Flamingo Funnel Large surgical smoke evacuation device recall
SurgiSmoke Solutions is recalling certain lots of the Flamingo Funnel Large (Model SQ20012-03) surgical device due to a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a manufacturing nonconformance with sterilization compatibility, which presents a potential risk but is classified as moderate because the source states no adverse health consequences have been documented.
Plain-English summary
SurgiSmoke Solutions is recalling certain lots of the Flamingo Funnel Large, Model Number SQ20012-03, a surgical smoke evacuation device. The recall is due to a manufacturing nonconformance involving the use of a non-gamma sterilization compatible drape.
The affected product (UDI-DI: 408882777851966; Lot 8264501) was distributed worldwide and within the United States in California, Colorado, Georgia, Massachusetts, Maryland, Maine, Minnesota, New Hampshire, New York, Ohio, Tennessee, Texas, and Utah, as well as in Canada. A total of 2,505 units were involved in this recall.
Patients or healthcare providers who have this product should contact SurgiSmoke Solutions for information on how to proceed. Healthcare facilities should review their inventory to identify affected units and take appropriate action.
The recalled product
- Product
- Flamingo Funnel Large, Model Number SQ20012-03
- Manufacturer
- SurgiSmoke Solutions
- Hazard
- sterilization-compatibility
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 408882777851966
- Lot 8264501
Distribution
Distributed nationwide across the United States.
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