Date Initiated by Firm |
May 25, 2005 |
Date Posted |
July 28, 2005 |
Recall Status1 |
Terminated 3 on December 02, 2005 |
Recall Number |
Z-1058-05 |
Recall Event ID |
32165 |
510(K)Number |
K980987
|
Product Classification |
Syringe, Piston - Product Code FMF
|
Product |
#309604 -- 10 mL syringe |
Code Information |
309604 10 ML Syringe 5074833 |
Recalling Firm/ Manufacturer |
Becton Dickinson & Company 1 Becton Dr Franklin Lakes NJ 07417-1815
|
For Additional Information Contact |
Greg Morgan, 201-847-4344
|
Manufacturer Reason for Recall |
The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose.
|
FDA Determined Cause 2 |
Other |
Action |
BD contacted their customers via phone and overnight mail letter . End users were notified by overnight mail with confirmation of delivery. |
Quantity in Commerce |
409200 units |
Distribution |
BD distributed the syringes to 18 wholesalers/direct accounts nationwide. These further distributed the products to hospitals and clinics. |
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 = FMF and Original Applicant = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
|