Serum Blood Collection Tubes
FDA device recall Z-0086-06 · posted 2005-10-22 · Terminated
Recall details
- Recalling firm
- Greiner VACUETTE North America
- Reason for recall
- Serum Blood Collection tubes found with excess of Blood Clot Accelerator (BCA) solution.
- Action taken
- Consignees were notified by letter on 07/28/2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- JKA
- Quantity affected
- 1623 cases (1,947,600 pieces)
- Distribution
- Nationwide, Chile, Costa Rica, Ecuador, El Salvador, Nicaragua and Uruguay.
- Date initiated
- 2005-07-28
- Date posted
- 2005-10-22
- Date terminated
- 2005-11-16
- Location
- Monroe, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GREINER VACUTTE BLOOD COLLECTION TUBE W/ CLOT ACTIVATOR & GEL SEPARATOR (K960858) | Greiner America, Inc. | 1996-08-30 |