| Date Initiated by Firm | December 01, 2005 |
|---|
| Date Posted | January 11, 2006 |
|---|
| Recall Status1 |
Terminated 3 on April 30, 2007 |
| Recall Number | Z-0372-06 |
|---|
| Recall Event ID |
34204 |
| 510(K)Number | K011984 |
|---|
| Product Classification |
Container, Empty, For Collection & Processing Of Blood & Blood Components - Product Code KSR
|
| Product | BD Vacutainer Push Button Blood Collection Set with Pre-Attached holder. |
|---|
| Code Information |
Catalog # -- Lot #: 367352 -- 5188576; 367352 -- 5208448; 367352 -- 5217290; 368656 -- 5164491; 368656 -- 5164526; 368656 -- 5187894; 368656 -- 5192496; 368656 -- 5220204; 368656 -- 5238936. |
| FEI Number |
2243072
|
Recalling Firm/
Manufacturer |
Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
|
| For Additional Information Contact | Kevin Nolan
201-847-5651 |
|---|
Manufacturer Reason
for Recall | Cracked finger grip luer adapter components on the Push Button Blood Collection Set. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Recall notification was sent out to the customers on 12/5/2005. |
|---|
| Quantity in Commerce | 118200 each |
|---|
| Distribution | The device was shipped to 23 wholesalers, 5 hospitals, and 1 VA govt. account nationwide. |
|---|
| 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 = KSR
|
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