| Date Initiated by Firm | December 17, 2003 |
|---|
| Date Posted | February 25, 2004 |
|---|
| Recall Status1 |
Terminated 3 on March 15, 2004 |
| Recall Number | Z-0549-04 |
|---|
| Recall Event ID |
28164 |
| 510(K)Number | K011984 |
|---|
| Product Classification |
Tubes, Vials, Systems, Serum Separators, Blood Collection - Product Code JKA
|
| Product | VACUTAINER Brand Push Button Blood Collection Sets. |
|---|
| Code Information |
Batch # 3218665 |
| FEI Number |
2243072
|
Recalling Firm/
Manufacturer |
Becton Dickinson & Company
1 Becton Dr
Franklin Lakes
NJ
07417-1815
|
| For Additional Information Contact | Mr. Kevin Nolan
201-847-5651 |
|---|
Manufacturer Reason
for Recall | A hole was noticed in the 'blister pack' that is used to package the device and provides the sterility barrier. Sterility could be compromised. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | BD Sales Organization directly contacted all customers with return instructions on December 22, 2003. All consignees responded. |
|---|
| Quantity in Commerce | 4400 |
|---|
| Distribution | The firm was able to determine that the product was distributed to 3 customers: Long Beach Memorial, Long Beach, CA; Potomac Hospital, Woodbridge Prince William, VA; and St. Joseph Hospital, Orange, CA. |
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| 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
|
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