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Orasoothe Oral Coating Rinse 4oz – Hygiene
SEPTODONT SAS SPECIALITES SEPTODONT · Model 01S0630 · UDI-DI 00303620002103
NAE
Prescription
10
510(k) clearances
105
Adverse events
6
Recalls
304
Facilities
Description
dressing wound
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-02-11 | Nelson Innovaions, Llc | Foreign material near or along the edge of the hydrogel adhesive within the pouch packaging |
| 2018-08-22 | Safe N Simple, LLC | The sterilization process used was unqualified. |
| 2018-08-22 | Safe N Simple, LLC | The sterilization process used was unqualified. |
| 2016-09-01 | CellEra LLC | Adhesive border was not sticky enough. |
| 2015-09-30 | O-Two Medical Technologies, Inc. | For lack of evidence to validate effectiveness of sterilization dose, O-Two Medical Technologies Inc. hereby announces a voluntary medical device recall of the suspected batches o |
| 2006-11-09 | Embeem Inc. | Foreign material- this device, a sterile wound care product, was found to be contaminated with clumps of brown/black foreign material |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.