Access Vascular, Inc: Medical Device Recall in 2023 - (Recall #: Z-0115-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004

Product Classification:

Class II

Date Initiated: August 31, 2023

Date Posted: October 25, 2023

Recall Number: Z-0115-2024

Event ID: 93043

Reason for Recall:

Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following warnings statement: HydroPICC Dual Lumen Catheter is for adult use only. There is a potential risk to health should the HydroPICC Dual Lumen Catheter be used in an inadequately sized vessel. There have been no reported adverse events to date.

Status: Ongoing

Product Quantity: 58 total

Code Information:

UDI-DI: 00850030354068; Lot Number: 11469666

Distribution Pattern:

US Nationwide distribution in the states of IL, TX.

Voluntary or Mandated:

Voluntary: Firm initiated