inforMED
FEI 1417592

Medline Industries, Lp - Northfield

Three Lakes Drive, Northfield, IL, US

MDR events328All time
Recalls812All time
Registered products622
Establishment typeDevelopDevelop Specifications But Do Not Manufacture At This Facility

Registered product codes

622 product codes

Recalls

812 on file

Compliance history

Matched by FEI 1417592.

FDA inspections

2 on file

  • Official Action Indicated (OAI)Jan 22, 2024

    Compliance: Devices · Citations posted

  • Voluntary Action Indicated (VAI)Jan 22, 2024

    Postmarket Assurance: Devices · Citations posted

Inspection citations

5 on file

  • 21 CFR 803.50(a)(2)Jan 22, 2024

    Individual Report of Malfunction

  • 21 CFR 820.30(i)Jan 22, 2024

    Design changes - Lack of or Inadequate Procedures

  • 21 CFR 820.50Jan 22, 2024

    Purchasing controls, Lack of or inadequate procedures

  • 21 CFR 820.100(a)Jan 22, 2024

    Lack of or inadequate procedures

  • 21 CFR 820.198(a)Jan 22, 2024

    Lack of or inadequate complaint procedures

Import refusals

2 on file

  • Division of Northern Border Imports (DNBI)Feb 13, 2025

    80LZA \ GLOVE, PATIENT EXAMINATION, POLY

  • Division of Northern Border Imports (DNBI)Feb 13, 2025

    80LZA \ GLOVE, PATIENT EXAMINATION, POLY