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Nexpowder
NEXTBIOMEDICAL CO., LTD. · Model NHS02 · UDI-DI 08800038405332
QAU
Prescription
10
510(k) clearances
1,077
Adverse events (9 deaths)
7
Recalls
18
Facilities
Description
Nexpowder is used for hemostasis of nonvariceal gastrointestinal bleeding.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-10-31 | Wilson-Cook Medical Inc. | Specific lots of product have been manufactured with nonconforming raw materials resulting in the red activation knob cracking or breaking at the activation knob internal threading |
| 2024-08-29 | Wilson-Cook Medical Inc. | Specific lots of product have been manufactured with nonconforming raw materials. |
| 2023-05-22 | Wilson-Cook Medical Inc. | There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or |
| 2023-05-22 | Wilson-Cook Medical Inc. | There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or |
| 2020-02-04 | Wilson-Cook Medical Inc. | Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when the device is activated. In some cases, this has caused the carbon dioxide cartrid |
| 2020-02-04 | Wilson-Cook Medical Inc. | Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when the device is activated. In some cases, this has caused the carbon dioxide cartrid |
| 2019-07-24 | Wilson-Cook Medical Inc. | Potential for Hemospray device to be unable to spray powder due to misassembly of devices. |
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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.