Class II — Medline Industries, LP
| 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 | Ongoing |
| Reason | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site. |
| Product | Medline Convenience Kits: 1) MULTIMED, 7FR, 20CM, 3L, CVC BUNDLE, Model Number: ECVC5995; 2) TRIPLE LUMEN CENTRAL LINE BUNDLE, Model Number: ECVC2625; 3) INTROFLEX 6F, 1L, TB, US, Model Number: STCVC26US; 4) AVA HIGH FLOW, Model Number: ECVC3720; 5) CDP, MM, 3L, 7F, 16CM, H, Model Number: 3K16H1838; 6) CVC Insertion Bundle 3L 7FR 20CM, Model Number: ECVC5610; 7) TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number: ECVC3810; 8) 16CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number: ECVC2555; 9) CENTRAL LINE BUNDLE W/7F, 20CM, 3L, Model Number: ECVC2750; 10) TRIPLE LUMEN COMPLETE CATH… |
| Quantity | 967 kits |
| Distribution | US Nationwide distribution. |
| Initiated | 2026-05-21 |
| Classified | 2026-06-29 |
| Recall number | Z-2536-2026 |
| 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 (Z-2536-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99162/
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