Z-0293-2016Class II

Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part...

Name: Z-0293-2016 Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part...
Creator: TZ Medical Inc.
Published: 2015-10-14
License: https://open.fda.gov/license/

TZ Medical Inc. / initiated 2015-10-14 / Terminated / root cause: labeling and UDI

FDA source

TZ Medical Inc. began a recall of Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03 on 2015-10-14. FDA classified it as Class II and gives the reason as "The IFU of the Neptune Plus Pads, does not match that submitted in the original 510k. Need to remove: for haemostasis following needle/sheath removal". 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-0293-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-14
Posted: 2015-11-18
Terminated: 2016-10-24
Recalling firm: TZ Medical Inc.
Product: Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03
Product code: FRO Dressing, Wound, Drug
Reason for recall: The IFU of the Neptune Plus Pads, does not match that submitted in the original 510k. Need to remove: for haemostasis following needle/sheath removal
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: TZ Medical Inc. began sending the Urgent: Medical Device Correction 8870-03 Neptune Plus letter, dated 10-7-2015, to consignees in October 2015. The firm is notifying all users of Neptune Plus wound dressing to a correction to the Instructions for Use (IFU). Consignees should discard the IFU in your current inventory and replace with new IFU. Consignees with questions should call TZ Medical Inc. at (503) 639-0282.
Quantity in commerce: 32,170 units
Distribution: US nationwide distribution.
Product codes and lots: Lot Numbers: AGR554; AGR554\20; AGR554\24; AGR554/24; AGR570\28; AGR570/43; AGR744124; AGR744137.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0293-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0293-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-18

Product code FRO

K071442UnclassifiedSuprasorb a +AgSpecialty Fibres and Materials, Ltd. / cleared 2008-05-01

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)