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Laurimed LLC recalls PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter. Sterile. Used fo
Recalled May 7, 2014 · FDA recall Z-1527-2014 · Laurimed
Hazard
The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a component failure in the device handle. · FDA Class III
Units
58
Sold at
Distributed in the states of CA, VT, NC, DO, TX, FL, PA, OR, AZ, IL, ID, and VA.
Description
The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a component failure in the device handle.
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(s)
Laurimed LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →