Device product
Neptune Plus (Hemostatic Pad), Part Numbers: 8870-03 Neptune Pad is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following surgical incision. It can be used to achieve hemostasis at the skin surface for arterial/venous catheterization/tubes, needle puncture, hemodialysis and in patients on anticoagulation therapy
Z-0298-2017
Product summary
- Firm
- TZ Medical, Inc.
- Event
- Event 74809
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1410 (141 boxes of 10)
- Official record key
device-enforcement:Z-0298-2017
Official wording
Reason: Neptune Plus was mis-labeled and included the statement WITH ANTIMICROBIAL BARRIER . This statement should not appear on label.
Code information: Lot R970249
Distribution pattern: Nationwide Distribution to AL, CA, FL, GA, IL, IN, KY, MO, MS, NC, NV, NY, PA, SC, TN, TX, and WV.
Derived failure modes
-
Unknown
Neptune Plus was mis-labeled and included the statement WITH ANTIMICROBIAL BARRIER . This statement should not appear on label.