Recall Z-0572-03 ยท FXX Mask, Surgical
Dynarex Corporation
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 ca
| Date | Feb 25, 2003 (initiated Dec 31, 2002) |
| Status | Terminated |
| Reason | Product labeled as 'latex free' but recent tests indicate that it contains minute amounts of latex. |
| Root cause | Other |
| Quantity | 1937 cases (50 masks per box, 12 boxes per case) |
| Distribution | Medical/dental supply distributors nationwide and Puerto Rico, and 2 foreign accounts in the Bahamas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.