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DentalJect Canister
Vapocoolshot, Inc · Model DJ03000-01 · UDI-DI 00860010587348
MLY
Prescription
1
510(k) clearances
24
Adverse events (2 deaths)
7
Recalls
19
Facilities
Description
DentalJect Oral Topical Anesthetic Canister; (40gm), One each
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2008-09-03 | Gebauer Company | Some units of Fluro-Ethyl containing the defective valve which could malfunction and spray refrigerant out from the side of the valve in addition to or instead of spraying in the n |
| 2007-04-17 | Gebauer Company | Mold contamination |
| 2007-04-17 | Gebauer Company | Mold contamination |
| 2007-04-17 | Gebauer Company | Mold contamination |
| 2007-04-17 | Gebauer Company | Mold contamination |
| 2007-04-17 | Gebauer Company | Mold contamination |
| 2007-04-17 | Gebauer Company | Mold contamination |
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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.