FDA-Device2015-11-25Class II
Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03
TZ Medical Inc.
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
Sold states
US nationwide distribution.
Affected count
32,170 units
Manufactured in
17750 SW Upper Boones Ferry Rd Ste 150, N/A, Portland, OR, United States
Products
Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0293-2016Don't want to check this manually?
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