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. |
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 and Original Applicant = BECTON DICKINSON & CO.
|