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.
Recall
- Recall Number
- Z-2454-2012
- Event Number
- 63156
- Firm
- Neomend Inc
- FEI Number
- 3001237235
- Product Code
- NBE
- Status
- Terminated
- Root Cause
- Incorrect or no expiration date
- Initiated
- August 13, 2012
- Posted
- September 25, 2012
- Terminated
- September 25, 2012
- Address
- 60 Technology Dr, Irvine, CA, 92618-2301
Description
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.
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.
Neomend sent a Product Recall Notice letter dated August 13, 2012 to all affected customers. The notification letter identified the product affected, problem and actions to be taken. Customers were instructed to check their stock supply and ask the Central Supply Department to determine whether they have any unused product from the affected lot. If you do have unused units of this product follow the instructions provided. If you do not have any product with the affected lot number complete and return the enclosed TrackingVerification Form. For questions contact your Neomend sales representative.
US Nationwide Distribution
95 units