Facility

MEDEFIL, INC.

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

Key facts

1recalls · worst Class III

1inspections · 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)	3001677091
Establishment type	Manufacture Medical Device; Repack or Relabel Medical Device; Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	250 WINDY POINT DR. GLENDALE HEIGHTS, IL, US 60139
Registration status	Active · expires 2026
Parent company	MEDEFIL, INC. (owner-operator 9036760)
Brand names	Normal Saline I. V. Flush Syringe

Activity by year

Recalls (1)
Inspections (1)

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 IIITerminated2014-02-19
The bar code that is printed on the Master Carton label does not correspond to the product code fully displayed on the Master Carton label. The non-matching information can only be detected by using a bar code reader. The defective bar codes will be read as Product No. MIH-3335 (…

FDA inspections (1)

VAI2016-06-17
Voluntary Action Indicated · Compliance: 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 MEDEFIL, INC.

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. “MEDEFIL, INC. (FEI 3001677091) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3001677091-medefil-inc/

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