Recall: Haemonetics List No. 620 PCS2 Plasma Harness Set, Haemonetics Corporation

DATE NOTIFICATION INITIATED:

April 10, 2009

PRODUCT / LOT NUMBER / EXPIRATION DATE 

List No. 620 PCS2 Plasma Harness Set

Expiration Date: December 2013

Lot Numbers:

081219511              081219512

081222510              081222511

081223510              081223511

081224510              081224511

081224512

MANUFACTURER:

Haemonetics Corporation

Braintree, Massachusetts

REASON: 

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.