Z-1391-2011

Haemonetics cardioPAT Cardiovascular - autotransfusion System Catalog Number: 02050-US

Name: Z-1391-2011 Haemonetics cardioPAT Cardiovascular - autotransfusion System Catalog Number: 02050-US
Creator: Haemonetics Corporation
Published: 2011-01-25
License: https://open.fda.gov/license/

Haemonetics Corporation / initiated 2011-01-25 / Terminated / root cause: labeling and UDI

FDA source

Haemonetics Corporation began a recall of Haemonetics cardioPAT Cardiovascular - autotransfusion System Catalog Number: 02050-US on 2011-01-25. The reason FDA records is "Update Instructions for Use for the CardioPAT® Manual for Leak Detection. User may mis-interpret the air-leak rate displayed by the cardioPAT device when making a determination about chest-drain removal, which could...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1391-2011
Status: Terminated
Initiated: 2011-01-25
Posted: 2011-02-22
Terminated: 2013-01-14
Recalling firm: Haemonetics Corporation
Product: Haemonetics cardioPAT Cardiovascular - autotransfusion System Catalog Number: 02050-US
Product code: CAC Apparatus, Autotransfusion
Reason for recall: Update Instructions for Use for the CardioPAT® Manual for Leak Detection. User may mis-interpret the air-leak rate displayed by the cardioPAT device when making a determination about chest-drain removal, which could result in the patient experiencing a pneumothorax.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Haemonetics issued a Field Correction Notice on 1/25/11 . with the Air Leak Detection addendum and index be inserted into the appropriate document, applied to all cardioPAT@ devices on site. The serial number for each cardioPAT device on site should be recorded on the attached acknowledgement and the completed acknowledgement should be returned to your Haemonetics Sales Consultant. A Haemonetics Sales Consultant will train on the content of these items and insert them into the Operator Manuals
Quantity in commerce: 309 units
Distribution: Worldwide distribution, including USA, Australia, Belgium, Canada, Switzerland, China, Germany, Finland, France, United Kingdom, Hong Kong, Israel, Italy, Japan, Netherlands, Russian Federation, and Sweden.
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)