Hobbs Medical, Inc. recalls Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained pe…
- Recall date
- May 1, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2052-2018
- FDA classification
- Class II
- Brand / firm
- Hobbs Medical, Inc.
- Sold / distributed
- US Nationwide Distribution to states of: AZ, CA, GA, IL, MD, NY, TN, TX, and VA.
Why it was recalled
Device was marketed for uses outside the 510(k) clearance.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What 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.
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