TZ Medical Inc. recalls Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 88…
- Recall date
- October 14, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0293-2016
- FDA classification
- Class II
- Brand / firm
- TZ Medical Inc.
- Sold / distributed
- US nationwide distribution.
Why it was recalled
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
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03
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