ROCKWELL MEDICAL
1 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (1)
- Inspections (3)
Devices registered here (1)
- Dialysate Concentrate For Hemodialysis (Liquid Or Powder)Product code KPO (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5820
Recalls & enforcement
- Class IITerminated2018-04-07A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch.
FDA inspections (3)
- VAI2024-09-16Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
- VAI2022-07-25Voluntary Action Indicated · Compliance: Devices · citations posted
- NAI2016-01-13No Action Indicated · Compliance: Devices
Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “ROCKWELL MEDICAL (FEI 3003463852) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003463852-rockwell-medical/
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