Class II — Neomend Inc
| Recalling firm | Neomend, Inc. |
|---|---|
| Registered facility | NEOMEND, INC. (the firm's only registered facility) |
| Classification | Class II |
| 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. |
| 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. |
| Quantity | 95 units |
| Distribution | US Nationwide Distribution |
| Initiated | 2012-08-13 |
| Classified | 2012-09-25 |
| Terminated | 2012-09-25 |
| Recall number | Z-2454-2012 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Neomend Inc (Z-2454-2012).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63156/
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