FDA Medical Device Recalls (openFDA)
Haemonetics Corporation: Haemonetics cardioPAT System, Product List Number 02050, Haemonetics Corporation, Braintree, MA 02184,(Cardiovascular Perioperative Autotransfusion)
- Recall number
- Z-0358-2008
- Recalling firm
- Haemonetics Corporation
- Product
- Haemonetics cardioPAT System, Product List Number 02050, Haemonetics Corporation, Braintree, MA 02184,(Cardiovascular Perioperative Autotransfusion)
- Status
- Terminated
- Initiated
- 2007-10-15
- Posted
- 2007-12-08
- Terminated
- 2012-03-19
- Reason
- Labeling (additional) use instructions: to clarify proper position of cardioPAT device and post-op line to prevent fluid build up from patient's chest
- Root cause
- Labeling design
- Action
- Haemonetics issued a Labeling suppplement to users via a Field Notification letter on October 15, 2007. Users are provide additional Directions for use for the Operator's Guide and Quick Reference Guide.
- Quantity
- 106 units
- Distribution
- Nationwide: USA including states of CA, CT, FL, IN, KY, MI, NC,NE, NH, PA, RI, SC,TX, and WA
- 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