# FDA recall Z-0404-2022

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2021-11-30.

## Product

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.

## Distribution

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

## Key facts

- **Recall number:** Z-0404-2022
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-11-30
- **Report date:** 2021-12-29
- **Termination date:** 2023-01-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0404-2022

## Citation

> AI Analytics. FDA recall Z-0404-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0404-2022. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*