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Sources: EU EUDAMED, US FDA
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FDA Recall
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SteriLyte Liquid Bicarbinate, Formula CL-02; 1 gallon (3.78 L); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051. This product is used in conjunction with C-Series RenalPure Liquid Acid Concentrate or DC-Series Dri-Sate Dry Acid Concentrate in artificial kidney (hemodialysis) machines.
FDA Recall
Terminated
·Rockwell Medical Technologies, Inc·Product code KPO·September 29, 2008
SteriLyte Liquid Bicarbinate, Formula RL-01; 1 gallon (3.78 L); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051. This product is used in conjunction with C-Series RenalPure Liquid Acid Concentrate or DC-Series Dri-Sate Dry Acid Concentrate in artificial kidney (hemodialysis) machines.
FDA Recall
Terminated
·Rockwell Medical Technologies, Inc·Product code KPO·September 29, 2008
Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)
FDA Recall
Open, Classified
·Pacific Medical Group Inc.·Product code FRN·March 24, 2021
Pacific Medical Philips M1355A Toco Transducer with belt wire/knob, FFPH3250
FDA Recall
Open, Classified
·Pacific Medical Group Inc.·Product code HGM·September 19, 2019
Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660
FDA Recall
Open, Classified
·Pacific Medical Group Inc.·Product code HGM·September 19, 2019
Pacific Medical Philips M1356A Ultrasound Transducer with belt/wire knob, FFPH5250
FDA Recall
Open, Classified
·Pacific Medical Group Inc.·Product code HGM·September 19, 2019
Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX, FFCM5260
FDA Recall
Open, Classified
·Pacific Medical Group Inc.·Product code HGM·September 19, 2019
Pacific Medical GE Corometrics Nautilus Toco Transducer w/knob, 2264HAX, FFCM3205
FDA Recall
Open, Classified
·Pacific Medical Group Inc.·Product code HFM·September 19, 2019
Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob, 5700HAX, FFCM5205
FDA Recall
Open, Classified
·Pacific Medical Group Inc.·Product code HGM·September 19, 2019
Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260
FDA Recall
Open, Classified
·Pacific Medical Group Inc.·Product code HFM·September 19, 2019