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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Medical Device Notification: Filtered Red Cell Disposable Kits-Haemonetics Corporation

DATE NOTIFICATION INITIATED:

February 26, 2008

PRODUCT / LOT NUMBER/ EXPIRATION DATE:

Filtered Red Cell Disposable Kits
List Number: 832F
Lot Number: A08059

MANUFACTURER:

Haemonetics Corporation
Braintree, Massachusetts

REASON:

Haemonetics has recently discovered a label discrepancy in lot number A08059 of their filtered red cell disposable kits, LN 832F. An undetermined quantity of disposable kits in this lot has the incorrect lot number printed on the red cell product bags only. The last two digits of the lot number on the red cell product bags were transposed as A08095 rather than the correct transcription of A08059. Customers are asked to quarantine any LN832F sets of this lot number and prepare them for return to Haemonetics.

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

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Building 71 Room 3103

Silver Spring, MD 20993-0002