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Single Use Cytology Brush
Zhejiang Chuangxiang Medical Technology Co., LTD. · Model MD-L-CB-1207-1006 · UDI-DI 06970401810697
FDX
Prescription
1
510(k) clearances
695
Adverse events (5 deaths)
5
Recalls
44
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-07-29 | Hobbs Medical, Inc. | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration |
| 2022-07-29 | Hobbs Medical, Inc. | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration |
| 2021-12-28 | Hobbs Medical, Inc. | The labeling for the Microbiology Brush identifies the device as a Bronchial Microbiology Brush. The device is only cleared for gastrointestinal use and is not cleared for bronchia |
| 2018-05-01 | Hobbs Medical, Inc. | Device was marketed for uses outside the 510(k) clearance. |
| 2006-10-12 | Ekos Corp | Carts distributed without an additional caution label directly on the cart, alerting users to tipping hazard. |
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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.