Home / Recalls / Access Vascular, Inc / Z-1156-2023

Z-1156-2023 Class II Ongoing

Recalled by Access Vascular, Inc — Billerica, MA

Recall Details

Product Type
Devices
Report Date
March 1, 2023
Initiation Date
December 22, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
445 units

Product Description

HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Number: 80004004

Reason for Recall

Label with the incorrect component listed on the inner kit Tyvek header bag

Distribution Pattern

US Nationwide distribution in the states of CT, FL, NE, TN, TX, WA.

Code Information

UDI-DI: (01)00850030354020 Lot Numbers: 11424032, 11432076

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-0115-2024 Class II — HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004 (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-1129-2023 Class II — HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002 (December 16, 2022)
  • Z-1130-2023 Class II — HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002 (December 16, 2022)
  • Z-1131-2023 Class II — HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001 (December 16, 2022)
  • Z-0199-2023 Class II — Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripheral (February 24, 2021)