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.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot Number: LFG-111813-1; Expiry date: June 2014; LFG020614-01, Expiry date: September 2014.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Laurimed LLC
Reason for Recall:
The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a component failure in the device handle.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

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

Distribution:

Distributed in: CA, VT, NC, DO, TX, FL, PA, OR, AZ, IL, ID, VA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1527-2014