Class II — Argon Medical Devices, Inc
| Recalling firm | ARGON MEDICAL DEVICES, INC |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray. |
| Product | T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G x 4 Ext Can, Part Number DBMNJ1104TL; Bone Marrow Biopsy Needle 13G x 4, Part Number DBMNJ1304 |
| Quantity | 10290 units |
| Distribution | US |
| Initiated | 2015-06-18 |
| Classified | 2015-07-21 |
| Terminated | 2016-06-23 |
| Recall number | Z-2189-2015 |
| 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 — Argon Medical Devices, Inc (Z-2189-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71533/
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