Reported Mar 9, 2022 · Ongoing
Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performed by compressing a spring as…
Hobbs Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hobbs Medical, Inc. · 8 Spring St · Stafford Springs, CT · 06076-1505
Is this the product you have?
- 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.
- Lot codes and dates
- Affected lots were distributed in the United States from 1/18/2017 to 8/26/2021. These lots have expiration dates of 1/01/2022 through 12/01/2026. Catalog Number 4310, Package DI M84943100, Package DI Number M84943101; Catalog Number 4320, Package DI M84943200, Package DI Number M84943201
- Lot Numbers
456 of 456 codes
H12-16-112H12-16-113H12-16-114H01-17-002H01-17-003H01-17-004H01-17-005H01-17-101H01-17-134H01-17-135H01-17-136H02-17-044H02-17-045H02-17-046H02-17-047H02-17-048H03-17-113H03-17-114H03-17-115H03-17-116H03-17-117H03-17-233H03-17-234H03-17-235H03-17-236H03-17-237H03-17-238H05-17-119H05-17-120H05-17-121H05-17-122H05-17-123H05-17-124H06-17-142H06-17-143H06-17-144H06-17-145H07-17-112H07-17-113H07-17-114H07-17-115H08-17-127H08-17-128H08-17-129H08-17-130H08-17-131H08-17-269H08-17-270H08-17-271H08-17-272H08-17-273H09-17-102H09-17-103H09-17-104H10-17-053H10-17-056H10-17-057H10-17-058H10-17-059H10-17-060
- Amount recalled
- 38,357 devices
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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