Recall Z-0711-2022— Hobbs Medical, Inc.

Name: FDA recall Z-0711-2022
Creator: U.S. Food and Drug Administration
Published: 2021-12-28

Class II · Ongoing

Class II FDA medical device recall by Hobbs Medical, Inc., initiated 2021-12-28. It names one FDA 510(k) clearance: K893729. 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: 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..

Recalling firm: Hobbs Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-12-28
Firm location: Stafford Springs, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K893729 — HOBBS MEDICAL MICROBIOLOGY BRUSHHobbs Medical, Inc.·cleared 1989-08-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.