtherOAO
AXP AUTOXPRESS PLATFORM
Received Nov 17, 2008 · Event occurred Oct 27, 2008
Report 2950374-2008-00002 · MDR key 1239127
Device
Product problems
- Foreign material
Patient
Not reported
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
A CUSTOMER CALLED TO REPORT THAT WHITE DEBRIS WAS FOUND IN THE FREEZING BAG.
Additional Manufacturer Narrative
THIS LOT IS INCLUDED IN A RECALL NOTIFICATION SENT TO FDA IN 2008. AN ASSIGNED FDA RECALL NUMBER IS STILL PENDING AT THE TIME OF WRITING. INTERNALLY, WE HAVE IDENTIFIED THIS RECALL. NO ADVERSE EVENT HAS BEEN REPORTED FOR THIS OCCURENCE.
Remedial action
- Recall