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U.S. Department of Health and Human Services

Class 2 Device Recall Progel Pleural Air Leak Sealant

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 Class 2 Device Recall Progel Pleural Air Leak Sealantsee related information
Date Initiated by FirmAugust 13, 2012
Date PostedSeptember 25, 2012
Recall Status1 Terminated 3 on September 25, 2012
Recall NumberZ-2454-2012
Recall Event ID 63156
PMA NumberP010047 
Product Classification Sealant,polymerizing - Product Code NBE
ProductProgel 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.
Code Information Model #: PGPS002 Lot #: 111202-002
Recalling Firm/
Manufacturer		 Neomend Inc
60 Technology Dr
Irvine CA 92618-2301
For Additional Information Contact
949-916-1630 Ext. 101
Manufacturer 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.
FDA Determined
Cause 2		Incorrect or no expiration date
ActionNeomend 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 Commerce95 units
DistributionUS Nationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA DatabasePMAs with Product Code = NBE
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