Date Initiated by Firm |
January 27, 2007 |
Date Posted |
March 03, 2007 |
Recall Status1 |
Terminated 3 on July 24, 2007 |
Recall Number |
Z-0582-2007 |
Recall Event ID |
37248 |
510(K)Number |
k023752
|
Product Classification |
Insulin Syringe - Product Code FMF
|
Product |
BD Integra 1ml Insulin Syringe with Retracting Precision Guide Needle 1 ml 29g 1/2'' (0.33mm x 13 mm) Re-Order No. 305282 U-100 insulin Lot 6073436 |
Code Information |
Lot # 6073436 Ref (Reorder number) 305282) |
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 needle becomes detached from the hub/syringe
|
FDA Determined Cause 2 |
Other |
Action |
Recall notification letters were sent via UPS second day air on January 27, 2007. Distributors were asked to provide end user contact information to recalling firm. |
Quantity in Commerce |
247,824 units |
Distribution |
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 = FMF and Original Applicant = BD
|