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.
FDA Recall Z-2052-2018 · Posted None
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Recalling FirmHobbs Medical, Inc.
Recall StatusTerminated
Product CodeFDX
Date Initiated2018-05-01
Date Terminated2020-04-10
Product Quantity1820 devices
Reason for Recall
Device was marketed for uses outside the 510(k) clearance.
Firm 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 at 800-344-6227.
Root Cause
Labeling False and Misleading
Distribution Pattern
US Nationwide Distribution to states of: AZ, CA, GA, IL, MD, NY, TN, TX, and VA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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