Reported Nov 25, 2015 · Terminated
Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number…
TZ Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: TZ Medical Inc. · 17750 SW Upper Boones Ferry Rd Ste 150 · Portland, OR · 97224-7086
Is this the product you have?
- Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03
- Lot codes and dates
- Lot Numbers
AGR554AGR554\20AGR554\24AGR554/24AGR570\28AGR570/43AGR744124AGR744137
- Lot Numbers
- Amount recalled
- 32,170 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
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
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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