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Nebulizer(direct patient interface)
Chen Qian Electronic Commerce (Hangzhou) Co., Ltd. · Model WHQ-1902WH(408D) · UDI-DI 06973401840015
CAF
Prescription
1
510(k) clearances
3,131
Adverse events (43 deaths)
36
Recalls
191
Facilities
Description
This unit operates on standard AC power. Treatments are delivered quickly, safely, and conveniently, making this unit ideal for all ages.This nebulizer should be used under the supervision of a licensed physician and/or a respiratory therapist. With you physician and/or respiratory therapist, you will feel comfortable and confident knowing that you are obtaining the most effective inhalation treatments for your respiratory condition.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-08-04 | MEDLINE INDUSTRIES, LP - Northfield | Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers. |
| 2021-03-31 | Smiths Medical ASD Inc. | The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels. |
| 2018-08-29 | SANRAI INTERNATIONAL LLC | The product was designed for 120V usage and is being used in South Africa with 220V. There is a potential for the device to overheat and the mouthpiece can pop off. |
| 2017-09-05 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. |
| 2017-09-05 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. |
| 2017-09-05 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. |
| 2017-09-05 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. |
| 2017-09-05 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. |
| 2017-09-05 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. |
| 2017-09-05 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company | Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. |
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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.