Home / Recalls / Access Vascular, Inc. / Z-0199-2023

Z-0199-2023 Class II Terminated

Recalled by Access Vascular, Inc. — Billerica, MA

Recall Details

Product Type: Devices
Report Date: November 16, 2022
Initiation Date: February 24, 2021
Termination Date: May 30, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 79 kits

Product Description

Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter

Reason for Recall

Scalpel and StatLock components packaged with specific lots of the HydroPICC catheter have a shorter expiration date than what is listed on the outer kit package.

Distribution Pattern

Domestic distribution to NC, RI, NJ, and IL. No foreign distribution.

Code Information

UDI-DI: 00862559000418 Catheter Kit Lots/Expiration Dates 09112001 Exp 9/24/2021 10212001 Exp 10/21/21 10282001 Exp 11/18/21 Scalpel Lots/Expiration Dates R18-08-010 Exp Feb-21 R19-01-009 Exp Jun-21 R20-01-010 Exp Aug-22 StatLock Lots/Expiration Dates R18-09-008 Exp 5/28/2021

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-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)