Home / Recalls / Access Vascular, Inc / Z-1131-2023

Z-1131-2023 Class II Ongoing

Recalled by Access Vascular, Inc — Billerica, MA

Recall Details

Product Type
Devices
Report Date
February 22, 2023
Initiation Date
December 16, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
302 HydroPICC devices

Product Description

HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001

Reason for Recall

Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.

Distribution Pattern

US Nationwide distribution in the states of CT, IL, IN, MA, NE, TN, and TX.

Code Information

UDI-DI: (01)00862559000456; Lot Number: 11398679, 11416178

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-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-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)