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.
Reported: June 13, 2018 Initiated: May 1, 2018 #Z-2052-2018
Product Description
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.
Reason for Recall
Device was marketed for uses outside the 510(k) clearance.
Details
- Recalling Firm
- Hobbs Medical, Inc.
- Units Affected
- 1820 devices
- Distribution
- US Nationwide Distribution to states of: AZ, CA, GA, IL, MD, NY, TN, TX, and VA.
- Location
- Stafford Springs, CT
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Hobbs Medical, Inc.. Units affected: 1820 devices.
Why was this product recalled? ▼
Device was marketed for uses outside the 510(k) clearance.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 13, 2018. Severity: Moderate. Recall number: Z-2052-2018.
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