Recall Z-0298-2017— TZ Medical, Inc.

Name: FDA recall Z-0298-2017
Creator: U.S. Food and Drug Administration
Published: 2016-07-07

Class II · Terminated

Class II FDA medical device recall by TZ Medical, Inc., initiated 2016-07-07, terminated 2016-10-28. It names one FDA 510(k) clearance: K040208. 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. Reason: Neptune Plus was mis-labeled and included the statement WITH ANTIMICROBIAL BARRIER. This statement should not appear on label..

Recalling firm: TZ Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-07-07
Terminated: 2016-10-28
Firm location: Portland, OR, United States

510(k) clearances named in this recall

1 on FDA's record

K040208 — NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BANDTz Medical, Inc.·cleared 2004-05-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.