Alerta De Seguridad para GDC Coils, Transform, Excelsior SL-10/Excelsior 1018 and Neuroform EZ Stent

Safety alert

2013-11-07

2013-11-07

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20131107.html

Medical device safety alert: stryker neurovascular gdc coils, transform, excelsior sl-10/excelsior 1018 and neuroform ez stent medical device manufacturer, stryker neurovascular has issued a medical device safety alert concerning gdc coils, transform, excelsior sl-10/excelsior 1018 and neuroform ez stent. an issue was noted within the global labeling software (gls) system in cork where the incorrect expiration date was assigned to printed production labels. the issue originated with an error in the code that handles updates to a work order on oracle (enterprise resource planning) that requires updates to gls. the code correctly updated the necessary data fields but incorrectly applied this update to all work order records in the database. this incorrect update was being applied to all records in the gls database every time an update record action was executed. the potential injuries from the use of expired products consist of local and systemic infections with sepsis (systemic blood infection) as the most serious adverse health consequence. stryker explains that all lots of manufactured products have two to three years of shelf live with the earliest expiration date of april 2015. the distribution of the products with incorrect expiration date occurred in the beginning of the products expected shelf live. therefore, all products released to the market remain within the expected expiration dates and patient injuries from the product use are unlikely. in addition, immediate action has been taken to add a step in the manufacturing process to verify expiration date printed on the labels. according to the local supplier, the affected products were distributed to hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 7 november 2013.