Class II — MEDLINE INDUSTRIES, LP - Northfield
| Recalling firm | Medline Industries, LP |
|---|---|
| Registered facility | View this company's 31 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Affected product was shipped from the warehouse at room temperature instead of the required refrigerated environment. |
| Product | Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605 |
| Quantity | 14 units (individual) |
| Distribution | US Nationwide distribution in the states of IL, OH, MS, and PA. |
| Initiated | 2021-11-30 |
| Classified | 2021-12-21 |
| Terminated | 2023-01-06 |
| Recall number | Z-0404-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — MEDLINE INDUSTRIES, LP - Northfield (Z-0404-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89150/
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