Access Vascular, Inc: Dual Lumen HydroPICC Kits Recalled for Incorrect Instructions and Missing Warning

Agency Publication Date: October 13, 2023

Summary

Access Vascular, Inc. has recalled 116 units of the HydroPICC 5Fr Dual Lumen Kits because they were shipped with the wrong version of the Instructions For Use (IFU). The incorrect instructions are missing a critical safety warning stating that the catheter is for adult use only and should not be used in vessels that are too small for the device. Affected models include the Basic Kit (Model 80002002) and the Maximal Barrier Kit (Model 80002004) distributed in Illinois and Texas. No injuries or adverse events have been reported to date.

Risk

Using these catheters in pediatric patients or in blood vessels that are too small may lead to serious health complications, such as vessel damage or blood clots, because the medical staff may not be aware of the adult-only usage restriction.

What You Should Do

Check your medical supplies for HydroPICC 5Fr Dual Lumen Kits with the following identifiers: Basic Kit Model 80002002 (Lot 11423187, UDI-DI 00850030354044) or Maximal Barrier Kit Model 80002004 (Lot 11469666, UDI-DI 00850030354068).
Verify that the Instructions For Use (IFU) included with your kit contains the warning: 'HydroPICC Dual Lumen Catheter is for adult use only.'
If you possess an affected kit with the incorrect instructions, contact your healthcare provider or Access Vascular, Inc. immediately for the corrected documentation and further instructions regarding the use or return of the device.
If you are a healthcare professional, ensure these specific lots are not used on pediatric patients or in inadequately sized vessels as per the intended adult-only use.
Contact Access Vascular, Inc. at their Billerica, MA headquarters for more information or to request the correct instruction revision.
For additional questions, you may contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Obtain corrected Instructions For Use (IFU) and usage guidance.

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

Affected Products

Product: HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit

Model / REF:

80002002

UPC Codes:

00850030354044

Lot Numbers:

11423187

Product: HydroPICC 5Fr Dual Lumen Maximal Barrier Kit

Model / REF:

80002004

UPC Codes:

00850030354068

Lot Numbers:

11469666

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93043

Status: Active

Manufacturer: Access Vascular, Inc

Sold By: Authorized distributors

Manufactured In: United States

Units Affected: 2 products (58 total)

Distributed To: Illinois, Texas

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 HydroPICC 5Fr Dual Lumen Kits with the following identifiers: Basic Kit Model 80002002 (Lot 11423187, UDI-DI 00850030354044) or Maximal Barrier Kit Model 80002004 (Lot 11469666, UDI-DI 00850030354068).

Verify that the Instructions For Use (IFU) included with your kit contains the warning: 'HydroPICC Dual Lumen Catheter is for adult use only.'

If you possess an affected kit with the incorrect instructions, contact your healthcare provider or Access Vascular, Inc. immediately for the corrected documentation and further instructions regarding the use or return of the device.

If you are a healthcare professional, ensure these specific lots are not used on pediatric patients or in inadequately sized vessels as per the intended adult-only use.

Contact Access Vascular, Inc. at their Billerica, MA headquarters for more information or to request the correct instruction revision.

For additional questions, you may contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.