Recall Z-2052-2018 ยท FDX Endoscopic Cytology Brush
Hobbs Medical, Inc.
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 cytological analysis.
| Date | May 1, 2018 |
| Status | Terminated |
| Reason | Device was marketed for uses outside the 510(k) clearance. |
| Root cause | Labeling False and Misleading |
| Action | The firm, Hobbs Medical, Inc., sent an "Voluntary Medical Device Recall Advisory Notice" letter to customers on 5/1/18. The letter described the product, problem and actions to be taken. Our records indicate that you have received the following Bronchial Cytology Brushes since the beginning of 2018: Please complete the quantity used and quantity returned section of the attached form and you may voluntarily return any unused device(s) referencing Return Authorization Number. Hobbs Medical will credit your account in a timely fashion. f you have any questions, please contact customer service |
| Quantity | 1820 devices |
| Distribution | US Nationwide Distribution to states of: AZ, CA, GA, IL, MD, NY, TN, TX, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K834402 | GASTROINTESTINAL SHEATH BRUSH Hobbs Medical, Inc., Feb 4, 1984 |