Drägerwerk AG & Co. KGaA has initiated a recall of its Dräger Carina Sub-Acute Care Ventilators to address potential contamination of the breathing gas with 1,3- Dichloropropan-2-ol, a biochemical constituent of the device’s sound insulating polyether polyurethane (PE-PUR) foam.
Drägerwerk subjected devices of different ages to biocompatibility tests to determine the long-term stability of the PE-PUR foam, the US Food and Drug Administration