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U.S. Department of Health and Human Services

Class 2 Device Recall DressitX

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  Class 2 Device Recall DressitX see related information
Date Initiated by Firm November 18, 2015
Create Date December 23, 2015
Recall Status1 Terminated 3 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
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 2		 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.
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