Recall Z-0711-2022 ยท FDX Endoscopic Cytology Brush
Hobbs Medical, Inc.
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 forc
| Date | Mar 2, 2022 (initiated Dec 28, 2021) |
| Status | Open, Classified |
| 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. |
| Root cause | No Marketing Application |
| Action | URGENT MEDICAL DEVICE RECALL notification letters were sent to customers beginning 12/28/21. Actions requested on your part: 1. Read the Description of the problem section. 2. Immediately identify and set aside all product listed herein in a manner that ensures the affected product will not be used and will be returned to Hobbs Medical. 3. Review, complete, and return the enclosed Acknowledgement Form directly to Hobbs Medical Customer Service, return via Fax at 860-684-7574, or email to CustomerService@HobbsMedical.com. 4. Pass on this notice to anyone in your facility that needs to be inf |
| Quantity | 38,357 devices |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K893729 | HOBBS MEDICAL MICROBIOLOGY BRUSH Hobbs Medical, Inc., Aug 28, 1989 |