Recall Z-2454-2012— Neomend Inc
Class II · Terminated
Class II FDA medical device recall by Neomend Inc, initiated 2012-08-13, terminated 2012-09-25. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- Neomend Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-08-13
- Terminated
- 2012-09-25
- Firm location
- Irvine, CA, United States
Product 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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.