Z-0298-2017Class II

Neptune Plus (Hemostatic Pad), Part Numbers: 8870-03 Neptune Pad is used to promote the rapid control of...

Name: Z-0298-2017 Neptune Plus (Hemostatic Pad), Part Numbers: 8870-03 Neptune Pad is used to promote the rapid control of...
Creator: TZ Medical, Inc.
Published: 2016-07-07
License: https://open.fda.gov/license/

TZ Medical Inc. / initiated 2016-07-07 / Terminated / root cause: labeling and UDI

FDA source

TZ Medical, Inc. began a recall of Neptune Plus (Hemostatic Pad), Part Numbers: 8870-03 Neptune Pad is used to promote the rapid control of bleeding and provide hemostasis for lacerations... on 2016-07-07. FDA classified it as Class II and gives the reason as "Neptune Plus was mis-labeled and included the statement WITH ANTIMICROBIAL BARRIER. This statement should not appear on label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0298-2017
Classification: Class II
Status: Terminated
Initiated: 2016-07-07
Posted: 2016-10-21
Terminated: 2016-10-28
Recalling firm: TZ Medical Inc.
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
Product code: FRO Dressing, Wound, Drug
Reason for recall: Neptune Plus was mis-labeled and included the statement WITH ANTIMICROBIAL BARRIER. This statement should not appear on label.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
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.
Quantity in commerce: 1410 (141 boxes of 10)
Distribution: Nationwide Distribution to AL, CA, FL, GA, IL, IN, KY, MO, MS, NC, NV, NY, PA, SC, TN, TX, and WV.
Product codes and lots: Lot R970249

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0298-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0298-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-02	2016-10-21

Product code FRO

K040208UnclassifiedNeptune Pad, Neptune Disc, Neptune Comfort-Band, Comfort-BandTz Medical, Inc. / cleared 2004-05-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)