Z-0500-03

Haemonetics Basic Low Volume (125ml) Cell Saver 5 Bowl Set List Number: 261

Name: Z-0500-03 Haemonetics Basic Low Volume (125ml) Cell Saver 5 Bowl Set List Number: 261
Creator: Haemonetics Corporation
Published: 2002-12-17
License: https://open.fda.gov/license/

Haemonetics Corporation / initiated 2002-12-17 / Terminated

FDA source

Haemonetics Corporation began a recall of Haemonetics Basic Low Volume (125ml) Cell Saver 5 Bowl Set List Number: 261 on 2002-12-17. The reason FDA records is "Disposable Set for Autologous Blood recovery may leak saline at the Y-connector". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0500-03
Status: Terminated
Initiated: 2002-12-17
Posted: 2003-01-30
Terminated: 2016-01-28
Recalling firm: Haemonetics Corporation
Product: Haemonetics Basic Low Volume (125ml) Cell Saver 5 Bowl Set List Number: 261
Product code: CAC Apparatus, Autotransfusion
Reason for recall: Disposable Set for Autologous Blood recovery may leak saline at the Y-connector
FDA root cause: Other
Action: Haemonetics notified accounts of the recall on December 17, 2002 by fax. A hard copy of the same letter was sent to each customer via certified mail, return receipt on December 18 and 19. Users are requested to cease use of product and return product to Haemonetics.
Quantity in commerce: 4138
Distribution: Nationwide Canada
Product codes and lots: G02151 G02160 H02197 H02211 J02087 J02095 J02219 K02003 K02092 K02098 K02186 K02198 L02031 L02039 L02125 L02133 M02038

Product code CAC

K932890Class IICell Saver 5 SystemHaemonetics Corp. / cleared 1994-01-05

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)