Device 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.
Z-2454-2012
Product summary
- Firm
- Neomend Inc
- Event
- Event 63156
- Status
- Terminated
- Classification
- Class II
- Quantity
- 95 units
- Official record key
device-enforcement:Z-2454-2012
Official wording
Reason: 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.
Code information: Model #: PGPS002 Lot #: 111202-002
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
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.