Urgent Field Safety Notice For 6008 Caresystem By Fresenius Medical Care Ag & Co. Kgaa

Summary Fresenius Medical Care is issuing an urgent safety notice for the 6008 CAREsystem dialysis machine due to an unspecified safety concern. This is a Class I notice, which indicates a serious issue. The affected devices were distributed in Germany and the European Union.

Recalling firm
Fresenius Medical Care AG & Co. KGaA
Product
6008 CAREsystem
Reason
Urgent Field Safety Notice for 6008 CAREsystem by Fresenius Medical Care AG & Co. KGaA
Classification
Class I
Category
medical device recall
Country
Germany
Agency
BFARM
Recall date
2026-10-27
Status
Ongoing
Distribution
Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/265acb37-4cae-4775-913d-75deb9a05595