FDA-Device2016-11-02Class II
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
TZ Medical, Inc.
Hazard
Neptune Plus was mis-labeled and included the statement WITH ANTIMICROBIAL BARRIER . This statement should not appear on label.
Sold states
Nationwide Distribution to AL, CA, FL, GA, IL, IN, KY, MO, MS, NC, NV, NY, PA, SC, TN, TX, and WV.
Affected count
1410 (141 boxes of 10)
Manufactured in
17750 SW Upper Boones Ferry Rd Ste 150, Portland, OR, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0298-2017Don't want to check this manually?
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