Z-0501-03

Haemonetics High Speed Cell Saver Bowl Set List Number: 263

Name: Z-0501-03 Haemonetics High Speed Cell Saver Bowl Set List Number: 263
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 High Speed Cell Saver Bowl Set List Number: 263 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-0501-03
Status: Terminated
Initiated: 2002-12-17
Posted: 2003-01-30
Terminated: 2016-01-28
Recalling firm: Haemonetics Corporation
Product: Haemonetics High Speed Cell Saver Bowl Set List Number: 263
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: 11302
Distribution: Nationwide Canada
Product codes and lots: J02115 J02131 J02142 J02150 J02162 G02081 G02086 G02092 G02103 G02133 G02141 H02007 H02015 H02024 H02038 H02102 H02108 H02120 H02147 H02157 H02165 H02239 H02249 J02032 J02040 J02049 J02058 J02061 J02076 J02172 J02194 J02208 K02015 K02027 K02037 K02045 K02056 K02066 K02139 K02161 K02171 K02208 K02217 K02224 K02236 L02002 L02049 L02059 L02093 L02103 L02113 L02144 L02163 L02199 M02002 M02010 M02014 M02022 M02027 M02035

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)