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Z-0298-2017 Class II Terminated

Recalled by TZ Medical, Inc. — Portland, OR

FDA device recall Z-0298-2017 was initiated by TZ Medical, Inc. on July 7, 2016 and is designated Class II. Reason for recall: Neptune Plus was mis-labeled and included the statement WITH ANTIMICROBIAL BARRIER. This statement should not appear on label. The recall status is terminated (terminated October 28, 2016). Affected quantity: 1410 (141 boxes of 10).

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