FDA recall Z-0404-2022

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

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

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

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