| Date Initiated by Firm | July 28, 2005 |
|---|
| Date Posted | October 22, 2005 |
|---|
| Recall Status1 |
Terminated 3 on November 16, 2005 |
| Recall Number | Z-0086-06 |
|---|
| Recall Event ID |
32826 |
| 510(K)Number | K960858 |
|---|
| Product Classification |
Tubes, Vials, Systems, Serum Separators, Blood Collection - Product Code JKA
|
| Product | Serum Blood Collection Tubes |
|---|
| Code Information |
Item #455071, Lot #B040513 and Item #455092, Lot #B040503 |
| FEI Number |
3001451379
|
Recalling Firm/
Manufacturer |
Greiner VACUETTE North America
4238 Capital Dr
Monroe
NC
28110-7681
|
| For Additional Information Contact | Manfred Pillichshammer
704-261-7823 |
|---|
Manufacturer Reason
for Recall | Serum Blood Collection tubes found with excess of Blood Clot Accelerator (BCA) solution. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Consignees were notified by letter on 07/28/2005. |
|---|
| Quantity in Commerce | 1623 cases (1,947,600 pieces) |
|---|
| Distribution | Nationwide, Chile, Costa Rica, Ecuador, El Salvador, Nicaragua and Uruguay. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
|
| 510(K) Database | 510(K)s with Product Code = JKA
|
|---|
