Z-0358-2008

Haemonetics cardioPAT System, Product List Number 02050, Haemonetics Corporation, Braintree, MA...

Name: Z-0358-2008 Haemonetics cardioPAT System, Product List Number 02050, Haemonetics Corporation, Braintree, MA...
Creator: Haemonetics Corporation
Published: 2007-10-15
License: https://open.fda.gov/license/

Haemonetics Corporation / initiated 2007-10-15 / Terminated / root cause: labeling and UDI

FDA source

Haemonetics Corporation began a recall of Haemonetics cardioPAT System, Product List Number 02050, Haemonetics Corporation, Braintree, MA 02184,(Cardiovascular Perioperative Autotransfusion) on 2007-10-15. The reason FDA records is "Labeling (additional) use instructions: to clarify proper position of cardioPAT device and post-op line to prevent fluid build up from patient's chest". 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-0358-2008
Status: Terminated
Initiated: 2007-10-15
Posted: 2007-12-08
Terminated: 2012-03-19
Recalling firm: Haemonetics Corporation
Product: Haemonetics cardioPAT System, Product List Number 02050, Haemonetics Corporation, Braintree, MA 02184,(Cardiovascular Perioperative Autotransfusion)
Product code: CAC Apparatus, Autotransfusion
Reason for recall: Labeling (additional) use instructions: to clarify proper position of cardioPAT device and post-op line to prevent fluid build up from patient's chest
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Haemonetics issued a Labeling suppplement to users via a Field Notification letter on October 15, 2007. Users are provide additional Directions for use for the Operator's Guide and Quick Reference Guide.
Quantity in commerce: 106 units
Distribution: Nationwide: USA including states of CA, CT, FL, IN, KY, MI, NC,NE, NH, PA, RI, SC,TX, and WA
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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)