Neptune Plus recalled over laceration hazard

Recall date

July 7, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

TZ Medical, Inc. recalls Neptune Plus (Hemostatic Pad), Part Numbers: 8870-03 Neptune Pad is used to promote the rapid control of bleeding and p…

Recall number

Z-0298-2017

FDA classification

Class II

Brand / firm

TZ Medical, Inc.

Sold / distributed

Nationwide Distribution to AL, CA, FL, GA, IL, IN, KY, MO, MS, NC, NV, NY, PA, SC, TN, TX, and WV.

Why it was recalled

Neptune Plus was mis-labeled and included the statement WITH ANTIMICROBIAL BARRIER. This statement should not appear on label.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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