Haemonetics cardioPAT Cardiovascular - autotransfusion System Catalog Number: 02050-US
This recall has been terminated (originally issued February 22, 2011).
- Company
- Haemonetics Corporation
- Recall Initiated
- January 25, 2011
- Posted
- February 22, 2011
- Terminated
- January 14, 2013
- Recall Number
- Z-1391-2011
- Quantity
- 309 units
- Firm Location
- Braintree, MA
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
All serial numbers
Root Cause
Labeling design
Action Taken
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