Class III — Medline Industries Inc
| 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 III |
| Status | Terminated |
| Reason | Medline Industries, Inc. is removing specific lots of STAT-Site® Controls (Low and High) S-O303000, from the market, due to the product being compromised during shipment. |
| Product | S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative determination of the ketone body -Hydroxybutyrate in serum or plasma. For laboratory use only. |
| Quantity | 46 units |
| Distribution | US Nationwide distribution in the states of MS, OH, IL. |
| Initiated | 2021-01-15 |
| Classified | 2021-02-19 |
| Terminated | 2023-01-09 |
| Recall number | Z-1135-2021 |
| 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 III recall — Medline Industries Inc (Z-1135-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87184/
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