Class 2 Device Recall AccuSure U100 31 Gauge, 1cc

• Date Initiated by Firm: October 27, 2009
• Date Posted: December 28, 2009
• Recall Status: Terminated on November 24, 2010
• Recall Number: Z-0576-2010
• Recall Event ID: 53709
• 510(K)Number: K080904 K021197
• 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 0603-7002-21
• Code Information: all lots
• Recalling Firm/ Manufacturer: Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals; 120 Vintage Dr NE; Huntsville AL 35811-8216
• For Additional Information Contact: Larry Kass; 256-859-4011
• Manufacturer Reason for Recall: Needles are becoming dislodged from the barrels.
• FDA Determined Cause: Other
• 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: 97,045 cartons of 100
• 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 = FEEL TECH; 510(K)s with Product Code = FMF and Original Applicant = HOSUK CO., LTD.