Class 3 Device Recall Liberty

• Date Initiated by Firm: February 24, 2003
• Date Posted: October 15, 2003
• Recall Status: Terminated on July 01, 2013
• Recall Number: Z-0003-04
• Recall Event ID: 25862
• 510(K)Number: K002921
• Product Classification: Syringe, Piston - Product Code FMF
• Product: Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
• Code Information: Lot # 2IE03
• FEI Number: 3003226337
• Recalling Firm/ Manufacturer: Liberty Medical Supplies; 10045 S Federal Hwy; Port Saint Lucie FL 349525607
• For Additional Information Contact: Mary Jo Thiboult; 800-762-8026
• Manufacturer Reason for Recall: The correct individual insulin syringe labeling size and guage may be different than what is on the incorrectly labeled shelf box .
• FDA Determined Cause: Process control
• Action: The firm mailed a recall letter to accounts on 2/25/2003 informing the user patients of the labeling error and requesting they examine all syringes they have received from Liberty Medical for the indicated lot numbers and to call the recalling firm, Libery Medical at 800-762-8026 for replacements. Also the letter contained a mailing label for the patient to return any recalled syringes.
• Quantity in Commerce: 9,472 boxes of 100 syringes each.
• Distribution: Product was distributed directly to 1352 patients nationwide. No international or government accounts are involved.
• 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