FDA Medical Device Recalls (openFDA)
Haemonetics Corporation: Haemonetics cardioPAT Cardiovascular - autotransfusion System Catalog Number: 02050-US
- Recall number
- Z-1391-2011
- Recalling firm
- Haemonetics Corporation
- Product
- Haemonetics cardioPAT Cardiovascular - autotransfusion System Catalog Number: 02050-US
- Status
- Terminated
- Initiated
- 2011-01-25
- Posted
- 2011-02-22
- Terminated
- 2013-01-14
- 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.
- Lot, serial or model codes
- All serial numbers
- 510(k) numbers
- ["K053000"]
- PMA numbers
- not on file
- Product code
- CAC
- Firm FEI
- 1219343
- Firm city
- Braintree
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28