The EU notified body DEKRA out of Germany has temporarily suspended the CE certificates for Getinge HLS and PLS sets, starting this month.
The Swedish medtech company announced the suspension on Feb. 23. Health providers use the HLS and PLS for extracorporeal respiratory and/or cardiovascular support.
Getinge had already announced potential breaches in sterile packaging for the sets. It says it engaged in package design improvements and advanced testing of the packaging. The company said the goal was to ensure that the products were protected by a sterile barrier according to the applicable standards and requirements.
DEKRA, however, found that the documentation the company submitted over the initiatives did not demonstrate compliance with the essential requirements under the Medical Device Directive and applicable standards.
Said Getinge: “Getinge is aware of the severe situation this suspension puts on healthcare and critically ill patients. The company is in dialogue with authorities and working urgently to minimize the impact on patients. The extensive work is continuing to secure compliance with essential requirements. All affected customers will receive communication from Getinge.”
The company does not expect the financial impact of the suspension to be material.