Important Notification:

Red Cell Collection Kits


September 8, 2008


Red Cell Collection Kits

Product Code: LN822-00

Lot Number Expiration Date
E08099 5/2011
E08102 5/2011
F08158 6/2011
F08163 6/2011
F08169 6/2011
F08175 6/2011

Product Code: LN832-00

Lot Number Expiration Date
E08200 5/2011
E08208 5/2011
F08052 6/2011
F08062 6/2011
F08071 6/2011
F08079 6/2011
F08098 6/2011
F08108 6/2011
F08119 6/2011
F08129 6/2011
F08133 6/2011
F08190 6/2011
F08193 6/2011
F08201 6/2011
F08208 6/2011
F08211 6/2011
G08096 7/2011
G08104 7/2011
G08114 7/2011


Haemonetics Corporation
Braintree, Massachusetts


Haemonetics Corporation has identified an issue on their LN 822 and LN 832 red cell kits. The issue relates to the printed numbers found on the segmented sample tubing attached to the product bags on the kits. The numbering sequence may include nine consecutive numbers that match and one that does not. The discrepant number could be located at the distal end of the tubing or located closest to the product bag. Customers who wish to return any kits with discrepant numbers should contact Haemonetics.

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.

Updated: September 12, 2008