Class II · Moderate risk
DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose
Lack of Sterility Assurance
77 recalls, newest first
Lack of Sterility Assurance
Non-Sterility
Non-Sterility
Non-Sterility
Non-Sterility
Non-Sterility
Non-Sterility
Non-Sterility
Non-Sterility
Non-Sterility
Non-Sterility
Non-Sterility
Non-Sterility
Non-Sterility
Non-Sterility
Non-Sterility
Non-Sterility
Non-Sterility
Non-Sterility
Non-Sterility
Non-Sterility
Non-Sterility
Non-Sterility
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.