Facility

Aquabiliti

4 recall(s) on record — most severe on record: Class II.

Key facts

4recalls · worst Class II

3inspections · worst OAI

—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)	1000151124
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	5209 Linbar Dr Ste 640 NASHVILLE, TN, US 37211
Registration status	Active · expires 2026
Parent company	MRP, LLC (owner-operator 9076844)
Brand names	AquastatSFR 20mL Sterile Saline flush

Activity by year

Recalls (4)
Inspections (3)

Devices registered here (1)

Saline, Vascular Access Flush
Product code NGT (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5200

Recalls & enforcement

Class IIOngoing2023-12-28
The saline flush syringes may fail to meet USP criteria for stated sodium chloride content after 12 months.
Class IITerminated2015-07-02
Procedures for the acceptance and control of in-process product have not been adequately established.
Class IITerminated2015-04-27
Incorrect expiration date on label
Class IITerminated2015-02-09
Incorrect labeling of the expiration date

FDA inspections (3)

VAI2022-10-18
Voluntary Action Indicated · Compliance: Devices · citations posted
VAI2020-02-27
Voluntary Action Indicated · Compliance: Devices · citations posted
OAI2016-04-28
Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

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 MRP, 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. “Aquabiliti (FEI 1000151124) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000151124-aquabiliti/

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