Z-2454-2012 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 3, 2012
- Initiation Date
- August 13, 2012
- Termination Date
- September 25, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 95 units
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.
Distribution Pattern
US Nationwide Distribution
Code Information
Model #: PGPS002 Lot #: 111202-002