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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 Recall
Progel Pleural Air Leak Sealant
see related information
Date Posted September 25, 2012
Recall Status1 Terminated on September 25, 2012
Recall Number Z-2454-2012
Recall Event ID 63156
Premarket Approval
PMA Number
P010047
Product Classification Sealant,Polymerizing - Product Code NBE
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.
Code Information Model #: PGPS002 Lot #: 111202-002
Recalling Firm/
Manufacturer
Neomend Inc
60 Technology Dr
Irvine, California 92618-2301
Consumer Instructions Contact the recalling firm for information
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
EXPIRATION DATING: Incorrect or No Expiration Date
Action Neomend 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 Commerce 95 units
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = NBE and Applicant = NEOMEND, INC.
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