FDA recall Z-2052-2018

Hobbs Medical, Inc. · Class II · device

Product

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.

Distribution

US Nationwide Distribution to states of: AZ, CA, GA, IL, MD, NY, TN, TX, and VA.

Key facts

Status
Terminated
Initiation date
2018-05-01
Report date
2018-06-13
Termination date
2020-04-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Stafford Springs, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2052-2018