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Michels Transport Medium, 20ML Prefilled Cont

FDA Recall #Z-0656-2022 — Class II — December 1, 2021

Recall #Z-0656-2022 Date: December 1, 2021 Classification: Class II Status: Terminated

Product Description

Michels Transport Medium, 20ML Prefilled Cont

Reason for Recall

Product stored incorrectly in temperature controlled setting instead of refrigeration.

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

2,816 units (22 cases, 128 per case)

Distribution

US Nationwide distribution in the states of Colorado, Florida, New York, North Carolina, and Texas.

Code Information

Model Number: AZSES3270, all lots with expiration date range of 08/28/2021 through 09/03/2023

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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