FDAClass IIIMay 7, 2014

PolypVac 3.5mm Microdebrider recall

PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter. Sterile. Used for the excision of polyps in the…

Why was PolypVac 3.5mm Microdebrider recalled?

The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a component failure in the device handle.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number: LFG-111813-1; Expiry date: June 2014; LFG020614-01, Expiry date: September 2014.

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…
Recalling firm
Laurimed LLC
Quantity
58
Distribution
Distributed in the states of CA, VT, NC, DO, TX, FL, PA, OR, AZ, IL, ID, and VA.
Recall date
May 7, 2014
Classification
Class III
Status
Terminated
Agency
FDA (device)
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