MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2021 - (Recall #: Z-0404-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 30, 2021

Date Posted: December 29, 2021

Recall Number: Z-0404-2022

Event ID: 89150

Reason for Recall:

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

Status: Terminated

Product Quantity: 14 units (individual)

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.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated