Supergrade Earloop Masks, surgical mask; 50 masks per box; Distributed by Safco Dental Supply Co., Northbrook, IL 60062
FDA device recall Z-0944-03 · posted 2003-06-21 · Terminated
Recall details
- Recalling firm
- Safco Dental Supply Co. Inc.
- Reason for recall
- The product labeling incorrectly lists the particle filtration efficiency as exceeding 99% at 0.1 micron when it should state 95% filtration.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FXX
- Quantity affected
- 60,000 boxes
- Distribution
- Nationwide
- Date initiated
- 2003-06-03
- Date posted
- 2003-06-21
- Date terminated
- 2004-03-24
- Location
- Northbrook, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SURGICAL MASK (K801036) | American Threshold Industries, Inc. | 1980-06-04 |