Recall Z-2454-2012 ยท NBE Sealant, Polymerizing
Neomend Inc
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.
| Date | Sep 25, 2012 (initiated Aug 13, 2012) |
| Status | Terminated |
| 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. |
| Root cause | Incorrect or no expiration date |
| Action | 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 represen |
| Quantity | 95 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.