Z-0823-06

Haemonetics Cell Saver 5+ Autogolous Blood Recovery System Model Number: LN02005-110EP

Name: Z-0823-06 Haemonetics Cell Saver 5+ Autogolous Blood Recovery System Model Number: LN02005-110EP
Creator: Haemonetics Corporation
Published: 2005-12-21
License: https://open.fda.gov/license/

Haemonetics Corporation / initiated 2005-12-21 / Terminated

FDA source

Haemonetics Corporation began a recall of Haemonetics Cell Saver 5+ Autogolous Blood Recovery System Model Number: LN02005-110EP on 2005-12-21. The reason FDA records is "Device emits radiofrequency which exceed the IEC 60601-1-2 International Standard". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0823-06
Status: Terminated
Initiated: 2005-12-21
Posted: 2006-04-29
Terminated: 2008-03-12
Recalling firm: Haemonetics Corporation
Product: Haemonetics Cell Saver 5+ Autogolous Blood Recovery System Model Number: LN02005-110EP
Product code: CAC Apparatus, Autotransfusion
Reason for recall: Device emits radiofrequency which exceed the IEC 60601-1-2 International Standard
FDA root cause: Other
Action: Haemonetics notified accounts by Certified Letter on 12/21/05. A field correction will be schedule to replace the LCD .
Quantity in commerce: 151 units
Distribution: Nationwide
Product codes and lots: 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

Product code CAC

K014083Class IIHaemonetics Cell Saver 5 Autologous Blood Recovery SystemHaemonetics Corp. / cleared 2002-01-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)