LivaNova (NSDQ:LIVN) issued an urgent field safety notice concerning possible endotoxin contamination of unnamed surgical equipment related to anesthesia.
LivaNova has not publicly released which specific devices, or the lot numbers associated with the products, are affected by the safety notice.
The notice indicates that the company identified a number of products with endotoxin levels “greater than the one accepted as per specifications,” during routine internal in-process controls.
LivaNova said that by the time it had realized the devices were contaminated with too much endotoxins, some lots had already been released, according to the safety notice.
Despite higher levels of endotoxins, the company said it has not received any adverse event reports from the field related to the issue.
LivaNova, the company formed by the union of Sorin and Cyberonics last year, said it began notifying customers with potentially contaminated products of the issue in late January, instructing them to check their inventory and return any compromised products.
The post LivaNova warns on possible endotoxin contamination in anesthesia equipment appeared first on MassDevice.
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