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 Microdebrider
    • Catalog 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 2014
    • LFG020614-01
  • 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 14, 2014 · Data as of Sep 19, 4:49 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.