FDA Medical Device Recalls (openFDA)
TZ Medical Inc.: Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03
- Recall number
- Z-0293-2016
- Recalling firm
- TZ Medical Inc.
- Product
- Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03
- Status
- Terminated
- Initiated
- 2015-10-14
- Posted
- not on file
- Terminated
- 2016-10-24
- Reason
- 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
- 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
- 32,170 units
- Distribution
- US nationwide distribution.
- Lot, serial or model codes
- Lot Numbers: AGR554; AGR554\20; AGR554\24; AGR554/24; AGR570\28; AGR570/43; AGR744124; AGR744137.
- 510(k) numbers
- ["K071442"]
- PMA numbers
- not on file
- Product code
- FRO
- Firm FEI
- 1000127185
- Firm city
- Portland
- Firm state
- OR
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28