HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001
FDA Recall #Z-1131-2023 — Class II — December 16, 2022
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.
Recalling Firm
Access Vascular, Inc — Billerica, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
302 HydroPICC devices
Distribution
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
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated