Reported May 7, 2014 · Terminated
PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter. Sterile. Used…
Laurimed LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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: Laurimed LLC · 500 Arguello St · Redwood City, CA · 94063-1566
Is this the product you have?
PolypVac 3.5mm MicrodebriderCatalog Number FG-000016
- contents1 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
- Lot codes and dates
- Lot NumberLFG-111813-1
- Expiry date
June 2014LFG020614-01
- Expiry dateSeptember 2014
- Amount recalled
- 58
Where it was sold
Why it was recalled
The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a component failure in the device handle.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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