Reported Oct 3, 2012 · Terminated

Progel Pleural Air Leak Sealant, Model #: PGPS002 Lot #: 111202-002 Product Usage: The Progel Pleural Air Leak Sealant…

Neomend Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

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: Neomend Inc · 60 Technology Dr · Irvine, CA · 92618-2301

Is this the product you have?

  • Progel Pleural Air Leak Sealant, Model #: PGPS002 Lot #: 111202-002
  • Product UsageThe Progel Pleural Air Leak Sealant is indicated for application to visceral pleura during an open thoracotomy after standard visceral pleural closure with, for example, sutures or staples, of visible air leaks (;::2mm) incurred during open resection of lung parenchyma
Lot codes and dates
  • Model #: PGPS002 Lot #: 111202-002
Amount recalled
95 units

Where it was sold

  • Nationwide

Why it was recalled

Product was distributed with an incorrect expiration date. Product was labeled with an expiration date of 2013-04 and should have been labeled with 2012-09.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 25, 2012 · Data as of Sep 19, 6:13 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.