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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