Class 2 Device Recall DressitX

• Date Initiated by Firm: November 18, 2015
• Create Date: December 23, 2015
• Recall Status: Terminated on May 02, 2016
• Recall Number: Z-0477-2016
• Recall Event ID: 72726
• Product Classification: Gauze/sponge, internal, x-ray detectable - Product Code GDY
• Product: Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingredients: Eugenol Oil
• Code Information: Lot - 5012, Exp-102016
• FEI Number: 3002654714
• Recalling Firm/ Manufacturer: Rainbow Specialty & Health Products; 3400 14th Ave, Unit #28; Markham Canada
• Manufacturer Reason for Recall: Rainbow Specialty & Health Products initiated a field action for Dressol-X and Dressit-X because the labeling does not currently list the percentage of drug components.
• FDA Determined Cause: Labeling design
• Action: Consignees have been made aware of the recall by FAX, e-mail and via telephone calls on 11/18/2015. Requested that distributors contact their clients, by telephone initially and then by email with written correspondence requesting them to recall the product from their clients.
• Quantity in Commerce: 150
• Distribution: Nationwide. No foreign, govt/VA/military consignees.
• 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.