Haemonetics Corporation Haemonetics cardioPAT System, Product List Number 02050, Haemonetics Corporation, Braintree, MA 02184,(Cardiovascular Perioperative Autotransfusion) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Haemonetics cardioPAT System, Product List Number 02050, Haemonetics Corporation, Braintree, MA 02184,(Cardiovascular Perioperative Autotransfusion)
Brand
Haemonetics Corporation
Lot Codes / Batch Numbers
All Serial numbers
Products Sold
All Serial numbers
Haemonetics Corporation is recalling Haemonetics cardioPAT System, Product List Number 02050, Haemonetics Corporation, Braintree, MA 0218 due to Labeling (additional) use instructions: to clarify proper position of cardioPAT device and post-op line to prevent fluid build up from patient's chest. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Labeling (additional) use instructions: to clarify proper position of cardioPAT device and post-op line to prevent fluid build up from patient's chest
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026