cardioPAT Cardiovascular Perioperative Autotransfusion System, Model: LN 2050-110-E and Disposables: cardioPAT Replaceme
FDA device recall Z-0174-06 · posted 2005-11-23 · Terminated
Recall details
- Recalling firm
- Haemonetics Corporation
- Reason for recall
- Blood clotting of patient post operative while on the cardioPAT Cardiovascular Perioperative Autotransfusion System
- Action taken
- Haemonetics issued a recall notification via Certified Mail on 7/22/05 to four user sites requesting return of the machine and all disposables received.
- Root cause
- Other
- Status
- Terminated
- Product code
- CAC
- Quantity affected
- 4 machines and 486 disposables
- Distribution
- CA, MN, NE, TX
- Date initiated
- 2005-07-22
- Date posted
- 2005-11-23
- Date terminated
- 2012-05-24
- 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 (K043127) | Haemonetics Corp. | 2005-01-04 |