Recall Z-0944-03 ยท FXX Mask, Surgical
Safco Dental Supply Co. Inc.
Supergrade Earloop Masks, surgical mask; 50 masks per box; Distributed by Safco Dental Supply Co., Northbrook, IL 60062
| Date | Jun 21, 2003 (initiated Jun 3, 2003) |
| Status | Terminated |
| Reason | The product labeling incorrectly lists the particle filtration efficiency as exceeding 99% at 0.1 micron when it should state 95% filtration. |
| Root cause | Other |
| Action | Recalled by letter dated 5/30/03, informing the dentists that the earloop masks were mislabled with the wrong particle filtration efficiency. Correction labels were included with the letter for the dentists to field correct the boxes of masks in their office inventory. |
| Quantity | 60,000 boxes |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K801036 | SURGICAL MASK American Threshold Industries, Inc., Jun 4, 1980 |