Recall Z-0293-2016— TZ Medical Inc.
Class II · Terminated
Class II FDA medical device recall by TZ Medical Inc., initiated 2015-10-14, terminated 2016-10-24. It names one FDA 510(k) clearance: K071442. Product: Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03. Reason: 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.
- Recalling firm
- TZ Medical Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-10-14
- Terminated
- 2016-10-24
- Firm location
- Portland, OR, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.