U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Sealant,polymerizing - Product Code NBE
원인
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.
조치
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.
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.