Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performed by compressing a spring as t

FDA device recall Z-0711-2022 · posted 2022-03-02 · Open, Classified

Recall details

Recalling firm

Hobbs Medical, Inc.

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.

Action taken

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 informed according to your internal notification procedures. 5. If any product listed below has been forwarded to another facility, contact that facility to arrange return. 6. Maintain awareness of this notice until all product listed above has been returned to Hobbs Medical. The following assistance is available: -For questions related to the issue or product replacement, please contact Hobbs Medical Customer Service. -For questions related to product return please contact Hobbs Medical Customer Service Return instructions are provided on the Acknowledgement Form. -For questions related to the Acknowledgement Form and its return, please contact Hobbs Customer Service at 1-800-344-6227

Root cause

No Marketing Application

Status

Open, Classified

Product code

FDX

Quantity affected

38,357 devices

Distribution

US Nationwide distribution.

Date initiated

2021-12-28

Date posted

2022-03-02

Location

Stafford Springs, CT

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