Progel Pleural Air Leak Sealant — Class II medical device recall Z-2454-2012
Terminated recall by Neomend Inc, reported 2012-10-03, distributed nationwide. Product was distributed with an incorrect expiration date. Product was labeled with an expiration date of 2013
| Recall number | Z-2454-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Neomend Inc, Irvine, CA, United States |
| Recall initiated | 2012-08-13 |
| Classified | 2012-09-25 |
| Reported by FDA | 2012-10-03 |
| Terminated | 2012-09-25 |
| Distributed | Nationwide (US) |
| Quantity | 95 units |
| Reason classes | labeling |
| Lot numbers | 111202-002 |
| Model numbers | PGPS002 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2454-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.