PlainRecalls
FDA Devices Moderate Class II Ongoing

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 handl

Reported: March 9, 2022 Initiated: December 28, 2021 #Z-0711-2022

Product Description

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.

Details

Recalling Firm
Hobbs Medical, Inc.
Units Affected
38,357 devices
Distribution
US Nationwide distribution.
Location
Stafford Springs, CT

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Hobbs Medical, Inc.. Units affected: 38,357 devices.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 9, 2022. Severity: Moderate. Recall number: Z-0711-2022.

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