Z-0298-2017 Class II Terminated

Recalled by TZ Medical, Inc. — Portland, OR

Recall Details

Product Type
Devices
Report Date
November 2, 2016
Initiation Date
July 7, 2016
Termination Date
October 28, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1410 (141 boxes of 10)

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.

Distribution Pattern

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

Code Information

Lot R970249