Cardinal Health 200, LLC - Premier Medical Device Distribution and Healthcare Supply Chain Subsidiar

📢 Key Updates (2025-2026):
   In April 2026, Health Canada announced discontinuation of Cardinal Health 200, LLC's Aqua-seal Chest Drainage Unit and Thora-seal 1 Chest Drainage Unit (License #69384) due to business reasons. In July 2024, the company initiated a voluntary Class I recall of approximately 24.7 million Salem Sump Dual Lumen Stomach Tubes due to Anti-Reflux Valve breakage risks. The company maintains active FDA 3PL (Third-Party Logistics) facility registrations with state licenses renewed through 2026-2027 across multiple jurisdictions including Illinois, Texas, Kansas, and others.

Company Overview (Updated April 2026)

Cardinal Health 200, LLC is a wholly-owned subsidiary of Cardinal Health, Inc. (NYSE: CAH), one of the largest integrated healthcare services and products companies globally. Founded on August 27, 1996, and headquartered in WaUKegan, Illinois, the entity operates as a Foreign Limited Liability Company registered in Delaware with qualifications to conduct business in Iowa, West Virginia, New York, Georgia, and multiple other states.

The company serves as a specialized distribution and manufacturing entity within the Cardinal Health enterprise, providing critical healthcare products including pharmaceuticals, medical devices, surgical supplies, and patient care equipment to hospitals, pharmacies, clinics, and U.S. government agencies. With FDA establishment registration (FEI: 3001236905) and multiple 510(k) clearances, the company maintains comprehensive regulatory compliance for both distribution and manufacturing operations.

Corporate Structure & Registration

- Parent Company: Cardinal Health, Inc. (NYSE: CAH) - Global healthcare services company ranked in Fortune 17

- Legal Entity: Foreign Limited Liability Company (Foreign LLC)

- State of Formation: Delaware

- Date Established: August 27, 1996 (per West Virginia Secretary of State records)

- Primary NAICS Code: 423450 - Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers

- CAGE Code: 07TA6 (for federal contracting)

- UEI: ZJEUBM5FYLQ2 (Unique Entity Identifier)

- FEI Number: 3001236905 (FDA Establishment Identifier)

Headquarters & Operations

Principal Office Address:
   3651 Birchwood Drive
   Waukegan, Illinois 60085
   United States

Additional Operational Locations:
   - 2101 Waukegan Road, Waukegan, IL (3PL facility)
   - 11300 Glenwood, Overland Park, KS (operational site)
   - 1320 Don Haskins Suite A, El Paso, TX (distribution center)
   - Cardinal Health Costa Rica, S.A. (manufacturing partner)
   - Cardinal Health PR 218, Inc., Añasco, Puerto Rico (manufacturing)

Key Personnel: Stacey A. Henning (Official Correspondent/FDA contact), Steve Inacker (Key Principal per Dun & Bradstreet)

Core Business Operations

Medical Device Manufacturing & Distribution

Cardinal Health 200, LLC maintains FDA establishment registration and multiple device listings, serving as both manufacturer and initial distributor for a comprehensive portfolio of medical products:

- Surgical Supplies: SmartGown™ EDGE Breathable Surgical Gowns with ASSIST™ Instrument Pockets (510(k) K230838, cleared July 2023); angiography drapes and surgical kits

- Patient Care & Monitoring: Kendall™ Disposable ECG Electrodes (multiple FDA registrations); anti-embolism stockings (TED-style compression garments)

- Enteral Feeding Systems: Kangaroo™ e-Pump Sets with Flush Bag and Anti-Free Flow mechanisms; Kangaroo™ enteral feeding tubes and accessories (manufactured in Costa Rica)

- Suction & Drainage: Medi-Vac™ Yankauer Suction Handles (bulbous and straight tip variants); Jackson-Pratt® Hemaduct® Wound Drains; Salem Sump Dual Lumen Stomach Tubes (subject to 2024 recall)

- Chest Drainage: Aqua-seal Chest Drainage Unit and Thora-seal 1 Chest Drainage Unit (discontinued in Canada, April 2026)

