CENTURION MEDICAL PRODUCTS, SILVER ANTIMICROBIAL VAD DRIVE, REF DT18760

FDA Recall #Z-1015-2023 — Class II — December 23, 2022

Recall #Z-1015-2023 Date: December 23, 2022 Classification: Class II Status: Ongoing

Product Description

CENTURION MEDICAL PRODUCTS, SILVER ANTIMICROBIAL VAD DRIVE, REF DT18760

Reason for Recall

The kit contained an expired component.

Recalling Firm

MEDLINE INDUSTRIES, LP - Northfield — Northfield, IL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

1050 kits

Distribution

US Nationwide distribution in the states of NY, IN, FL, NJ, IL.

Code Information

UDI/DI 10653160274841, Lot Numbers 22ABO498

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated