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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Important Notification: Red Cell Collection Kits-Haemonetics Corporation

DATE NOTIFICATION INITIATED:

September 8, 2008

PRODUCT / LOT NUMBER/ EXPIRATION DATE:

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

MANUFACTURER:

Haemonetics Corporation
Braintree, Massachusetts

REASON:

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

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448