FDAFDA · Food and drugs·Recall number Z-1527-2014
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.
Published May 7, 2014 · Recall initiated: April 7, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a component failure in the device handle.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Laurimed LLC
- Distributor
- Distributed in the states of CA, VT, NC, DO, TX, FL, PA, OR, AZ, IL, ID, and VA.
- Lot
- Lot Number: LFG-111813-1; Expiry date: June 2014; LFG020614-01, Expiry date: September 2014.
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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