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U.S. Department of Health and Human Services

Class 2 Device Recall AccuSure U100 28 Gauge 1/2 cc

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 Class 2 Device Recall AccuSure U100 28 Gauge 1/2 cc see related information
Date Posted December 28, 2009
Recall Status1 Terminated on November 24, 2010
Recall Number Z-0569-2010
Recall Event ID 53709
510(K)Number K021197  K080904  K993017 
Product Classification Insulin Syringe - Product Code FMF
Product AccuSure, U-100 28 Gauge, 1/2cc Insulin Syringe, 1/2" Needles, Short Needle, packaged 10 syringes per package, 10 packages per carton, NDC 0603-6995-21. The device is intended to be used as an insulin syringe.
Code Information all lots
Recalling Firm/
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
120 Vintage Dr NE
Huntsville AL 35811-8216
For Additional Information Contact Larry Kass
Manufacturer Reason
for Recall
Needles are becoming dislodged from the barrels.
FDA Determined
Cause 2
Action The recall is being conducted to the Consumer level. A Press Release was issued on October 27, 2009 stating that Qualitest Pharmaceuticals was issuing a nationwide recall of all Accusure ¿¿ Insulin Syringes. The consignees were asked to post a copy of the press release in their retail stores and to alert patients of this action. Also, Recall Notifications were sent to all of the firm's consignees by First Class Mail on October 30, 2009. The consignees were instructed to notify their customers or sub accounts who may have been sold or dispensed the affected syringes starting in 2002, and to return the affected product. Questions are directed to the firm at telephone number 800-444-4011.
Quantity in Commerce 321,990 cartons of 100
Distribution Nationwide
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FMF and Original Applicant = HOSUK CO., LTD.
510(K)s with Product Code = FMF and Original Applicant = SHIN CHANG MEDICAL CO., LTD.