Getinge Life Support Sets CE Marks Suspended for Potential Sterile Packaging Breaches

The German-based certification organization DEKRA has temporarily suspended the CE certificates for Getinge’s HLS and PLS life support sets effective March 1 due to noncompliance with the EU’s Medical Device Directive.

The HLS tubes and PLS circuitry provide monitoring of extracorporeal respiratory or cardiovascular support in emergency rooms, intensive care units or during surgical procedures.

Getinge had identified that some of the life support sets could have damaged sterile packaging and issued urgent medical device field safety notices in July 2022. In the notice, the Swedish company introduced a field safety corrective action but said that no adverse events had been reported.

Getinge said it has submitted information on its progress in correcting the issues, however, DEKRA has determined that the documentation does not “demonstrate compliance with the essential requirements.”