Class 2 Device Recall dynarex brand Ear Loop Procedure Masks With Plastic Shield

• Date Initiated by Firm: December 31, 2002
• Date Posted: February 25, 2003
• Recall Status: Terminated on August 30, 2012
• Recall Number: Z-0573-03
• Recall Event ID: 25310
• Product Classification: Mask, Surgical - Product Code FXX
• Product: Ear Loop Procedure Masks With Plastic Shield, For one time use only, Glass-Free, Reorder No. 2202, packed in a cardboard box (unit box). Manufactured for dynarex Corporation, Orangeburg, NY 10962. Made in China. Product is labeled with a Latex-free symbol that states ''This product does not contain any natural rubber latex'' . A total of 50 masks are in one unit box, and 4 boxes are placed into one shipping carton/case.
• Code Information: Reorder No. 2202, Lot Number 14929, Barcode # 16784 22023
• Recalling Firm/ Manufacturer: Dynarex Corporation; 10 Glenshaw St; Orangeburg NY 10962
• Manufacturer Reason for Recall: Product labeled as 'latex free' but recent tests indicate that it contains minute amounts of latex.
• FDA Determined Cause: Other
• Quantity in Commerce: 396 cases (50 masks per box, 4 boxes per case)
• Distribution: Medical/dental supply distributors nationwide and Puerto Rico, and 2 foreign accounts in the Bahamas.
• 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.