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Water Trap
ENTER MEDICAL CORPORATION · Model ENT-2013 · UDI-DI 04719872104124
BYH
Prescription
10
510(k) clearances
39
Adverse events (3 deaths)
2
Recalls
63
Facilities
Description
A non-sterile device intended to be integrated within a breathing circuit
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2004-07-12 | Medex Inc | The non-rebreathing masks and watertraps were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containinig latex. |
| 2004-07-12 | Medex Inc | The non-rebreathing masks and watertraps were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containinig latex. |
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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.