Z-0498-03

Haemonetics Cell Saver 5 Fast Pack List Number: 260

Name: Z-0498-03 Haemonetics Cell Saver 5 Fast Pack List Number: 260
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 Cell Saver 5 Fast Pack List Number: 260 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-0498-03
Status: Terminated
Initiated: 2002-12-17
Posted: 2003-01-30
Terminated: 2016-01-28
Recalling firm: Haemonetics Corporation
Product: Haemonetics Cell Saver 5 Fast Pack List Number: 260
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: 15,150
Distribution: Nationwide Canada
Product codes and lots: JJ02013 JJ02016 JJ02019 JJ02020 KK02002 KK02004 KK02005 KK02006 KK02007 KK02008 KK02013 KK02016 KK02017 KK02019 KK02021 KK02023 KK02025 LL02002 LL02005 LL02007 LL02008 LL02010 LL02011 LL02013 LL02014 LL02016 LL02017 LL02021 LL02023 LL02024 MM02001 MM02002 MM02003 MM02004 MM02005 MM02006

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)