FDAFDA · Food and drugs·Recall number Z-2454-2012
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.
Published October 3, 2012 · Recall initiated: August 13, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Neomend Inc
- Distributor
- US Nationwide Distribution
- Lot
- Model #: PGPS002 Lot #: 111202-002
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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