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DeRoyal
DEROYAL INDUSTRIES, INC. · Model 86-001801 · UDI-DI 00749756669986
OFP
Prescription
0
510(k) clearances
104
Adverse events (2 deaths)
33
Recalls
50
Facilities
Description
60 In EXP PEDI BREATHING CIRCUIT
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-03-12 | Draeger, Inc. | The potential for cracks forming in the breathing circuit hose. |
| 2025-03-12 | Draeger, Inc. | The potential for cracks forming in the breathing circuit hose. |
| 2025-03-12 | Draeger, Inc. | The potential for cracks forming in the breathing circuit hose. |
| 2025-03-12 | Draeger, Inc. | The potential for cracks forming in the breathing circuit hose. |
| 2025-03-12 | Draeger, Inc. | The potential for cracks forming in the breathing circuit hose. |
| 2021-01-29 | Draeger Medical, Inc. | Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder ventilation of the patient. |
| 2021-01-29 | Draeger Medical, Inc. | Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder ventilation of the patient. |
| 2021-01-29 | Draeger Medical, Inc. | Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder ventilation of the patient. |
| 2021-01-29 | Draeger Medical, Inc. | Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder ventilation of the patient. |
| 2020-11-11 | Intersurgical Inc | The device was assembled with the incorrect exhalation port which can cause gas leakage. |
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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.