DATE NOTIFICATION INITIATED:
April 10, 2009
PRODUCT / LOT NUMBER / EXPIRATION DATE
List No. 620 PCS2 Plasma Harness Set
Expiration Date: December 2013
Haemonetics recently identified a potential issue with nine lot numbers of manufactured List Number 620 PCS2 Harness Sets. Their investigation has determined that a small number of Harness Sets within the affected lot numbers may have the potential to exhibit leaks at the filter cap assembly. Customers have been asked to contact the manufacturer to arrange for product return.
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.