Haemonetics cardioPAT System, Product List Number 02050, Haemonetics Corporation, Braintree, MA 02184,(Cardiovascular Pe
FDA device recall Z-0358-2008 · posted 2007-12-08 · Terminated
Recall details
- Recalling firm
- Haemonetics Corporation
- Reason for recall
- Labeling (additional) use instructions: to clarify proper position of cardioPAT device and post-op line to prevent fluid build up from patient's chest
- Action taken
- 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.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- CAC
- Quantity affected
- 106 units
- Distribution
- Nationwide: USA including states of CA, CT, FL, IN, KY, MI, NC,NE, NH, PA, RI, SC,TX, and WA
- Date initiated
- 2007-10-15
- Date posted
- 2007-12-08
- Date terminated
- 2012-03-19
- Location
- Braintree, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT) (K053000) | Haemonetics Corp. | 2005-11-21 |