Recall Z-1391-2011 · CAC Apparatus, Autotransfusion
Haemonetics Corporation
Haemonetics cardioPAT Cardiovascular - autotransfusion System Catalog Number: 02050-US
| Date | Feb 22, 2011 (initiated Jan 25, 2011) |
| Status | Terminated |
| Reason | 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 | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053000 | HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT) Haemonetics Corp., Nov 21, 2005 |