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Ethox Medical
ETHOX MEDICAL, LLC · Model 450085003 · UDI-DI 10889483131091
KDH
Prescription
1
510(k) clearances
66
Adverse events (6 deaths)
2
Recalls
11
Facilities
Description
Gastric Lavage Kit with 3L Bag
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-02-23 | MEDLINE INDUSTRIES, LP - Northfield | Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2012-05-10 | MEDDEV USA, INC. | The device was marketed without a 510(k) and is not sterile. |
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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.