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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
(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