Pharmaceutical & Specialty Distribution

As a licensed wholesale distributor, the company maintains active 3PL (Third-Party Logistics) registrations across multiple states with licenses valid through 2026-2027:

- Illinois (expires 12-31-2026)
   - Texas (multiple facilities)
   - Kansas (11300 Glenwood, Overland Park)
   - Ohio, North Carolina, South Carolina, Virginia, Tennessee, and others

Government & Federal Contracts

Cardinal Health 200, LLC is a major federal contractor with established relationships with U.S. government agencies:

- Department of Veterans Affairs: Medical/Surgical Prime Vendor (MSPV) Gen-Z V1 program participant; awarded delivery orders for distribution and supply management to VA Medical Centers nationwide

- National Institutes of Health (NIH): Supply chain and distribution services

- CAGE Code 07TA6: Active registration for federal procurement

Regulatory Compliance & Quality

FDA Establishment Registration: Active status as of 2025 (Registration #1423537, Owner/Operator #9028292)

510(k) Clearances (Recent):

- K230838: Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown (cleared July 27, 2023)

- Multiple cleared devices for ECG electrodes, suction handles, and enteral feeding systems

International Registrations:

- Philippines FDA: Active registrations for Medi-Vac Yankauer Suction Handles (CMDR-2025-04185, CMDR-2025-04186), Kangaroo e-Pump Sets (CMDR-2025-04394, CMDR-2025-04395), Jackson-Pratt Hemaduct Wound Drains (MDR-03952A/B), and others with validity through 2030

- Health Canada: Medical Device License #69384 for chest drainage products (now discontinued as of April 2026)

Recent Product Recalls & Safety Notices

July 2024 - Class I Recall (Z-3302-2024):
   Cardinal Health 200, LLC initiated a voluntary nationwide recall of approximately 24,761,100 units of Salem Sump Dual Lumen Stomach Tubes with Anti-Reflux Valve. The recall was classified as Class I (most serious type) due to risks of serious injury or death from Anti-Reflux Valve breakage caused by improper use. The affected products Included sizes 12 Fr/Ch through 18 Fr/Ch distributed nationwide, including Puerto Rico, Guam, and Chile.

April 2026 - Health Canada Discontinuation:
   Health Canada announced discontinuation of the Aqua-seal Chest Drainage Unit (Device ID 8888571299) and Thora-seal 1 Chest Drainage Unit (Device ID 8884713100), both manufactured by Cardinal Health 200, LLC, due to business reasons (not safety-related).

Strategic Positioning

Distribution Network Scale:

- Serves as a critical node in Cardinal Health's global supply chain

- Maintains extensive warehousing and 3PL logistics infrastructure across multiple states

- Integrates manufacturing operations (Costa Rica, Puerto Rico) with U.S. distribution

Competitive Advantages:

- Direct integration with Cardinal Health's global purchasing power and supply chain networks

- Established relationships with major medical product manufacturers (Covidien, Kenmex Medical Specialties, Well Lead Medical)

- Comprehensive regulatory compliance expertise across FDA, Health Canada, and international markets

- Robust government contracting capabilities and federal agency relationships

Parent Company: Cardinal Health, Inc.

Cardinal Health, Inc. (NYSE: CAH) is a global integrated healthcare services and products company. As of Fiscal Year 2026 (Q2), the parent company reports:

- Specialty segment revenue expected to exceed $50 billion in FY2026 (16% CAGR)

- BioPharma Solutions anticipated revenue growth of 30%+ in FY2026

- Serves nearly 90% of U.S. hospitals and over 100,000 healthcare locations

Contact Information

Operations Headquarters:
   3651 Birchwood Drive
   Waukegan, IL 60085
   United States
   Phone: +1 (847) 887-4151 / +1 (312) 270-2081

FDA Official Correspondent:
   Stacey A. Henning
   stacey.henning@cardinalhealth.com
   Cardinal Health
   3651 Birchwood Drive
   Waukegan, IL 60085

Parent Company Corporate:
   7000 Cardinal Place
   Dublin, OH 43017
   United States

Website: www.cardinalhealth.com

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