Smiths Medical ASD Inc.: Arterial Blood Sampling Kits Recalled for Missing Syringe Caps

Agency Publication Date: October 20, 2023

Summary

Smiths Medical ASD Inc. has recalled 31,900 Portex Pro-Vent Arterial Blood Sampling Kits because they may be missing a critical component called the 'ASM Filter-Pro ABG SYR CAP.' These kits are used to collect blood samples for testing gases and electrolytes. Without the protective cap, the blood sample can be compromised, leading to incorrect medical test results or exposing healthcare workers and patients to infectious blood.

Risk

Missing syringe caps can allow room air to contaminate blood samples, causing delayed or inaccurate test results that could lead to improper patient treatment. Additionally, an uncapped syringe increases the risk of blood spills and direct exposure to bloodborne pathogens.

What You Should Do

Identify your product by checking the packaging for Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, Reference Number 4599P-1.
Verify the specific affected lot by looking for Lot Number 4331283 and UDI/DI 30351688028635 on the kit label.
Immediately stop using any kits from the affected lot and set them aside to ensure they are not used for patient care.
Contact your healthcare provider or Smiths Medical ASD Inc. directly to report possession of the affected kits and to receive further instructions regarding returns or replacements.
For additional information or questions, contact the FDA at 1-888-463-6332 or visit the official website at www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Contact manufacturer for instructions

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

Affected Products

Product: Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1

Model / REF:

REF 4599P-1

FGSKU# 4599P-1

UPC Codes:

30351688028635

Lot Numbers:

4331283

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93094

Status: Active

Manufacturer: Smiths Medical ASD Inc.

Manufactured In: United States

Units Affected: 31900 devices

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

Identify your product by checking the packaging for Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, Reference Number 4599P-1.

Verify the specific affected lot by looking for Lot Number 4331283 and UDI/DI 30351688028635 on the kit label.

Immediately stop using any kits from the affected lot and set them aside to ensure they are not used for patient care.

Contact your healthcare provider or Smiths Medical ASD Inc. directly to report possession of the affected kits and to receive further instructions regarding returns or replacements.

For additional information or questions, contact the FDA at 1-888-463-6332 or visit the official website at www.fda.gov/medical-devices/medical-device-recalls.