Drug recall
Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or…
FDA recall event 79903 · Class II · Hobbs Medical, Inc.
Key facts
| Event ID | 79903 |
|---|---|
| Recall numbers | Z-2052-2018 |
| Recalling firm | Hobbs Medical, Inc. |
| Product type | Devices |
| Products | Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained personnel through a flexible endoscope when brush cell samples are required for… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Device was marketed for uses outside the 510(k) clearance. |
| Initiation date | May 1, 2018 |
| Report date | Jun 13, 2018 |
| Termination date | Apr 10, 2020 |
| City | Stafford Springs |
| State | CT |
| Country | United States |
| FEI number | 1220592 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: