Recall Z-0293-2016 ยท FRO Dressing, Wound, Drug
TZ Medical Inc.
Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03
| Date | Oct 14, 2015 |
| Status | Terminated |
| 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 |
| Root cause | Labeling False and Misleading |
| 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. |
| Quantity | 32,170 units |
| Distribution | US nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071442 | SUPRASORB A +AG Specialty Fibres and Materials, Ltd., May 1, 2008 |