Class 2 Device Recall AccuSure

• Date Initiated by Firm: August 21, 2009
• Date Posted: September 24, 2009
• Recall Status: Terminated 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: 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