Date Initiated by Firm |
April 09, 2009 |
Date Posted |
June 24, 2009 |
Recall Status1 |
Terminated 3 on November 01, 2010 |
Recall Number |
Z-1504-2009 |
Recall Event ID |
51817 |
510(K)Number |
K070917
|
Product Classification |
insulin syringe - Product Code FMF
|
Product |
AccuSure, U-100 31 Gauge, 1cc Insulin Syringe, 5/16" (8mm) Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-7002-2 |
Code Information |
Lot A07001, exp 07/2012 |
Recalling Firm/ Manufacturer |
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals 120 Vintage Dr Ne Huntsville AL 35811-8216
|
For Additional Information Contact |
Mr. Larry Kass 256-859-2222
|
Manufacturer Reason for Recall |
Needles separate from the barrel of the syringes.
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
On 04/09/2009, Qualitest issued a press release and sent out recall notifications to their consignees by US Mail. The recall was extended to the User level. Qualitest will send a second letter to all non-responders after thirty days. Thirty days after the second letter, Qualitest will perform a recall effectiveness check by telephone on a percentage of non-responders (in accordance with FDA request). |
Quantity in Commerce |
559,500 syringes |
Distribution |
Nationwide. |
Total Product Life Cycle |
TPLC Device Report
|
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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 = FEEL TECH
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