FDA recall Z-0711-2022

Hobbs Medical, Inc. · Class II · device

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.

Reason for recall

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.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2021-12-28
Report date
2022-03-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Stafford Springs, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0711-2022