Haemonetics cardioPAT Cardiovascular - autotransfusion System Catalog Number: 02050-US
FDA device recall Z-1391-2011 · posted 2011-02-22 · Terminated
Recall details
- Recalling firm
- Haemonetics Corporation
- 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.
- 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
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- CAC
- Quantity affected
- 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 S
- Date initiated
- 2011-01-25
- Date posted
- 2011-02-22
- Date terminated
- 2013-01-14
- Location
- Braintree, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT) (K053000) | Haemonetics Corp. | 2005-11-21 |