Home / Recalls / TZ Medical Inc. / Z-0293-2016

Z-0293-2016 Class II Terminated

Recalled by TZ Medical Inc. — Portland, OR

Recall Details

Product Type
Devices
Report Date
November 25, 2015
Initiation Date
October 14, 2015
Termination Date
October 24, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
32,170 units

Product Description

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

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

Distribution Pattern

US nationwide distribution.

Code Information

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

Other recalls by TZ Medical Inc.

  • Z-0298-2017 Class II — Neptune Plus (Hemostatic Pad), Part Numbers: 8870-03 Neptune Pad is used to pro (July 7, 2016)
  • Z-0318-2016 Class II — SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate (October 14, 2015)
  • Z-1438-2013 Class II — adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, M (April 30, 2013)