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Terminated

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

FDA Recall Z-0293-2016 · Posted None

Recalling FirmTZ Medical Inc.
Recall StatusTerminated
Product CodeFRO
Date Initiated2015-10-14
Date Terminated2016-10-24
Product Quantity32,170 units

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

Firm 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.

Root Cause

Labeling False and Misleading

Distribution Pattern

US nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K071442SUPRASORB A +AGSpecialty Fibres and Materials, Ltd. · 2008-05-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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