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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 LN9000 Mobile Collection System-Haemontics Corp

DATE NOTIFICATIONS INITIATED:

 

October 18-26, 2004

PRODUCT:

Automated Blood Cell Separator, Haemonetics LN9000 Mobile Collection System
MCS+ 9000
Model Number: LN09000-110-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
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002