Device product
Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605
Z-0404-2022
Product summary
- Event
- Event 89150
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14 units (individual)
- Official record key
device-enforcement:Z-0404-2022
Official wording
Reason: Affected product was shipped from the warehouse at room temperature instead of the required refrigerated environment.
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.
Derived failure modes
-
Unknown
Affected product was shipped from the warehouse at room temperature instead of the required refrigerated environment.