Device product
Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03
Z-0293-2016
Product summary
- Firm
- TZ Medical Inc.
- Event
- Event 72451
- Status
- Terminated
- Classification
- Class II
- Quantity
- 32,170 units
- Official record key
device-enforcement:Z-0293-2016
Official wording
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
Code information: Lot Numbers: AGR554; AGR554\20; AGR554\24; AGR554/24; AGR570\28; AGR570/43; AGR744124; AGR744137.
Distribution pattern: US nationwide distribution.
Derived failure modes
-
Unknown
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