UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT Plus. Product Usage: The UltraSeal XT Plus i
FDA device recall Z-0704-2017 · posted 2016-12-03 · Terminated
Recall details
- Recalling firm
- Ultradent Products, Inc.
- Reason for recall
- There was a labeling error with product, UltraSeal XT Plus Clear Refill, Part Number (PN) 565, Lot Number (Lot) BD79T. The package was mislabeled as PQ1, PN 641; while the barcode, IFU and products were labeled for UltraSeal XT Plus Clear Refill, PN 565, Lot BD79T.
- Action taken
- Consignees notified via phone on 17Nov2016 and by letter on 22Nov2016 to identify and return products. Consignees with any questions regarding this field action can be sent to 801-553-4858 or 801-553-4220.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- EBC
- Quantity affected
- 31
- Distribution
- Worldwide Distribution - US Nationwide
- Date initiated
- 2016-11-17
- Date posted
- 2016-12-03
- Date terminated
- 2017-06-05
- Location
- South Jordan, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ULTRASEAL XT PLUS (K993846) | Ultradent Products, Inc. | 2000-02-16 |