Z-0174-06

cardioPAT Cardiovascular Perioperative Autotransfusion System, Model: LN 2050-110-E and Disposables...

Name: Z-0174-06 cardioPAT Cardiovascular Perioperative Autotransfusion System, Model: LN 2050-110-E and Disposables...
Creator: Haemonetics Corporation
Published: 2005-07-22
License: https://open.fda.gov/license/

Haemonetics Corporation / initiated 2005-07-22 / Terminated

FDA source

Haemonetics Corporation began a recall of cardioPAT Cardiovascular Perioperative Autotransfusion System, Model: LN 2050-110-E and Disposables: cardioPAT Replacement RBC Bags, LN 00270 cardioPAT... on 2005-07-22. The reason FDA records is "Blood clotting of patient post operative while on the cardioPAT Cardiovascular Perioperative Autotransfusion System". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0174-06
Status: Terminated
Initiated: 2005-07-22
Posted: 2005-11-23
Terminated: 2012-05-24
Recalling firm: Haemonetics Corporation
Product: cardioPAT Cardiovascular Perioperative Autotransfusion System, Model: LN 2050-110-E and Disposables: cardioPAT Replacement RBC Bags, LN 00270 cardioPAT Replacement Waste Bags, LN 00271 cardioPAT Replacement Intraoperative Suction Set, LN 00272 cardioPAT Replacement Postoperative Suction Set, LN 00273 cardioPAT cardiovascular Perioperative Autotransfusion System Disposable Set, LN 00274 cardioPAT Replacement One-Way Valve Assembly LN 00275
Product code: CAC Apparatus, Autotransfusion
Reason for recall: Blood clotting of patient post operative while on the cardioPAT Cardiovascular Perioperative Autotransfusion System
FDA root cause: Other
Action: Haemonetics issued a recall notification via Certified Mail on 7/22/05 to four user sites requesting return of the machine and all disposables received.
Quantity in commerce: 4 machines and 486 disposables
Distribution: CA, MN, NE, TX
Product codes and lots: All lot numbers

Product code CAC

K043127Class IIHaemonetics Cardiovascular Perioperative Autotransfusion SystemHaemonetics Corp. / cleared 2005-01-04

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)