FDA Recall
Terminated
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.
Recall: Z-0572-03
·
Initiated December 31, 2002
Recall
- Recall Number
- Z-0572-03
- Event Number
- 25310
- Firm
- Dynarex Corporation
- FEI Number
- 2431014
- Product Code
- FXX
- Status
- Terminated
- Root Cause
- Other
- Initiated
- December 31, 2002
- Posted
- February 25, 2003
- Terminated
- August 30, 2012
- Address
- 10 Glenshaw St, Orangeburg, NY, 10962
Description
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.
Reason
Product labeled as 'latex free' but recent tests indicate that it contains minute amounts of latex.
Distribution
Medical/dental supply distributors nationwide and Puerto Rico, and 2 foreign accounts in the Bahamas.
Quantity
1937 cases (50 masks per box, 12 boxes per case)