Ear Loop Procedure Masks, For one time use only, Glass-Free, Reorder No. 2201, packed in a cardboard box (unit box). Manufactured for dynarex Corporation, Brewster, NY 10509. 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 12 boxes are placed into one shipping carton/case.
FDA Recall Z-0572-03 · Posted 2003-02-25
Recalling FirmDynarex Corporation
Recall StatusTerminated
Product CodeFXX
Date Initiated2002-12-31
Date Terminated2012-08-30
Product Quantity1937 cases (50 masks per box, 12 boxes per case)
Reason for Recall
Product labeled as 'latex free' but recent tests indicate that it contains minute amounts of latex.
Root Cause
Other
Distribution Pattern
Medical/dental supply distributors nationwide and Puerto Rico, and 2 foreign accounts in the Bahamas.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.