FDA Recall
Terminated
Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03
Recall: Z-0293-2016
·
Initiated October 14, 2015
Recall
- Recall Number
- Z-0293-2016
- Event Number
- 72451
- Firm
- TZ Medical Inc.
- FEI Number
- 1000127185
- Product Code
- FRO
- Status
- Terminated
- Root Cause
- Labeling False and Misleading
- Initiated
- October 14, 2015
- Terminated
- October 24, 2016
- Address
- 17750 SW Upper Boones Ferry Rd, Ste 150, Portland, OR, 97224-7086
Description
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
Action
TZ Medical Inc. began sending the Urgent: Medical Device Correction 8870-03 Neptune Plus letter, dated 10-7-2015, to consignees in October 2015. The firm is notifying all users of Neptune Plus wound dressing to a correction to the Instructions for Use (IFU). Consignees should discard the IFU in your current inventory and replace with new IFU. Consignees with questions should call TZ Medical Inc. at (503) 639-0282.
Distribution
US nationwide distribution.
Quantity
32,170 units