SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US
FDA device recall Z-0035-2007 · posted 2006-10-12 · Terminated
Recall details
- Recalling firm
- Haemonetics Corporation
- Reason for recall
- Faulty circuit board may short circuit and cause electric shock to operator
- Action taken
- Haemonetics issued recall leters on July 28, 2006 via Certified Mail, Return Receipt. Users are requested to return unit for repair or replacement.
- Root cause
- Other
- Status
- Terminated
- Product code
- BTA
- Quantity affected
- 15 units
- Distribution
- AZ, CT, GA, NE, MS Austria, France, Taiwan
- Date initiated
- 2006-07-28
- Date posted
- 2006-10-12
- Date terminated
- 2006-10-24
- 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 |
|---|---|---|
| SMARTSUCTION HARMONY DEVICE (K052626) | Haemonetics Corp. | 2005-10-05 |