Z-2454-2012Class II

Progel Pleural Air Leak Sealant, Model #: PGPS002 Lot #: 111202-002

Name: Z-2454-2012 Progel Pleural Air Leak Sealant, Model #: PGPS002 Lot #: 111202-002
Creator: Neomend Inc
Published: 2012-08-13
License: https://open.fda.gov/license/

Neomend Inc / initiated 2012-08-13 / Terminated / root cause: labeling and UDI

FDA source

Neomend Inc began a recall of Progel Pleural Air Leak Sealant, Model #: PGPS002 Lot #: 111202-002 Product Usage: The Progel Pleural Air Leak Sealant is indicated for application to visceral... on 2012-08-13. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2454-2012
Classification: Class II
Status: Terminated
Initiated: 2012-08-13
Posted: 2012-09-25
Terminated: 2012-09-25
Recalling firm: Neomend Inc
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.
Product code: NBE Sealant, Polymerizing
Reason for recall: 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 tag: labeling and UDI
FDA 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 representative.
Quantity in commerce: 95 units
Distribution: US Nationwide Distribution
Product codes and lots: Model #: PGPS002 Lot #: 111202-002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2454-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2454-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-03	2012-09-25

Product code NBE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)