Z-0404-2022 Class II Terminated
FDA device recall Z-0404-2022 was initiated by MEDLINE INDUSTRIES, LP - Northfield on November 30, 2021 and is designated Class II. Reason for recall: Affected product was shipped from the warehouse at room temperature instead of the required refrigerated environment. The recall status is terminated (terminated January 6, 2023). Affected quantity: 14 units (individual).
Recall Details
- Product Type
- Devices
- Report Date
- December 29, 2021
- Initiation Date
- November 30, 2021
- Termination Date
- January 6, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14 units (individual)
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.
Distribution Pattern
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.