Home / Recalls / Access Vascular, Inc / Z-0115-2024

Z-0115-2024 Class II Ongoing

Recalled by Access Vascular, Inc — Billerica, MA

Recall Details

Product Type
Devices
Report Date
October 25, 2023
Initiation Date
August 31, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
58 total

Product Description

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

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.

Distribution Pattern

US Nationwide distribution in the states of IL, TX.

Code Information

UDI-DI: 00850030354068; Lot Number: 11469666

Other recalls by Access Vascular, Inc

  • Z-0114-2024 Class II — HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002 (August 31, 2023)
  • Z-1605-2023 Class II — HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004 (March 3, 2023)
  • Z-1155-2023 Class II — HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (December 22, 2022)
  • Z-1156-2023 Class II — HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (December 22, 2022)
  • Z-1129-2023 Class II — HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002 (December 16, 2022)
  • Z-1131-2023 Class II — HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001 (December 16, 2022)
  • Z-1130-2023 Class II — HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002 (December 16, 2022)
  • Z-0199-2023 Class II — Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripheral (February 24, 2021)