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U.S. Department of Health and Human Services

Class 2 Device Recall AccuSure

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  Class 2 Device Recall AccuSure see related information
Date Initiated by Firm August 21, 2009
Date Posted September 24, 2009
Recall Status1 Terminated 3 on November 24, 2010
Recall Number Z-2247-2009
Recall Event ID 52849
510(K)Number K021197  
Product Classification Insulin Syringe - Product Code FMF
Product AccuSure, U-100, 31Gauge, 1/2cc Insulin Syringe, 5/16" (8mm), Short Needle, NDC 0603-7001-21, packaged 10 syringes per package, 10 packages per carton
Code Information Lot 6JCB1
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 37,340 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.
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