Class II — TZ Medical Inc.
| Recalling firm | TZ MEDICAL, INC. |
|---|---|
| Registered facility | TZ MEDICAL, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The IFU of the Neptune Plus Pads, does not match that submitted in the original 510k. Need to remove: for haemostasis following needle/sheath removal |
| Product | Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03 |
| Quantity | 32,170 units |
| Distribution | US nationwide distribution. |
| Initiated | 2015-10-14 |
| Classified | 2015-11-18 |
| Terminated | 2016-10-24 |
| Recall number | Z-0293-2016 |
| 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 — TZ Medical Inc. (Z-0293-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72451/
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