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AMSure® Aerosol Drainage System
AMSINO INTERNATIONAL, INC. · Model 1 · UDI-DI 10704411008187
BTC
Prescription
10
510(k) clearances
173
Adverse events (5 deaths)
7
Recalls
99
Facilities
Description
AMSure® Aerosol Drainage System 750 mL Drainage Bag with a Y Adaptor
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-04-17 | Draeger Medical, Inc. | Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. |
| 2023-04-17 | Draeger Medical, Inc. | Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces. |
| 2018-03-15 | Teleflex Medical Europe Ltd | These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause All |
| 2007-12-07 | Medline Industries Inc | Separation from Bushing: The breathing bag may separate from the bushing during use. |
| 2007-12-07 | Medline Industries Inc | Separation from Bushing: The breathing bag may separate from the bushing during use. |
| 2007-12-07 | Medline Industries Inc | Separation from Bushing: The breathing bag may separate from the bushing during use. |
| 2007-12-05 | Ventlab Corporation | During setup and potentially during procedures, the breathing bag can become separated from the taped bushing that is part of the breathing bag assembly. |
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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.