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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Notice of Field Correction: Automated Blood Cell Separator, Haemonetics Mobile Collection Systems Update-Haemonetics Corp

DATE NOTIFICATIONS INITIATED:

 

October 18-26, 2004

 

PRODUCT:

 

Automated Blood Cell Separator, Haemonetics Mobile Collection Systems
MCS+ 9000
MCS+ 7000
MCS+ 8100

 

Model Numbers
LN 09000-110-E
LN 07000-110-E
LN 08100-110-E

 

MANUFACTURER:

 

Haemonetics Corporation
Braintree, Massachusetts

 

REASON:

 

Haemonetics is aware of the possibility when using an MCS machine that a small leak at the base of the Latham bowl may cause the collection of blood from a donor to exceed the recommended extracorporeal volume limit. A bowl base leak causes blood to leak out of the base of the bowl and into the waste bag. Haemonetics began equipping the MCS with a base leak detector starting with serial number 01M185. A Haemonetics service representative will contact consignees.

 

In the meantime, Haemonetics recommends that operators periodically observe the waste bag during a collection procedure. If there are indications of blood products in the waste bag, the procedure should be terminated.

 

 

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