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Terminated

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

FDA Recall Z-0298-2017 · Posted None

Recalling FirmTZ Medical, Inc.
Recall StatusTerminated
Product CodeFRO
Date Initiated2016-07-07
Date Terminated2016-10-28
Product Quantity1410 (141 boxes of 10)

Reason for Recall

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

Firm Action

TZ Medical notified their consignees by telephone on July 7, 2016. Customers with the boxes with the identified statement, "With Antimicrobial barrier, the firm plans to overlabel the statement on-site. If customer does not have the mis-labeled box upon contact, no action is planned. The firm also determined to overlabel devices on-hand. For questions regarding this recall call 503-639-0282.

Root Cause

Labeling Change Control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040208NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BANDTz Medical, Inc. · 2004-05-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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