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Neomend Inc recalls Progel Pleural Air Leak Sealant, Model #: PGPS002 Lot #: 111202-002 Product Usage: The Progel Pleural Air Leak Seal
Recalled October 3, 2012 · FDA recall Z-2454-2012 · Neomend
Hazard
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. · FDA Class II
Units
95 units
Sold at
US Nationwide Distribution
Description
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.
Product
Progel Pleural Air Leak Sealant, Model #: PGPS002 Lot #: 111202-002 Product Usage: The 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.
Manufacturer(s)
Neomend Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →