Rockwell Medical
4051 Freeport Pkwy Ste 100, GRAPEVINE, TX, US
Registered product codes
1 product codes
Recent MDR events
5 on file
Recalls
8 on file
- TerminatedJan 5, 2009
Microbial growth was observed in the retain samples of 4 lots of Liquid Bicarbonate after products had been distributed.
View FDA record ↗ - TerminatedJan 5, 2009
Microbial growth was observed in the retain samples of 4 lots of Liquid Bicarbonate after products had been distributed.
View FDA record ↗ - TerminatedFeb 13, 2008
Foil Seal Deterioration; occuring on the tamper resistant foil seals on dialysis liquid concentrate and Dri-Sate product containers older than two years old.
View FDA record ↗ - TerminatedFeb 13, 2008
Foil Seal Deterioration; occuring on the tamper resistant foil seals on dialysis liquid concentrate and Dri-Sate product containers older than two years old.
View FDA record ↗ - TerminatedFeb 13, 2008
Foil Seal Deterioration; occuring on the tamper resistant foil seals on dialysis liquid concentrate and Dri-Sate product containers older than two years old.
View FDA record ↗ - TerminatedFeb 13, 2008
Foil Seal Deterioration; occuring on the tamper resistant foil seals on dialysis liquid concentrate and Dri-Sate product containers older than two years old.
View FDA record ↗ - TerminatedFeb 13, 2008
Foil Seal Deterioration; occuring on the tamper resistant foil seals on dialysis liquid concentrate and Dri-Sate product containers older than two years old.
View FDA record ↗ - TerminatedUnknown
A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch.
View FDA record ↗
Compliance history
Matched by FEI 3003463852.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Sep 16, 2024
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Sep 16, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.198(a)Sep 16, 2024
Complaints
- 21 CFR 820.80(e)Sep 16, 2024
Documentation
- 21 CFR 820.100(b)Sep 16, 2024
Documentation
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.