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TZ Medical Inc. recalls Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 887
Recalled November 25, 2015 · FDA recall Z-0293-2016 · TZ Medical
Hazard
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 · FDA Class II
Units
32,170 units
Sold at
US nationwide distribution.
Description
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
Product
Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03
Manufacturer(s)
TZ Medical Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →