Z-2956-2011

Haemonetics cardioPAT -Cardiovascular Perioperative Autotransfusion System Model 2050 US Models Out-Side the...

Name: Z-2956-2011 Haemonetics cardioPAT -Cardiovascular Perioperative Autotransfusion System Model 2050 US Models Out-Side the...
Creator: Haemonetics Corporation
Published: 2011-07-27
License: https://open.fda.gov/license/

Haemonetics Corporation / initiated 2011-07-27 / Terminated / root cause: design

FDA source

Haemonetics Corporation began a recall of Haemonetics cardioPAT -Cardiovascular Perioperative Autotransfusion System Model 2050 US Models Out-Side the US: 02050-UK, 02050-ES, 02050-IT, 02050-NL... on 2011-07-27. The reason FDA records is "Updated Operations Manual for the deployment of the spill collection system and cleaning". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2956-2011
Status: Terminated
Initiated: 2011-07-27
Posted: 2011-08-05
Terminated: 2014-06-09
Recalling firm: Haemonetics Corporation
Product: Haemonetics cardioPAT -Cardiovascular Perioperative Autotransfusion System Model 2050 US Models Out-Side the US: 02050-UK, 02050-ES, 02050-IT, 02050-NL, 02050-GE, 02050-FR, 02050-JA The Haemonetics Cardiovascular Perioperative Autotransfusion System for Use (cardioPAT) is indicated for use to salvage red blood cells from blood lost intraoperatively and postoperatively during cardiovascular surgical procedures, where the expected rate of processing of salvaged blood and fluid aspirated from the surgical site is less than or equal to two liters per hour.
Product code: CAC Apparatus, Autotransfusion
Reason for recall: Updated Operations Manual for the deployment of the spill collection system and cleaning
Root cause tag: design
FDA root cause: Component design/selection
Action: Haemonetics sent a "FIELD NOTIFICATION: UPDATE OF CardioPAT OPERATIONS MANUAL FOR DEPLOYMENT OF SPILL COLLECTION BAG AND CLEANING" letter dated July 27, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter requests that customers complete an enclosed Customer Confirmation sheet indicating that the affected devices are in their possession and to return the sheet via fax to Haemonetics at 781-987-9252. Additionally, instructions for deployment of the spill collection drainage system, revised Operations Manual and Quick Reference Guide Addendum are enclosed with the letter. Contact Haemonetics at 1-800-537-2802 for questions regarding this notice..
Quantity in commerce: 316 units
Distribution: Worldwide Distribution--USA (nationwide) and the countries of Canada, France, Germany, Great Britain, Italy, Japan, Spain, and The Netherlands.
Product codes and lots: All serial numbers

Product code CAC

K053000Class IIHaemonetics Cardiovascular Perioperative Autotransfusion System (Cardiopat)Haemonetics Corp. / cleared 2005-11-21

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)