Recall Z-0404-2022— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-0404-2022
Creator: U.S. Food and Drug Administration
Published: 2021-11-30

Class II · Terminated

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2021-11-30, terminated 2023-01-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605. Reason: Affected product was shipped from the warehouse at room temperature instead of the required refrigerated environment..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Terminated
Initiated: 2021-11-30
Terminated: 2023-01-06
Firm location: Northfield, IL, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.