Class 2 Device Recall AccuSure

• Date Initiated by Firm: April 09, 2009
• Date Posted: June 24, 2009
• Recall Status: Terminated 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: 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

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