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Terminated

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

FDA Recall Z-1391-2011 · Posted 2011-02-22

Recalling FirmHaemonetics Corporation
Recall StatusTerminated
Product CodeCAC
Date Initiated2011-01-25
Date Terminated2013-01-14
Product Quantity309 units

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.

Firm 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

Root Cause

Labeling design

Distribution Pattern

Worldwide distribution, including USA, Australia, Belgium, Canada, Switzerland, China, Germany, Finland, France, United Kingdom, Hong Kong, Israel, Italy, Japan, Netherlands, Russian Federation, and Sweden.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K053000HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT)Haemonetics Corp. · 2005-11-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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