Class 2 Device Recall AccuSure Insulin Syringe, 1cc, 28 guage, 1/2"

• Date Initiated by Firm: June 14, 2005
• Date Posted: June 30, 2005
• Recall Status: Terminated on May 10, 2006
• Recall Number: Z-0942-05
• Recall Event ID: 32366
• Product Classification: Syringe, Piston - Product Code FMF
• Product: AccuSure Insulin Syringe, 1cc, 28 guage, 1/2'', packaged in boxes of 100, each containing 10 bundles of 10 syringes, disposable, NDC 0603-6996-21.
• Code Information: All codes
• FEI Number: 1039144
• Recalling Firm/ Manufacturer: Qualitest Pharmaceuticals Inc; 130 Vintage Drive; Huntsville AL 35811-8216
• For Additional Information Contact: Charles V. (Trey) Probst; 800-444-4011
• Manufacturer Reason for Recall: Labeling error. There is a possibility that 1cc syringes are labeled at 1/2cc on the plastic inner wrap holding bundles of 10 syringes.
• FDA Determined Cause: Other
• Action: The firm initiated the recall on June 14, 2005 with a press release and followed with a letter initially sent via fax and then by letter requesting return of the product and posting of a copy of the press release at the retail level.
• Quantity in Commerce: unknown
• 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.