International Medical Devices Database

Manufacturer Address
Rockwell Medical Technologies, Inc, 4051 Freeport Pkwy Ste 100, Grapevine TX 76099
Manufacturer Parent Company (2017)
Rockwell Medical Inc.
Source
USFDA
7 Events

7 devices in the database

Device Recall DriSate

Model / Serial
Lot #2530-1020052.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution to the following states: AL, AR, FL, KS, LA, MO, MS, OK, TN and TX.
Product Description
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.

Device Recall DriSate Dry

Model / Serial
Lot #2233-0615052.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution to the following states: AL, AR, FL, KS, LA, MO, MS, OK, TN and TX.
Product Description
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.

Device Recall RenalPure

Model / Serial
Lot #1906-0118052C.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution to the following states: AL, AR, FL, KS, LA, MO, MS, OK, TN and TX.
Product Description
RenalPure¿ Liquid Acid Concentrate R-259; One Gallon (3.78 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051.

Device Recall RenalPure

Model / Serial
Lot #1956-0207052C.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution to the following states: AL, AR, FL, KS, LA, MO, MS, OK, TN and TX.
Product Description
RenalPure¿ Liquid Acid Concentrate R-235; One Gallon (3.78 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051.

Device Recall RenalPure

Model / Serial
Lot #1677-1018042C.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution to the following states: AL, AR, FL, KS, LA, MO, MS, OK, TN and TX.
Product Description
RenalPure¿ Liquid Acid Concentrate R-006; One Gallon (3.78 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051.

2 more

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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Rockwell Medical Technologies, Inc

7 devices in the database

Device Recall DriSate

Device Recall DriSate Dry

Device Recall RenalPure

Device Recall RenalPure

Device Recall RenalPure