FDA Device recall Z-0293-2016
Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03
- FDA Device
- Class II
- terminated
- Published 2015-11-25
On 2015-11-25 the FDA classified a Class II recall of Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03 by Tz Medical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0293-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-14 |
| Published | 2015-11-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Tz Medical |
| Distribution | US |
Product
Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03
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
Identifiers
| code_info | Lot Numbers: AGR554; AGR554\20; AGR554\24; AGR554/24; AGR570\28; AGR570/43; AGR744124; AGR744137. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0293-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.