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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Notice of Field Correction: Haemonetics MCS+ 9000, Cell Saver 5, Cell Saver 5+-Haemonetics Corp

DATE NOTIFICATION INITIATED:

December 15, 2005

PRODUCT / MODEL NUMBER
Haemonetics LN9000 Collection System (Model Number: LN9000-110-E)

Serial Numbers: 05D056; 05F064-1; 05F065; 05G101; 05G103; 05H094

Haemonetics Cell Saver 5 Autologous Blood Recovery System (Model Number: LN02005-110-E)

Serial Numbers: 94H180CD-1; 95A048CS; 95J177CS

Haemonetics Cell Saver 5+ Autologous Blood Recovery System (Model Number LN02005-110EP)

 

Serial Numbers: 05F022-1; 05F023-1; 05H103;05C083-05C084; 05C087-05C089;05D006-05D011;05D037--05D040; 05D043-05D047;05D060-05D068; 05D080--05D081; 05D085-05D089; 05E026-05E035;05E054-1; 05E055-1; 05E056;05E061-05E070; 05E091-05E095; 05F021; 05F066-05F072; 05F098-05F107;05F142-05F144; 05F147; 05F149; 05F150; 05F157-05F159;05G008-1; 05G009-05G012; 05G035-05G037; 05G038-1; 05G055-1; 05G057-05G059; 05G080-05G084;05H018; 05H022; 05H024- 05H027; 05H073-05H077; 05H100-05H101; 05H104; 05H163; 05J185-05J189; 05K011-05K013; 05K015-05K017; 05K092-05K096; 05K168-05K173 ; 05K175; 05K201

MANUFACTURER:

Haemonetics Corporation
Braintree, Massachusetts

REASON:

Haemonetics has become aware that the Liquid Crystal Display (LCD) on the above listed devices may emit radiofrequency waves that exceed the level permitted by International Standards. Haemonetics is executing a field correction to upgrade devices with a new, compliant LCD.

 

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