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Hobbs Medical, Inc. recalls Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performed by compressing a spring as t
Recalled March 9, 2022 · FDA recall Z-0711-2022 · Hobbs Medical
Hazard
The labeling for the Microbiology Brush identifies the device as a Bronchial Microbiology Brush. The device is only cleared for gastrointestinal use and is not cleared for bronchial use. · FDA Class II
Units
38,357 devices
Sold at
US Nationwide distribution.
Description
The labeling for the Microbiology Brush identifies the device as a Bronchial Microbiology Brush. The device is only cleared for gastrointestinal use and is not cleared for bronchial use.
Product
Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performed by compressing a spring as the base of brush wire to expose the brush, scraping the desired surface, and releasing the compression on the spring which retracts the brush back into the sheath. A protector tip on the end of the brush prevent contamination of the sample during the endoscopy procedure. The force required to dislodge the tip from the bristle is greater than to break the brush wire at the handle body.
Manufacturer(s)
Hobbs Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →