Galt and B Braun Medical Catheters and Kits Recalled for Packaging Defects

Agency Publication Date: May 7, 2025

Summary

Galt Medical Corporation is recalling approximately 9,451 medical devices including catheters, dilators, guidewires, and introducer needles and kits. This recall was initiated due to potential defects in the sterile barrier packaging, where open seals were discovered. These products are used in various surgical and interventional procedures, such as draining fluids and positioning other medical tools inside the body. No incidents or injuries have been reported in connection with this defect.

Risk

A defective or open seal on sterile packaging can allow bacteria and other contaminants to enter the device. If these non-sterile devices are used during a medical procedure, they pose a significant risk of infection or other serious complications for the patient.

What You Should Do

This recall involves approximately 9,451 medical devices including Galt Centeze Catheters, B Braun Interventional Coaxial Dilators, B Braun ELITE HV Introducer Systems, Galt Guidewires, and various introducer needles and kits.
Identify if your device is part of the recall by checking the Catalog Number, REF, Model Number, UDI-DI code, and Lot Number printed on the product packaging. See the Affected Products section below for the full list of affected codes.
Stop using the recalled devices immediately and quarantine any remaining inventory to ensure they are not used in patient procedures.
Contact Galt Medical Corporation or your medical device distributor directly to arrange for the return, replacement, or correction of affected units.
Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit their website for additional questions or to report adverse events.

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: GALT Centeze Catheter

Model / REF:

DRC-002-05

DRC-002-06

Lot Numbers:

25051843

25034783

UDI:

00841268100381

00841268100398

Quantity: 2,881 catheters. Intended for percutaneous fluid aspirations and small volume drainage.

Product: B Braun Interventional Coaxial Dilator

Model / REF:

KIT-018-47

KIT-019-67

KIT-018-41

KIT-019-37

Lot Numbers:

S25052261

P25052052

S25064124

P25115062

UDI:

0404696432727

0404696432738

0404696432750

0404696432802

Quantity: 1,400 dilators. Intended to introduce up to a .038 inch guidewire or catheter into the vascular system.

Product: B Braun Interventional ELITE HV Hemostasis Valve Introducer System

Model / REF:

612802

BCL-100-04

Lot Numbers:

S25128171

Quantity: 100 systems. Indicated for use in percutaneous procedures to introduce catheters into the vasculature.

Product: GALT Guidewire

Model / REF:

SGW-051-07

Lot Numbers:

25050797

UDI:

0084126810132

Quantity: 100 guidewires. Intended for use in percutaneous procedures within coronary and peripheral vasculature.

Product: Introducer Kit- Coaxial Dilator

Model / REF:

KIT-002-28

KIT-002-34

KIT-002-35

KIT-011-40

KIT-011-62

KIT-038-04

KIT-039-03

KIT-039-13

KIT-081-02 / PS2-38

Lot Numbers:

G25038156

G25064259

G25029077

S25031227

G25052163

G25080165

G25092186

G25050190

G25078192

G25050202

G25056231

UDI:

00841268104730

00841268104792

00841268104808

00841268105553

00841268105614

00841268104556

00841268104587

00841268106055

00841268108394

Quantity: 4,280 kits. Intended to introduce guidewires or catheters into the peripheral vascular system.

Product: Introducer Needle

Model / REF:

NDL-107-04

Lot Numbers:

24108670

UDI:

00841268102729

Quantity: 200 needles. Used for the percutaneous introduction of guidewires.

Product: Introducer Kit- Tearaway MicroSlide

Model / REF:

KIT-051-01

INT-101-15

Lot Numbers:

24298473

24190504

24284447

UDI:

00841268106130

00841268107380

Quantity: 490 units. Used for introducing catheters into the coronary and peripheral vasculature.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96622

Status: Active

Manufacturer: Galt Medical Corporation

Sold By: B Braun; Direct to hospitals; Direct to clinics

Manufactured In: United States

Units Affected: 7 products (2,881 catheters; 1,400 dilators; 100 systems; 100 guidewires; 4,280 kits; 200 needles; 490 units)

Distributed To: Alabama, Florida, Georgia, Illinois, Massachusetts, Ohio, Pennsylvania, Utah

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 involves approximately 9,451 medical devices including Galt Centeze Catheters, B Braun Interventional Coaxial Dilators, B Braun ELITE HV Introducer Systems, Galt Guidewires, and various introducer needles and kits.

Identify if your device is part of the recall by checking the Catalog Number, REF, Model Number, UDI-DI code, and Lot Number printed on the product packaging. See the Affected Products section below for the full list of affected codes.

Stop using the recalled devices immediately and quarantine any remaining inventory to ensure they are not used in patient procedures.

Contact Galt Medical Corporation or your medical device distributor directly to arrange for the return, replacement, or correction of affected units.

Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit their website for additional questions or to report adverse events.

Affected Products

Product: GALT Centeze Catheter

Model / REF:

DRC-002-05

DRC-002-06

Lot Numbers:

25051843

25034783

UDI:

00841268100381

00841268100398

Quantity: 2,881 catheters. Intended for percutaneous fluid aspirations and small volume drainage.

Product: B Braun Interventional Coaxial Dilator

Model / REF:

KIT-018-47

KIT-019-67

KIT-018-41

KIT-019-37

Lot Numbers:

S25052261

P25052052

S25064124

P25115062

UDI:

0404696432727

0404696432738

0404696432750

0404696432802

Quantity: 1,400 dilators. Intended to introduce up to a .038 inch guidewire or catheter into the vascular system.

Product: B Braun Interventional ELITE HV Hemostasis Valve Introducer System

Model / REF:

612802

BCL-100-04

Lot Numbers:

S25128171

Quantity: 100 systems. Indicated for use in percutaneous procedures to introduce catheters into the vasculature.

Product: GALT Guidewire

Model / REF:

SGW-051-07

Lot Numbers:

25050797

UDI:

0084126810132

Quantity: 100 guidewires. Intended for use in percutaneous procedures within coronary and peripheral vasculature.

Product: Introducer Kit- Coaxial Dilator

Model / REF:

KIT-002-28

KIT-002-34

KIT-002-35

KIT-011-40

KIT-011-62

KIT-038-04

KIT-039-03

KIT-039-13

KIT-081-02 / PS2-38

Lot Numbers:

G25038156

G25064259

G25029077

S25031227

G25052163

G25080165

G25092186

G25050190

G25078192

G25050202

G25056231

UDI:

00841268104730

00841268104792

00841268104808

00841268105553

00841268105614

00841268104556

00841268104587

00841268106055

00841268108394

Quantity: 4,280 kits. Intended to introduce guidewires or catheters into the peripheral vascular system.

Product: Introducer Needle

Model / REF:

NDL-107-04

Lot Numbers:

24108670

UDI:

00841268102729

Quantity: 200 needles. Used for the percutaneous introduction of guidewires.

Product: Introducer Kit- Tearaway MicroSlide

Model / REF:

KIT-051-01

INT-101-15

Lot Numbers:

24298473

24190504

24284447

UDI:

00841268106130

00841268107380

Quantity: 490 units. Used for introducing catheters into the coronary and peripheral vasculature.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96622

Status: Active

Manufacturer: Galt Medical Corporation

Sold By: B Braun; Direct to hospitals; Direct to clinics

Manufactured In: United States

Units Affected: 7 products (2,881 catheters; 1,400 dilators; 100 systems; 100 guidewires; 4,280 kits; 200 needles; 490 units)

Distributed To: Alabama, Florida, Georgia, Illinois, Massachusetts, Ohio, Pennsylvania, Utah