TZ Medical Inc.: Medical Device Recall in 2015 - (Recall #: Z-0293-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03

Product Classification:

Class II

Date Initiated: October 14, 2015

Date Posted: November 25, 2015

Recall Number: Z-0293-2016

Event ID: 72451

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

Status: Terminated

Product Quantity: 32,170 units

Code Information:

Lot Numbers: AGR554; AGR554\20; AGR554\24; AGR554/24; AGR570\28; AGR570/43; AGR744124; AGR744137.

Distribution Pattern:

US nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated