Rockwell Medical Technologies, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
- FDA recalls
- 7
At a glance
Market reach
- United States
- FDA recalls
What Rockwell Medical Technologies, Inc. makes
Rockwell Medical Technologies, Inc. manufactures acidified component concentrates for bicarbonate dialysis, including dry acid concentrates and bicarbonate dialysate concentrates. Their portfolio includes specialized mixers for preparing acidified dialysate concentrates, such as the 50-gallon and 100-gallon bicarbonate dialysate concentrate mixers and the Dri-Sate mixer. The company also produces Citrapure, a component used in dialysis solutions.
These devices are classified under FDA Class II and are subject to 510(k) clearance requirements. The company is based in the United States and its products are listed in the FDA’s 510(k) registry.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Rockwell Medicaltechnologies, Inc. Citrapure Ref K062399
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 7 recalls initiated by Rockwell Medical Technologies, Inc., the earliest on 2007-12-03 and the most recent on 2008-09-29. By recorded status: 7 terminated. The reasons filed fall into these groups: sterility or contamination and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2008
- 29 Sep 2008 Z-0439-2009 Unclassified (pre-2012) Terminated Microbial growth was observed in the retain samples of 4 lots of Liquid Bicarbonate after products had been distributed.
- 29 Sep 2008 Z-0440-2009 Unclassified (pre-2012) Terminated Microbial growth was observed in the retain samples of 4 lots of Liquid Bicarbonate after products had been distributed.
2007
- 3 Dec 2007 Z-0871-2008 Unclassified (pre-2012) Terminated Foil Seal Deterioration; occuring on the tamper resistant foil seals on dialysis liquid concentrate and Dri-Sate product containers older than two years old.
- 3 Dec 2007 Z-0872-2008 Unclassified (pre-2012) Terminated Foil Seal Deterioration; occuring on the tamper resistant foil seals on dialysis liquid concentrate and Dri-Sate product containers older than two years old.
- 3 Dec 2007 Z-0873-2008 Unclassified (pre-2012) Terminated Foil Seal Deterioration; occuring on the tamper resistant foil seals on dialysis liquid concentrate and Dri-Sate product containers older than two years old.
- 3 Dec 2007 Z-0874-2008 Unclassified (pre-2012) Terminated Foil Seal Deterioration; occuring on the tamper resistant foil seals on dialysis liquid concentrate and Dri-Sate product containers older than two years old.
- 3 Dec 2007 Z-0875-2008 Unclassified (pre-2012) Terminated Foil Seal Deterioration; occuring on the tamper resistant foil seals on dialysis liquid concentrate and Dri-Sate product containers older than two years old.
Frequently asked questions
How many devices does Rockwell Medical Technologies, Inc. have in the registry?
The registry currently lists 5 devices for Rockwell Medical Technologies, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Rockwell Medical Technologies, Inc.'s devices?
Among its 5 most recently registered devices, Rockwell Medical Technologies, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Rockwell Medical Technologies, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Rockwell Medical Technologies, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Rockwell Medical Technologies, Inc.?
FDA recall records list 7 recalls initiated by Rockwell Medical Technologies, Inc., the most recent initiated on 29 Sep 2008. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Rockwell Medical Technologies, Inc. in the registry?
The most recently registered devices listed for Rockwell Medical Technologies, Inc. include ACIDIFIED COMPONENT CONCENTRATES FOR BICARBONATE DIALYSIS CONTAINING DI-ACETATE, DRI-SATE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSATE, ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE and BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 GALLON.