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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall dynarex brand Ear Loop Procedure Masks With Plastic Shield see related information
Date Initiated by Firm December 31, 2002
Date Posted February 25, 2003
Recall Status1 Terminated 3 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 2		 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.
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