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Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605

FDA Recall #Z-0404-2022 — Class II — November 30, 2021

Recall #Z-0404-2022 Date: November 30, 2021 Classification: Class II Status: Terminated

Product Description

Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605

Reason for Recall

Affected product was shipped from the warehouse at room temperature instead of the required refrigerated environment.

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

14 units (individual)

Distribution

US Nationwide distribution in the states of IL, OH, MS, and PA.

Code Information

Model No.: S-O2460605; Batch No.: 161603, 165148, 156205, 158144, 169124, 171961, and 175250; Serial No.:161603, 165148, 156205, 158144, 169124, 171961, and 175250.

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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