Facility

Elite Biomedical Solutions LLC

1 recall(s) on record — most severe on record: Class I.

Key facts

1recalls · worst Class I

3inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3009712113
Establishment type	Manufacture Medical Device
Location	756 CINCINNATI BATAVIA PIKE STE C Cincinnati, OH, US 45245
Registration status	Active · expires 2026
Parent company	Elite Biomedical Solutions LLC (owner-operator 10041252)
Brand names	Elite Biomedical Solutions Dose Request Cord

Activity by year

Recalls (1)
Inspections (3)

Devices registered here (1)

Accessories, Pump, Infusion
Product code MRZ (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5725

Recalls & enforcement

Class ITerminated2015-06-03
Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death.

FDA inspections (3)

NAI2024-05-10
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2021-11-09
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2017-04-06
Voluntary 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.

All facilities operated by Elite Biomedical Solutions LLC

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. “Elite Biomedical Solutions LLC (FEI 3009712113) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009712113-elite-biomedical-solutions-llc/

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