Haemonetics Cell Saver 5+ Autogolous Blood Recovery System Model Number: LN02005-110EP
This recall has been terminated (originally issued April 29, 2006).
- Company
- Haemonetics Corporation
- Recall Initiated
- December 21, 2005
- Posted
- April 29, 2006
- Terminated
- March 12, 2008
- Recall Number
- Z-0823-06
- Quantity
- 151 units
- Firm Location
- Braintree, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Device emits radiofrequency which exceed the IEC 60601-1-2 International Standard
Distribution
Nationwide
Lot / Code Info
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
Root Cause
Other
Action Taken
Haemonetics notified accounts by Certified Letter on 12/21/05. A field correction will be schedule to replace the LCD .