Medline Procedure Kits Recalled for Non-Compliant Surgical Masks

Agency Publication Date: January 28, 2025

Summary

Medline Industries, LP has recalled approximately 2,449 procedure kits, including Port Access Kits, Vantex CVC Bundles, and Dressing Kits. These kits were manufactured with certain "SO SOFT" and "SOFT TOUCH II" surgical masks that failed bioburden testing, meaning they did not meet microbial cleanliness standards. No injuries or medical incidents have been reported to date.

Risk

The surgical masks inside these kits failed to meet bioburden testing requirements, which could lead to an increased risk of infection for patients or healthcare providers during sterile medical procedures.

What You Should Do

This recall affects Medline procedure kits including the Port Access Kit (CVI5130), VANTEX 7FR 3L 20CM CVC Bundle (STCVC01USGV), Short Term Infusaport Access Kit (DYNDC3188), and Central Line Dressing Kit (DYNDC3189).
Affected units can be identified by lot numbers such as 2024040490, 2024073190, 2024082790, 2024101790, 2024050990, 2024040390, 2024051490, 2024070590, 2024100790, 2024030690, 2024041990, and 2024082390. See the Affected Products section below for the full list of affected codes.
Stop using the recalled kits immediately. Contact Medline Industries or your medical supply distributor to arrange for a return, replacement, or correction of the kits.
Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding this recall.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Port Access Kit (CVI5130)

Model / REF:

CVI5130

Lot Numbers:

2024040490

2024073190

2024082790

2024101790

UDI:

10653160372349

00653160372342

Recall #: Z-1040-2025

Product: VANTEX 7FR 3L 20CM CVC STOCK+ BUNDLE US (STCVC01USGV)

Model / REF:

STCVC01USGV

Lot Numbers:

2024050990

UDI:

10653160376965

00653160376968

Recall #: Z-1040-2025

Product: SHORT TERM INFUSAPORT ACCESS KIT (DYNDC3188)

Model / REF:

DYNDC3188

Lot Numbers:

2024040390

2024051490

2024070590

2024100790

UDI:

10653160348825

00653160348828

Recall #: Z-1041-2025

Product: CENTRAL LINE DRESSING KIT (DYNDC3189)

Model / REF:

DYNDC3189

Lot Numbers:

2024030690

2024041990

2024082390

UDI:

10653160348818

00653160348811

Recall #: Z-1042-2025

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96110

Status: Active

Manufacturer: MEDLINE INDUSTRIES, LP - Northfield

Sold By: Hospital supply distributors; Medical facilities

Manufactured In: United States

Units Affected: 3 products (749 units; 1450 units; 250 units)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Medline procedure kits including the Port Access Kit (CVI5130), VANTEX 7FR 3L 20CM CVC Bundle (STCVC01USGV), Short Term Infusaport Access Kit (DYNDC3188), and Central Line Dressing Kit (DYNDC3189).

Affected units can be identified by lot numbers such as 2024040490, 2024073190, 2024082790, 2024101790, 2024050990, 2024040390, 2024051490, 2024070590, 2024100790, 2024030690, 2024041990, and 2024082390. See the Affected Products section below for the full list of affected codes.

Stop using the recalled kits immediately. Contact Medline Industries or your medical supply distributor to arrange for a return, replacement, or correction of the kits.

Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding this recall.

Affected Products

Product: Port Access Kit (CVI5130)

Model / REF:

CVI5130

Lot Numbers:

2024040490

2024073190

2024082790

2024101790

UDI:

10653160372349

00653160372342

Recall #: Z-1040-2025

Product: VANTEX 7FR 3L 20CM CVC STOCK+ BUNDLE US (STCVC01USGV)

Model / REF:

STCVC01USGV

Lot Numbers:

2024050990

UDI:

10653160376965

00653160376968

Recall #: Z-1040-2025

Product: SHORT TERM INFUSAPORT ACCESS KIT (DYNDC3188)

Model / REF:

DYNDC3188

Lot Numbers:

2024040390

2024051490

2024070590

2024100790

UDI:

10653160348825

00653160348828

Recall #: Z-1041-2025

Product: CENTRAL LINE DRESSING KIT (DYNDC3189)

Model / REF:

DYNDC3189

Lot Numbers:

2024030690

2024041990

2024082390

UDI:

10653160348818

00653160348811

Recall #: Z-1042-2025