Smiths Medical Asd Inc: Medical Infusion Tubing and Stopcocks Recalled for Potential Leaks

Agency Publication Date: January 17, 2024

Summary

Smiths Medical Asd Inc is recalling 285,165 units of various Medex LOGICAL kits, stopcocks, and high-pressure infusion lines because of a manufacturing defect in the device's O-ring. The inner diameter of these seals may be too large, which can cause the device to leak during the infusion of medication. This defect could lead to a patient receiving less medication than prescribed. These products were distributed worldwide, including across the United States, between approximately November 2023 and January 2024.

Risk

An inadequate seal in the rotator component can cause medication to leak out of the tubing system during use. This pose a serious risk of under-infusion, meaning the patient may not receive the full required dose of life-saving or necessary medications.

What You Should Do

Check your medical supplies for affected Medex and high-pressure tubing products by matching the List Number and Lot Number on the packaging.
Identify affected Medex LOGICAL CATH LAB KITS (M20754) with UDI-DI 10351688510686 and Lot Number 4371054.
Check for affected 700PSI Stopcocks (MX4331R) with lot numbers 4355397, 4380735, 4387234, or 4404740.
Verify if you have affected 6-inch Pressure Tubing (MX20617) with lot numbers 4380614 or 4416451, or High Pressure Rotators (MX496HP/MX497HP) with lot numbers 4332915, 4408772, 4330826, or 4384397.
Identify 20-inch or 48-inch Injection Lines (MX682BR, MX682R, MX694R) with lot numbers including 4398428, 4404690, 4398433, 4383431, 4387987, or 4404698.
Immediately stop using any products identified as part of the recalled lots and contact your healthcare provider or Smiths Medical Asd Inc for further instructions and potential product replacement.
Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional assistance or to report any adverse events.

Your Remedy Options

Other Action

Healthcare provider or manufacturer contact

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Medex LOGICAL CATH LAB KIT

Model / REF:

M20754

UPC Codes:

10351688510686

Lot Numbers:

4371054

Product: 1050 STOPCOCK LEFT ROTATOR OFF HANDLE

Model / REF:

MX1431MRL

Lot Numbers:

4387166

Product: 6IN PRESSURE TUBING

Model / REF:

MX20617

Lot Numbers:

4380614

4416451

Product: Medex 700PSI STOPCOCK W/ROTATOR

Model / REF:

MX4331R

Lot Numbers:

4355397

4380735

4387234

4404740

Product: HIGH PRESSURE ROTATOR WITH MALE LUER LOCK

Model / REF:

MX496HP

Lot Numbers:

4332915

4408772

Product: HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK

Model / REF:

MX497HP

Lot Numbers:

4330826

4384397

Product: 20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT

Model / REF:

MX682BR

Lot Numbers:

4398428

4404690

Product: Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT

Model / REF:

MX682R

Lot Numbers:

4398433

Product: 48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi)

Model / REF:

MX694R

Lot Numbers:

4383431

4387987

4404698

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93506

Status: Active

Manufacturer: Smiths Medical Asd Inc

Sold By: Hospital supply distributors; Medical device wholesalers

Manufactured In: United States

Units Affected: 9 products (31,685 total)

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

Check your medical supplies for affected Medex and high-pressure tubing products by matching the List Number and Lot Number on the packaging.

Identify affected Medex LOGICAL CATH LAB KITS (M20754) with UDI-DI 10351688510686 and Lot Number 4371054.

Check for affected 700PSI Stopcocks (MX4331R) with lot numbers 4355397, 4380735, 4387234, or 4404740.

Verify if you have affected 6-inch Pressure Tubing (MX20617) with lot numbers 4380614 or 4416451, or High Pressure Rotators (MX496HP/MX497HP) with lot numbers 4332915, 4408772, 4330826, or 4384397.

Identify 20-inch or 48-inch Injection Lines (MX682BR, MX682R, MX694R) with lot numbers including 4398428, 4404690, 4398433, 4383431, 4387987, or 4404698.

Immediately stop using any products identified as part of the recalled lots and contact your healthcare provider or Smiths Medical Asd Inc for further instructions and potential product replacement.

Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional assistance or to report any adverse events.

Affected Products

Product: Medex LOGICAL CATH LAB KIT

Model / REF:

M20754

UPC Codes:

10351688510686

Lot Numbers:

4371054

Product: 1050 STOPCOCK LEFT ROTATOR OFF HANDLE

Model / REF:

MX1431MRL

Lot Numbers:

4387166

Product: 6IN PRESSURE TUBING

Model / REF:

MX20617

Lot Numbers:

4380614

4416451

Product: Medex 700PSI STOPCOCK W/ROTATOR

Model / REF:

MX4331R

Lot Numbers:

4355397

4380735

4387234

4404740

Product: HIGH PRESSURE ROTATOR WITH MALE LUER LOCK

Model / REF:

MX496HP

Lot Numbers:

4332915

4408772

Product: HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK

Model / REF:

MX497HP

Lot Numbers:

4330826

4384397

Product: 20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT

Model / REF:

MX682BR

Lot Numbers:

4398428

4404690

Product: Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT

Model / REF:

MX682R

Lot Numbers:

4398433

Product: 48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi)

Model / REF:

MX694R

Lot Numbers:

4383431

4387987

4404698