9 results
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36ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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RenalPure Liquid Acid Concentrate R-006; One Gallon (3.78 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051.
FDA Recall
Terminated
·Rockwell Medical Technologies, Inc·Product code KPO·December 3, 2007
RenalPure Liquid Acid Concentrate R-235; One Gallon (3.78 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051.
FDA Recall
Terminated
·Rockwell Medical Technologies, Inc·Product code KPO·December 3, 2007
RenalPure Liquid Acid Concentrate R-259; One Gallon (3.78 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051.
FDA Recall
Terminated
·Rockwell Medical Technologies, Inc·Product code KPO·December 3, 2007
Glacial Acidic Acid (liquid component of Dri-Sate Dry Acid Concentrate DR-215); 1 quart (0.95 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051.
FDA Recall
Terminated
·Rockwell Medical Technologies, Inc·Product code KPO·December 3, 2007
Dri-Sate Glacial Acidic Acid (liquid component of Dri-Sate Dry Acid Concentrate DR-240); 1 quart (0.95 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051.
FDA Recall
Terminated
·Rockwell Medical Technologies, Inc·Product code KPO·December 3, 2007
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
DriSate¿ Product Code DR-145 The acid concentrate powders and liquids are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/monitor and bicarbonate concentrate.
FDA Enforcement
Class II
·Terminated·Rockwell Medical, Inc·May 23, 2018
DriSate Product Code DR-145 The acid concentrate powders and liquids are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/monitor and bicarbonate concentrate.
FDA Recall
Terminated
·Rockwell Medical, Inc·Product code KPO·April 7, 2018