SmartInfuser Set, 5-15 ml/hr
Ambu A/S · Model 418000506 · UDI-DI 05707480119233
MEB
Prescription
1
510(k) clearances
33,422
Adverse events (58 deaths)
109
Recalls
24
Facilities
Description
Regulating Set 5-15, stand alone, complementary accessory (to be used with ACTion Block and ACTion Fuser ONLY)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-05-23 | Leventon S. A. U. | The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market. |
| 2018-10-02 | Arrow International Inc | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alte |
| 2018-10-02 | Arrow International Inc | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alte |
| 2018-10-02 | Arrow International Inc | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alte |
| 2018-10-02 | Arrow International Inc | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alte |
| 2018-10-02 | Arrow International Inc | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alte |
| 2018-10-02 | Arrow International Inc | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alte |
| 2018-10-02 | Arrow International Inc | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alte |
| 2018-10-02 | Arrow International Inc | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alte |
| 2018-10-02 | Arrow International Inc | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alte |
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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.