Laurimed Recalls PolypVac Microdebriders Due to Premature Mechanism Shutdown
Laurimed LLC is recalling 58 PolypVac 3.5mm Microdebriders because the reciprocation mechanism may turn off prematurely due to a component failure in the handle.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The hazard is a functional defect (premature shutdown) with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Laurimed LLC is recalling 58 units of the PolypVac 3.5mm Microdebrider, Catalog Number FG-000016. The device is sterile and used for the excision of polyps in the nasal passageways and sinuses. The recall includes two lots: LFG-111813-1 with an expiry date of June 2014, and LFG020614-01 with an expiry date of September 2014.
The recall was initiated because the reciprocation mechanism in the device may turn off prematurely due to a component failure in the device handle. This defect could interrupt the intended function of the microdebrider during use.
The affected units were distributed in the states of California, Vermont, North Carolina, Texas, Florida, Pennsylvania, Oregon, Arizona, Illinois, Idaho, and Virginia, as well as the U.S. territory of Puerto Rico. The source text does not report any illnesses, injuries, or deaths associated with this recall.
The recalled product
- Product
- PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter. Sterile. Used for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established.
- Manufacturer
- Laurimed LLC
- Hazard
- Affected units
- 58
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 (4)
- Lot Number: LFG-111813-1
- Expiry date: June 2014
- LFG020614-01
- Expiry date: September 2014.
Distribution
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