Date Initiated by Firm |
August 21, 2009 |
Date Posted |
September 24, 2009 |
Recall Status1 |
Terminated 3 on November 24, 2010 |
Recall Number |
Z-2248-2009 |
Recall Event ID |
52849 |
510(K)Number |
K021197
|
Product Classification |
Insulin Syringe - Product Code FMF
|
Product |
AccuSure, U-100, 31Gauge, 1cc Insulin Syringe, 5/16" (8mm), Short Needle, NDC 0603-7002-21, packaged 10 syringes per package, 10 packages per carton |
Code Information |
Lot 7CPT1 |
Recalling Firm/ Manufacturer |
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals 120 Vintage Dr Ne Huntsville AL 35811-8216
|
For Additional Information Contact |
Larry Kass 256-319-4801
|
Manufacturer Reason for Recall |
Needles separate from the barrels of the syringes
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
The firm initiated the recall via a press release on 08/21/2009. They began notifying their consignees of the problem and the recall by letter on 08/21/2009. email: recallresponse@qualitestrx.com |
Quantity in Commerce |
16,520 boxes of 100 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 = HOSUK CO., LTD.
|